OHRP Proposes New IRB Rule

ORHP has issued an Advanced Notice of Proposed Rule Making to enable OHRP to hold institutional review boards (IRB) and the institutions or organizations operating the IRBs directly accountable for meeting certain regulatory requirements of the DHHS regulations for the protection of human subjects. (http://edocket.access.gpo.gov/2009/E9-4628.htm) Comments on this proposal are due by June 3, 2009.

If adopted, this proposal could change the relationship between research institutions and external IRBs. Is this a good thing or not? Although I think that external IRBs should be held accountable for compliance, I am concerned that this will make some of the problems concerning external IRBs worse. One problem with external IRBs is what was illustrated with the GAO sting. Research organizations just pick an IRB without making sure that they meet appropriate standards. If the organizations are no longer responsible for IRB compliance, this will increase the likelihood that organizations will just pick an IRB that is fast and easy. Second, organizations that use an external IRB often do not realize that they need to have an HRPP and oversee the research. They think they have IRB approval so that's all they need to do. This new rule could increase that tendency.

So, I think that holding external IRBs accountable is fine, but OHRP should continue to hold the research organizations accountable for IRB compliance as well.

Accountability: Preserving Public Trust

Human research protection programs primarily focus on ethics and regulatory compliance. However, those are not the only functions of HRPPs; they also serve to preserve public trust in research. We must remember that there is no right to conduct research. Research, especially research involving human subjects, is a privilege granted to the research community by the public. That privilege is granted based on the trust that the research will be conducted according to appropriate ethical principles and regulations. Anything that erodes that trust can result in that privilege being restricted or withdrawn. When the public has serious concerns about research it puts pressure on Congress and federal agencies to further regulate research, which is how we got to the current regulatory situation in this country.

So, how do HRPPs serve to maintain the public trust in human research? Through accountability; that is, being able to demonstrate that organizations and investigators are conducting research according to ethical and regulatory standards. It is not good enough just to do the right thing; we must be able to demonstrate to others that we are doing the right thing!

Accountability begins with investigators and institutions maintaining appropriate documentation. If you examine the federal regulations you will see that, although part of the regulations address the implementation of ethical principles (informed consent, risk/benefit, etc.), the rest is about documentation (consent forms, minutes, etc.). This is because the regulations, when they were drafted, were designed to restore public trust in human research.

The next level of accountability involves oversight by government agencies. The federal human subject regulations were first imposed back in the 70s because the public trust in research had eroded. When public trust eroded again in the mid-90s, federal oversight increased. By issuing regulations and overseeing the compliance with those regulations, the government assures the public that human research is being conducted with appropriate safeguards for the rights and welfare of subjects.

Finally, accountability involves accreditation. Organizations must be able to demonstrate that they have an HRPP that meets appropriate standards. An independent accrediting body, currently AAHRPP, develops HRPP standards and assesses organizations as to how well their HRPP meets those standards. Accreditation involves more than just compliance with regulations and appropriate documentation; it also involves the evaluation of the effectiveness of the HRPP through a site visit and interviews. As more organizations become accredited, the public can trust that research at those institutions at least meets AAHRPP standards.

Many people in our field see accountability as just so much bureaucratic nonsense and fail to appreciate the important role it plays in ensuring that important research can continue to be done. Maintaining the public's trust in research is as important as the ethical conduct of research for, without that trust, the conduct of research will be even more difficult.

IRB Stings & Accreditation

The IRB world has been rocked by the recent "stings" conducted by the Congressional Government Accountability Office (GAO) to investigate IRBs. This investigation was conducted at the behest of Congress because of concern over the adequacy of IRB review. Those who are not familiar with the results of the investigation should review the GAO and testimony from the hearings:
http://energycommerce.house.gov/index.php?option=com_content&task=view&id=1552

Although the focus of the hearings was on Independent IRBs and most of the attention has been on Coast IRB, the concerns raised by this investigation and these hearings apply to the whole field of human research protections. The best response to this investigation is accreditation. Accreditation not only raises the standards for what constitutes adequate IRB review, it provide helps ensure that organizations are meeting those standards. How would accreditation have addressed the GAO findings in this investigation?

1) Due diligence to verify information

The GAO faked 510(k) status of the device and the qualifications of PI. AAHRPP expects IRBs to obtain documentation of INDs, IDEs and 510(k) status. AAHRPP also expects organizations to have an ongoing quality assurance program, which should include audits and site visits.

2) Inadequate information to make determinations

The GAO selected IRBs that "...had less burdensome initial paperwork requirements than other IRBs for protocol submission" and "...designed our protocol so that it would contain vague information about certain aspects of our proposed study." AAHRPP expects detailed information in the protocol on all aspects of human subject protections, including subject populations, subject recruitment, consent process and safety monitoring. If the protocol requirements had been that detailed, the GAO could not have provided the information.

3) Lack of substantive IRB review

The GAO raised concerns that one IRB approved the protocol even though there were safety concerns. AAHRPP expects that all IRB review will be substantive and will address all of the regulatory criteria for approval for each review. This must be documented in the minutes with protocol-specific justification that the criteria have been met.

4) Inadequate federal oversight

The GAO was able to register a fake IRB and get an assurance for a fake medical device company. Beyond assuring that the minimum regulatory requirements have been met, OHRP is unable to review the quality of IRBs or research institutions. Accreditation will provide the accountability to help ensure that there is adequate IRB of human research.

The best protection that institutions and IRBs have against the kind of investigation conducted by the GAO (and, for that matter, against litigation) is accreditation. Not only will AAHRPP accreditation help ensure adequate IRB review, but organizations will be able to say, "We're doing it right and you don't have to take our word for it!"

Posts from Newsletter

We have sent out three newsletters so far (they are available in the Newsletter Archive: http://archive.constantcontact.com/fs039/1102478511527/archive/1102495502466.html). In the newsletter we have included articles and discussions which should be of general interest to the HRPP community so we will be copying them here on the blog. This will also allow ongoing discussion on these topics.

Doing More With Less

As we all know, we are living in difficult times. Those of us in the human research protections field are faced with the challenge of maintaining an appropriate level of protection with diminishing resources. Here are some ways that institutions can "do more with less":

Increase Efficiency

• Review policies and procedures to evaluate efficiency
• Track the "life of a protocol" to look for bottle-necks and unnecessary steps that can be eliminated without compromising the quality of IRB review
• Automate processes to save steps and time

Reduce Waste, Save Time

• Make full use of the flexibiltiy available in the regulations. No need to take up IRB time for research that is exempt or eligible for expedited review
• Poorly prepared protocols waste staff, IRB and investigator time
  
• Improve forms to ensure that IRB receives all the necessary information
• Improve investigator education and guidance to obtain better protocols

Cope with Staff Reductions

• Computerized IRB System
• Equivalent of at least .5 FTE
• Outsource IRB functions
• Quality Assurance
• Education and Training
• Webinars
  
• Full IRB Administration
• Use an external IRB