When a research protocol and application materials are submitted to the Human Subjects Review program office, the administrator will review the protocol and determine whether it is Exempt from Further Institutional Review, or requires either a Minimal Risk ("expedited") or Full Board Review. If the protocol is, in fact, exempt, the administrator will send a letter of institutional approval to the principle Investigator, indicating that the research is exempt from review. Following receipt of this letter, the investigator may implement the study-related procedures.
NOTE: Recruitment activities are considered study-related procedures and thus, cannot begin until after institutional approval has been obtained.
Research protocols that do not meet the requirements for an exemption may be reviewed in one of two ways. If the research protocol is eligible for a minimal risk review, the investigator's materials will require review by a subcommittee of the HSRC. Although this minimal risk or "expedited" review usually takes less time than a full board review, it is only available to research activities meeting specific criteria. Second, those protocols not eligible for an expedited review should be submitted to the HSRC for review by the full board at a convened meeting.
For AY 2016-17 review and processing times may take up to three weeks for exemptions and up to 8 weeks for minimal risk and full board protocols.
1. Carefully evaluate whether or not the proposed study meets the criteria for exemption, minimal risk, or full board review. (NOTE: If your study uses already existing data collected for purposes other than this research, complete the Archival Data Checklist to determine your next step.)
2. Complete the appropriate form. Students should review the application materials with the faculty sponsor before obtaining required signatures.
3. Submit one hard copy and one electronic copy of the application materials to the HSRC.
4. Complete the RCR training.
NOTE: Complete the checklist at the end of the application to ensure all materials are submitted. Incomplete applications including questions not thoroughly answered or content with considerable spelling and grammar errors will be returned.
The federal regulations (45 CFR 46.101) specify the criteria by which a research protocol is eligible for an exemption from institutional review. The following excerpts from the federal regulations define the categories used to determine such exemptions.
Note: All research proposals must be submitted for review by either the HSRC administrator or the council. Investigators who believe their research protocols meet the criteria for exemption from further institutional review may submit the Request for Exemption Form rather than the lengthier initial application for HSRC approval.
Minimal Risk Review (sometimes referred to as "Expedited Review") is intended to provide a review for research projects that pose only a minimal amount of risk to subjects. A minimal amount of risk is equivalent to that which would be encountered by an average person in their daily life. Rather than requiring a meeting of the full Human Subjects Review Council, Minimal Risk review is conducted by a subcommittee of its members. Typically, subcommittee members independently review the application materials and forward their recommendations to the HSRC Chair. The proposal is approved if all subcommittee members approve it; otherwise it is referred for "Full Board Review" at a scheduled meeting of the Human Subjects Review Council.
Investigators should consider submitting a research protocol for "Minimal Risk" (i.e., expedited) review only after carefully evaluating whether or not the proposed study meets the criteria for such a review (see next question). Investigators should note that when proposals are improperly submitted for Minimal Risk Review, the review process may actually be slowed. Any doubts about submission can be addressed by the administrator of the review program.
According to the Federal regulations, a research protocol qualifies for Minimal Risk (Expedited) review if it involves "no more than minimal risk" as defined by specific categories [see the Expedited Review Categories for more information]. These categories include, but are not limited to:
It is important to remember that it is not the presence of the above activities that qualifies an application for minimal risk review, but the absence of anything beyond such activities. If the study involves any activities that are more intrusive, more personal, or more risky than the above, it is unlikely to qualify for minimal risk review. Instead, such research protocols would receive a full board review at a convened meeting of the Human Subjects Review Council (HSRC).
If, after carefully reviewing the criteria for minimal risk, or "expedited review" described in the Federal regulations, an investigator should submit the Initial Application for HSRC Review application. On the first page of the application form, the first section provides an opportunity for the investigator to request an minimal risk (or "expedited") review of the research protocol and application materials. Please note that the "Request for Exemption" form should not be used when applying for a "Minimal Risk Review."
Any research protocol that does not fall into one of the other two categories (i.e., "exempt" or "minimal risk") shall be submitted for full board review. The principle investigator will be requested to submit one signed hard copy of the HSRC Application form and supporting documents along with an electronic copy of the entire packet for review by the full board. HSRC approval is usually valid for one year and may be amended or modified using the requisite applications forms (e.g., Request for Continuing Approval, Request for Approval of Modifications).
With Apple's new ResearchKit, medical researchers can create apps for their studies that will help rAs Data Overflows Online, Researchers Grapple With Ethics
Social media has the potential to change social science research, but with it come new ethical impli