Revised Common Rule - January, 21, 2019
The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). There are new consent requirements which the revised Common Rule Guidance and the Consent Form Template address.
Consent or a waiver of consent is no longer necessary for screening, recruiting, or determining eligibility (45CFR46.116(g)(1) or (2)). An IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining eligibility of prospective participants if either of the following conditions are met:
- The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
- The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
Telephone screens may require a HIPAA Waiver form (see link). See also the HIPAA Guidance under Consent in the menu bar.
New Good Clinical Practice Requirements - Friday, April 28, 2017
As you know, NIH has been placing increasing emphasis on rigor and reproducibility in research and expanding the application of Good Clinical Practice standards. To meet these new standards, our Research Compliance Administrator has refined the monitoring process to align with national trends and expectations. She has also been working to train investigators and research coordinators in effective self-monitoring techniques, with the goal of improving data quality and increasing our readiness for sponsor and regulatory inspections.
Multi-Site Trial Subcommittee: - Friday, April 28, 2017
The IRBâs Multi-Site Subcommittee has just completed its first year of operation. This pilot initiative was launched in anticipation of the âsingle IRB mandateâ and in order to provide timely review for industry- or NIH-sponsored multisite trials that are especially time-sensitive. As industry sponsors increasingly employ free-standing clinics and contract research organizations to carry out trials, we need to be able to move quickly while maintaining high standards for ethics and subject protections. The subcommittee consists of members with expertise in pharmacotherapy trials with new compounds and with the methods and logistics of multi-center trials. The goal is for the interval between initial IRB submission and approval to be 4 weeks or less. Guidelines are provided to investigators in an effort to promote high quality submissions and help Investigators anticipate problems that typically arise in the review of such trials. Over the past year, the multi-site subcommittee has met its turn-around-time target.
Significant Changes in IRB Review are Just Around the Corner - Friday, April 28, 2017
As many of you know, the NIH has issued a policy on single IRB review, effective September 25, 2017, âestablishing the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the National Institutes of Health (NIH) will use a single Institutional Review Board.â
More substantially, January 19, 2018, is the effective date for the final revisions to the Common Rule. Significant changes in the regulations governing human subjects research involve its applicability to non-federal research, the definition of research and human subject, new categories of research that may be exempt from IRB review, additional requirements for informed consent for clinical trials, and a relaxation of requirements for continuing review. A single IRB mandate for âcooperativeâ research becomes effective in January, 2020.
IRB leadership and staff are working in concert with OMH leadership, Counselâs Office, and ITS to adapt and revise our policies, procedures, and information systems to the new regulations and policies. We will keep you informed of actions you will need to take as implementation dates near.