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Before conducting any research involving human subjects, you must submit a protocol application for IRB review and approval. Depending on the nature of your study and the level of risk involved, your research fall under one of three types of review: Exempt, Expedited or Full Board.
Exempt Review
“Exempt” does not mean that your research is excluded from IRB review. Although certain research activities are exempt, only the IRB Chair, IRB member, or IRB staff (acting as a designee of the Chair), may determine if a protocol is granted exempt status under the six categories described in 45 CFR 46.101(b). After its review, the IRB will determine a protocol application’s exempt status. A principal investigator cannot make the final determination of exemption. If a study qualifies as exempt, then it is exempt from expedited or full board IRB review.
The IRB staff reviews the protocol application and all of the material required for submission for exempt studies. The IRB staff member may contact the PI directly to resolve any questions or concerns, or to require amendments prior to approving the exempt status. Contact will generally be made via e-mail to provide documentation of the correspondence. Materials will then be forwarded to the IRB Chair or IRB Member for approval of exempt status. The IRB staff, after consultation with the IRB Chair or an IRB member, may determine that the research qualifies for expedited or full-board review, but may not deny the project. The PI will be notified via e-mail if expedited or full board review is required, be given the reasons why it is required, and be asked to resubmit the study on the Expedited/Full Board Protocol Application form.
Exempt research must be minimal risk. Research activities in which the only involvement of human participants falls under one or more of the specified EXEMPT CATEGORIES are exempt from the Federal Policy for the Protection of Human Participants. Per 45 CFR 46.101(i), the exemptions at 45 CFR 46.101(b) do not apply to research involving prisoners or research with children, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.
If the study qualifies for exempt status, the IRB staff will notify the PI via the standard exemption notification letter.
Although the regulations do not require informed consent for exempt research, the IRB has determined that informed consent is ethically appropriate to ensure that prospective participants are informed of the research and have an opportunity to decide for themselves whether or not to participate. In most cases, the IRB will waive written consent and ask that the PI prepare an information sheet according to the requirements set forth under 45 CFR 46.116.
An exempt determination does not permit you to make changes to your study at any time without IRB review. You must notify the IRB to any changes in your study by completing a MODIFICATION FORM before they can be implemented. To be eligible for review under the exempt procedures the amendment must be minor. A minor change is one which makes no substantial alteration in:
- The level of risk to participants;
- The research design or methodology;
- The participant population;
- Qualifications of the research team;
- The facilities available to support the safe conduct of the research
Any other requested amendments may require the application be changed to expedited or full board.
Exempt protocols have a separate application from expedited and full board review. Please allow up to two weeks for the exempt review process.
Expedited Review
To receive an expedited review, your study must fall into one or more of the EXPEDITED CATEGORIES. Expedited research does not have to go before the full board to be approved.
Expedited research must involve no more than minimal risk. As defined in the federal regulations, “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 (45 CFR 46.102(i)). Only the expedited IRB reviewers may determine if a protocol is granted expedited status under seven of the nine categories as published in the federal register as 45 CFR 46.110. Categories 8 and 9 do not pertain to initial review.
The IRB staff reviews the protocol application and all of the material required for submission for expedited review. The IRB staff member may contact the PI directly to resolve any questions or concerns, or to require amendments prior to approving the exempt status. Contact will generally be made via e-mail to provide documentation of the correspondence. Materials will then be forwarded to the expedited reviewers.
The IRB staff, in consultation with the IRB Chair, may determine the application to be of no greater than minimal risk and qualify for exempt review. The protocol application will be added to the queue for exempt review. You will not need to resubmit an exempt application.
The expedited review is conducted in accord with the criteria set forth in 45 CFR 46.111. In addition, the reviewers must also determine 1) that the research is minimal risk, 2) that if identification of the participants and/or their responses reasonably place them at risk of criminal or civil liability or could be damaging to the participants’ financial standing, employability, insurability, or reputation, or be stigmatizing there are reasonable and appropriate protections that will be implemented so that risk related to invasion of privacy and breach of confidentiality are no greater than minimal, and 3) that the research is not classified or does not involve prisoners, with the exception that the expedited review of minor amendments for approved studies involving prisoners may be used.
The expedited IRB reviewers will make one of the following three determinations in regard to the protocol and consent forms:
APPROVED: IRB approval indicates that the IRB reviewer(s) has concluded that the research and consent forms meet the federal criteria for approval.
MODIFICATIONS REQUIRED IN ORDER TO SECURE APPROVAL: The IRB reviewers withhold approval pending submission of revisions/additional information.
FULL REVIEW REQUIRED: The IRB reviewers may determine that the protocol requires full review by the IRB at a convened meeting.
If the reviewer determines the protocol is approved, the IRB staff will notify the PI or correspondent via the standard expedited approval letter. The approval letter describes the expedited category under which the study was approved. The approval period for studies approved through expedited review will be for one year from the date the initial approval or approval for continuation is granted. Approval is valid through the expiration date noted in the approval letter. For example, an expedited study given approval (either initially or for continuing review) on October 8, 2011 would be approved as valid through October 7, 2012, meaning that research is approved to be conducted on October 7, 2012, but will no longer be approved on October 8, 2012, and may not be conducted on or after that date without continuing approval by the IRB.
If the reviewers determined the protocol requires modifications to secure approval, the IRB staff will send a letter by e-mail to the PI or correspondent listed on the protocol detailing the additional information needed or changes required. The PI responds to revisions requested by the IRB in writing and sends the response to the ORC. The IRB Reviewers who conducted the original review will review the revisions to determine if all concerns were properly addressed. If the IRB staff and reviewers determine that all concerns have been addressed, the IRB staff will issue the approval letter. The approval letter describes the expedited category under which the study was approved. If the reviewers and the investigator cannot agree on the amendments required for approval, the research will be sent to the convened IRB for review. The PI will be notified by the IRB staff via e-mail if full board review is required and given the reasons as to why it is required.
The expedited reviewers may not disapprove any research reviewed using the expedited procedures.
An expedited determination does not permit you to make changes to your study at any time without IRB review. You must notify the IRB to any changes in your study by completing a MODIFICATION FORM before they can be implemented. To be eligible for review under the expedited procedures the amendment must be minor. A minor change is one which makes no substantial alteration in:
- The level of risk to participants;
- The research design or methodology;
- The participant population;
- Qualifications of the research team;
- The facilities available to support the safe conduct of the research; or
Any other factor which would warrant review of the proposed changes by the convened IRB.
The expedited application and full board application are one in the same. On the application, please indicate which review category your research falls under. Please allow up to four weeks for the expedited review process.
Full Board
Any research involving the use of human participants that does not fall into the exempt or expedited categories must be submitted as full board. Full board applications are reviewed and approved by all members of the IRB.
Prior to the meeting, the IRB staff, in consultation with the IRB Chair, reviews the protocol to determine if the PI’s assessment is correct. If the submission is determined to be of no greater than minimal risk and satisfies the criteria for expedited review, the protocol is added to the queue for review by expedited procedure.
Each member of the IRB receives a complete copy of the protocol submission and grant proposal (if applicable). At the convened meeting, all IRB Members will present any concerns they may have had with protocol application. Discussion and voting will follow.
Full Board reviews are conducted in accord with the criteria set forth in 45 CFR 46.111. The Board can make one of the following four determinations in regard to the protocol and consent forms:
APPROVED: IRB approval indicates that the Board has concluded that the research and consent forms meet the federal criteria for approval.
MODIFICATIONS REQUIRED IN ORDER TO SECURE APPROVAL: A vote for amendments required indicates the IRB has given the meeting Chair the authority to approve the minor revisions. The IRB withholds approval pending submission of minor revisions/additional information.
TABLED: The IRB withholds approval pending submission of major revisions / additional information. For some studies, the IRB may appoint one or more members of the IRB to discuss the reasons with the investigator. Once the revisions have been made by the PI and submitted to the ORC, the revised protocol is added to the next IRB meeting agenda for review.
DISAPPROVED: Disapproval of a protocol usually occurs when the IRB determines that the risk of the procedures outweighs any benefit to be gained or if the proposed research does not meet the federal criteria for IRB approval.
If the full board determines the protocol is approved, the IRB staff will notify the PI via the standard full board approval letter. During the convened meeting, the IRB determines the approval period, as appropriate to the degree of risk but not less frequently than once per year. The IRB will generally set a shorter approval period for high risk protocols or protocols with high risk/low potential benefit ratios.
If the full board determines the protocol requires modifications to secure approval, the IRB staff prepares a letter based upon the IRB’s discussion at the meeting. The letter describes the revisions requested by the IRB. The IRB staff sends the letter by e-mail to the PI and Co-Is listed on the protocol. The PI responds to revisions requested by the IRB in writing and sends the response to the ORC. Depending upon the level of changes requested, the revisions may be reviewed by the IRB Chair or by all IRB Members. If the IRB Chair and/or Members determine that all concerns have been addressed, the IRB staff will issue the approval letter. During the convened meeting, the IRB determines the approval period, as appropriate to the degree of risk but not less frequently than once per year. The IRB may set a shorter approval period for high risk protocols or protocols with high risk/low potential benefit ratios. When the PI completes the revisions and they are approved by the IRB Chair and/or IRB Members, the approval period starts from the date the protocol was finally approved.
If the full board determines that a protocol must be tabled, the IRB staff will prepare a letter based upon the IRB’s discussion at the meeting. The letter lists the reasons for the tabling and includes a description of the revisions or clarifications requested. The determination letter is sent by e-mail to the PI listed on the protocol. The PI responds to revisions requested by the IRB in writing and sends the response to the ORC. The protocol is then added to the agenda for the next scheduled IRB meeting. When a protocol that was initially tabled receives final approval, the IRB staff assigns the start of the approval period as the date of the meeting the protocol was approved.
If the full board determined the protocol must be disapproved, the IRB prepares a determination letter based upon the IRB’s discussion at the meeting. The approved letter is sent to the PI by email.
A full board approval determination does not permit you to make changes to your study at any time without IRB review. You must notify the IRB to any changes in your study by completing a MODIFICATION FORM before they can be implemented.
The expedited application and full board application are one in the same. Please indicate which review category your research falls under. The final determination that a research project falls under full board can only be made by the IRB.
Full Board Submission Deadline: You must submit full board applications at least two weeks before the IRB’s regularly scheduled meetings. All applications that are not received within two weeks of the IRB meeting will be reviewed at the next month’s meeting. Please allow up to six weeks for the full board review process; longer if the protocol is tabled.
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