Why yes, there are problems with the federal regulations!

by Wendy Tate, PSM, CIP, PRIM&R Blog Squad member

PRIM&R is pleased to bring you blog posts from the PRIM&R Blog Squad during the 2010 Advancing Ethical Research Conference. The PRIM&R Blog Squad will be blogging every day from the conference, so continue to check back for updates.

After the release of the PHS Inoculation Study in Guatemala, President Obama issued a press release asking for a nine-month review of human subject regulations. Personally, I welcome a review of regulations. The United States Department of Health and Human Services (HHS) regulations regarding human subjects are now 30 years old. The regulations do not adequately address some current issues, such as cultural/community involvement and consent, low literacy/non-literate subjects, collaborative research, international research, and the definition of a vulnerable population (decisionally impaired, students, employees, patients, etc.).

Yesterday’s general sessions shared a common theme of how to approach reassessing regulations, starting with the keynote address from Dr. Francis Collins, director of the NIH.. Dr. Collins spoke of the need to consider ethics as we proceed into an ever-changing, technologically advanced era. Thirty years ago, having the ability to map all six billion base pairs of human DNA was a dream. Today, not only has it been done, but the cost to do so is exponentially dropping. The NIH is interested in making genomic data available to researchers to do large-scale epidemiologic studies and find causes for disease. They support the transition of information from basic research to bedside, locally and worldwide. This mission alone shows where the current federal regulations are severely lacking.

The Great Debate topic was whether we should keep or abolish informed consent forms. While debating, both sides agreed on one fact: Consent forms are not sufficient. The federal regulations describe the elements that must be in consent forms. Institutions work hard to ensure that we include all of the elements, resulting in 15-, 20-, or even 30-page consent forms that are written in language that is not only at a level higher than subject comprehension, but actually contains no information. How many of you have contemplated the value of saying that a subject may experience benefit, experience no change, or become worse? Has the federal requirement of a written, signed document overtaken the need for study staff to sit down with the potential subject and have a frank, engaging discussion on the study?

Immediately following the debate was a plenary talk given by Ezekiel Emanuel, MD, PhD. Dr. Emanuel touched on many areas where current regulations could be changed, such asthe scope of human subjects regulation, repetitive IRB review, annual review (which is really a misnomer), inconsistent use of the exempt and expedite regulations, uncertainty about what research requires review, information risks, informed consent, inconsistent federal guidelines, and adverse event reporting.

Panel I closed the day’s theme of reassessing the regulations as several researchers who conduct campus-based research discussed innovative research studies involving students as subjects. The panel reminded us that college students are extremely vulnerable, but never considered in the regulations. The IRB side of things is also interesting in these studies. One presenter stated that it took 18 months to gain IRB approval, and it almost cost him his graduate degree. However, the IRB was likely discussing if the project was protecting these students, who were all vulnerable on several levels. The length of approval can impede pertinent, timely research that can help a community or society as a whole.

The audience at AER appears to be enthusiastic that Washington is finally hearing the outcries of the front lines and willing to open the discussion, no holds barred, on reassessing the regulations. I would challenge federal regulators to go a step further and push to consolidate human research regulations. Get all the players at the table. Don’t encourage, but require that OHRP, FDA, OCR, VA, and all other Common Rule agencies to make one set of common regulations. Otherwise, the focus will remain on meeting the regulations and not ensuring that subjects are protected through ethical research.

Hold on, because as Ivor Pritchard and Michele Russell-Einhorn reminded us yesterday morning with a serenade, “the rules, they are-a changin’.”