New SACHRP chair looks to the future

Q&A focuses on harmonization & IC

Barbara Bierer, MD, professor of medicine at Harvard Medical School, and the senior vice president for research and the director of faculty development and diversity at Brigham and Women's Hospital in Boston, MA, is the new chair of the U.S. Health and Human Services (HHS) Secretary's Advisory Committee on Human Research Protections (SACHRP). IRB Advisor asked Bierer some questions about where she sees SACHRP directing its focus in the coming year in this question-and-answer session.

IRB Advisor: We'd like to know what you hope to bring to SACHRP as the chair, some of the things you'd like to see the committee do.

Bierer: For my own tenure, I think there are certainly areas on which we as SACHRP will advise OHRP [Office of Human Research Protection] as questions arise.

Importantly I think that one of the most critical avenues that we can pursue as a committee is looking to harmonization of the privacy rule and common rule and also harmonizing FDA approaches to human subjects research protections and the common rule.

I say that knowing we're the committee advisory to the secretary with purview specifically being OHRP, and OHRP does not have the privacy rule or common rule under its umbrella. It's a little bit difficult to find the path to how we can have the department review areas of opportunity in order to make human subjects protection robust and synchronized. And we'd like it to be easier for investigators to know which rule applies when.

So if I could wish for any effort to be synthesized over the next few years that would be it. As I say, I know that this [objective] is not entirely in our purview. We certainly could make recommendations.

IRB Advisor: Could you be more specific about the privacy rule and harmonizing that with human subjects research?

Bierer: We can get you some specific issues. But the Institute of Medicine (IOM) is even considering this in a committee now. They're looking at the number of both definitions and approaches that are quite different with the privacy rule and common rule.

For instance what are the protections for data involving someone who has died? Those are interpreted differently. What are the approaches to future research, to limited data sets, to informing the patient or subjects? SACHRP will consider it, but I'm pretty sure we will not consider it in our next meeting because the IOM panel is completing its work, and we're going to look toward the IOM panel's recommendation before considering our own public commentary.

IRB Advisor: And the IOM's own recommendation will be about the privacy rule and the common rule?

Bierer: It's about the privacy rule, but there are specific recommendations apparently. I do not know whether they are about the intersection of the privacy rule and common rule. Until they can complete their work, they're not in a position to discuss this. They anticipate the work will be completed by the spring of 2009; we'll take that on then.

I do think one of the things I'd like to see addressed is how we make the informed consent document truly informative to human subjects. We have expectations for having the document use 8th grade language. The documents are becoming so long and arcane that people, participants have trouble understanding what is the research question, particularly in a therapeutic trial where the question being asked might be quite small on the background of a clinical approach that is actually the standard of care.

And I think we need to address how to make the documents or how to assess whether an informed consent is truly understood by participants. I think back on the days when I was doing pediatric oncology. I'm an adult oncologist and an adult hematology oncologist, but I spent some time doing pediatric oncology. And the informed consent documents for pediatric acute lymphoblastic leukemia (ALL) were 13-16 pages long. For pediatric ALL there is a standard of care and we do ask incremental questions on background of standard of care. But for parents and children old enough to give consent, it was difficult to understand the research question as they approached the next three months of their care for treatment of ALL.

IRB Advisor: Do you believe there are long legal paragraphs in the informed consent that should be taken out because they are there for legal issues and not for informing subjects?

Bierer: I personally think there is a role for an executive summary so that one could very clearly say, 'Here's the question being asked and you don't have to participate, but if you choose to participate this is the way we would approach this question.' So people could decide and, in a short document, understand what the question was. That said, I do think the human participants do have the right to the whole document to see all of it, including the whole boilerplate of legal reasons. They should be aware of it, and if they're interested in seeing it, they should have that available to them.

IRB Advisor: What role should SACHRP play in the human subjects research community? Why is it important to have a committee like this?

Bierer: I think it's critical to have a responsive committee that is there to address questions as they arise, to make recommendations when appropriate, and to be as an advisory body independent of the office itself. After all, we are the user group for people for whom the regulations are intended. The regulations may need further clarifications, since they were written some 30 years ago and now are applied in a very different world of research with different sensibilities. We need a forum where these can be discussed, analyzed, and thoroughly reviewed.