The Common Rule is undoubtedly one of the most significant governing documents in research today, with jurisdiction over human research subjects and Institutional Review Boards, or IRBs. Human subjects research protections and relating policies are critical to the public good, and have the potential to dramatically impact the conduct of research. As such, they are of the utmost importance to AcademyHealth and its members. In late 2014, two different comment opportunities surfaced that had the potential to affect human subjects research, and AcademyHealth had a responsibility to respond on behalf of the field.
Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care
In October, the Office for Human Research Protections (OHRP) announced the invitation of public comments on its Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care. Within the draft guidance, OHRP specifically addressed what risks to subjects are presented by research evaluating standards of care, and which of these risks are reasonably foreseeable and should be disclosed to prospective research subjects as part of their informed consent.
As written, AcademyHealth felt the guidelines would have a negative effect—both on the ability to develop critically needed knowledge and on the likelihood of patients enrolling in studies that would provide them with more information on risks and benefits than they currently receive as part of routine care. There is important work being done to clarify public attitudes on consent in this type of research, and if OHRP were to implement this draft, the participation of those patients representative of the intended target population could be jeopardized.
The full set of comments can be found here.
Use of a Single Institutional Review Board for Multi-Site Research
In December the National Institutes of Health (NIH) released a request for comments on the Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research.
AcademyHealth believes the proposed revision from NIH will speed the initiation of studies by reducing administrative burdens to scientific innovation and progress while simultaneously assuring the rigorous and potentially enhanced protection of human subjects.
The full set of comments can be found here.
AcademyHealth continues to monitor for comment opportunities that would advance our field, promote the interests of our members, and ultimately contribute to the improvement of health and health care. Continue to monitor our work through the AcademyHealth blog and on the advocacy portion of our website.