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Noncompliance calls for corrective actions policy
Develop policy before issues arise
By J. Mark Waxman, JD
CareGroup Healthcare System
Inevitably, some investigators will not be compliant with the federal or state statutes and regulations, institutional rules, or IRB policies when conducting clinical research. While applicable state and federal laws have their own set of remedies, even criminal sanctions where appropriate, the IRB should develop its own corrective action and sanctions process.
The first step is development of the policy. That process would involve a series of defined steps, with the ultimate goal of having both the IRB and the institution adopt a Corrective Action and Sanctions Policy. The steps might be as follows:
1. The IRB would initiate the process by providing a notice that the IRB is developing such policies and seeking representatives from affected constituencies to participate in the policy development committee ("Committee") effort. The affected constituencies would include the medical staff, the principal investigator (PI) community, administration, and the IRB staff and membership, including its public member.
2. The Committee should develop a statement of the goals of corrective action and IRB sanctions. These goals would include the ability to take action to ensure patient protection, require the ethical conduct of research, educate PIs to prevent recurrences of inappropriate conduct, and protect the involved institution.
3. Standards should be developed as to when corrective action will be required. One standard, which uses the language applicable in a number of research contexts, is that such action is required when there has been more than a minimal failure to adhere to the applicable rules, requirements or policies in a way that has the potential to place either patients or the institution at risk. The actual risk involved need not have actually occurred to impose corrective action or sanctions.
4. An itemization of potential corrective or sanction actions should be developed. A listing of the potential actions should provide the flexibility to deal with a wide range of violations and indicate to PIs what steps might be necessary to cure violations. Actions listed would likely include a range from delay in approval or resubmission of a protocol, through suspension of a trial or preclusion of the ability of a PI to proceed with trials at the institution.
Another tool to be considered is the requirement of a proctor or clinical research overseer ("CRO") who would be responsible for providing assurance to the IRB that the PI involved has the necessary tools to conduct research at the institution. In listing the potential actions, and going so far as to develop standards for their use, PIs should be told that the emphasis in the first instance will be on required education and training. Corrective action is not designed to be punitive, but to assure the integrity, trustworthiness, and reliability of the research enterprise within the institution. PIs often do not really understand that one bad event can call all of that into very serious question.
5. A determination will be necessary with respect to who is responsible for corrective action and sanction decisions. The IRB will determine the specific action it will impose. It will typically hear from the PI involved before making a final decision. Where appropriate, input from others, such as the chief of the department, will be solicited.
There will be no appeal process from IRB decisions, as it is the responsible entity for research protection oversight for the institution and in the eyes of the federal government. Once the corrective action is determined, the PI and the responsible administrative officials should be notified. It should be the responsibility of the PI to complete the necessary corrective action, including ensuring any CRO reports are timely obtained and submitted.
The process will need to include input and consideration of other processes, which either may impact or could be implicated by corrective action or sanctions. There are two in particular:
First, the PI’s or other members of the clinical research team may be employees of the institution. It may be that a violation also constitutes grounds that implicate an employment counseling process. There should be a mechanism to cross-refer when it is appropriate to do so.
Second, the PI’s or team members may be medical staff members and events, that came to the IRB’s attention, also may fall into those professional conduct issues that would involve the formal peer review process. This can be a complex question. Certainly, consideration must be given to a peer review issue as clinical quality issues arise.
It is unfortunate that from time to time, corrective action — or even sanctions — will need to be implemented. To ensure their effects are as positive as possible and that the goals and reasons for their implementation are understood, IRB’s should, in a fairly public way, develop an overall policy in this area.