- To assure the rights and well-being of human subjects participating in research are protected
- To educate researchers about how to improve study conduct
- To provide resources to the Research Community
Office for Human Subject Protection
On November 5th 2018, the Office for Human Subject Protection (OHSP) went LIVE with a new IRB review system. Click® IRB, is the product through which all human subject research will be reviewed (Huron Consulting is the vendor of this product). The Click® product is a large suite of modules that facilitates and integrates research administration. As part of the Research Administration Modernization Project (see additional information in the OHSP Q2 Newsletter), once the IRB review module has stabilized, the project will shift focus to the grants module (e.g., pre- and post-award grant management). For additional information see the OHSP Q4 Newsletter, which provides detail about accessing and logging into the system, and finding studies approved in ROSS and completing a modification to "fill the shell" in the new system.
As a reminder for security purposes, two-factor authentication is now required when users log into the new IRB review system from outside of the University’s network. Therefore, users will be asked to verify their identity via an alternate physical device (i.e., via your mobile phone, tablet or a landline phone). To facilitate this, OHSP recommends that users who anticipate accessing the review system remotely on a regular basis, enroll in Duo (instructions for doing so are available here). Additional information on two-factor authentication is available through University IT.
**IMPORTANT REGULATORY UPDATE**
The Department of Health and Human Service (HHS) released revisions to the Common Rule (the ‘Federal Policy for the Protection of Human Subjects’) in January 2017, with an initial compliance and effective date of January 19, 2018. An announcement released to the research community on April 19th proposes to further delay the effective and general compliance date to January 21, 2019.
What Does That Mean For You?
- Until January 21, 2019, all new and ongoing research must comply with the current Common Rule (i.e., business as usual, complying with the Common Rule regulations last revised in 1991). Updates concerning exemption categories, continuing review, subject screening, clinical trial consent posting, etc. will not be implemented until January 21, 2019.
- Continue to use the new consent form templates. Although the new consent form templates available on the RSRB website include additional elements of consent and the presentation of ‘key information’ as required in the new regulations, the use of these templates remain consistent with the pre-2018 Common Rule and will not be reverted to the prior version. While the additional elements and presentation of ‘key information’ are not required under the current rule, they do not conflict with current regulations.
Additional information concerning these updates will be provided as it becomes available. Further training concerning the revised regulations will resume as the new effective date (January 21, 2019) nears. Patience, forgiveness and camaraderie will be appreciated during this transition period.
In the conduct of research involving human subjects, the University of Rochester is guided by the ethical principles stated in the Belmont Report. The University's fundamental commitment to the protection of human subjects applies to all human subject research conducted by University faculty or staff, regardless of funding source or site of the research. The University follows the Department of Health and Human Services (DHHS) regulations at 45 CFR Part 46, and the Food and Drug Administration (FDA) regulations at 21 CFR Parts 50 and 56. In developing its policies and procedures, the University considers the guidance provided by the Office of Human Research Protection (OHRP) and by the FDA as part of our commitment. The University will provide written assurance documents to the OHRP to comply with the requirement of 45 CFR 46.103. Assurance documents will be maintained and renewed in accordance with regulations.
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