Non-Exempt Research
When your research involves human subjects and doesn't qualify for exemption under federal regulations, it's called non-exempt human subjects’ research. This type of research needs to be reviewed by the NIH IRB to make sure subjects' rights, welfare, and privacy are protected.
When your research involves human subjects and doesn't qualify for exemption under federal regulations, it's called non-exempt human subjects’ research. This type of research needs to be reviewed by the NIH IRB to make sure subjects' rights, welfare, and privacy are protected.
Non-Exempt Research (Full board and Expedited Review)
Non-exempt research involves research procedures that are either minimal risk or more than minimal risk to subjects and doesn't meet the criteria for exempt research. Non-exempt human subjects research can be divided into two categories: research that qualifies for expedited review and research that needs full board review. The main difference between these two is how the review process is done. In expedited review, a designated member of the IRB reviews your research. In full board review, a meeting of the IRB evaluates your research thoroughly.
Research Eligible for Expedited Review
Criteria
Your research can qualify for expedited review if it poses no more than minimal risk to participants. This means the potential harm or discomfort from your research should not be greater than what people experience in their daily lives or during routine physical or psychological exams.
Applicability
Subject Identification Risks: You cannot use expedited review if identifying the subjects could lead to criminal or civil liability, harm their financial standing, employability, insurability, reputation, or stigmatize them, unless you have protections in place to keep these risks minimal.
Informed Consent: You must still follow the standard requirements for informed consent, no matter the type of review.
Review Type: Expedited review can be used for both initial and continuing reviews by the IRB.
Research Categories
Your research must present no more than minimal risk to participants and involve only the following types of procedures:
Process
Reviewers: An experienced IRB member or the IRB chair will conduct the expedited review.
Speed: Expedited reviews are not “fast” however they are usually reviewed quicker than full board reviews because they don't require a full IRB meeting.
Approval: The reviewer can approve the research, ask for modifications, or refer it to the full board if it doesn't meet the criteria for expedited review.
Research Requiring Full Board Review
Criteria
More than Minimal Risk: Your research needs a full board review if it poses more than minimal risk to participants.
Complex or Sensitive Topics: If your study involves complex procedures, sensitive topics, or vulnerable populations (like prisoners), it usually requires a full board review.
Process
Reviewers: The Institutional Review Board (IRB) will meet and review your research. The IRB includes members with various backgrounds and expertise to ensure a thorough evaluation.
Meeting: Your research will be reviewed during a scheduled IRB meeting where a quorum (a minimum number of members) is present. This allows for a detailed discussion about the ethical aspects of your study.
Deliberation and Voting: The full board will discuss and vote on your research proposal. A majority vote is needed to make a decision. The possible outcomes are approval, modifications required to secure approval (MRSA), deferral (requesting more information), or disapproval.
Timeframe: Full board reviews usually take longer than expedited reviews because they require scheduling a meeting and having an in-depth discussion.
For the IRB to approve your non-exempt human subjects research under Health and Human Services (HHS) regulations, whether reviewed by expedited review or by the full board, you must meet all the following criteria. These requirements, called "criteria for approval," are listed in 45 CFR 46.111, and for Food and Drug Administration (FDA)-regulated research, in 21 CFR 56.111.
Here are the criteria for approval:
- Minimize risks to subjects: Use procedures that follow sound research design and don’t unnecessarily expose subjects to risk. Whenever possible, use procedures already being done on the subjects for diagnosis or treatment.
- Risks to subjects should be reasonable in relation to the anticipated benefits, if any, to subjects, and the importance of the knowledge that is expected to result.
- Ensure the selection of subjects is fair.
- Seek informed consent from each prospective subject or their legally authorized representative, as required by federal regulations (§46.116).
- Document informed consent appropriately or have it appropriately waived by the IRB in accordance with federal regulations (§46.117).
- When appropriate, ensure the research plan includes provisions to monitor the data collected to ensure subjects' safety.
- When appropriate, ensure there are provisions to protect subjects' privacy and maintain data confidentiality.
- If some or all subjects are likely to be vulnerable to coercion or undue influence (such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons), include additional safeguards to protect their rights and welfare.
The IRB can make one of the following decisions:
- Approve as submitted: The convened IRB, the expedited reviewer, or the limited IRB reviewer approves the research study with no changes.
- Modifications Required to Secure Approval (MRSA): The convened IRB, the expedited reviewer, or the limited IRB reviewer approves the research study contingent on stipulated changes to the research.
- Defer: The convened IRB determines that your research study needs resolution of one or more of the criteria for approval, or other substantive issues (e.g., risks have not been identified, risks are significant and have not been adequately minimized, or the safety monitoring plan is not adequate). In this case, the IRB may suggest substantive changes to your research study. Deferred actions must be re-reviewed by the convened IRB before they can be approved.
- Disapprove: The convened IRB determines that your research study cannot be approved in its current form or is inappropriate based on its current design (e.g., due to subject safety or study design).