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IX. Operations of the IRB

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.

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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:

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes.

    6. Collection of data from voice, video, digital, or image recordings made for research purposes.

    7. 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.

    8. 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.

    9. 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 - TThe review of an application by the IRB could include the following outcomes: (1) Approve As Submitted, (2) Approve With Conditions, (3) Requires Modifications for Approval, or (4) Disapprove.

A) Approve As Submitted: 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.

B) Approve with Conditions: At the time when the IRB reviews and approves a research study (or proposed changes to a previously approved research study), the IRB may require as a condition of approval that the investigator (a) make specified changes to the research protocol or informed consent document(s), (b) confirm specific assumptions or understandings on the part of the IRB regarding how the research will be conducted, or (c) submit additional documents, such that, based on the assumption that the conditions are satisfied, the IRB is able to make all of the determinations required for approval under the HHS regulations at 45 CFR 46.111 and, if applicable, subparts B, C, or D of 45 CFR part 46. With respect to research reviewed and approved with conditions by the IRB at a convened meeting, note that because the IRB is able to make all these determinations, the IRB may designate the IRB chairperson (and/or other individual(s) with appropriate expertise or qualifications) to review responsive materials from the investigator and determine that the conditions have been satisfied, and further review by the IRB at a subsequent convened meeting would not be necessary. However, this authority also applies to IRB review of research under an expedited review procedure.

When the IRB approves research with conditions, verification procedures must be included as part of the IRB approval process, under which the IRB chairperson (and/or other individual(s) designated by the IRB) will review responsive materials from the investigator required by the IRB, and determine whether the conditions of approval have been satisfied (45 CFR 46.102(h)). The IRB’s verification that the investigator has satisfied all conditions of approval stipulated by the IRB helps to ensure that the investigator does not initiate any research that is different from what was approved by the IRB (45 CFR 46.102(h)).

C) Requires Modifications for Approval: “Approve As Submitted” or “Approve with Conditions” is not possible due to lack of information, inability to determine criteria for approval under the HHS regulations 45 CFR 46.111, and/or inability to specify changes that would allow the IRB to make these determinations. The IRB may request modifications to secure approval and defer or table the research study or proposed changes for further review at a future date after the required modifications are submitted by the investigator. After the initial review by the convened IRB, the list of required modifications will be sent to the investigator detailing the request for application revisions, clarification, or additional information.

D) Disapprove: Any time the IRB cannot make one or more of the determinations required for approval by the HHS regulations at 45 CFR 46.111 and, if applicable, subparts B, C, or D of 45 CFR part 46, the IRB cannot approve the research project. This applies to both initial and continuing review of research, and review of proposed changes to previously approved research. Investigators are advised to consult with the IRB Staff prior to resubmission of previously disapproved applications

When the IRB is unable to approve research because it cannot make the determinations required for approval, the IRB can either disapprove the project, or defer or table the project for further review at a future date. When deferring or tabling the project, the IRB, under its authority to require modifications in order for an investigator to secure approval, may require that the investigator (a) make changes to the protocol or informed consent documents, or (b) submit clarifications or additional documents prior to the next review. If the IRB defers or tables a research project, the research may not proceed until the IRB reviews the revised research project and approves it at a subsequent convened meeting.

When the IRB reviews a research project under an expedited review procedure and is unable to approve the project because the chairperson (or designated reviewer(s)) cannot make the determinations required for approval, the IRB chairperson (or designated reviewer(s)) can either refer the project to the IRB for further review and action at a convened meeting, or defer approval of the research project and require that the investigator (a) make changes to the protocol or informed consent documents, or (b) submit clarifications or additional documents prior to further review by the IRB chairperson (or designated reviewer(s)). Research may not be disapproved under an expedited review procedure (45 CFR 46.110(a)).

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 must follow the procedures outlined in Section IX, 10, “Appeal of IRB Decisions.”

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 researcher 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 by 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 UTA, 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 [45 CFR 46.103(b)(4)]The approval documentation sent to investigators of exempt and non-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, as the HHS protection of human subject regulations do allow for expedited review and approval of requests for minor changes in previously approved studies [45 CFR 46.110(b)(2)].

The IRB Staff will make the initial review of modifications to determine if the modification is minor or major.

Major modifications:

Minor modifications do not change the level of risk to subjects, while a major modification could increase the probability or magnitude of risk to subjects. Major modifications may also involve a decrease in benefit or that otherwise result in alteration of the risk/benefit assessment of the research. Major modifications would not follow an administrative review process and would need either expedited or full board review. If the modification meets the criteria for expedited review and the study is currently an Expedited-level project, the major modification would be reviewed under expedited review. However, if the study is currently an Expedited-level project, and the major modification involves procedures outside the expedited categories listed in section IX.3.B and/or increases the risk level to more than minimal risk, the major modification will be reviewed at a convened meeting of the IRB.  If the study is currently a Full Board-level project, the major modification will be reviewed at a convened meeting of the IRB.

Examples of major modifications:

  • Adding additional procedures where the risk of the additional procedure is greater than minimal risk

  • Significant changes in design or research questions of the study, such as the addition of a new subject population or the elimination of a study arm

  • New study documents to be distributed to or to be seen by subjects that include information or questions that are substantively different from materials already approved by the IRB

  • Increasing the probability or magnitude 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 Informed Consent Document

  • Expanding the eligibility criteria

  • Changes in the PI or study personnel*

  • Alterations in the dosage or route of administration of an administered drug

  • Extending substantially the duration of exposure to the test material or invention

  • The deletion of laboratory tests, monitoring procedures, or study visits directed at the collection of information for safety evaluations

  • The addition of a qualified investigator with a disclosable conflict of interest

  • The addition of serious unexpected adverse events or other significant risks to the Informed Consent

  • Changes, which, in the opinion of the IRB chairperson or his/her designee, do not meet the criteria or intent of a minor modification

  • An increase in subject enrollment of greater than 20%

Minor modifications:*

Minor modifications are those which do not increase the probability or magnitude of risk to subjects.  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 (less than 20% change)

  • 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 the minor modification meets the criteria for expedited review and the study is currently an Expedited-level project, the minor modification would be reviewed under expedited review or administrative review*. If the minor modification meets the criteria for expedited review and the study is currently a Full Board-level project, the minor modification will be reviewed under expedited review or administrative review*. 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.

Examples of minor modifications*:

  • Scientific and/or therapeutic changes that leave the research population at the same or lower risk than risk(s) already approved

  • Changes in research procedures that have a minor impact on risks of harm, such as changes in the amount and frequency of blood draws (which remain within the expedited criteria), addition of a clinic visit that involves no new procedures, or addition of a questionnaire that does not introduce new and significantly different subject matter

  • A decrease in subject enrollment, or an increase of no more than 20%

  • Alterations in the dosage form (e.g., tablet to capsule or oral liquid) of an administered drug, provided the dose and route of administration remains constant

  • Decreasing the number or volume of biological samples collections, provided that such a change does not affect the collection of information related to safety evaluations

  • Alterations in human research participant payment or alteration of the payment schedule with proper justification

*Some minor modifications may qualify for Administrative Review; please see section IX, 12, C.

C) Administrative Review of Minor, Non-Exempt Modifications

Some minor modifications can be classified as Administrative in nature.

The IRB has delegated authority to the Regulatory Services IRB Staff to conduct Administrative Review and approval of certain minor modifications of currently approved, non-exempt IRB protocols.

The minor modifications that may undergo Administrative Review by the IRB staff have all of the following characteristics:

All requested changes to the study have been adequately justified

The modifications do not change the risk/benefit assessment

The modifications do not change the category of research currently assigned

Any personnel added have completed required training and conflict of interest disclosures

The types of minor, non-substantive modifications that qualify for Administrative Review are limited to the following:

Addition of documents translated into non-English versions, when accompanied by a description of the service or personnel responsible for the translation, and their qualifications

Update to study title

Update in study funding (grant congruency will be verified by IRB Staff)

Updated contact phone number, address, email address, and other contact information of research personnel in the protocol or study documents

Deleting items from a research tool, questionnaire, survey, or interview without changing risk level of project

Adding items to a research tool, questionnaire, survey, or interview that are substantially similar in nature to previously approved materials and do not change risk level of project

Minor editorial revision(s) to Informed Consent document, recruitment materials, and other study documents that do not alter the intent or meaning of the previously approved version

Addition of recruitment materials (flyers, advertisements, communication pieces) when the content is substantially similar to previously approved materials

Addition/deletion of protocol personnel

Change of Principal Investigator or Co-PI, if the qualifications and experience are substantially similar to the previous PI/Co-PI

Deletion of a research site/location, or addition of a new site/location when site approval is confirmed/documented, and procedures taking place at the new site are substantially similar to those previously approved

Approval of these administratively-reviewed minor modifications will be completed by the IRB Staff and documented via an approval letter referencing the review process utilized under this section.  An approval letter and stamped consent document (if applicable) will be sent to the research team.

13. 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.

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