- Authority of Institutional Officials
- Compliance with Federal Regulations
- Review of Research Activities by Other University Committees
- Appointment of Members
- Regular Members
- Compensation of IRB Members
- Member Liability
- Alternate Members
- Non-Voting Members
- Consultants/Ad Hoc Reviewers
- Conflicts of Interest
- IRB Chair
- IRB Staff
- Scope of Review
- Special Consideration for Projects Involving Vulnerable Populations
- Suspension or Termination of IRB Approval
- Noncompliance Investigations and Actions
- Reporting to Federal Oversight Agencies
- Scheduling of Meetings
- Submission of New Applications
- Determination of Type of Review
- Notification of Meetings and Distribution of Materials
- Urgent Review of Applications
- Meeting Procedures
- Meeting Minutes
- Approval of Research
- Appeal of IRB Decisions
- Length of Approval
- Monitoring Approved Projects
- Study Closure and Protocol Expiration
- General Requirements for Informed Consent
- Waiver of Consent or Elements of Consent
- Waiver of Documentation of Consent
- Record Retention Policy
- Educational Activities Aimed at the Research Community at Large
- Educational Activities Aimed at Members of the IRB
- Educational Activities Aimed at Investigators/Research Personnel
- UT Arlington Business Affairs
- IRS Considerations
- Informed Consent Information
I. Institutional Authority- The University of Texas at Arlington operates a centralized human participant’s review program under the Office of the Vice President for Research (VPR) at UT Arlington. The IRB reviews projects in a wide range of research protocols in the social, behavioral, educational, and clinical fields.
II. Purpose- The purpose of the UT Arlington IRB is to assure that the rights and welfare of human participants are adequately protected in research. The UT Arlington IRB advises investigators in the design of research projects in order to minimize potential harm to human participants; reviews all planned research involving human participants prior to initiation of the research; approves research that meets established criteria for protection of human participants; and monitors approved research protocols to ascertain whether human participants are indeed protected.
The UT Arlington IRB also informs and assists UT Arlington faculty, Staff, and students of ethical and procedural issues related to the use of human participants in research in order to facilitate compliance with relevant federal regulations and to provide a framework suitable for continued support by federal funding agencies, private foundations and industry.
Primary responsibility for assuring that the rights and welfare of research participants are protected continues to rest with the Principal Investigator (PI) conducting the research. Others engaged in the research share this responsibility. Faculty who assign or supervise research conducted by students or Staff have an obligation to consider carefully whether those individuals are qualified to safeguard adequately the rights and welfare of participants.
III. Principles- All research at UT Arlington that involves human participants is guided by the ethical principles set forth in the report of the National Commission for the Protection of Human Participants of Biomedical and Behavioral Research entitled “Ethical Principles and Guidelines for the Protection of Human Subject of Research (Belmont Report)”. This document is listed as the guiding statement of ethical principles as part of UT Arlington’s Federalwide Assurance for the Protection of Human Subjects with the federal government.
IV. Scope and Authority of the IRB- The participation of humans in research carried out at the University or under its auspices must be reviewed and approved by an IRB prior to the start of the research.
1. Scope- The UT Arlington IRB reviews protocols for research involving human participants when conducted by or under the direction of any employee, student, or agent of UT Arlington in connection with his or her institutional responsibilities or using any institutional property or facility. Also, the IRB reviews research protocols of non-UT Arlington investigators when UT Arlington faculty, Staff, or students are involved.
2. Authority- The authority conveyed to the IRB includes:
Review/approval of new/continuing research protocols involving human participants and associated informed consent documents (ICD) prior to initiation/continuation of research;
Monitoring of approved projects including regularly scheduled continuing review at least every twelve (12) months for non-exempt studies;
Verification of compliance with approved research protocols and informed consent procedures;
Review of all planned changes to approved protocols prior to implementation;
Review of all adverse events occurring in approved projects, or in other projects related in context to the approved projects;
Restriction of approved research activities to protect participants when necessary; and
Suspension/termination of previously approved protocols for non-compliance with established policies.
3. Authority of Institutional Officials- The VPR (or designated IO) has the authority to review decisions of the IRB. In instances of disagreement, the IO works with the IRB to resolve specific issues.
1. Compliance with Federal Regulations- UT Arlington has filed a Federalwide Assurance (FWA) with the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) affirming that the University is in compliance with 45 CFR 46. This assurance applies to all research involving human participants as defined and regulated by the “Common Rule” – (DHHS regulations incorporate theCommon Rule as Subpart A of 45 CFR 46).
In studies involving products regulated by the Food and Drug Administration regulations, the UT Arlington IRB complies with the requirements set forth in21 CFR 50,21 CFR 56,21 CFR 312, and21 CFR 812.
2. Review of Research Activities by Other University Committees- UT Arlington IRB coordinates the review with other institutional committees as described below. None of these committees are a formal part of UT Arlington IRB structure, but there is communication between the committees regarding status of review and/or conditions of approval if there are human participants involved.
Institutional Animal Care and Use Committee (IACUC) - The IACUC is responsible for insuring that research involving animal participants complies with the Animal Welfare Act and Animal Welfare Regulations, the Public Health Service Policy, and Office of Laboratory Animal Welfare (OLAW) guidelines. Investigators are required to submit a protocol to the IACUC for all research involving live vertebrate animals. The protocol must be reviewed and approved by the IACUC prior to the initiation of the research.
IACUC deliberations are normally not shared with the IRB unless there are specific issues involving human participants. In instances where both animal and human participant research issues are involved, investigators should: i) notify the IRB and IACUC chairs; and ii) submit separate protocols to the IRB and IACUC, respectively. In certain instances, the IRB may deem it appropriate to receive notification of the related IACUC approval before approving the IRB protocol.
Institutional Biosafety Committee (IBC) - The IBC is responsible for ensuring that recombinant DNA activities comply with the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules. Investigators are required to submit an exemption form and/or an application form to the IBC for all recombinant DNA experiments. The investigator must receive approval from the IBC prior to the initiation of the research.
IBC deliberations are generally not shared with the IRB unless there are specific issues related to human participants. In instances where both biosafety and human participant research issues are involved, investigators should: i) notify the IRB and IBC chairs; and ii) submit separate protocols to the IRB and IBC, respectively. In certain instances, the IRB may deem it appropriate to receive notification of the related IBC approval before approving the IRB protocol.
1. Appointment of Members- The IRB Chair recommends to the Vice President for Research the appointment of all IRB members and their alternates. IRB members are appointed to three (3) year terms. After their initial appointment, members (and alternates) may be reappointed for no more than two (2) additional consecutive terms. The appointment of members (and alternates) should not exceed three (3) consecutive terms or a total of nine (9) consecutive years of service on the IRB.
Should a member have 3 absences from consecutive IRB meetings, he/she can be removed at the discretion of the IRB Chair.
2. Regular Members- The IRB has at least five (5) members with varying types of expertise, experience, and diversity to promote complete and adequate review of human subject research at UT Arlington. At least one member should be from outside UT Arlington (i.e., not otherwise affiliated with UT Arlington and who is not part of the immediate family of a person who is affiliated with UT Arlington) and represent community interests and values. Membership will also include at least one member whose primary concerns are in nonscientific areas.
3. Responsibilities- Responsibilities of members include (i) attending IRB meetings; (ii) determining the appropriate type of review for submitted protocols (exempt, expedited, full board); (iii) reviewing protocols to be discussed at IRB meetings; (iv) being prepared to discuss issues related to human participants protections at IRB meetings; (v) serving as primary reviewer at IRB meetings or on expedited protocols when requested by the IRB Chair; (vi) being informed about the specific requirements regulating the participation of human subjects in research; and (vii) maintaining the confidentiality of IRB meeting discussions.
4. Compensation of IRB Members- IRB members do not generally receive monetary compensation above their University salary for participation on the board. The IRB Chair may receive financial compensation and/or release time authorized by the Office of the VPR to ensure a sustained level of high performance.
5. Member Liability– IRB members are covered by UT Arlington general liability coverage when acting within the course and scope of their IRB duties.
6. Alternate Members–Alternate members of the IRB are appointed three (3) year terms and may be reappointed as alternate members or appointed as a regular member. Total service to the IRB should not exceed three (3) consecutive terms or nine (9) consecutive years.
Alternates serve at-large and only vote when replacing a regular member. If both the alternate and the regular member attend the same meeting, only one vote will be counted. In such cases, the meeting minutes reflect the primary member as the voting member.
7. Non-Voting Members- The VPR may, at his/her discretion, recruit non-voting (ex officio) members from among the academic or administrative Staff of UT Arlington, whose presence at the meetings of the IRB would aid the IRB in conducting its duties. These members may take part in all meetings of the IRB, participate in the discussions, and make recommendations to influence decisions, but they may not vote on the decisions. Non-voting members are not included in determining or establishing a quorum (see Section IX, Part G) at the meetings. IRB meeting minutes reflect the presence of non-voting members.
8. Consultants/Ad hoc Reviewers- At its discretion, the UT Arlington IRB may invite scientists or non-scientists from within or outside UT Arlington, who have special expertise, to function as consultants and ad hoc reviewers of a protocol application. These individuals have access to all documents submitted to the IRB relevant to the specific project under review, may participate at the deliberations and make recommendations on the project, but may not vote.
9. Conflicts of Interest- IRB members may not participate in the initial or continuing review of any project in which the IRB member has a conflict of interest, except to provide information requested by the board. In cases where the initial reviewer has a conflict of interest, that study application is re-assigned to another reviewer or taken to the full board. When the investigator-member has a conflicting interest, he or she may be present at IRB meetings, like any investigator, only to provide information requested by the board. He or she must leave the meeting room during the subsequent discussion and voting phases of the review and may not vote (e.g., abstain, table, approve, disapprove) on the study. Members that are absent during the vote do not count toward a quorum. Minutes reflect whether or not these requirements have been met.
1. IRB Chair– The VPR recommends to the President individuals willing to serve as IRB Chairperson. It is the Vice President for Research’s responsibility to formalize the appointment through a written appointment letter. Chairpersons are appointed to a three (3) year term; their appointments may be renewed for additional terms, but should not exceed three consecutive terms or a total of nine (9) consecutive years on the IRB. The Chairperson should be a respected, active member of the University community who is well-informed in regulations relevant to the use of human participants in research. Whenever the IRB Chair is not available to conduct IRB business, he/she may designate a board member to assume his/her responsibilities during the period of his/her absence.
Responsibilities of the IRB Chair include: (i) determining the type of review appropriate for new protocols (exempt, expedited, full board); (ii) insuring that submitted protocols receive expeditious review; (iii) serving as primary reviewer of protocols when appropriate or delegating this responsibility to another IRB member; (iv) conducting the business of full board meetings following basic parliamentary rules, (v) convening expedited review panels when necessary and appropriate; (vi) reviewing on behalf of the IRB, revisions to protocols/consent documents required as a condition of approval, (vii) reviewing serious adverse experience reports; (viii) recommending to the VPR new and/or replacement IRB members;(ix) reviewing reports of non-compliance in coordination with Regulatory Services ; (x) assess and recommend appropriate IRB training for the IRB, investigators, and support Staff; (xi) serve as a resource for investigators and IRB members regarding issues related to University and federal policies.
2. IRB Staff – IRB Staff is part of the Office of Research Administration and provides administrative support to the IRB. The IRB Staff is an integral part of the IRB, but serves in a non-voting, ex-officio capacity.
The IRB Staff: (i) provides administrative support to the IRB and investigators in all aspects of the IRB process; (ii) assists investigators throughout the protocol submission, review and approval processes, and provides information regarding protocol status; (iii) organizes, coordinates and attends all IRB meetings and records detailed minutes of all meetings; iv) maintains all IRB records (e.g., agendas, minutes, policies, regulations, reference materials and individual protocol files) in a secure environment; (v) maintains the electronic system for tracking IRB protocols (e.g., new protocol submissions, protocol/informed consent modifications, annual continuation applications, safety reports, adverse event documentation, etc.); (vi) coordinates with IRB Chair for follow-thru on all action items resulting from IRB meetings (e.g., modifications to protocol documentation, Informed Consent changes, etc.); (vii) works with IRB Chair/Vice Chair to evaluate investigator responses to documentation changes to determine appropriateness; (viii) is designated responsibility and authority by the IRB to conduct review of exempt research and make exempt determinations in accordance with 45 CFR 46.101, including documentation of the specific exempt category or categories which apply; (ix) keeps abreast of changes to federal rules/regulations and updates IRB Chair regarding changes; (x) is designated responsibility and authority by the IRB and IRB Chair to conduct review and initial evaluation of issues of non-compliance and make determinations of serious or non-serious, resolution plans for non-serious issues, and escalation plans for serious issues; and (xi) organizes and coordinates a comprehensive campus outreach program to communicate regulatory requirements, university policies/procedures, and provides guidance on proper protocol preparations.
3. Resources- The University provides adequate facilities and equipment to support the operation of the IRB in the performance of the functions described in this document.
1. Scope of Review– The IRB reviews all new and continuing protocol applications for the following:
Determine that the use of human participants has research relevance and that ethical issues have been addressed -with regard to the study’s design and conduct;
Review of funded and unfunded research;
(i)UT Arlington IRB will rely on the peer review process of a federal funded agency. This reliance applies to all protocols that have received a formal peer review from a federal funding agency. In this instance, the UT Arlington IRB will not be required to consider the research design and scientific merit of federally-funded protocols.
(ii) For unfunded research protocols, the UT Arlington IRB is responsible for assessing the research design and scientific merit in order to determine the risk vs. benefit analysis. In this assessment, the IRB will determine the validity of the research and the nature and degree of risk as well as the nature and level of the anticipated benefits in the research design.
Identify the levels of risk and that everything has been done to minimize risk to the extent possible;
Identify the probable benefits to be derived from the research;
Evaluate the scientific merit for protocols above minimal risk;
(iii) The IRB is responsible for reviewing and evaluating the probability of risk and the state of benefits associated with the research.
(iv) The IRB may consider ways to minimize risk by reviewing information in the protocol regarding the experimental design and the scientific rationale underlying the proposed research, which includes the results of previous studies. For protocols above minimal risk, the IRB may request additional information to support its review of research design and scientific merit. This may include justification for inclusion of human subjects, literature review, additional explanations of direct or indirect benefit, and additional explanation of research design.
Balance the risks against the benefits and importance of the knowledge to be gained;;
Assure that potential participants are provided with an accurate and fair description of the risks or discomforts and the anticipated benefits;
Evaluate the proposed research design in the context of a risk vs. benefit analysis;
(v) Consider the research design as it relates directly to the scientific merit and prospect to yield knowledge that is beneficial to society;
(vi) Consider the research design as it relates directly to the risk assessment and protection of human subjects;
(vii) Examine the proposed research design and risk vs. benefit assessment to determine if the risks that will be presented to the subjects are justified;
(viii) The review of research design is not required by federal regulation for exempt research; however, recommendations may be made by the IRB (or designee) to improve research design in the context of a risk vs. benefit analysis. The IRB has no obligation to disapprove the research on this basis.
Determine intervals for periodic review;
Where appropriate, determine that adequate provisions are in place for monitoring the collected data;
Determine the adequacy of the provisions to protect subject privacy and maintain data confidentiality; and
Where the participants are likely to be members of a vulnerable population, determine that appropriate additional safeguards are in place to protect the rights and welfare of these participants..
2. Special Consideration for Projects Involving Vulnerable Populations- The IRB considers certain groups of human participants to be particularly vulnerable in a research setting and considers additional protections for research activities involving pregnant women, human fetuses and neonates, prisoners, children, and cognitively impaired persons. In reviewing these research projects, the IRB ascertains that the inclusion of the vulnerable population is adequately justified and that safeguards are implemented to minimize risks unique to each population.
The IRB considers for approval research projects involving vulnerable populations if one of the following conditions is met: i) the research does not involve more than minimal risk to the subject; ii) the research is likely to benefit the subject directly, even if the risks are considered to be more than minimal; or iii) the research involves greater than minimal risk with no prospect of direct benefit to individual participants, but is likely to yield generalizable knowledge about the subject's disorder or condition.
Requests for approval of any research that exposes vulnerable populations to risks that do not meet one of the above criteria must be submitted to the Secretary of the Department of Health and Human Services (DHHS) for review and approval.
For review of protocols involving the use of prisoners in research, the IRB must have a designated prisoner advocate present at the meeting. An IRB member may approve new studies limited to retrospective review of prisoner records and minor modifications using expedited review procedures after review and comment by the prisoner advocate.
3. Suspension or Termination of IRB Approval- The IRB has the authority to suspend or terminate approval of research involving human participants that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to participants. Any suspension or termination of approval shall include a statement of the reasons for the IRB’s action and shall be reported promptly to the investigator, appropriate IOs, and the department or agency head.
4. Noncompliance Investigations and Actions- Non-compliance is defined as a failure on the part of the PI or any member of the study team to follow: (1) federal regulations, state laws, or institutional policies relevant to human subjects research; or (2) the requirements and determinations issued by the reviewing Institutional Review Board (IRB). Information regarding non-compliance in research studies involving human subjects may come to the attention of the IRB through several pathways. These include internal monitoring of research projects, information contained in new applications, continuing reviews, adverse experience reports, and reports from collaborators, employees, subjects, or others.
Serious non-compliance is defined as non-compliance with federal regulations or institutional policies that, in the judgment of the reviewing IRB, affects the rights and welfare of subjects or that may cause a significant risk to enrolled subjects or others.
Continuing non-compliance is defined as a pattern of non-compliance that indicates a deficiency likely to result in further non-compliance (e.g., a pattern that indicates lack of attention to or knowledge or understanding about regulations or ethics) or a circumstance in which an investigator fails to cooperate with investigating or correcting non-compliance.
A.) Non-compliance Allegations or Findings - Reports can be either allegations or findings of non-compliance. Allegations of non-compliance that have yet to be proven are reviewed and investigated. An allegation determined to be true based on a preponderance of the evidence becomes a finding. Generally, self-reported instances by investigators will be accepted as a finding of non-compliance.
B.) Reviews of Allegations or Findings of Non-compliance - All reports of non-compliance are initially evaluated by the IRB Staff as the designee of the IRB. A report will either be designated as not requiring further action by the IRB, or will be escalated for review and/or action by the IRB.
(i) A report requires no further action by the IRB if the non-compliance is:
(ii) A factual assertion of non-compliance (generally self-reported by the investigators);
(iii) Neither serious nor continuing; and
(iv) Addressed by the investigator through a corrective action plan to remedy the problem.
If a report of non-compliance does not require further action, the incident and corrective action plan will be documented in writing and stored in appropriate files, and reported to the IRB at the next convened meeting. Findings of possible serious or continuing non-compliance are referred to the IRB for review.
If a report of non-compliance is an allegation, the Director of Regulatory Services or designee will review the report and choose one of the following courses of action in investigating the allegation:
(a) Conduct the review alone
(b) Conduct the initial review in coordination with the IRB Chair
(c) Delegate some of the review to IRB Staff
(d) Delegate all of the review to IRB Staff
(e) Empanel a reviewing subcommittee of the IRB
(f) Request that legal counsel provide advice and conduct the review
(g) Request assistance from others at UT Arlington (e.g., Office of Internal Audit, Office of General Counsel, or outside consultants)
The individual(s) or subcommittee conducting the investigation may take any of the following actions necessary to determine whether allegations are true, and to determine the seriousness or number of occurrences of the actions: (1) Review written materials, (2) Interview knowledgeable sources, and (3) Collect relevant documentation
Allegations which, in the opinion of the Director or delegate and the IRB Chair, are supported by the preponderance of evidence are determined to be findings of non-compliance. If the non-compliance is neither serious nor continuing, the Director or delegate, alone or with the IRB Chair, will examine whether the Investigator understands the non-compliance and has an adequate corrective action plan. If so, the decision and corrective action plan are documented and filed; otherwise the report is referred to the IRB (the convened IRB, the IRB Chair, or their delegate) for additional review. Findings of possible serious or continuing non-compliance are referred to the IRB for review.
C.) Noncompliance Determined to be Serious and/or Continuing - If the acts of noncompliance appear to be serious or continuing, the IRB Staff will notify the Chair, and the issue will be discussed at the next available convened IRB meeting. If necessary or appropriate, an emergency meeting may be scheduled. At the convened meeting, the IRB will review the circumstances regarding the incident and will determine if the alleged practices appear to: (1) cause injury or any other unanticipated problems involving risks to subjects or others, or (2) constitute serious or continuing noncompliance with IRB determinations or federal regulations.
As a result of this review, the following actions may be taken:
(i) The IRB may determine that additional information is needed and request that such information be obtained before further action is taken.
(ii) The IRB may determine that non-compliance did not occur or that non-compliance occurred but was neither serious nor continuing, and either take no further action or require or recommend an appropriate corrective action plan.
(iii) The IRB may determine that non-compliance occurred and that it was serious or continuing. In this case, the IRB will: (1) Take action appropriate for the situation (see possible actions below), (2) Follow the reporting procedure required by federal regulation 45 CFR 46 and/or funding agency requirements, and (3) Notify the Institutional Official
For concerns not within the IRB’s purview (e.g., research misconduct), the IRB will refer the matter to the appropriate official at the University. IRB determinations and actions will be recorded and communicated as appropriate to the relevant, involved individual(s), normally including the Investigator.
D.) Possible IRB Corrective Actions for Serious and/or Continuing Non-Compliance - In considering actions for serious and/or continuing non-compliance, the IRB seeks to:
(i)Correct the non-compliance,
(ii) Deter it from occurring again (e.g., hold the relevant individuals accountable for their actions and provide education on how to comply), and
(iii) Attempt to mitigate any adverse effects on participants.
(iv) The IRB must consider: (1) Suspension or termination of the protocol pursuant to 45 CFR 46.113. The IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the relevant regulatory or funding agencies. (2) Notification of current subjects (required when such information may relate to subjects’ willingness to continue to take part in the research).
Other possible actions include, but are not limited to, the following:
(a) Monitoring of the research
(b) Monitoring of the consent process
(c) Referral to other organizational entities (e.g., legal counsel, risk management, institutional official)
(d) Modification of the research protocol
(e) Modification of the information disclosed during the consent process
(f) Provision of additional information to past subjects
(g) Requiring re-consent of current subjects to continued participation
(h) Modification of the continuing review schedule
(i) Participation by research team members in additional training or education
When appropriate, applying any corrective action to all similar protocols.
5. Reporting to Federal Oversight Agencies- The Institutional Official or designee notifies the Office for Human Research Protections (OHRP) of any changes to the Federalwide Assurance Statement and IRB Registration. When applicable, the Institutional Official or designee reports to OHRP, FDA, and/or any applicable funding agencies for instances of serious and/or continuing non-compliance, any unanticipated problems involving risks to subjects or others, or suspension or termination of IRB approval.
1. Scheduling of Meetings- The IRB normally meets once per month. Individual meetings may be cancelled by the IRB Chair due to a) insufficient applications requiring full board review, b) University holiday, c) inability to secure a quorum for attendance, or d) other reasons as may arise that make a scheduled meeting unnecessary or otherwise inappropriate. Following a cancelled meeting, the IRB Chair will work with the IRB Staff to schedule an alternate meeting date as soon as possible.
2. Submission of New Applications- IRB applications should be submitted electronically through the online submission system to the IRB Staff for IRB review. IRB Staff conduct preliminary review of IRB protocol submissions.
3. Determination of Type of Review- The IRB Chair or designee reviews the entire application and makes determinations as to whether the project constitutes human participants research and, if so, the appropriate type of review (full board review, expedited review, or exempt).
A. Exempt Review- Federal regulations recognize certain types of research involving human participants as being exempt from IRB oversight. UT Arlington requires that all “research” involving humans be submitted to the IRB for review. Upon review of initial applications, the IRB can determine whether the proposed research meets the qualifications for exempt review. If so, there is no requirement for continuing review unless explicitly stated by the IRB with a written justification.
Exemptions are limited to research involving no more than minimal risk and the only involvement of human participants falls into one or more of the following categories.
Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as research on regular and special educational instructional strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless (a) information obtained is recorded in such a manner that human participants can be identified, directly or through identifiers linked to the participants; and (b) any disclosure of the human participants’ responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, or reputation.
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior not otherwise exempt under the above two categories if the human participants are elected or appointed public officials or candidates for public office; or federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
Research involving the collection or study of existing data, documents, records if these sources are publicly available or if the information is recorded by the investigator in such a manner that participants cannot be identified, directly or through identifiers linked to the participants.
Research and demonstration projects which are designed to study, evaluate, or otherwise examine public benefit or service programs; procedures for obtaining benefits or services under those programs; possible changes in or alternatives to those programs or procedures; or possible changes in methods or levels of payments for benefits or services under those programs.
The IRB, at its discretion, retains the right to require continuing review when warranted by the nature of the research and/or inclusion of vulnerable subject populations.
B. Expedited Review- The expedited review process may be used by the IRB to review applications that (1) present no more than minimal risk to human subjects, and (2)involve only procedures listed in one or more of the categories specified in either 45CFR46.110 (OHRP) or 21 CFR 56.110 (FDA).
The investigator may request expedited review of a project when submitting an application by so noting in the IRB Form. However, the IRB Chair has the ultimate responsibility for determining whether it is appropriate to review the application through the expedited process or refer it to the full board.
Approved studies are subject to at least annual review and this information is communicated to the investigator in the approval letter.
Protocols that are reviewed and approved through the expedited process or determined to be exempt are reported to all IRB members on a monthly basis.
The expedited review process may be used for projects involving a) no more than minimal risk, and b) only those procedures listed in one or more of the following categories:
Clinical studies of drugs and medical devices only when condition (a) or (b) is met: (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.); (b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: (a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or (b) from other adults and children2, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings in a non disfiguring manner; (b) deciduous teeth at the time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes.
Collection of data from voice, video, digital, or image recordings made for research purposes.
Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
Continuing review of research previously approved by the convened IRB (a) where the research is permanently closed to the enrollment of new participants, and all participants have completed all research-related interventions, and the research remains active only for long-term follow-up of participants; or (b) where no participants have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis.
Continuing review of research, not conducted under an investigational new drug application or an investigational device exemption where categories (2) through (8) do not apply, but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
The expedited review procedure is not used where identification of the participants and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections are implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
Even when the above criteria are met, the IRB Chair or another member of the IRB retains the right to require full board review when warranted by the nature of the research.
C.Primary Reviewer Review Process -The IRB may elect to utilize a Primary Review for a submission, prior to review by the full board at a convened meeting. The IRB Chair, a member of the IRB, or a designee of the Chair serves as the primary reviewer for a full board meeting. In selecting the primary reviewer, consideration is given to the individual’s knowledge of the subject area embodied in the proposal.
The primary reviewer reviews the application, Informed Consent Document(s), and all supplemental materials (including, if applicable, the grant application, protocol, and investigator’s brochure). In addition, for continuing review applications, the primary reviewer reviews the complete project file, which includes all modifications and reports of unanticipated problems involving risks to participants. The primary reviewer will also take into consideration all correspondence between the IRB Staff and the investigator(s) in preparation for protocol submission to the IRB.
The primary reviewer may contact the investigator in advance of or during the board meeting for additional information or clarification. The primary reviewer leads the discussion of the new project or continuing review application. The primary reviewer may not have a conflict of interest regarding the project under review and is expected to notify the IRB Chair of any conflict.
4. Consultants- At the time of preliminary review of a new project application or modification, the IRB Chair may determine that the study requires further review by a consultant with expertise outside of the current IRB membership. This determination may be made based on the scientific design of the study, the ethical issues of the study, the potential risks or benefits of the study, specific privacy and confidentiality concerns, or considerations relative to a particular study population.
Upon identifying the need for a consultant review, the IRB Chair will identify a consultant based on the particular issues to be addressed. For issues requiring only simple clarification, a written set of questions will be developed for submission to the consultant. The consultant’s written response to these questions will be provided to the full IRB for review at the time of the convened meeting. For issues requiring more than simple clarification, the consultant may also be invited to attend the full board meeting during the review of that particular study. Documentation of the discussion with the consultant will be included in the meeting minutes.
No person with a conflict of interest as defined in Section XV of this SOP will serve as a consultant for the purposes described in this section.
5. Notification of Meetings and Distribution of Materials- Agenda and application materials will be distributed to IRB members with sufficient time in advance of the meeting date to allow time for review, generally one to two weeks in advance. The agenda indicates the date, time, and place of the meeting. For new projects, modification requests and continuing reviews by the full board, IRB members receive the application form, Informed Consent and/or Assent Document(s), recruitment materials, other correspondence with participants (if applicable), and other materials as determined by the IRB Chair.
6. Urgent Review of Applications- Urgent review procedures may be invoked only under unusual circumstances. This does not include urgency that is a result of negligence or delay on the part of the investigator or his/her Staff to submit IRB applications in a timely fashion.
On occasion, however, an investigator is faced with an immediate deadline beyond his or her control. If the IRB Chair permits urgent review of a protocol, the materials are distributed as soon as possible to IRB members for review prior to the meeting.
7. Meeting Procedures- IRB meetings are called to order when a quorum of members is in attendance. Initial and continuing reviews of research must be conducted by the IRB at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. The meeting is ended by adjournment or suspended whenever a quorum is no longer present for deliberations. Alternates can substitute for regular IRB members. When this occurs, the alternate member counts toward the quorum.
At the discretion of the IRB Chair, IRB Staff and/or primary reviewer, investigator(s) may be invited to attend the IRB meeting to answer questions, clarification of specific points, or discussion. Invited investigator(s) are required to leave the meeting for subsequent discussion and voting on their protocol.
Voting is by a show of hands. The official meeting minutes document, the number of votes for, against, or abstaining. A simple majority vote of the members present at the meeting is required for approval.
Investigators are notified in writing of the decision of the IRB and suggested modifications that might be required for approval.
8. Meeting Minutes- Minutes are generated immediately following each IRB meeting and must contain the following elements: (1) The names of members in attendance at each meeting;(2) A record of the vote on actions taken including the number, for, against and abstaining;(3) The basis for requiring modifications or disapproving of research;(4) The length of time of an approval (if less than 1 year); (5) A brief summary of the discussion of issues and their resolution; (6) Specific comments relevant to inclusion of certain populations; (7) In addition to the review of pending applications, meeting minutes may sometimes include information regarding expedited approvals, modifications, terminations, emergency/single patient use, adverse experiences, and any other business appropriate for board meetings.
9. Approval of Research - The review of an application by the convened IRB could include the following outcomes: (1) tabled, (2) approved, (3) approved with conditions, or (4) disapproved.
A) Tabled: If the proposal generates significant ethical questions or appears to be scientifically unsound, the proposal will be tabled and additional information will be requested. Studies may also be tabled if the protocol, consent documents, or other study documents are poorly written or do not provide adequate information. The application may be reviewed at a subsequent IRB meeting once the investigator has submitted the requested revisions.
B) Approved: If the proposal is approved by a majority vote by the IRB, the investigator is notified that the application is approved and does not require further revisions. The IRB Staff will provide the approval letter and stamped consent documents to the investigator.
C) Approved with Conditions: If minor revisions are required by the IRB for approval, the investigator must complete the revisions and resubmit the application. In most cases, the revisions or clarifications will be reviewed by IRB Staff and administratively approved. In the instance that revisions to new and continuing human participant applications may be required, correspondence is sent to the investigator detailing requests for application revisions, clarification, or additional information. If the investigator does not respond in an appropriate amount of time, as determined at the discretion of the IRB Staff or Chair, the application is deactivated. If the investigator wishes to conduct a study that has been deactivated, he/she must submit a new application, incorporating comments from the prior IRB review.When specific application revisions are requested, the revisions are reviewed by the primary reviewer and/or the IRB Chair depending on the nature of the revisions. Final approval will not be granted until all of the revisions have been submitted. In instances where a project is tabled at a full board review, the revised documents are returned to the full board for its review and approval. In instances where a project is contingently approved at a full board review, the revised documents are reviewed by an IRB member and/or Chair depending on the nature of the revisions. In either case, the application only receives final approval once all required changes have been submitted.
D) Disapproved: Applications will be disapproved if they are determined to be ethically or scientifically unsound. Investigators are not advised to resubmit disapproved applications without consulting the IRB Staff.
If the IRB decides to disapprove an application for research involving human participants, the investigator(s) shall be notified in writing of the decision of the IRB along with a detailed statement summarizing the IRB concerns that led to the decision. The investigator(s) must be afforded an opportunity to respond to the decision in person and/or in writing. An appeal of a disapproved research project must be reviewed at a full board meeting.
Upon receipt of final approval, the IRB Staff transmits the IRB approval notification to the investigator that indicates the date of approval, date of expiration, and a summary of investigator responsibilities. If the investigator is a student, copies are sent directly to the Faculty Advisor. The memo reminds investigators that changes in research activity may not be initiated without prior IRB review and approval. Research that has been approved by the UTA IRB may require further appropriate review and approval by officials of the institution. However, those officials may not approve the research if it has not been approved by the UTA IRB (45 CFR 46.112).
10. Appeal of IRB Decisions - Investigators may appeal the IRB’s approval decision, or the IRB’s requirement for specific changes in the protocol and/or consent document(s). An investigator may appeal to the IRB for a formal re-review of a decision in the instances below:
- There have been multiple unsuccessful efforts by the investigator and the IRB to resolve a disagreement; and,
- The investigator believes that the IRB’s decision is due to: (1) inadequate or inaccurate information; or, (2) IRB non-compliance with UTA policy, state law, or federal regulation.
At the discretion of the IRB Chair, the investigator may make such an appeal in person and/or in writing to the IRB. The appeal request consists of sending the IRB Staff a cover letter outlining the basis for the appeal and documents that support the appeal. The IRB Staff reviews the appeal request to determine whether an appeal is appropriate. This may include consultation with the investigator, the Institutional Official, the IRB Chair, and select members of the IRB, as needed. The IRB Staff informs the investigator by email of whether the request has been accepted for review.
The appeal is heard at an IRB meeting. This may be a regularly scheduled IRB meeting, or it may be a meeting convened for this specific purpose. If the decision being appealed was made by a full IRB committee: that same IRB will hear the appeal. Or, if the decision being appealed was made by the Expedited or Exempt (both minimal risk) process: the IRB Chair will hear the appeal.
During the IRB meeting:
- The IRB Chair may hold a closed session without the researcher, prior to the appeal portion of the meeting, to establish the key issues and questions to consider.
- The researcher is invited to present information and rationale to the IRB.
- There is a question-and-answer session with the researcher.
- The research leaves the meeting room.
- The IRB members and other meeting attendees discuss the appeal.
- The IRB Staff prepares anonymous written ballots to distribute to the members for voting when the discussion has ended. After voting, the ballots are read by the IRB Chair. The IRB moves and then votes whether to take one of the following actions: (1) Approve the appeal and modify the original decision; (2) Disapprove the appeal and uphold the original determination; or, (3) Defer the appeal and obtain additional information or consultation in order to make a final decision.
The IRB’s appeal determination, and any other considerations or requirements associated with it, are communicated to the researcher in a letter within 10 business days of the IRB’s determination. If appropriate, the determination may also be communicated by email or telephone call with follow-up email, but the IRB Staff.
A decision by the IRB to disapprove, suspend, or terminate a project is not subject to reversal by the VPR or any other officer/agency of UT Arlington, state, or federal government. Only one appeal will be allowed on a given matter. The concluding IRB decision of an appeal is final and cannot be appealed.
11. Length of Approval- Except for exempt studies, all research involving human participants is subject to continuing review based on the level of risk as assessed by the board. This review takes place no less than annually as required by federal regulation, and may require more frequent review or reports as determined by the IRB. For projects receiving full board review, the length of approval is calculated from the date of the full board review.
As a courtesy, IRB Staff shall notify Investigators when their projects are due for continuing review; however, the Principal Investigator is ultimately responsible for keeping track of continuing review deadlines and ensuring that materials are submitted in a timely manner to maintain approval of research and avoid expiration.
A) Lapse in Approval - The HHS regulations at 45 CFR part 46 make no provision for any grace period extending the conduct of research beyond the expiration date of IRB approval. A lapse in IRB approval of research occurs whenever an investigator has failed to provide continuing review information to the IRB or the IRB has not conducted continuing review and re-approved the research – with or without conditions – by the expiration date of IRB approval.
In such circumstances, IRB approval has expired, and all research activities involving human subjects must stop. Enrollment of new subjects cannot occur after the expiration of IRB approval. Continuing participation of already enrolled subjects in a research project during the period when IRB approval has lapsed may be appropriate, for example, when the research interventions hold out the prospect of direct benefit to the subjects or when withholding those interventions poses increased risk to the subjects (see section J below for additional guidance).The determination regarding whether it is in the best interests of already enrolled subjects to continue to participate in the research after IRB approval has expired may be made initially by the investigator, possibly in consultation with the subjects’ treating physicians (if the investigator is not the subjects’ treating physician), but the investigator as soon as possible should submit a request for confirmation that the IRB agrees with this determination.
The determination by the IRB may be made by the IRB chairperson, by another IRB member or group of IRB members designated by the IRB chairperson, or at a convened meeting of the IRB. Furthermore, this determination may be made for all enrolled subjects as a group or for each individual subject. If the investigator or IRB determines that it is not in the best interests of already enrolled subjects to continue to participate, investigators must stop all human subjects research activities, including intervening or interacting with subjects and obtaining or analyzing identifiable private information about human subjects (45 CFR 46.109(a) and (e)).
B) Determining the Effective Date of Initial IRB Approval and the Dates for Continuing Review - If a study is approved (with no conditions), the final approval is effective the day the study is approved, i.e. the date of the convened IRB meeting for full board protocols and the date of designated review approval for expedited protocols.
For example, if the IRB conducts initial review of a research project at a convened meeting on October 1, 2009 and approves the project for one year without requiring (a) any changes to protocol or informed consent documents, or (b) submission of any clarifications or additional documents. The effective date of the initial IRB approval would be October 1, 2009, and the expiration date of the initial approval period and the date by which the first continuing review must occur is one year after the date of the IRB meeting, that is, October 1, 2010.
If a study is approved pending specific minor modifications, the final approval is effective on the day the protocol was reviewed and conditions were decided upon by the IRB at the convened IRB meeting (full board protocols) or the date the designated reviewer decided upon conditions (expedited protocols). The effective date of the initial approval is the date on which the IRB chairperson or IRB staff has reviewed and accepted as satisfactory all changes to the protocol or informed consent documents, or any other responsive material, required by the IRB from the investigator. If this is the case, the expiration date of the initial approval period, which is the date of the first continuing review must occur, may be as late as one calendar year after that effective date of initial IRB approval. This determination will be documented in the IRB meeting minutes. The expiration date and date for continuing review will be based on the date it was approved and will be no longer than one calendar year from the approval date.
For example, if the IRB conducts an initial review of a research project at a convened meeting on October 1, 2009, approves the project for one year, and requires that the investigator make minor changes to the protocol as a condition of its approval. The IRB directs the IRB Staff, on behalf of the IRB, the revised protocol and determine whether the changes required by the IRB have been made. On November 1, 2009, the IRB Staff reviews the revised protocol and determines that the changes made by the investigator are satisfactory. The effective date of the initial IRB approval is November 1, 2009. When approving research for one year with conditions at the time of initial review, the IRB will establish the expiration date of the initial approval period one year from the date of the IRB meeting at which the research project initially was approved with conditions. Therefore, the expiration date of the initial approval period and the date by which the first continuing review must occur is October 1, 2010.
If a study is reviewed at a convened IRB meeting and tabled pending major modifications, further review by the IRB at a subsequent convened meeting is necessary in order for the approval to become effective.
C) Determining the Date for the Second and all Subsequent Continuing Reviews - The use of the “effective date” of UTA IRB approval as opposed to the date of the convened meeting at which the IRB approved a research study with minor revisions is only applicable to determine the first continuing review. For all subsequent continuing reviews of a study, the IRB will perform a continuing review and may re-approve (with or without conditions) the protocol within 30 days before the IRB approval period expires. In this instance, the IRB will retain the anniversary of the expiration date of the initial IRB approval as the expiration date of each subsequent one-year approval period.This is done in order to keep the expiration date of the IRB approval period constant from year to year.
For example, if an IRB conducts initial review of a research project and approves it without conditions on October 1, 2009 for one year, the IRB may conduct its first continuing review anytime between September 1 and October 1, 2010, and re-approve the research for another one-year period that expires on October 1, 2011.
12. Monitoring Approved Projects
A) Continuing Review– Full board and expedited level of review studies are subject to continuing review. This review takes place no less than annually as required by federal regulation, and may require more frequent review or reports as determined by the IRB. When a research project is due for continuing review, a courtesy reminder is generated by the IRB Staff and sent to the investigator via email at approximately 30 days from the protocol expiration date and again at 7 days if the continuing review has not yet been submitted. Lists of investigators receiving these emails are maintained by the IRB Staff and documented on the protocol submission page online. The Principal Investigator is ultimately responsible for keeping track of continuing review deadlines and ensuring that materials are submitted in a timely manner to maintain approval of research and avoid expiration. It is the responsibility of each investigator to insure that his/her project is renewed by the IRB prior to the expiration date.
Applications intended for IRB continuing reviews are submitted to the Office of Research Administration; Regulatory Services through the online submission system. Research approved previously by expedited review is considered eligible for expedited review at the time of its regular continuing review, if, during the course of the study, the risks of the study have not increased. Projects that were initially reviewed by the full board continue to receive full board review unless the IRB Chair determines that the study meets the specific criteria for expedited. The IRB Staff and/or IRB will consult with collaborating sites and/or other institutional agencies that no material changes have occurred since previous IRB review. The IRB Staff will compare all continuing review materials and compare them to the previous IRB review (including modifications) to ensure that no changes have been made without IRB review and approval.
The criteria for IRB approval of research undergoing continuing review are listed below:
(i) Risks to subjects are minimized (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes (45 CFR 46.111(a)(1));
(ii) Risks to subjects are reasonable in relation to anticipated benefits, if any, to the subjects and the importance of the knowledge that may reasonably be expected to result (45 CFR 46.111(a)(2));
(iii) Selection of subjects is equitable (45 CFR 46.111(a)(3));
(iv) Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, and appropriately documented in accordance with, and to the extent required by, HHS regulations at 45 CFR 46.116 and 46.117, respectively (45 CFR 46.111(a)(4) and (5));
(v) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects (45 CFR 46.111(a)(6));
(vi) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data (45 CFR 46.111(a)(7));
(vii) Appropriate safeguards are included to protect subjects likely to be vulnerable to coercion or undue influence (45 CFR 46.111(b)); and
(viii) When the research involves pregnant women, fetuses, or neonates; prisoners; or children, the research satisfies the additional requirements for IRB approval under HHS regulations at subpart B, C, or D, respectively, of 45 CFR part 46.
B) Modifications- Investigators must report planned changes in the conduct of a study and receive approval from the IRB prior to implementing these changes. The approval documentation sent to investigators of exempt, expedited, and full board studies notifies them of the need for submitting any changes in their research projects to the IRB for review and approval. Modifications include, but are not limited to, procedural changes to a protocol, adding or removing protocol personnel, requesting additional participants beyond the approved number, change in funding, and changes in Informed Consent Document(s). Modifications may only be initiated without IRB review and approval when necessary to eliminate apparent immediate hazard to the subject(s). When an investigator wishes to modify a protocol, he or she must submit these modifications online along with all supporting documentation. Minor modifications may be expedited even for full board studies.
The IRB Staff will make the initial review of modifications to determine if the modification is minor or major. Minor modifications do not change the level of risk to subjects, while a major modification would increase the probability of risk to subjects. For minor modifications, if the research met the criteria for expedited review during the initial or most recent continuing review, and the proposed change does not affect that status, the UTA IRB review will be conducted using an expedited review process. If the proposed change does not qualify for an expedited review procedure, the proposed change will be reviewed at a convened meeting of the UTA IRB and the status of the study will be changed from expedited review to full board review. The below examples are presented as general guidance only. Specific minor/major determinations are made on a case-by-case basis:
Expedited review may be used for modifications with minor changes. A minor change is one in which makes no substantial change in:
-the risk-benefit ratio
-the presumed willingness of current subjects to remain in the study
-the scientific validity
-the number of subjects enrolled
-the qualifications of the research team (Note: the addition or deletion of investigators usually is minor; however, a change in PI may not qualify as a minor change)
-the facilities available to support safe conduct of the research
If an informed consent document is updated as part of the modifications being requested, the new version will be stamped reflecting the updated approval date.
-Increasing the probability of risk to subject
-Major change in the design or research questions of the study
-Making repeated changes in the protocol, instruments, and/or consent
-Adding a new consent form
-Expanding the eligibility criteria
-Increasing the number of participants at risk
-Changes in the PI or study personnel
-Reduction of risk/discomfort to the participant
-Adding or removing an institution
-Editorial modifications to documents
-Adding or removing a questionnaire or instrument similar to the one already approved
C) Reviewing and Reporting Unanticipated Problems and Adverse Events- IRB continuing review responsibilities include reviewing reports of any unanticipated problems that involve risk to research participants or others.
Unanticipated problems are defined as any incident, experience, or outcome that meets all of the following criteria: (1) unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied; (2) related or possibly related to participation in the research (in this guidance document, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and (3) suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
Adverse events are defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research.
(i) Adverse Events (FDA) versus Unanticipated Problems (OHRP) - To summarize, (1) All adverse events are not necessarily unanticipated problems , (2) All unanticipated problems are not necessarily adverse events, (3) Some events may be both. Unanticipated problems that are serious adverse events should be reported by the Investigator to the IRB within 1 week of the investigator becoming aware of the event. Any other unanticipated problem should be reported to the IRB within 2 weeks of the investigator becoming aware of the problem.
(ii) Content of Reports of Unanticipated Problems - The IRB will ask that the report provided by the investigator include the following information:
(a) Identifying information for the research protocol, including the study title, investigator name, and the IRB project number;
(b) A detailed description of the adverse event, incident, experience, or outcome;
(c) An explanation of the basis for determining that the adverse event, incident, experience, or outcome represents an unanticipated problem; and,
(d) A description of any changes to the protocol or other corrective actions that have been taken or are proposed in response to the unanticipated problem.
The IRB Chair reviews reports of unanticipated problems and unanticipated problems that constitute serious adverse events that meet the above criteria and may at his/her discretion add the event as an agenda item of a convened full board meeting. Corrective actions that the IRB may require include, but are not limited to: informing enrolled participants of the AE, modifying the Informed Consent Document, or modifying other aspects of the protocol or its procedures.
All unanticipated problems shall be reported to appropriate institutional officials, the supporting agency head (or designee), and OHRP within one month of the IRB’s receipt of the report (as applicable). If the IRB suspends or terminates a study due to reported adverse experiences, the University notifies federal regulatory agencies in accordance with UTA policy.
D) Other Monitoring Activities- IRB members may conduct monitoring visits. The reason(s) for on-site review may include, for example, (1) random selection, (2) complex projects involving unusual levels or types of risks to participants, (3) projects conducted by an investigator who previously failed to comply with IRB determinations, or (4) projects where continuing review or reports from other sources have indicated that changes without IRB approval may have occurred.
An on-site review may include (1) requests for progress reports from investigators, (2) examinations of research records, including signed Informed Consent Documents, protocol amendments, and serious and/or unexpected adverse experience reports, (3) contacts with research participants, or (4) observation of the consent process.
Examples of when observation of the consent process could occur are: (1) the full board IRB determines during review of a project that a conflict of interest exists such that the informed consent process should be observed by a neutral party; (2) the IRB is made aware of a complaint or concern with regard to the informed consent process; or (3) the IRB determines as a result of the monitoring process that the consent process is insufficient and education/training is required for conduct of consent.
A written record of monitoring activities is maintained in the study file and in the Office of Research Administration. Any of the following may occur as a result of a monitoring report:
(a) If the IRB Chair or designee determines that the issues identified do not reflect serious or ongoing noncompliance and they do not involve risk to participants, the IRB Chair or designee may approve the report that is then sent to the investigator (or Faculty Advisor) for response and resolution of any outstanding issues.
(b) If the IRB Chair or designee cannot make a clear determination with regard to the findings, or if the findings clearly reflect either serious or ongoing noncompliance, or risk to participants, the VPR (or designated IO) is notified and the findings are referred to full board for review.
(c) The IRB Chair may temporarily halt enrollment and/or data collection until full board review occurs (with consideration of effect in therapeutic trials).
(d) The IRB Chair or designee may immediately refer the findings to the full board IRB.
Study Closure and Protocol Expiration - The IRB provides, upon request or through their website, a form by which an investigator can notify the IRB that he/she has completed an approved IRB study. If a study has not received continuing review prior to the expiration date, the IRB Staff sends a memo to the investigator, explaining that IRB approval has lapsed and cannot be renewed, since it has been permanently closed. This memo includes a notice that no human participants research activities may be conducted until IRB approval is re-obtained by submitting a new application submission. This memo also clarifies that the new submission will be treated as a brand new project based on the remaining activities in the project. The new submission will receive a new IRB approval number after it has been reviewed and approved by the IRB. The IRB does not approve continuing review applications that are received beyond the one-year expiration date.Aforementioned sections IX(11) Length of Approval and IX(12)(A) Continuing Review policies also apply to this section.
X. Notification of IRB Activities- Members and alternates of the IRB receive minutes of full board meetings and reports of IRB business. Reports include written notification of all new projects approved (full board and expedited), projects determined to be exempt, and continuing reviews (full board and expedited).
1) General Requirements for Informed Consent - Except under alternative procedures approved by the IRB (detailed in parts B and C below), no investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.
In seeking informed consent the following information shall be provided to each subject:
A) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
B) A description of any reasonably foreseeable risks or discomforts to the subject;
C) A description of any benefits to the subject or to others which may reasonably be expected from the research;
D) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
E) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
F) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
G) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and
H) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
When appropriate, one or more of the following elements of information shall also be provided to each subject:
I) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
J) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
K) Any additional costs to the subject that may result from participation in the research;
L) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
M) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
N) The approximate number of subjects involved in the study.
Except under alternative procedures approved by the IRB (detailed in part C below), informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form. The consent form may be either of the following:
(a) A written consent document that embodies the elements of informed consent required by §46.116. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed; or
(b) A short form written consent document stating that the elements of informed consent required by §46.116 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.
2) Waiver of Consent or Elements of Consent- The IRB may approve a consent procedure, which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent, provided the IRB finds and documents that:
The research or demonstration project is to be conducted by, or subject to the approval of, state or local government officials, and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and
A) The research could not practicably be carried out without the waiver or alteration.
B) The IRB may approve a consent procedure, which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent, provided the IRB finds and documents that:
C) The research involves no more than minimal risk to the participants;
D) The waiver or alteration will not adversely affect the rights and welfare of the participants;
E) The research could not practicably be carried out without the waiver or alteration; and
F) Whenever appropriate, the participants will be provided with additional pertinent information after participation.
3) Waiver of Documentation of Consent- The IRB may waive the requirement for the investigator to obtain signed consent forms for some or all participants, if it finds either:
A) The only record linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
B) The research presents no more than minimal risk of harm to participants, and involves no procedures for which written consent is normally required outside of the research context.
In cases in which the documentation requirement is waived, the IRB may require the investigator to provide participants with a written statement regarding the research.
4) Record Retention Policy- The UT Arlington Office of Research Administration maintains electronic copies of all research proposals reviewed, scientific evaluations, if any, approved sample Informed Consent Documents, adverse event reports, and other study-specific documentation. Physical copies of meeting minutes showing attendance, action taken, vote with number of members voting for against, abstaining, the basis for requiring changes in or disapproving research, a written summary of the discussion of controverted issues and their resolution, and other correspondence pertaining to IRB operations are also maintained. Electronic and/or physical files and records on human participants’ research protocols are maintained by the Office of Research Administration for at least three (3) years after study termination [45 CFR 46.115(b)].
Principal Investigators are responsible for maintaining all records relating to research which is conducted for at least three (3) years after study termination. All records shall be accessible for inspection and copying by authorized representatives of the department or agency at reasonable times and in a reasonable manner. Recordkeeping requirements may vary depending upon individual sponsor or agency requirements. Examples of common types of research records to be retained include signed Informed Consent Documents, completed data collection tools such as surveys and questionnaires, and interview recordings and / or transcripts. The Principal Investigator must maintain the study data in a manner that is consistent with the approved IRB protocol, and must inform the IRB via study modification request before changing the storage method or location of any research data collected. Research data collected under IRB protocols at UT Arlington is recognized as a form of protected intellectual property that is typically owned by the University of Texas at Arlington, and is subject to protection by University policies, Data Use Agreements, and applicable US laws.
XII. Education and Training- The IRB and Office of Research Administration provide services to inform the research community on issues related to use of human participants in research and ethics in research, and to make researchers aware of applicable Federal regulations.
1) Educational Activities Aimed at the Research Community at Large- UT Arlington Office of Research Administration maintains an internet website that contains detailed information on the human participants review process as well as links to federal regulations and regulatory agencies, the OHRP Institutional Review Board (IRB) Guidebook, and other guidance documents.
A) Office of Research Administration also maintains a small library of materials that includes the OHRP Institutional Review Board (IRB) Guidebook, federal regulations, and other books and videotapes discussing ethical and regulatory issues relating to human participants research.
B) Application materials are provided with appropriate guidance (e.g., templates, instructional documents, internet links) as a means of educating investigators regarding the proper process for conducting research with human participants.
C) Office of Research Administration schedules and advertises numerous educational workshops throughout the calendar year directed at investigators and their research associates. These workshops cover topics that include UT Arlington policies and procedures as well as federal regulatory requirements.
D) Members of the IRB or Office of Research Administration Staff may present information at meetings in academic departments or give scheduled lectures to emphasize selected aspects of human subject research, and to keep various constituencies abreast of activities of the IRB.
2) Educational Activities Aimed at Members of the IRB- At the time of induction of a new member, the IRB Chair and/or a professional Staff member from Office of Research Administration provides the individual with the procedures of the IRB and the general regulatory framework from which procedures and policies are derived.
UT Arlington provides the opportunities for IRB members to participate in continuing education/training, and to attend conferences/workshops on human participant issues in research. Upon return, these individuals will be expected to provide relevant information to all board members and, as appropriate, the rest of the University community.
Educational Activities Aimed at Investigators / Research Personnel - Prior to conducting human subjects research, investigators will be provided training in the relevant ethical principles and federal regulations pertaining to the protection of human subject research participants. Training will also include subject matter pertaining to institutional policies for protection of human subjects, and policies/procedures of the UT Arlington IRB. Training may be offered online or in person by the IRB Chair or designee.
This policy details the process for the payment of compensation to human subjects participating in research projects at UTA. UTA faculty and staff have the legal obligation to maintain confidentiality of human subjects as well as fulfill financial accountability. This guidance is to help UTA staff and investigators work together in order to achieve the following goals: (1) Ensure the confidentiality of research subjects; (2) Provide timely, convenient compensation to participants to facilitate, not hinder, the study; (3) Provide sufficient financial documentation for the University’s records and for IRS purposes; (4) Provide sufficient documentation that compensation was provided to research subjects for participation in a study; and, (5) Ensure that appropriate internal controls and adequate safeguards exist for items of value used to compensate, whether cash, checks, or other.
The process for paying research participants depends on the source of the payment and on the method in which you are distributing the funds. For payments made to human subjects from UTA funds or federal, state, or local grants, the payments human subjects receive for time and effort involved in participating in a study are considered taxable income, regardless of the amount. Payments may take many forms, including check, cash, money order, gift card, or any gift with a monetary value.
1) UTA Business Affairs department - This policy requires that UTA funds (i.e., working fund, procard, grant account) a W-9 and tax information should be collected from each subject. If an investigator plans to collect this information, the investigator is asked to describe in the protocol the confidential and safely transfer of the information to the accounting office. Please note: if personal funds are used to compensate subjects, this policy does not apply
2) IRS Considerations - The IRS treats human subject payments, no matter the form, as taxable income to the recipient. All forms of payment are subject to IRS guidelines:
A) The IRS W-9 form (UTA Form 1-18, Office of Business Affairs), must be collected from human subjects receiving payments from UTA or a gift or gift card with monetary value.
B) UTA is obligated to report to the IRS all non-university employees (U.S. citizens or resident aliens) who receive income greater than $600 in an annual year. If UTA pays $600 or more to a U.S. tax resident during the calendar year, then UTA is required to report the payments to the IRS and issue the recipient a Form 1099. Where reporting is required, UTA must collect the recipient's full legal name, SSN/ITIN (or HUID), permanent address, mailing address (if different) and Foreign National Information Form (FNIF, for foreign nationals).
C) UTA is obligated to add research payment income to UTA employee research participants (including student employees) on the UTA employee's W-2 annual earnings. These payments are subject to income tax and other withholdings as applicable.
D) Payments made to human subjects who are nonresident aliens must be paid by an Accounts Payable check or through UTA Payroll if a foreign National is a UTA employee and must be reported on Form 1042-S, Foreign Person's U.S. Source Income Subject to Withholding, regardless of the dollar amount or W-2. All payments to nonresident aliens are subject to 30% federal income tax. Researchers anticipating payments to Non-Resident Foreign Nationals should contact the UTA Payroll and Tax Compliance Office for guidance prior to making such payments.
3) Informed Consent Information - The information below is suggested information to include in the informed consent document:
“The Internal Revenue Service (IRS) considers all payments made to research subjects to be taxable income. Your personal information, including your name, address, and social security number, may be acquired from you and provided to UT Arlington’s accounting office for the purpose of payment. If your total payments for the year exceed $600.00, UT Arlington will report this information to the IRS as income and you will receive a Form 1099 at the end of the year. If you receive less than $600.00 total for payments in a year, you are personally responsible for reporting the payments to the IRS.”
UTA IRB review is required for all human subject research projects in which UTA faculty, staff, or students are engaged in the research, including projects with a collaborating institute. In general, an institute (either UTA or the collaborator) is considered engaged in a research project when its agents for the purposes of the research project obtain: (1) Data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or, (3) The informed consent of human subjects for the research.
Multi-center research may be eligible for an acknowledgement agreement, which can allow investigators who are conducting a research project at UTA and other institution(s) to request that participating institution(s) IRB rely on the review of one IRB, the “IRB of Record.”
UTA has a reciprocity agreement with the following institutes:
(i) All UT System universities and health science centers
(ii) University of North Texas Health Science Center
For these institutes, UTA is prepared to accept and acknowledge the approval determination of the collaborating institute IRB as the “IRB of Record.” In order to formally document that the collaborating institute will be the “IRB of Record,” the investigator is responsible for submitting the “Institutional Agreement” form to the collaborating IRB. The collaborating institute may need to add this form and the reciprocity agreement as a modification to the approved protocol. The research would then submit an acknowledgment request to the UTA IRB through the online protocol submission system. This submission would include all approved study application documents (as approved by the collaborating institution) as an exempt-level study to the UTA IRB for review. Example study application documents include the protocol, informed consent, recruitment material, the signed “Institutional Agreement” form, and the IRB approval letter from the collaborating institution. Once the UTA IRB has received this study submission in the online system, the IRB is then able to accept this study as an acknowledgment at UTA.
1) Adverse events- any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research.
2) Conflict of Interest– an IRB member may not vote on a project, and is not counted towards a quorum, when s/he serves as a co-investigator or other member of the research team or when s/he or an immediate family member has a conflict of interest with a project being reviewed. Conflict of Interest (COI) is defined as a significant financial interest that could directly and significantly affect the design, conduct, or reporting of research.
3) FDA – The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting health through the regulation and supervision of clinical trials, including new drugs and investigational new medical devices
4) Human Subject –a living individual about whom an investigator (whether professional or student) conducting research obtains a) data through intervention or interaction with the individual, or b) identifiable private information.
5) Interaction - includes communication or interpersonal contact between investigator and subject.
6) Intervention - includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
7) Minimal Risk– the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
8) Minor Modifications– modifications to a research project and/or consent documents that pose no additional risk to participants; or modifications that maintain similar or increased safeguards to protect the subject.
9) OHRP – The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and social-behavioral research.
10) Principal Investigator– the principal investigator (PI) is the person who directs a research project or program. The principal investigator usually writes and submits the grant application, oversees the scientific/technical aspects of the grant, and has responsibility for the management of the research.
11) Private information - includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
12) Quorum– a majority of voting members of an IRB, including at least one member whose primary expertise is in a nonscientific area.
13) Research- a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research even if they are a component of a larger non-research activity (e.g., instruction, demonstration).
14) Risk– the probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude may vary from minimal to significant.
15) Serious Adverse Experience (SAE)– Any adverse experience associated with the use of a medical product in a patientthat results in any of the following outcomes: death, a life-threatening adverse experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, required intervention to prevent permanent impairment or damage (devices), or other serious medical events.
16) Unanticipated problems - any incident, experience, or outcome that meets all of the following criteria:
(i) unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
(ii) related or possibly related to participation in the research (in this guidance document, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
(iii) suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
Unexpected Adverse Experience (UAE)– Any adverse experience or suspected adverse reaction that is not listed in the investigator brochure or is not listed at the specificity or severity that has been observed; or, if an investigator brochure is not available, is not consistent with the risk information described in the general investigational plan or elsewhere in the current application, as amended.
For questions regarding IRB
policies or protocol submissions
IRB training opportunities
please contact Mary-Colette Lybrand at
817-272-9329 or firstname.lastname@example.org