Organizations add input on IC with biospecimens

Most oppose wholesale changes

National research organizations and individual researchers have weighed in on the government's proposed changes to the Common Rule, saying regulators should reconsider their plans for requiring informed consent for all biospecimens.

In a comment to the Office for Human Research Protections (OHRP), the American Association for the Study of Liver Diseases writes that the issue of biospecimens is of significant concern to its members.

"We urge HHS to work with interested parties in crafting the policy governing the biospecimens," writes W. Ray Kim, MD, AASLD clinical research committee chair, in a letter submitted Sept. 23, 2011.

"We would like to highlight that many of the seminal discoveries made in our field were based upon biospecimens obtained from purposes other than the questions they ended up answering," Kim writes. "We believe it is possible to strike a good balance between fostering opportunities for new discoveries based on archived biospecimens and ensuring protection of private information of research subjects."

If the Department of Health and Human Services (HHS) continues with the proposed requirement of requiring all studies involving biospecimens to obtain informed consent of people from whom the tissue was extracted, the end result will be fewer researchers and research institutions, writes Helen P. Cathro, MBChB, MPH, in a personal comment to OHRP. Cathro is an associate professor in the department of pathology at the University of Virginia in Charlottesville, VA.

"This requirement would increase the time and resources by orders of magnitude, and put many smaller academic centers out of the business of research altogether," Cathro comments. "In addition, the cost of funding grants will also increase exponentially, further impacting an already stunted research atmosphere."

The Mayo Clinic of Rochester, MN, in a letter sent to OHRP in September, 2011, comments that HHS has raised an important issue with regard to informed consent and biospecimens, particularly because the current Common Rule requirements are not clear and can lead to inefficiencies.

"Of the possibilities mentioned in the ANPRM, Mayo Clinic believes that a notification and opt-out process would strike the best balance," writes Robert A. Rizza, MD, executive dean for research and William J. Tremaine, MD, director of the institutional review board.

"If DHHS considers a notification and opt-out process, Mayo Clinic suggests that it also consider the fact that many biospecimens are not collected by the research institution," Rizza and Tremaine write. "For example, physicians may send biospecimens to a hospital for testing, but the hospital may never interact directly with the patients."

So it may not be feasible for researchers to contact patients, they add.

The Mayo Clinic suggests that HHS consider these options:

  • Permit a waiver of informed consent where the biospecimen is not collected from the individual by the research institution
  • Make the notification process a national effort, giving individuals who wish to opt out the opportunity to register in a single location. Researchers would submit a query and presume a biospecimen could be used if the individual had not opted out.