be different for different types of organizations, and also because the separate structure seemed to reflect the committee's charge more clearly.

The committee was impressed with the commitment to privacy and confidentiality that the representatives of several private companies presented at the workshop. Companies appear to be at different stages of developing internal privacy or confidentiality policies regarding HSR and should be encouraged to continue to develop these organizational policies and procedures. The committee believes this recommendation to be consistent with the spirit of proposed federal regulations on privacy (DHHS, 1999). It is, however, outside the scope of this project to make a detailed critique of those regulations.


Recommendation 4-1. Researchers should have all HSR reviewed by an IRB or other review board regardless of the source of support or whether the research is subject to pertinent federal regulations.

Recommendation 4-2. IRBs and other boards that review HSR that is not subject to federal regulation should assess their practices in comparison with the best practices of IRBs working under pertinent federal regulations and, when the latter offer improvements, adopt them. Alternatively, when their own practices are superior though not subject to federal regulation, they should share them with IRBs applying the Common Rule.

IRBs, or other suitable review bodies, offer a review of research projects by knowledgeable persons not directly associated with the project. This independent review protects subjects of research because independent reviewers may identify concerns and suggest ways to minimize risks that were not apparent to investigators. The committee heard several examples of protocols that were or could have been substantially improved with respect to confidentiality by relatively simple modifications. Research subjects, who undergo risks for the benefit of science and society as a whole, should have the protections of such independent review as a matter of ethical best practice, regardless of funding source. There is little ethical justification for making a distinction between the level of protection afforded subjects in federally funded projects and that given subjects in projects funded by private sources if the risks to these subjects are comparable; indeed, proprietary projects could have additional conflict-of-interest pressures and thus might greatly benefit from outside review.

The committee found that some organizations and their IRBs apply the federal regulations to all health services research, regardless of funding source even though they are not legally required to do so.

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