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Sept. 2 — A long-awaited proposed rule to modernize regulations governing human research subjects was released by federal agencies Sept. 2, marking the first proposed overhaul of the so-called Common Rule (45 C.F.R. Part 46) in nearly 25 years.
The notice of proposed rulemaking (NPRM), Federal Policy for the Protection of Human Subjects, is designed to update a rule that has been in place since 1991 to account for the evolution of the research enterprise and introduction of new disciplines and new technologies, such as whole genome sequencing. The Department of Health and Human Services and 17 other federal departments and agencies, whose authority to oversee clinical trials would broaden under the proposed rule, said in the summary that the changes are designed to build public trust in the research system.
Jerry A. Menikoff, director of the HHS Office for Human Research Protections, which administers the Common Rule, told Bloomberg BNA Sept. 2 that the proposal improves upon the advance notice of proposed rulemaking (ANPRM) issued in July 2011.
He identified two main goals of the proposed changes: to better protect those who agree to participate in research studies and to eliminate processes that burden the research system without adding any protections.
“We tried to go back to our basic ethical principles,” he said.
The summary of the 519-page proposed rule highlighted several key changes, including an effort to revamp the informed consent process to move away from lengthy documents filled with legal jargon that fail to convey a meaningful message about what it means to agree to participate in a study.
Menikoff said the proposed changes would require the consent form to be a short, core document that puts the most important information at the top, implements a reasonable-person standard for legal disclosures and requires consent forms for clinical trials to be posted publicly online 60 days after the trial ends.
“We're going to put in place rules that will enable the process and the consent form to do a much better job” of making sure people who are asked to enroll in a clinical trial get all the information they need to make an informed decision, Menikoff said. “These are really big-ticket, major changes that will substantially improve informed consent.”
Michele Russell-Einhorn, senior director of the Office for Human Research Studies at Dana-Farber Cancer Institute in Boston, told Bloomberg BNA that the public posting requirement “will add administrative burden to investigators and to clinical research staff.” She said institutions will have to implement procedures to track when a trial is closed to recruitment, when the consent has to be posted on the federal website and who is responsible for doing that. Also, she said, it's unclear whether there will be penalties for late postings or a failure to post the consent form.
The proposed rule also would require informed consent for the use of stored biospecimens in secondary research, such as research using part of a blood sample that's left over from a prior clinical use. Currently, biospecimens that have been stripped of identifiers aren't subject to the regulations.
IRBs could waive or alter the biospecimen research informed consent requirements only in very rare circumstances under the proposal.
Menikoff said he expects the new biospecimen consent requirement to be a broad, forward-looking consent for all future uses that's captured at the point of data collection.
The proposed rule would create new categories of research that would be excluded from Common Rule jurisdiction because they either aren't defined as human subject research or are inherently low-risk, or the subjects already are protected from informational risks under a separate mandate such as the Health Insurance Portability and Accountability Act Privacy Rule.
Menikoff said the exclusion categories are distinct from the current Common Rule exemption categories—which also would be expanded under the proposed rule—because an IRB must determine whether research is exempt, whereas excluded research wouldn't need to be submitted to an IRB in the first place. This is an effort to better calibrate the level of review to the level of risk involved in the research, the proposed rule said. The regulations still would require certain exempt and all nonexempt research to provide privacy safeguards for biospecimens and identifiable personal information.
T. Howard Stone, administrator of the Washington State Department of Social & Health Services IRB, told Bloomberg BNA that excluding these activities from any administrative or IRB review would lead to significantly less regulatory burden, consistency within and between institutions and reduced ambiguity. “Clearly the research community will be cheered by the prospects of this change,” he said.
The proposed rule summary said the HHS also plans to develop a Web-based “decision tool” to determine whether research is exempt from the regulations.
The NPRM would extend the scope of the Common Rule to cover all clinical trials conducted at a U.S. institution, regardless of funding source, if the institution receives federal funding for nonexempt human subjects research. The current regulations apply only to federally funded research unless an institution checks a box in its compliance agreement with the OHRP indicating that it agrees to have all of its research subject to the Common Rule.
Menikoff said the NPRM would limit the proposed expanded authority to clinical trials, focusing on studies that pose the greatest potential risk to subjects.
“We think it's important that there be protections, absolutely, on those trials in particular,” Menikoff told Bloomberg BNA. “Those are the studies where there are actual health risks at stake.”
The NPRM kept the advance notice proposal to require a single institutional review board to review multisite studies. As part of the ANPRM, that proposal received a split response, with researchers and disease groups tending to favor the change and IRBs opposing the mandate, according to a Feb. 28 presentation by an OHRP staff member.
Menikoff said there's little evidence that having an IRB at each institution review the same study enhances subject protections, and the practice can create administrative burdens and delay the start of studies.
The National Institutes of Health, meanwhile, has moved forward with its own draft policy that would require all multisite studies to undergo review by a single IRB. “That's part of the discussion, and we are looking forward to all the comments,” Menikoff said about the NIH draft policy.
Menikoff noted that the single IRB and new biospecimen consent requirements wouldn't take effect until three years after publication of the final rule. The HHS installed these “delayed triggering” steps out of a recognition of the initial costs and to ensure that institutions have the proper infrastructure in place.
The NPRM also would eliminate the continuing review requirement—typically once a year—for studies that undergo an expedited review process and studies that have completed study interventions and are merely analyzing data or involve only observational follow-up in conjunction with standard clinical care.
The public release of the proposed rule represents the first major action on Common Rule modernization since the White House issued the ANRPM more than four years ago. The lapse in time between the ANPRM and proposed rule led to skepticism at some points about whether the federal government would ever move forward with a proposed rule.
• the House-passed 21st Century Cures bill (H.R. 6), which includes language to “reduce regulatory duplication and unnecessary delays” by harmonizing the Common Rule with the corresponding Food and Drug Administration regulations (21 C.F.R. Part 50); and
• the White House Precision Medicine Initiative, which also calls for modernizing the human subject protection regulations.
Once finalized, the updated Common Rule will affect research regulations at 18 federal departments and agencies, including the HHS, the NIH and the federal departments of Agriculture, Education, and Homeland Security.
The NPRM is scheduled to be published in the Sept. 8 Federal Register, and public comments will be accepted through Dec. 7.
Ann Bonham, chief scientific officer of the Association of American Medical Colleges, told Bloomberg BNA her organization is pleased that the text of the proposed rule is available and appreciates the work of the agencies that collaborated on its development.
“This is a critical opportunity to shape the regulations that will govern human subjects research, protecting and engaging research subjects while facilitating research to advance the health of patients and populations,” she said Sept. 2.
Stone said, “While the cheering may be deafening, only with time will we better understand whether the proposed changes—clearly intended to reduce the regulatory burden associated with such reviews and oversight—do not result in any measurable increase in risk to research subjects.”
To help ensure that these and other changes also serve the public interest, the rule's impact on the protection of study subjects should be carefully monitored, he said.
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