Frequently Asked Questions

Q: What is the Institutional Review Board (IRB)?

A: The IRB is the committee at Meharry that is required by federal regulation to review all research with human subjects to ensure that the rights, safety, and welfare of the subjects are protected. Federal regulations also specify the criteria that the IRB must use to evaluate research that involves human subjects.

Q: What are the federal regulations that govern research with
human subjects?

45 C.F.R. § 46 was first promulgated in 1974 by the Department of Health and Human Services and has since undergone a number of revisions. FDA regulations also govern research with human subjects: 21 C.F.R. § 50, 21 C.F.R. § 56, 21 C.F.R. § 312, and 21 C.F.R. § 812.

Q: To what activities does 45 C.F.R. § 46 apply?

The regulations for the protection of human participants in research apply to all research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research. Meharry, like many other institutions, has stipulated in its Federalwide Assurance (FWA), which is the binding agreement between Meharry and the federal government, that it will comply with these federal regulations regardless of a study’s source of funding. The FWA stipulates the method(s) by which the institution will protect the rights and welfare of research subjects in accordance with the regulations.

Q: How does the IRB review research?

The IRB can review research at a meeting of the full committee, or via expedited review. The IRB may also determine that a study with human subjects fits under one of the categories of exempt research that are specified in 45 C.F.R. § 46. Research that involves greater than minimal risk to subjects is reviewed at a meeting of the full committee. Research with vulnerable populations may also be reviewed by the full committee. Research that poses minimal risk to subjects is eligible for expedited review.

Q: If I read the federal regulations and discover that my research qualifies as exempt from 45 C.F.R. § 46, do I still need to submit my project to the IRB for review?

Yes. A research project involving human subjects cannot be initiated until the IRB reviews and approves it or determines that it is exempt. Meharry's IRB procedures state that researchers may not determine for themselves whether research with human subjects is exempt. This rule is not designed to hinder the progress of research but to protect human subjects from harm and is consistent with federal regulations and guidance pertaining to research with human subjects.

Q: How long does it take to get IRB approval for a project if it must undergo full board review?

The IRB meets on the first and third Tuesday of every month. If you submit the completed Human Subjects Review Form by the second or fourth Tuesday of that month, the project should be reviewed at a meeting that month. However, if necessary and/or required protocol materials are not submitted, this may delay review. The IRB reviews the applications at the meetings of the full committee and decides to approve, disapprove, or approve with corrections. You will be notified of the IRB's decision no later than three days following the IRB meeting. If you receive an approval letter, you are ready to start; if you receive a letter requiring modifications to your protocol, you may not begin your work until the corrections have been submitted and you receive a final approval letter. In some circumstances, so many revisions may be required that you will be asked to revise the protocol and resubmit it for review at another IRB meeting.

Q: What are the responsibilities of an investigator who wants to conduct research with human subjects?

Any investigator who wants to conduct research with human subjects must submit the necessary application materials to the IRB and receive IRB approval prior to beginning any activities with human subjects, including recruiting people to participate in the study. Additionally, any time an investigator wants to make a change to an IRB-approved study, the investigator must submit that change to the IRB and receive approval for the change prior to implementing it. This change is called a "modification" and the Meharry IRB has a modification form for investigators to submit. Investigators must also submit a continuing review form to the IRB at least annually in order to be able to continue to work on the study. The IRB will let the investigator know if review must take place more frequently than once per year.

Q: What if I had IRB approval for a project that ended several months ago and I decided to make some modifications today and continue the project. Can I begin work on this project under the approval given before?

No. If the project ended, the IRB closed the records. If the project is modified and started again, it is considered a new project by the IRB. You must submit a new Human Subjects Review Form and other necessary accompanying materials so the review process can begin again.

Q: Must an IRB perform continuing reviews of protocols in which patient accruals have been closed and the research interventions are completed but investigators are still collecting follow-up data?

Yes. So long as data are being collected for a research project, the IRB must continue to review the status of the protocols and the details of the continuing data gathering activity. If the continued research meets the requirements for expedited review, the expedited review process may be used, if desired by the IRB.

Q: Can treatment of a single patient constitute "research"?

Yes, if there is a clear intent before treating the patient to use systematically collected data that would not ordinarily be collected in the course of clinical practice in reporting and publishing a case study. Treating with the intent of conducting research should be distinguished from the use of innovative treatment practices.

Q: If my graduate student conducts thesis research or applies for a fellowship under a project for which I already have IRB approval, do we have to fill out the Human Subjects Review Form and seek approval for the same project?

Yes. All projects involving human subjects must be reviewed by the IRB. On the Human Subjects Review Form, you should indicate to the IRB that it is a submission based on a previously approved protocol. Please provide the title and study number of the previously approved protocol.

Q: Why would a standard cooperative research protocol or a standard informed consent document need review at the local level when it has already been reviewed by another national organization (e.g., the National Institutes of Health, the National Cancer Institute, or a cooperative research group), or even by the IRB of another institution with an approved Assurance?

A: Cooperative protocol requirements may be standard, but the research setting is not standard across institutions. In addition, one should not assume that because a protocol or informed consent document has been reviewed by another entity it necessarily conforms to pertinent regulations, local laws, or the local research setting. For example, local laws, institutional policies and constraints, professional and community standards, and population differences are all factors that can influence the research setting. (See 45 CFR 46.103(d), 46.107(a), and 46.111(a)(3), noting the relevance of the particular setting in which the research is to take place.)

Q: How can independent investigators (i.e., investigators not associated with an Assurance-holding institution) who wish to engage in cooperative research in their private practices obtain local IRB approval for their research?

A: The proper approach is for the independent investigator to seek permission from OHRP (and the institution) to rely upon the IRB of a local institution with an OHRP-approved Assurance for the research in question. If no such local institution is available or permission is denied, the independent investigator must identify another IRB that holds an appropriate Assurance for reviewing the research. It will be important for the investigator to ensure that the IRB he or she selects can evaluate the research in accordance with the needs of the research setting (e.g., local laws, professional and community standards, and cultural differences due to different geographical or research settings).