The common rule and the IRB
By J. Mark Waxman, JD
General Counsel
CareGroup Healthcare System
Boston
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The recent controversy over federal funding of stem cell research has heightened interest in the role of the federal government in protection of human subjects participating in research. The federal policy in the human research protection area is, in general, set forth in what is called the common rule, which has been adopted by all significant federal agencies with oversight responsibility in human research protection. The policy is expansive and applies to all research involving human subjects "conducted, supported, or otherwise subject to regulation by a federal department or agency."
The first area addressed by policy is the definition of research, which is: a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Of critical importance as well is the definition of a human subject. The federal definition is a living individual about whom an investigator (whether professional or student) conducting research obtains the following:
- data through intervention or interaction with the individual;
- identifiable private information.
These definitions encompass physical procedures to gather data for research purposes. This of course is to be distinguished from individual care and treatment that is directed toward diagnostic or therapeutic goals of a specific patient. The definition also encompasses simply communication of information without any physical procedure. Finally, there is a focus on identifiable private information — the information that is reasonably expected to not be made public. The best example of this type of information is the medical record and its contents. It should be noted that this latter primary interest will be taken to a new level of scrutiny with the newly articulated restrictions (and attendant problems) set forth in regulations that are the product of the Health Insurance Portability and Accountability Act of 1996, commonly known as HIPAA.
At the core of the policy are two mandates:
- Each institution covered by the policy must provide a written assurance that it will comply with the policy.
- The research itself must be reviewed and approved by a properly constituted and operating institutional review board — the IRB.
Oversight of these two mandates is in the hands of the Office for Human Research Protections (OHRP) within the Department of Health and Human Services. OHRP negotiates and approves the assurances provided by the Boston-based Beth Israel Deaconess Medical Center, for example, which describes the means to be employed to comply with the applicable regulations. OHRP also reviews IRB performance. A failure to comply with the assurances or the performance requirements can lead to a suspension of the approval of the assurance and with it, the ability to continue with covered research activities. Recent highly publicized cases illustrate that this is not an idle threat or remote possibility.
The IRB
The policy imposes a series of demanding requirements on IRB composition and process. An IRB must have at least five members who may not be all men or all women, whose backgrounds and expertise allow for sensitivity to community attitudes and respect for their duty to safeguard human subjects.
In addition to having professional competence, the IRB "shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable laws, and standards of professional conduct and practice." Its participating members must be free of conflicts of interest. It may receive advice from independent experts to fulfill its responsibilities.
Just as the breadth of IRB membership is large, so are its duties. In short, the IRB must review and have authority to oversee all research activities from inception through completion of a research project, including any modifications along the way. To do so, it must establish a formal process and written procedures and, with the exception of an expedited review process, review proposed research at a meeting with a quorum that must include at least one member whose primary concerns are nonscientific. There must be a majority vote of a quorum to move forward, and the investigator is to be furnished an opportunity to respond in the event of an adverse determination.
Common deficiencies identified by OHRP in reviewing IRB performance illustrate the need for a carefully run process. These deficiencies include:
- failure of the IRB to review HHS grant applications;
- failure to have adequate review;
- the loss of a quorum during a meeting;
- lack of sufficient information;
- lack of a nonscientist at a meeting;
- failure to advise IRB members of expedited approvals;
- failure or inadequate review of protocol changes.
Any noncompliance will result in a failure to have the proper IRB approval, meaning that the research in question may not proceed.
Criteria for approval
There are seven requirements (46 CFR 46.101) imposed for IRB research approval. First, the risks to subjects are to be minimized by sound research design and use of procedures that do not expose subject to unnecessary risk. When appropriate, procedures already being performed for nonresearch-related necessary medical care are to be employed.
Second, the risk to be imposed must be reasonable given the potential anticipated benefit and the importance of the knowledge sought. This can be a complex question that requires a careful and thoughtful analysis focused on the research at hand, which may not consider the possible long-range public-policy effects. Third, the selection of subjects must be equitable and recognize the special problems presented when the research involves children, prisoners, pregnant women, or economically or educationally disadvantaged people.
Fourth, consideration must be given to the requirements to procure an effective informed consent document. A fifth requirement is that the consent (discussed in more detail in a future article) must be in writing and obtained in a timely basis. Sixth, when appropriate, the research plan must make adequate provisions for monitoring the data to ensure the safety of subjects. Seventh, privacy and confidentiality concerns with respect to both the subjects and the data must be addressed.
Research may not be conducted that has not been approved as meeting these requirements. Where more than one institution is involved, such as cooperative research projects, each institution must ensure human subject safety. This does not, however, mean there is a need for multiple IRB reviews. A joint review can suffice, or the review of a contracted qualified IRB may be used. Of course, all IRB activities must be documented and the records retained for three years after completion of the relevant research. These records should be available for review by officials representing the federal government and its agencies.
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