HRPP SOP 101
- Policy Title: Initial Review of Research
Responsible Office: Office of Research Administration
Responsible Official: Associate Provost for Research Administration
Effective Date: March 9, 2018
Revision Date: Feb. 12, 2019 July 25, 2022
I. Purpose of This SOP
The purpose of this SOP is to set forth the procedures to be followed in the initial review of human subjects research protocol submitted to the Brandeis University Institutional Review Board for research to be conducted under the auspices of Brandeis University.
II. Scope of This SOP
This SOP applies to human subjects research projects conducted under the auspices of Brandeis University.
III. Statement of SOP
It is the standard operating procedure of Brandeis University that all human subjects research conducted under its auspices must be reviewed by HRPP staff for determination of its review status (exempt, expedited, full) and, if nonexempt, by the Institutional Review Board for approval.
Institutional Review Board protocols must be submitted electronically via the online system, with all relevant signatures attached.
All Institutional Review Board protocols undergo an initial administrative review by HRPP Staff. At this time, the IRB administrator may request additional information about the research, additional documentation and/or revisions to the protocol. Once all additional information, additional documentation and/or revisions are submitted, HRPP staff reviews the protocol for an initial review category determination.
Projects that meet the requirements for one or more of the exempt status categories specified in the federal regulations, involve no more than minimal risk to subjects, do not involve deception (incomplete disclosure may be allowed if subject agrees to the incomplete disclosure prospectively), do not involve children unless expressly allowed by the category of review, and do not involve prisoners (or their data), undergo review by a qualified HRPP staff member and/or by an Institutional Review Board member designated by the chair.
Projects that meet the requirements for limited Institutional Review Board review under exempt category two or three, as well as the additional requirements listed above, undergo review by an IRB member designated by the chair.
Possible outcomes of review for exemption status:
Exempt: The protocol is exempt and research may proceed.
Does Not Qualify for Exempt Status: The protocol does not qualify for exempt status and the applicable review process is observed.
Exempt Status Categories
Projects are eligible for expedited review if they involve no more than minimal risk to subjects and meet one of nine categories specified by the federal regulations. For protocols qualifying for expedited review, the Institutional Review Board chair or his/her designee assigns one or more designated reviewers to evaluate the submission and make a final determination about the acceptability of the research protocol. IRB members are assigned to review protocols based on relevant disciplinary and regulatory knowledge and experience with study contexts and populations.
Possible outcomes of an expedited review are:
Approval: The protocol is approved and no changes are required or recommended. Research may proceed.
Conditional Approval: The protocol is approved contingent on minor revisions being made. (At this point, revisions may be reviewed by the IRB administrator.)
Requires Revision: The protocol cannot be approved without revisions, clarifications or additional documents. Once these are submitted, the review process is repeated.
Does Not Qualify for Expedited Review: The protocol does not qualify for expedited review and the applicable review process is observed.
Note that assigned reviewers of an expedited review may not disapprove a research protocol. If the reviewer believes the research should not be approved, it must be referred to the full committee for a final determination.
Expedited Review Categories
Full Committee Review
Projects that involve more than minimal risk or prisoners, or those that do not fit into one or more of the categories for expedited review or exempt status, must be reviewed by the full board at a convened meeting at which a majority of the membership of the IRB is present, including at least one member whose primary interests are non-scientific.
In the event the IRB lacks the appropriate expertise to assess scientific merit and the research is judged by the IRB to have greater than minimal risk, the IRB may seek outside expertise to assist its evaluation of the proposed research.
Approximately one week prior to the next scheduled board meeting, all application materials scheduled to be reviewed are distributed to the full board. It is the expectation that all members of the committee review the application materials prior to the meeting and be prepared to participate in the discussion of the significant concerns, raise additional concerns, provide necessary clarifications, and/or propose resolutions.
The meeting is called to order by the board chair once a quorum of committee members is reached. If a quorum of members is not reached or is lost once the meeting has begun, all proposals not reviewed are tabled and reviewed at the next scheduled meeting or the meeting is rescheduled for such a time that a quorum of members are present.
Once the application has been sufficiently discussed by a quorum of committee members, the members present vote on the review determination. In order for a given project to be approved, it must receive the approval of a majority of the members present at the meeting.
Possible outcomes of a full committee review are:
- Approval: The application is approved and no changes are required or recommended. Research may proceed.
- Conditional Approval: The application is approved contingent on minor revisions being made. (At this point, revisions may be reviewed by the IRB administrator.)
- Requires Revision: The application cannot be approved without revisions, clarifications, or additional documents. Once these are submitted, the review process is repeated (at this point a subset of the committee may be designated by the chair to review the revised application on a rolling basis).
- Disapproval: The application cannot be approved due to issues the committee believes are non-revisable and inherent in the research.
Note: For an application to be approved, a majority of the committee members present must vote to approve the application.
In addition to determination of approval/disapproval of the research application, the reviewer(s) of non-exempt research will assess the level of risk to subjects involved in the research and determine a continuing review schedule that will be no less than annual.
Note: Any application approved by the IRB may be subject to further review by officials of the institution. The institution may not, however, override the IRB’s decision to disapprove an application.
Once the review process is complete, the IRB administrator notifies the investigator electronically of the determination and next steps, including any revisions or clarifications needed. A signed hard copy is available upon request by the principal investigator.
V. Applicable Regulations and Guidance
The U.S. government code of Federal Regulations for the Protection of Human Subjects (45 CFR 46) contains the following requirements involving the procedures for the initial review of institutional review board protocols: