Common Rule changes under the Notice of Proposed Rulemaking (NPRM) could impact how IRBs handle the informed consent process, by both increasing transparency and imposing stricter new requirements about information provided to prospective subjects.1
For example, the NPRM states that rules will be tightened to make sure the informed consent process becomes more meaningful and to shorten the length of informed consent documents so that the most important information isn’t buried and hard to find.1
IRBs and research institutions likely will need guidance on these new requirements for consent, notes Julie Kaneshiro, deputy director of OHRP.
“As part of that guidance development process, we would at least be contemplating whether or not to develop model consents to facilitate the community’s understanding of what we think would be necessary to satisfy new requirements,” Kaneshiro says.
The goal for improving IC is to bring it back to its true purpose of telling potential research participants what a study is about, what its risks and benefits are, and other required elements, says Ivor Pritchard, PhD, senior advisor to the director of OHRP.
“Informed consent is cluttered with extraneous information that often is designed to protect the institution from liability,” Kaneshiro says. “That cannot be part of the core consent document; the consent document has to be something that was designed to help the person decide whether or not they want to participate in a study.”
Institutions that want to add more than the required IC elements to the document should include these as secondary pieces, such as in appendices, she adds.
Some studies in recent years have used electronic informed consent with links to extra language, and this model is fine, Pritchard says.
“Present the information that is required by regulations first, in its own section, and then give people reams of other institutional legalese — but have that in another section of the document,” Pritchard explains.
The NPRM also will require informed consent for the use of stored biospecimens in secondary research, such as studies done of blood samples left over after being drawn for clinical purposes. This type of consent would be broad consent applied to their storage and potential research use.
One example would be blood spots collected routinely of newborn infants to identify disorders that are not apparent at birth, including metabolic disorders, sickle cell disorder, cystic fibrosis, and toxoplasmosis. These blood spots are saved and can be excellent resources for genetic and other research. But in recent years, they have caused controversy, including in Texas, which destroyed hundreds of thousands of samples following a lawsuit over their collection.
“In the past, there hasn’t been consent for all research use of clinically collected blood spots,” Kaneshiro says.
“Now, Texas is providing consent with research use, which is consistent with what NPRM is proposing,” she says. “One of the biggest changes involves research use of a specimen collected for clinical purposes or some other research activity that falls outside of our rule because it’s stripped of all identifiers.”
The NPRM proposes that all research uses of biospecimens will be covered by the Common Rule, and most of these would need at least broad informed consent, Kaneshiro says.
“We’re envisioning this could be a very broad statement and it wouldn’t have to be limited to just cancer research,” she adds. “Also, there is a companion requirement that the standardized privacy protections would have to be in place.”
The informed consent template probably would say something like this: “Your biospecimen will be used in laboratories using procedures designed to identify various kinds of diseases and factors related to those diseases or causes of those diseases,” Pritchard says. “They would not specifically identify the diseases because nobody knows about these yet, but it will give the subject the general idea that this biospecimen may be used to uncover a disease.”
The idea of requiring broad informed consent is in the middle of the spectrum of options regarding biospecimens and research, Pritchard notes.
“The notion here is that people are going to be more likely and willing to participate in or support the research enterprise if they are asked for some kind of permission to use their specimens,” he explains. “There is empirical evidence showing that people’s preference is to be asked.”
However, most people would be annoyed if they were asked 50 or more times for permission to use their specimen, and it would be difficult for researchers to do this, Pritchard says.
“This notion of asking for broad consent represents a middle way of honoring that general preference without creating a large burden for researchers,” he adds.
Surveys that ask people about biospecimens in research likely overrepresent the average person’s interest in what researchers do with specimens and resulting data, suggests William Smith, JD, director of the institutional review board at Nova Southeastern University in Davie, FL.
“They ask, ‘Do you want us to take into consideration what we do with your biospecimens and data,’ and people are going to say, ‘Yes,’” Smith says. “But they’re not asking the follow-up questions.”
For instance, are people really interested in how their leftover blood or tissue samples are used?
“The people who mind are very vocal about it,” Smith says. “Most people don’t mind.”
The NPRM’s changes to informed consent and biobanking are particularly disturbing because it focuses on biobanking as its own special entity, he says.
“I’m upset that biobanking has its own standard of review,” Smith says. “I don’t think that’s going to work, and one reason why I don’t think it’s going to work is that they’ve rearranged the definition of research around biobanking.”
Biobanking on its face is de-identified, so it should not require full informed consent. But the NPRM requires broad consent even when the investigator does not have information available to identify donors of the biospecimens.
It would be better if the NPRM did not pay extra attention to biobanking, Smith says.
“Get rid of biobanking as its own category of review and let it be folded into the other categories instead of being given special treatment,” Smith adds.
REFERENCE
- Federal policy for the protection of human subjects; proposed rules. Fed Reg. 2015;80(173):53933-54061.
Common Rule changes under the Notice of Proposed Rulemaking could impact how IRBs handle the informed consent process, by both increasing transparency and imposing stricter new requirements about information provided to prospective subjects.
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