Proposed Common Rule changes have pros and cons for institutions

Harmonization: thumbs up; Exempt policy: thumbs down

When human subjects research directors finish sifting through the proposed Common Rule changes, they likely will find some things they can live with and plenty of others they'd like to modify.

For one thing, IRB and researcher directors might object to the proposed requirement that they register exempt studies with the IRB even though the proposal also states that an IRB review is not required.

"I disagree with requiring a form to be filed and not reviewed, both in principle and as a practical matter," says Paul W. Goebel, Jr., CIP, president of Paul W. Goebel Consulting Inc. of Monrovia, MD. Goebel is a member of the Chesapeake IRB in Columbia, MD, and previously was chair of the Food and Drug Administration IRB and a member of the Dana Farber Cancer Institute IRB in Boston, MA.

"In general, you shouldn't have someone submit something that won't be reviewed," he says.

The risk is that regulators will have new leadership, leading to regulatory creep. Federal auditors might note in findings that the forms were not reviewed, and this could have negative consequences on research organizations.

"Also, how do you enforce having investigators submit this form if nobody looks at it?" Goebel says.

Exempt studies should be reviewed at least by IRB staff, he suggests.

"It doesn't have to be reviewed in a convened meeting or even by IRB members," Goebel adds. "If it's exempt that document can be sent back to the investigator, stating the IRB agrees it's exempt."

This affirmation is a good thing for investigators to keep on hand in case regulators second-guess their decision. And it's an incentive for investigators to file their studies with the IRB, he says.

The U.S. Department of Health and Human Services (HHS) published the advance notice of proposed rulemaking (ANPRM) in the July 26, 2011, issue of the Federal Register. The 20-page notice includes an explanation about why HHS is proposing changes to 45 CFR 46, 150, and 164, as well as to Food and Drug Administration's (FDA's) 21 CFR Parts 50 and 56. The proposed changes answer critics' charge that IRBs spend too much time reviewing minimal risk research and that some IRBs overestimate these studies' risks.

Critics also note IRB review inefficiencies, including overlapping reviews for a single study and bureaucratic complexity, the notice states.

One the changes proposed in the ANPRM directly relates to the fundamental goal of enhancing research oversight while reducing burdens, delays, and ambiguity. The notice seeks to improve harmonization of regulations and related agency guidance.

This isn't a new goal, but the changes will help focus more attention on this objective, says Jerry Menikoff, MD, JD, director of the Office for Human Research Protections (OHRP).

"Over the years, OHRP has worked with FDA and other entities to ensure — to the degree possible — harmonization on related rules, regulations, and guidance," Menikoff says.

"The Common Rule departments and agencies have procedures in place for sharing proposed guidance before they are adopted," he adds. "OHRP will continue to work with these entities in the future to attempt to maximize harmonization of any future rules, regulations, and guidance."

One area that should be harmonized involves confidentiality rules in the existing Common Rule versus the HIPAA privacy rule, Goebel notes.

"The rules and definition in the HIPAA privacy rule and the Common Rule regarding de-identification, anonymization, authorization, and informed consent should be made absolutely identical," he says. "There is no reason why IRBs and investigators must make multiple decisions in this area and why the informed consent document and the HIPAA authorization form are separate documents."

The way it works currently, IRBs and investigators have to ask separate questions of studies: "Does this meet HIPAA, yes or not? Does this meet the Common Rule, yes or no?" Goebel says.

Harmonization also would eliminate the Common Rule add-ons that various agencies, such as the Department of Education and the Department of Justice, have, he adds.

"The DOJ has its own separate rules for the research of prisoners," he says. "How is that different, and should they be harmonized? Why are their rules not good enough for everybody? I think that's worth pursuing."

Wholesale harmonization could be impractical, Menikoff notes.

"As the name Common Rule' suggests, there is a compelling case for consistency across federal departments and agencies regarding protections of human subjects," Menikoff says. "Nevertheless, there are arguments in favor of some departments or agencies imposing specific requirements, apart from the Common Rule, that are tailored to certain types of research."

The proposed changes focus on data security and information protection standards, strengthening consent protections related to reuse or additional analysis of existing data and biospecimens, as well as expanding HIPAA privacy protections. HHS proposes having all research involving the collection and use of identifiable data adhere to data security standards modeled on HIPAA. Since these mandatory protections would apply to all research studies, IRBs would not need to review studies posing only informational risks, the ANPRM states.

Current technology already provides bulletproof protection in how private data are de-identified, but the proposed changes could call for a specific recipe for de-identification, and that might require clinical trial sites and technology vendors to make significant changes, notes Dan Kerpelman, chief executive officer of Bio-Optronics Inc. of Rochester, NY. Bio-Optronics develops software products and information technology solutions for the health care and clinical trial industries.

"It's an unfolding rule change, so we'll have to see how deeply it will go," Kerpelman says.

From an IRB's perspective, the proposed revisions in data security and information protection standards are positive, Goebel says.

"Setting uniform specific standards assures appropriate privacy and confidentiality protections to all subjects, without administrative burden of needing a specific committee review of each study," Goebel says.

"If there were uniform rules for confidentiality then I don't think this type of research needs to come before an IRB," he adds. "The only risk is disclosure of protected health information, and the IRBs are not very good at assessing that anyway."

The ANPRM addresses the criticism that IRBs are overburdened and attempts to alleviate some of that burden through proposals to change the review process for multisite studies and standardizing informed consent and adverse event reporting.

"Specific changes that are expected to reduce the burden to IRBs include the proposed single IRB of record for multi-site studies; streamlined forms for informed consent; a standardized system for reporting adverse events; and clearly delineated categories of risk," Menikoff says.

In principle, the change to allow a single IRB review multi-site studies is a good one, Goebel says.

"Much depends on how it is implemented," he says.

If HHS uses the National Cancer Institute's (NCI's) central IRB process as a model, then this change likely will not work, Goebel says.

"The CIRB model utilized for NCI-sponsored studies is fatally flawed," he adds. "Their process is more trouble than it's worth: the central IRB reviews it; then the local IRB still has to review it, and then the question is, Who reviews the adverse events?'"

HHS has asked for extensive comments on the ANPRM, which was designed to improve human research subject protections while answering critics' charges that the process has become too burdensome, Menikoff says. (See info box on submitting comments to HHS, below.)

"The goal of the proposed changes is to enhance the effectiveness of the Common Rule in protecting human research subjects while facilitating research and reducing burden, delay, and ambiguity," Menikoff says. "These and other changes under consideration are intended to enable IRBs to focus their energies on higher risk studies."

Here's how to give HHS your opinion on Common Rule changes

The U.S. Department of Health and Human Services (HHS) has given IRBs, researchers, and others in the human subjects research industry until 5 p.m. on Sept. 26, 2011, to comment on the advanced notice of proposed rulemaking for changes to the research Common Rule.

HHS seeks a thorough discussion process and has included dozens of questions seeking input throughout the 20-page ANPRM, published in the Federal Register, on July 26, 2011.

Throughout the 20-page document, there are sections stating, "Comments and recommendations are requested on the following."

Here are a few examples:

  • Question 30: What are the advantages and disadvantages of mandating, as opposed to simply encouraging, one IRB of record for domestic multi-site research studies?
  • Question 35: What factors contribute to the excessive length and complexity of informed consent forms, and how might they be addressed?
  • Question 48: What, if any, are the circumstances in which it would be appropriate to waive the requirement to obtain consent for additional analysis of biospecimens?

To answer these and any other questions, send comments to HHS through the Federal eRulemaking Portal at, or mail/hand deliver/courier comments to Jerry Menikoff, MD, JD, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.