General

Review

Consent

Post Approval

Who can I talk to if I have a question about human participants research?

The IRB staff is available to provide assistance to investigators who are engaged in research with human participants. Amanda Boone ext. 4575 and Mary Beth Goodnight ext. 4595 are your resources for any general questions.

Who serves on the IRB?

IRB members are appointed by the President for one-year terms, and may be reappointed for successive periods. In accordance with applicable federal regulations, UTD policy (UTDPP1035) requires the IRB have a minimum of nine members, including at least one individual who would be considered a non-scientist. Members are selected from faculty, staff, students, and community members. Considerable effort is expended to recruit individuals who have expertise in different areas. This diversity helps to ensure that protocols are evaluated fairly by knowledgeable individuals. If necessary, non-voting consultants may be enlisted to review specific protocols for which there is no IRB member with sufficient knowledge of the research method or scientific discipline to conduct a substantive review.

When is IRB review required?

IRB review is required whenever an investigator who is affiliated with the institution conducts research with human participants. Research is defined in 45 CFR 46 as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”. Student projects are considered to be research whether or not there is intent to disseminate study results, if all other conditions are met. A human participant (or human subject) is defined in 45 CFR 46 as “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information”. Individuals who provide information for research that is not about themselves are not considered to be human participant in this context. While researchers should take steps to ensure that these individuals are not placed at risk, it is not necessary for the IRB to approve their participation.

What is Private Information?

According to the Office for Human Research Protections (OHRP) 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.”

What is Minimal Risk?

Under 45 CFR 46.404, 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.”

What is archival data?

Archival Data are data that were collected in the past, usually for a purpose other than research. The complete data set must exist prior to the initiation of a research project using the data.

Who is required to complete the human participants training?

All faculty, students, and staff proposing to use human participants in research under the auspices of UTD are required to complete the human participants training. Approvals for including human participants in proposed research projects will be not be granted until this training has been completed and verified by UTD’s IRB staff. The required training can be completed through one of the following websites:

Do student research projects need IRB approval?

Yes. Projects conducted by UTD undergraduate and graduate students need IRB approval, if the project fits the definitions of “research” and “human participants” as described above. If the project is to be used in classroom setting only to teach research methods, the project may not constitute human participant research. However, this means that at no point during or after the conclusion of the course can the results or the data be used for publication, presentation or other research purposes. Therefore, students should discuss these limitations with their instructor or faculty advisor so that they can determine whether IRB review is necessary.

Do studies involving simple surveys require IRB review?

Yes, if the study meets the definition for research with human participants, as explained above. UTD’s Federal wide Assurance (FWA) with the U.S. Department of Health and Human Services states that all research being conducted under the auspices of this institution is participant to review and approval by the IRB. Written approval from the IRB must be in place before any interventions or interactions with human participants (e.g., recruitment) actually begin.

What if my research is exempt?

Federal Regulations do make certain categories of research exempt from IRB review. However, UTD policy does not allow investigators to self-exempt their human participant research projects. Instead, determining if a project is exempt from IRB review is an administrative review process handled by the IRB staff.

Do I need to submit a protocol for review when I am only analyzing existing data?

Yes. Research involving the secondary analysis of existing data must be reviewed by the IRB and/or by the IRB staff to ensure that the original data were properly and ethically obtained and to ensure that the objectives of the secondary analysis are in keeping with those for which consent was obtained. Depending on the nature of the data, your protocol may fall under a federal exemption; however, the determination for exemption must be made by the IRB office, thus submitting a protocol to the IRB office is still necessary.

I will be collaborating with another institution, doing research on their campus. Do I need to submit to UTD IRB approval?

If you are a member of UTD faculty or staff, or a UTD student, and you are a person involved in the conduct of the study, you must get UTD IRB approval to conduct your research regardless of where the research takes place. Investigators should contact the IRB office whenever collaborative research is occurring.

How long will it take to get an approval for my project?

It depends on the nature of the study. However, for Expedited Review protocol, it typically takes about 2 weeks. For Full Board Review protocol, it can take about 4 – 6 weeks. These are the estimated timeline for protocols once all required materials are received by the IRB office; therefore, the length of time can take longer if the investigator needs to make modifications to the protocol as a result of administrative review and/or the committee review. Please also note that the protocol review may take longer than the above timeline as a large volume of protocols appear in the reviewing queue at certain times of the year.

What information needs to be included on the consent document?

The informed consent process should ensure that all critical information about a study is completely disclosed, and that prospective participants or their legally authorized representatives adequately understand the research so that they can make informed choices. Thus, the information must be conveyed in language understandable to those being asked to be a participant in the research.

What is informed consent?

Informed consent is one of the primary ethical requirements underpinning research with human participants; it reflects the basic principle of respect for persons. It is too often forgotten that informed consent is an ongoing process, not a piece of paper or a discrete moment in time. Informed consent assures that prospective human participants will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate. The prospective participant should be presented with the information, and then given an opportunity to ask questions and have them answered, prior to signing the consent document.

Do I always have to obtain the informed consent?

In general, yes, but there are some limited exceptions. The UTD IRB is responsible for ensuring that basic ethical principles are abided by in all UTD research activities. The expectation that the informed consent of research participants be obtained is based upon the Belmont principle of respect for persons, and regarded as extremely important in conducting ethical research. The IRB has the authority to waive some or all of the federal requirements for informed consent in certain extenuating circumstances. A request for waiver of informed consent must be specifically justified by the researcher in the protocol application submitted to the IRB.

What is signed informed consent?

Used most commonly, signed informed consent allows prospective participants to document their agreement to take part in research activities by signing and dating the consent document.

If my research qualifies as exempt, does this mean that I don’t have to submit a protocol for review?

No. The Federal Regulations do make certain categories of research exempt from IRB review. However, UTD policy does not allow investigators to self-exempt their human participant research projects. Instead, determining if a project is exempt from IRB review is an administrative review process handled by the IRB staff.

Do research participants always have to sign the consent document?

Not always. In certain situations, the IRB can waive the requirement that you obtain the participant’s signature on the consent form.

When is a modification (amendment) to an approved research study be required?

Any and all changes to an approved research study, including any revisions to IRB approved consent forms, must be submitted for review and approval prior to implementing the change(s) into the research study.

When my modification is approved, is the term of the study automatically extended?

No. The expiration date of the original approval is not changed by the review and approval of a modification.

After my approved protocol has passed the one year expiration date what do I do?

If IRB approval of the human research expires, all study procedures related to the protocol under review must cease, including recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection of private identifiable information. Continuing human research procedures is a violation of federal regulations. You must receive continued approval from the IRB in order to continue research.

How do I obtain continued approval (renewal) for my research study?

It is the responsibility of the principal investigator (PI) to ensure continued approval of his or her human participant research study. As a courtesy, approximately 30 days prior to the approval expiration date, the IRB office will send an email to the PI and the Faculty Sponsor (if the PI is a student), alerting them to the impending approval expiration. If no response is received to the reminders, a notice indicating the approval for the study expired may be sent after the approval expiration date. If approval is allowed to expire, all research on the study must cease until renewed approval is granted. Progress of approved research must be reported, in the manner prescribed by the IRB, on the basis of risks to participants, no less than once a year. For all renewal forms and more information visit our forms website.

When is the Principal Investigator expected to report an unanticipated problem to the IRB?

Serious adverse events must be reported to the IRB immediately, with a written report by the PI following within 24 hours of the PI’s becoming aware of the event. Serious adverse events are (1) death of a research participant; or (2) serious injury to a research participant. All other non-serious unanticipated problems should be reported to the IRB within 2 weeks of the first awareness of the problem by the protocol PI or another researcher, the Office of Research Compliance, or a member of the IRB. Prompt reporting is important, as unanticipated problems often require some modification of study procedures, protocols, and/or informed consent processes. Such modifications require the review and approval of the IRB.