Proposed HHS rule changes cause IRB concerns
Although shorter informed consents, greater use of central IRBs and broader biospecimen consent for unspecified future research were among the possible changes outlined by the Department of Health and Human Services (HHS) in its recent notice of proposed rulemaking for human subject research protections, not all IRBs are fully on board.
The session follows the Sept. 2 release of the draft overhaul that proposed mandatory use of central IRBs for many federally funded studies, although the requirement does not bind any site to participation in such a study and is not covered in cases of studies with sites located both inside and outside the U.S. Some local IRBs have maintained they want to review studies that are under a central IRB’s supervision.
“It’s a hard thing for government to say, ‘We’re going to prevent you from doing that,’” Jerry Menikoff, director of the HHS Office for Human Research Protections (OHRP), said at the public meeting where some of the proposed changes were presented. The session also sought stakeholder comments on proposals to better protect human subjects involved in research and reduce the burden, delay and ambiguity for investigators.
To reduce the length and streamline the focus for what a reasonable person would want to know when discussing informed consent, HHS proposed a two-part form: a short form that includes the core information, with additional data for study participants in a supplementary document. Although informed consent is not part of the Common Rule—the rule of ethics regarding biomedical and behavioral research involving human subjects—an FDA official said the regulatory agency will examine the changes proposed by HHS with an eye toward some degree of harmonization.
The possibility of trimming informed consent received mixed reviews from several IRBs, who liked the focus on addressing the needs of trial participants but cited several key issues of concern. Menikoff acknowledged that the proposed revisions for informed consent are based on complaints that consent forms are too long and complicated, and are written largely to protect the institution from legal liability rather than informing potential subjects.
“Unfortunately, the proposal only adds to the issues we have to address in the consent form, rather than reducing the number of issues that have to be included,” said Cami Gearhart, CEO of Quorum Review. “The HHS proposal ultimately would be just as long, if not longer.”
At WIRB-Copernicus Group, David Borasky, vice president of quality management, had concerns regarding federally funded trials using the HHS approach.
“One practical concern is there are no boundaries for what could be put in the appendix of the informed consent, and my fear is that it could grow in size and eclipse the already lengthy documents that are prevalent in today’s clinical trials,” said Borasky.
As for the reasons why HHS is calling for posting the final copy of the informed consent on a government website 60 days after recruitment is closed, Menikoff said the intent is to make aspects of federally funded research more apparent and possibly prod enrollees in the trial to take more care in reading informed-consent forms.
According to Lynn Meyer, founder and president of IntegReview IRB, the posting doesn’t pre-empt any discussion or findings from the trial. She said the purpose of that provision is to improve the quality of consent forms in federally funded research, as those documents have been difficult to obtain and now will be subject to public scrutiny.
“What initially surprised me is: Why have a red-lined copy of the final consent after recruitment is closed? But it’s a key way for getting minimum posting for greater transparency,” said Meyer.
Another major change deals with secondary research with de-identified biospecimens with the stipulation that consent almost always will be needed when researchers use specimens for studies. Biospecimens include human tissue, blood, plasma and urine that can be stored and used for later research; they usually contain DNA, proteins and other molecules crucial to understanding disease progression. Human biospecimens are stored in biobanks, which are “libraries” that enable scientists to study them for clinical research purposes. The specimens are commonly annotated with information about each patient, including data about their medical conditions and background.
HHS outlined two proposed alternatives for getting needed biospecimen secondary-use consents. The first, known as Alternative A, is consent for sequencing of entire genomes or portions that would expand the definition of “human subject” without regard to the ability to identify the subject who provided the tissue. Alternative B is broader than A and expands the definition of a human subject to include information generated about that individual, which in some situations could be used to identify the source of the tissue—something Menikoff described as “bio-unique information.”
In Alternative B, people would be covered by a broad consent form that enables biospecimen use for unspecified future research. Signing the form would cover the storage of biospecimens and future unspecified uses. It also would eliminate any need for additional consent for later use.
“Whether in privately funded or government-funded research, this represents an unprecedented shift and creates a new form of human subject protection that requires informed consent and has long-term implications,” said Borasky, noting that any biospecimens collected in the course of clinical care would require consent in order to be available for future research use, even if the specimen would be considered de-identified under the current regulations.
The deadline for additional comments and suggestions for the notice of proposed rulemaking for human subject research protections is Dec. 7, under docket number HHS-OPHS-2015-0008.
Ronald Rosenberg is a former business and science reporter for The Boston Globe. He has written features for New Scientist and Inc. magazine. His lengthy journalism career includes editing an award-winning weekly newspaper in Cornwall, N.Y. Ron also was a media relations specialist for the science faculty at Boston University, and a Knight Science Journalism Fellow at the Massachusetts Institute of Technology.
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