The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies announced proposed revisions to make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. A Notice of Proposed Rulemaking (NPRM) was published in the Federal Register on September 8, 2015 and seeks comments on proposals to better protect human subjects involved in research, while facilitating valuable research.
One of the major changes will pertain to the rules of informed consents. The rules will be become significantly tightened so that consent forms are not long documents with important information often buried and hard to find. In addition, informed consent would generally be required for secondary research with a biospecimen (for example, part of a blood sample that is left over after being drawn for clinical purposes), even if the investigator is not being given information that would enable him or her to identify whose biospecimen it is. Such consent would not need to be obtained for each specific research use of the biospecimen, but rather could be obtained using a “broad” consent form in which a person would give consent to future unspecified research uses.
The NPRM also attempts to strengthen the effectiveness and efficiency of the oversight system by making the level of review more proportional to the seriousness of the harm or danger to be avoided. Research that poses greater risk to subjects should receive more oversight and deliberation than less risky research.
The changes to the Common Rule proposed in the NPRM can be found by visiting: NPRM Summary of Proposed Changes to Common Rule
The full notice can be found by visiting: Federal Register Notice of Proposed Changes
To submit comments or feedback:
DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on December 7, 2015.
ADDRESSES: You may submit comments, identified by docket ID number HHS– OPHS–2015–0008, by one of the following methods:
Federal eRulemaking Portal:http:// www.regulations.gov. Enter the above docket ID number in the ‘‘Enter Keyword or ID’’ field and click on ‘‘Search.’’ On the next Web page, click on ‘‘Submit a Comment’’ action and follow the instructions.
Comments received, including any personal information, will be posted without change to http:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Jerry Menikoff, M.D., J.D., Office for Human Research Protections (OHRP), Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852; telephone: 240–453–6900 or 1–866–447–4777