What and why an IRB? The institutional review board (IRB) is a committee of faculty and community members who review the involvement/participation of individuals in research programs/projects conducted by any Kenyon College researcher, faculty, student or staff. This requirement is legislated and mandated by federal legislation for any Federally funded research. Federal legislation on human subjects protection as well as the Kenyon College IRB legislation were enacted to protect research participants from violation of their human rights. The Kenyon College IRB is regeistered as: IRB00006294 Kenyon College IRB #1.
What is the IRB concerned about? • consent of subjects • participant safety • scientific merit of the research • conflicts of interest • risks versus benefits • protection of vulnerable people • disclosure of information to participants and their families • privacy • confidentiality.
What happens when a protocol is reveiwed? Usually, the IRB administrator initially reviews an application to determine: • whether an activity is research that can qualify for an exemption from further IRB review, or • whether the review may be performed by expedited procedures, and • whether informed consent or its documentation may be waived or altered.
Is what I am doing research? Research is any activity which gathers information on individuals participating in any activity. Research means a systematic investigation, any investigation designed to develop or contribute to knowledge or understanding about a question. It includes surveys, testing, program evaluation, interviews, and focus groups. Research is collecting information (data) on people and using that data in reports presented, published, or reported outside of the activity. If the data are only for program/activity improvement and not reported to anyone or any where else ever, then it is not research and does not have to go to the IRB. If after conducting the program/activity, the findings are so exciting that they just have to be communicated at the next annual meeting, then those findings become research and the IRB must be consulted. The IRB gets to decide if your activity is research using human subjects, but here is a process that can help you think about your project: Is it Human Subjects Research?
When can human subjects research qualify for an exemption? Consult the U.S. Code of Federal Regulations Title 45 CFR, Part 46 Protection of Human Subjects. The Office for Human Research Protections (OHRP) provides a decision tree on what constitutes a 'human subject' as a guide for institutional review boards (IRBs), investigators, and others who need to decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46 OHRP Exempt Research Guidance Kenyon Is it Human Subjects Research?
If I think my research is exempt, why should I apply for IRB review? You must apply to the IRB to have your research proposal approved as exempt. Only the IRB can finally decide if your research project will be exempt from further review. Be sure to highlight the reasons you think your research protocol should have exempt status in your IRB application.
If I think my research is exempt, why should I go through HS training? If your research involves Human Subjects, even if you think your project will be exempt, you must complete HS training. Kenyon College believes all research should be governed by ethical research methodology and concern for Human Subjects. The Kenyon College IRB requires all Investigators to complete HS protections training.
I am the faculty adviser/sponsor of a student doing research involving human subjects. Why do I need to take the tutorial? Although your student may be doing the research, as the faculty sponsor you are responsible for ensuring appropriate research design when human subjects are involved and for assisting in development of the application to the Kenyon College IRB. In addition, you have responsibility for his or her conduct in the field, adherence to the protocol, and any adverse events or problems that may occur. You should also be able to appropriately address any questions from subjects concerning their rights as a subject or potential violations of such rights.
All I'm doing is a survey, do I have to apply to the IRB? The IRB has three levels of review: exempt, expedited, and full review. Much of what takes place at Kenyon College may fall under the "exempt" status. Exempt review covers things like surveys, classroom tests, and questionnaires. A program reviewed under the exempt category typically is a program of minimal risk to participants. An exception to this category is programs involving children. The Kenyon IRB, defines children as any one under 18 years of age. Children, pregnant women, prisoners, and individuals with disabilities are all considered special populations and may require a Full IRB review.
Are evaluations research? Evaluations are considered research when the findings of the evaluation are reported or going to be reported outside the program. Findings can be data from surveys, focus groups, interviews, questionnaires (such as attitude or knowledge questionnaires), or observations. If a program is evaluated solely for the purpose of program improvement, and NOT EVER reported to any one or any group outside the program, the evaluation protocol does not need IRB approval. However, if after conducting the program, the findings are so exciting or insightful or ground breaking that they need to be disseminated or communicated to a larger audience, then IRB approval is needed to do that. It is easier to get IRB approval at the beginning of a program than go back after a program is completed and try to track down all the participants to document consent.
Is my Oral History Project considered "Human Subjects" research? It depends. See what the Oral History Association has to say. You should also look at the OHA's Principles and Best Practices and the standards and principles of other professional organizations such as the AmericanFolklore Society that pertain to your discipline. Research using surveys, observational or ethnographic methods, cognitive and educational tests, etc. may be "Exempt" unless two things apply: a. The information would allow subjects to be identified, AND b. Disclosure of the data would reasonably place the subject at risk of harm. (see details at 45CFR690.101). See the Kenyon IRB Oral History Page.
I'm submitting a grant proposal to an outside funding agency, what do I have to do regarding the IRB? All sponsored programs/projects involving human subjects need Kenyon IRB approval. Some funding agencies will not even review a proposal without IRB assurances. Almost all government funding agencies require an IRB assurance and some agencies and government departments have their own human research protection requirements. Some funding agencies will conduct a proposal review with the assurance that the IRB review will follow by the time the award is made. This is called a pending review. Kenyon College requires all grant proposals involving human subjects to have a Kenyon IRB review. No research may be done under the auspices of Kenyon College without IRB review. The principal investigator/program director is responsible for completing and filing the IRB review.
What is minimal risk? Definitions of terms used in Human Subjects regulations may be found at §46.102 Definitions Title 45 CFR, Part 46.102 (i) 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 implied consent? Complied consent is the tacit indication that a person has knowingly agreed to participate in research by performing a research activity or task. By completing the research task (e.g., completion of a questionnaire, interview, survey, etc.), the participant has provided consent to participate in the research. Implied consent is actually a type of a waiver of documentation of informed consent. Before granting such a waiver, the IRB may require the researcher to provide the participants with a written summary or an information sheet about the research, including: (1) purpose of research; (2) time involved; (3) assessment of minimal risk; (4) statement regarding benefit to participants; (5) contact for questions about the research; and (6) contact for questions about rights as a research participant. There are a number of instances where this type of consent is helpful. For example, you wish to mail out a survey. The survey does not ask for any identifiable information. The cover letter accompanying the survey could be written in such a manner as to serve as the "implied" informed consent form. The letter would need to contain a statement indicating that completion and return of the survey implies consent to participate in the research.
What is an FWA? FWA stands for Federal Wide Assurance. An institution must obtain an FWA in order to conduct any human subjects research that is supported by the US Department of Health and Human Services. The FWA is essentially the legal permission to do such research. OHRP is authorized to restrict, suspend or revoke an FWA if it finds that the institution, its IRB or an investigator using the IRB failed to comply with regulations. Each institution that receives an FWA from OHRP is assigned a unique FWA number. Kenyon's Federal-Wide Assurance No. is FWA00015567
My data collection is complete, but the project itself is not yet complete. The IRB approval for the data collection has expired. Do I need to apply to the IRB for approval to continue the project even though I am no longer collecting data? Yes, you need IRB review because according to 45CFR46.102(f) you are still conducting research that involves human subjects (you are still using their identifiable private information).