Consent is a major focus of commission's report
IC process is most challenging
Whole genome sequencing research raises important informed consent issues for IRBs and investigators, and the recent report by the Presidential Commission for the Study of Bioethical Issues (PCSBI) addresses these in its recommendations.
"The specific informed consent recommendations the commission made have to do with two important pieces of consent: One is the consent process and the other is consent forms," says Lisa M. Lee, PhD, MS, executive director of the PCSBI.
"The commission recognizes these are two different things, and the easy one is the informed consent forms," she adds. "We recommend OHRP [Office for Human Research Protections] or another agency specifically provide guidance to researchers who do whole genome sequencing about what should be included in consent forms."
This recommendation stems from researchers telling the commission that they are not sure what to include because this type of research is very complicated, Lee notes.
For example, how should researchers describe the safeguards in place to protect whole genome sequence data from being re-identified through some future advances in technology?
Whole genome sequence data can be stripped of traditional identifiers, but it remains unique to one particular person. These data would be confidential so long as it remains de-identifiable. So informed consent could be waived by an IRB, according to the Common Rule, the PCSBI report states.
"The Common Rule states that data and specimens collected in the clinic, when stripped of traditional identifiers, can be used in research without consent," the report says. "Because consent requirements differ in clinical and research settings, researchers could theoretically seek out data and specimens collected in the clinic to bypass the more involved research consent requirements."
However, the commission states that it does not condone researchers circumventing IRB approval by seeking out clinical data and specimens for use in research when they could not otherwise obtain IRB approval.
Evolving technologies have made the concept of de-identified data fluid in the public's mind, the report notes.
"If data becomes readily re-identifiable, and some people think that would be possible soon, then we're dealing with a different set of circumstances," Lee says.
The commission's report suggests that even when data are being accessed and used with informed consent, the privacy of individuals should be well protected by the researchers using the data.
In general, the informed consent form should include a definition of whole genome sequencing, how the data will be used, stored, and analyzed, and whether the participant would have any say over that use, and whether incidental findings will be returned to individuals or the participant's physician, Lee says.
The report also notes that some informed consent documents acknowledge that absolute privacy cannot be guaranteed and that IC policies will evolve as the public's notions of privacy evolve and change.
The informed consent process is an even more complicated issue, and experts have proposed a variety of methods for handling it, she says.
"There are many other types of consent processes being considered now with these studies," Lee says. "Many folks are experimenting with things like dynamic consent where people who are participating are contacted or re-contacted based on new studies and opportunities for their data to be used."
Others are considering the broader issue of how people want their data used and offering them opportunities to opt out of research at the time the specimen is collected, she adds.
"One suggestion from OHRP and the ANPRM [Advanced Notice of Proposed Rule Making] is that people have control over what kind of study their data can be used for, and they can pick that at the outset," Lee says. "The commission studied different types of consent, evaluating what works and taking a hard look at what kind of consent people want and what works; the commission recommends that they be studied."
Whole genome sequencing research raises important informed consent issues for IRBs and investigators, and the recent report by the Presidential Commission for the Study of Bioethical Issues (PCSBI) addresses these in its recommendations.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content