If you have questions please call Regulatory Services at 817-272-3723 or email us at regulatoryservices@uta.edu

Regulatory Requirements

If your research involves human subjects you must become familiar with the regulations governing the rights and safety of the research participants.
These regulations include:

• The researcher’s institutional rules
• The requirements of the researcher’s Institutional Review Board (IRB)
• Regulations in the Code of Federal Regulations, Title 45, Part 46:  Protection of Human Subjects and Food and Drug Administration Regulations, 21 CFR, Part 50, 56

Please consult your Research Regulatory Specialist if unsure of these regulations.

In addition, The University of Texas at Arlington has a Federalwide Assurance (FWA).  Any institution engaged in federally conducted or supported human subjects research must commit itself in writing to the protection of those subjects.  This written commitment is called an Assurance of Compliance.
For human subjects research conducted or supported by the Department of Health and Human Services (HHS), the Office for Human Research Protections (OHRP) must approve an institution's Assurance before the funds can be awarded and human subjects research can begin.

Definitions

• Research according to OHRP means a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for the purposes of this policy, whether or not they are supported under a program which is considered research for other purposes. --- 45 CFR46.102(d)
• Research according to FDA regulations is any experiment that involves any drug or biological product for human use, a medical device for human use, a food additive, an electronic product or any other article subject to regulation by the Food, Drug and Cosmetic Act.

• Human subject means a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. --- 45 CFR 46.102(f)(1),(2)

• Identifiable private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonable expect will not be made public (for example, a medical record). --- 45 CFR 46.102(f)(2)
• Participant is a living individual about whom a research investigator (whether a professional or a student) obtains data through intervention or interaction with the individual or from individually identifiable information.  45 CFR 46.102(f).
• IRB is an Institutional Review Board, a committee appointed annually by the Vice President for Research.  The IRB is charged with reviewing research to ensure it complies with 45 CFR 46, 21 CFR 56, UT Arlington polices and procedures and applicable law.
• IRB membership consists of qualified and diverse faculty and community, scientist and non scientist.  The membership provides review of specific research protocols across the range of disciplines on the UT Arlington campus.  The IRB at UT Arlington is chaired by Dr. Patricia Turpin of the Department of Nursing.
• IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.
• Minimal risk means that 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.

Applicability

If you are a student conducting research because of a class assignment then you do not submit a research protocol.  A class assignment is defined as a systematic investigation students conduct as assignments designed to teach human research methods, where the results and data are not being disseminated outside of the classroom.

• Class projects cannot involve the following participants:  institutionalized persons, persons unable to consent themselves, or children.
• If you are a student conducting human subjects research you must have a faculty sponsor.

• Your sponsor must approve your application prior to IRB submission.
• Choose a faculty sponsor who works well with you.  Your sponsor will provide valuable recommendations about research designs aimed at reducing the risk to human subjects and is your primary contact for human subject concerns and questions.

International human subjects research must always be guided by ethical principles.  All of the Institution’s human subjects research activities, regardless of whether the research is subject to U.S. federal regulations, will be guided by one of the following statements of ethical principles:

• The World Medical Association's Declaration of Helsinki (as adopted in 1996 or 2000);
• The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; or
• Other appropriate international ethical standards recognized by U.S. federal departments and agencies that have adopted the U.S. Federal Policy for the Protection of Human Subjects, known as the Common Rule. 
• Please consult your faculty advisor, the IRB and the country where the research is conducted.  

Collaborative research may include:

• equal partnership between two academic faculty members who are pursuing mutually interesting and beneficial research, or
• researchers of differing stature, funding status, and types of organizations, or
• post-doctoral fellows, research staff members, graduate students, and/or undergraduate students.

Members of a collaboration, including those within a research group, should communicate clearly and frankly with each other in such a way that all members can answer the questions: What am I expected to contribute to this joint research project? What do I expect to get out of this collaboration?

Collaborative research may also include partnerships with other institutions.  Typical partners include UT Southwestern, UT Dallas, Veterans Administration, Department of Defense, Air Force and many others. 

• If you are conducting research in a collaborative partnership please advise your faculty advisor and the IRB. 
• The research is subject to the same IRB approval process by one of the institutions. 
• The UT Arlington IRB recognizes the collaborative institution (listed above) as the IRB of record and will acknowledge their approval process. 
• The UT researcher must submit the collaborative research protocol, the approval letter and maintain all the rules and regulations required from the UT IRB. 

Application Process and Review Timeline

There are three types of research that the IRB reviews. 

• Exempt research
• Expedited research
• Full Board research

Your human subjects research is exempt Persuant to 45 CFR 46.101 if all of the proposed research meets the criteria for one or more of the following exemptions:

• established educational settings – involving normal education practices
• does it involve educational tests, (cognitive, diagnostic, aptitude, achievement) survey procedures, interview or observation; unless (i) information is recorded so that subjects can be identified and (ii) disclosure of subjects’ responses could place them at risk of criminal or civil liability or be damaging to their financial standing, employability, or reputation
• if it involves educational tests, (cognitive, diagnostic, aptitude, achievement) survey procedures, or observation; that is not exempt under (2) of this section if: (i) subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter,
• does the research involve collection of existing data, documents, records, or pathological or diagnostic specimens,
• if it evaluates or examines public benefit or service programs;
• if it involves taste and food quality evaluation or consumer acceptance studies,

UT Arlington policies and Federal Regulations stipulate that studies involving prisoners, mentally incapacitated individuals, clinical trials on pregnant women, fetuses or neonates and research involving children cannot be reviewed as exempt.  Additionally, research that is FDA regulated cannot be reviewed as exempt unless it falls under taste and food quality consumer acceptance studies.

Expedited Research:  Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110.
(1) Clinical studies of drugs and medical devices only when:
(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (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, or (b) from other adults and children, 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.
(3) Prospective collection of biological specimens for research purposes by noninvasive means.  Please contact Regulatory Services for details. 
(4) Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice.
(5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).
(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 as follows:  (a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or (b) where no subjects 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 investigational device exemption where categories two (2) through eight (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 may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
• The expedited review procedure may not be used for classified research involving human subjects.

Full Board Review:  All submissions for initial review, continuing review, or review of modifications to previously approved research determined, by the Regulatory Services staff or the IRB Chair, to not be eligible for exemption or review by expedited procedures by regulation must be reviewed and approved, at a fully convened IRB meeting. The Institutional Review Board adheres to the following process to facilitate the thorough review of each protocol according to Federal regulations (45 CFR 46 and 21 CFR 50 and 56).

• After submission, each new protocol is given an IRB specific number for tracking purposes.
• The Regulatory Service staff provides a complete set of documents (provided by the investigator) to each IRB member each of whom is asked to review the protocols and supporting documentation in detail.
• Additionally the IRB Chair specifically assigns each new protocol to two IRB members for review. Every effort is made to identify reviewers based upon expertise, relevance, interest, and possible conflict of interests.
• Prior to the IRB meeting the reviewers may correspond with the investigator(s) to resolve any questions. Furthermore, any IRB member may contact the investigator, co-investigators, other IRB members, or outside sources as necessary to insure a thorough evaluation of risks and benefits of the proposed research.

The IRB meets on the second Tuesday of each month to review and discuss each full board protocol. The protocols undergoing initial review are presented and discussed individually by the IRB, as well as those protocols undergoing continuing review. The assigned reviewers present each new study to the board raising any additional points for discussion. The investigator are asked to join the Board and address, any outstanding issues. A brief discussion takes place after the investigators leave the room and a vote is taken. There are four possible dispositions.
The Board may vote to approve, disapprove, table, or approve with explicit conditions.

1. Approve - The IRB accepts and endorses without reservations.
2. Disapprove - The IRB deems the research inappropiate. No research may be done.
3. Table - A study may be tabled because the Board did not have sufficient time, expertise, or appropriate personnel present (i.e., absence of prisoner advocate for a study involving prisoners) to vote on the study, or because the Board needed substantive clarification or modifications regarding the protocol or informed consent documents to determine whether to approve or disapprove the study.
4. Approved with explicit conditions when the convened IRB is able to stipulate specific revisions that require simple concurrence by the investigator. If the IRB approves a study with explicit conditions, then the IRB member or another member designated by the Chair may approve the revised research protocol under an expedited review procedure to determine whether the investigator has incorporated the specified explicit conditions into his or her project.

Informed Consent:  Informed consent represents the voluntary consent of a person to participate once s/he has been told about the study and understands the following required elements:

• Confidentiality procedures
• What to do in case of injury
• Possible conflict of interest
• Study procedures
• Withdrawal statements
• Expected benefits
• Contact phone numbers
• Study purpose
• Possible risks involved
• Study alternatives
• New findings

Informed consent must be given “before” the subject participates in any study protocol.

Non-English speaking subjects must have informed consent information presented in a written language that they can understand [21 CFR 50.20-27 and FDA information Sheets]  IRB approved informed consent documents must be available in English and other languages as appropriate to the subject population(s).

Every subject must be given a copy of the consent form for their personal records.

The informed consent document is vital to your research.  Consult your faculty advisor or Human Subjects Research Specialist when designing your consent document. 

Waiver of Consent:  In studies with sensitive, stigmatizing, or illegal personal information, keeping the identity of participants confidential may be as or more important than keeping the data obtained about the participants confidential.  In such cases, any written record linking subjects to the study can create a threat to confidentiality. 

Current federal policy allows the IRB to waive the requirement for the researcher to obtain a signed consent form in cases where it will be the only record linking participants to the research, and where a breach of confidentiality presents the principal risk of harm that might result from research.

A waiver or alternation of the informed consent process can be granted by the IRB if all of the following conditions are met:

• Research involves no more than minimal risk
• Waiver will not adversely affect rights and welfare of subjects
• Research could not practicably be carried out without waiver
• Subjects will be provided with additional pertinent information after participation, when appropriate

Assigned consent form may be waived if

• The only record linking the subject to the research is the informed consent and there is a risk of brench of cofidentionallity, or
• Research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required.

Note: All subjects under the agae of 18 must be consented by a guardia/parent and must assent themselves.

Training

For research involving human subjects, you will need to complete UTA's Human Subjects Protection (HSP) training modules found here    http://www.uta.edu/ra/real/loginscreen.php?view=7

1. Login at http://www.uta.edu/ra/real/loginscreen.php?view=7 using your UTA NetID and password
2. Locate the training that says Human Subjects Protection (HSP). It can be under Registered Trainings or Available Trainings..
3. Click on the Start or Resume button to begin the training.

You will be able to save your progress at any point during the training and resume it again later by following steps 1-3. Any questions should be directed to Robin Dickey in the Office of Research Administration; Regulatory Services at robind@uta.edu or 817-272-9329.

Student Responsibilities Following Research Approval

Continuing Review:  Every approved research study has an expiration date.  It is the responsibility of the researcher to keep track of this expiration date.  Prior to the expiration date, the researcher must submit a continuing review application (link) in order to obtain approval for the next 12 months.

• Researchers may not continue their research activities past the expiration date.
• If the study is completed, the researcher is requested to complete a continuation review to close the study.

Modifications: Researchers are required to submit a modification form to the IRB for approval, for any change to the protocol or consent.

• Researchers may not implement changes to their approved research studies without IRB approval
• Any new advertisements or changes to existing advertisements for a study must be approved by the IRB prior to its use.  Additionally, if the advertisement is posted on campus the researcher must obtain approval from the ‘Student Governance & Organizations Office’. 

Unanticipated Problem/Adverse Events:  When a participant or researcher in a research study experiences an unanticipated problem, the PI must report this incident to the IRB within 5 days.  A summary of the unanticipated problem must be submitted to the IRB using the IRB adverse events form (link).

OHRP and UT Arlington consider unanticipated problems, in general, to include any incident, experience, or outcome that meets all of the following criteria:

• 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;

• related or possibly related to participation in the research (there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and

• 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.

The IRB votes to determine whether the unanticipated problem represents a problem involving risks to participants or others.  The IRB votes to take one of the following actions:

• accept the actions taken by the PI to report and resolve the incident
• notifying current participants when information about the unanticipated problem might affect their willingness to continue to take part in the research
• alter the continuing review schedule;
• suspension of some or all research activities
• approve the study for a shorter period of time
• termination

Researcher Responsibilities for Study Design:  The researcher is responsible for ensuring that:

• the study is properly designed and is scientifically sound
• the investigator and research staff have necessary backgrounds to comply with human subjects and research regulations, such as,
  • regulations concerning IRB review
  • informed consent requirements
  • reporting requirements
  • maintenance of records
  • retention of records
  • supervision of research conduct
• the study must be designed to ensure minimal risk to participants
• Investigators must identify possible risks
• Must evaluate alternatives to the experimental design that could minimize risk
• Must report conflict of interest to the IRB