The revised Common Rule, scheduled to take effect July 19, includes new requirements for the structure of informed consent documents, including that they begin with a concise presentation of the form’s essential points — a change that could turn the form into a tool that can help guide a patient’s clinical decision-making.
Under the new regulations, sponsors must include upfront statements and explanations: how consent is being sought for research, and that participation is voluntary; the purpose, expected duration and procedures of the study; the reasonably foreseeable risks and discomforts; the potential benefits; and any alternative treatments available.
“Many of us view this provision as one of the most important innovations to the regulations, and we think it has a huge potential for improving the system,” said HHS Office of Human Research Protections Director Jerry Menikoff, during a March 14 meeting of the HHS Secretary’s Advisory Committee on Human Research Protections, which was tasked with exploring the impact of the new regulations on the research community.
The most common complaints about consent forms have been that they are too long and unwieldy, with large portions acting as boilerplate, or written vaguely enough to apply to any trial, Menikoff said. He compared other forms to television advertisements for medicines, with wonderful, colorful descriptions of the drug’s potential benefits and then buried, compressed lists or grids of possible risks, ad nauseam.
OHRP has said, for example, that a complicated clinical trial involving cancer patients with 20- to 25-page-long consent forms may have a key information section of no more than a few pages. A 10-page description of potential risks, accompanied by complex charts and graphs, however, would not satisfy the rule’s requirements to be concise and focused, they said. While it does not strictly specify the types of information that should be included, OHRP said it expects sponsors to keep the new sections relatively short, and summarize the more detailed information found later in the consent form.
“The overall purpose of the changes to the consent provisions, at heart, is to be truer to the ethical underpinnings of the regulations... giving a person the information they need to make an enlightened decision,” he said.
However, the mandated changes might not have any effect on shortening the overall document, said David Forster, a member of the SACHRP harmonization subcommittee and chief compliance officer at WCG, who described the new requirements as additive.
“It will probably lead to consent forms that are as long, perhaps longer — but if we do this correctly, they will be more understandable to subjects,” Forster said. “No previously existing elements in the current rule were removed,” he noted.
SACHRP member Nancy King said she hopes the new regulations motivate sponsors to think about the clarity of the rest of the consent form.
“What we don’t want is to give directions on how to do this beautiful key information section, and then just have them plop 25 pages of bulleted, unstructured lists after it,” said King, a health policy professor at Wake Forest University.
“I have to say, we talked about length as long as I can remember, and they keep getting longer,” said Stephen Rosenfeld, chair of SACHRP, describing how the key information requirement is a signal of giving up, in a way, of trying to simplify the process.
“There are going to be these drivers — whether they’re liability concerns, compliance concerns or other things — that have stood in the way of us making better, more streamlined consents in the first place,” said Rosenfeld, chair of the executive board for Quorum Review IRB.
“So now we’re going to put all of those things aside, and build a tool that will be part of the consent process that will be focused explicitly and only on participant decision-making,” he said. “If there are side effects that improve the rest, that’s great — but we’ve been trying to do that for an awfully long time without success.”
Hours before the new Common Rule was scheduled to go into effect January 19, the federal government pushed back the implementation date by six months to July, with the possibility of enacting further delays.
However, companies can begin implementing certain provisions of the new rule before the deadline — such as the informed consent key information requirements — because the changes are not prohibited by and do not conflict with current law, according to the OHRP.