Keep up with new regs, know existing ones

Experts offer regulatory advice

Sometimes there are just too many acronyms, but it’s important for research professionals to learn the regulatory power wielded by the big three: OHRP (Office for Human Research Protections), FDA (Food and Drug Administration), and NIH (National Institutes of Health).

Judith Brooks, MS, public health analyst with the division of education and development at OHRP in Rockville, MD, often speaks to the research community about the regulatory relationship between the three agencies.

"I use a diagram that shows how the FDA has regulatory authority over certain parts of research, and how we at OHRP have regulatory authority over HHS research," Brooks says. "And if you have an FDA-regulated product and get government money, then you have the two regulatory bodies."

Also, it can be a full-time job keeping up with the new regulations and guidance issued by the various federal agencies. For instance, the Secretary’s Advisory Committee, which met for the first time in July 2003, is expected to issue a report within the next year, and this could change the way investigators look at many aspects of research.

One issue under study is adverse event reporting and how to clarify reporting requirements to satisfy both FDA and Department of Health and Human Services (DHHS) regulations, Brooks says.

One reason DHHS is working toward better educating the research community and better explaining regulations is because of the trend of greater public scrutiny paid to human subjects research.

"The modern approach and modern sensitivity have been driven by several very unfortunate incidents in which research subjects enrolled in clinical trials have either been seriously injured or, in some cases, died," says Robert Bienkowski, PhD, executive director of research at Iowa Health-Des Moines.

"An investigation and a very extensive evaluation of what happened has revealed many cases of shortcomings in the process," he says. "The institutions are not following their own policies and procedures or are not following or observing the requirements of federal regulations for protection of research subjects."

Add to the mix the Health Insurance Portability and Accountability Act (HIPAA), and the regulatory protections given to human subjects research may seem a bit overwhelming. However, research institutions and investigators can improve their own protocols and clinical trial system by making certain regulatory changes a priority and becoming educated about others.

Brooks and Bienkowski offer this advice:

• Be careful how you add HIPAA language to an informed consent document. When investigators merge HIPAA language into an informed consent document, they need to pay attention to several areas that are outlined in the NIH guidance document, Brooks says.

Also, keep in mind that if there is a HIPAA template that is inserted into the existing document, then this addition can be reviewed in an expedited way, Brooks says.

"When HIPAA came into effect, there were all of these existing protocols with existing consent forms, and some institutions wrote their own authorization form, while others wanted to revise forms and put HIPAA language in it," Brooks explains. "OHRP said that as long as it was HIPAA-specific language that you inserted in every form it can be done in an expedited way."

Alternately, any consent form that is protocol-specific and if there are consent form revisions then it has to be reviewed by the full IRB, Brooks adds.

• Learn when HIPAA waivers can be used. HIPAA only applies to covered entities, such as health care providers, hospitals, physicians, etc. Any person who falls under HIPAA’s umbrella has to receive authorization from patients to do anything with their medical records, Brooks says.

"In certain situations under HIPAA you can waive that authorization, such as if you’re a hospital and are doing a research study or collecting information from patient records," Brooks says.

"And if it meets the definition of human subject research, you may be able to waive HIPAA requirements," Brooks adds. "But you can’t waive the regulations that require informed consent unless it meets our waiver requirements."

• Know all of the identifiable information and then think up some more. HIPAA regulations provide a list of identifiable information that cannot be used, but OHRP also emphasizes that anything else that would make someone identifiable, should be avoided. This may include cases with a very rare disease, for example, Brooks says.

"We say it extends to any information that would reveal a subject’s identity," Brooks explains. "If you live in a small community, and there’s one person with leukemia in town then that person would be easily identifiable."

The regulations prevent investigators from revealing any such information that could be used to identify a person, including personal characteristics, Brooks says.

If an investigator has some question about this factor in a protocol, then it’s best to send it to the full IRB for review, Brooks adds.

• Create a research subject advocate position. Iowa Health-Des Moines completely revised its own policies and procedures in 2002 to more clearly reflect federal and state regulations, Bienkowski says.

Another major change was that the institution has invested in a new position, called research subject advocate, he notes.

"The person appointed to the job is our director of corporate ethics, and she serves as the associate chair of the IRB and is a nurse by training with a master’s degree in ethics," Bienkowski says.

"This position developed because we felt as part of our institutional commitment to the program of human subject research protection that it would be important to embody that role in one person, an ombudsman if you will," he says.

"This is someone who has no ties to the research and would be devoid of any possible conflict of interest," Bienkowski adds. "So if he research subject has any question, complaint, or concern then this would be yet another person the subject could turn to for advice, counseling, and to learn of the rights of research subjects."