Protecting Data Privacy in Health Services Research (2000) / Chapter Skim
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4 Best Practices for IRB or Other Review Board Oversight of Health Services Research Not Necessarily Subject to Federal Regulations
4 Best Practices for IRB or Other Review Board Oversight of Health Services Research Not Necessarily Subject to Federal Regulations
Pages 71-77
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From page 71... ...
The committee believes that studies involving human subjects should be reviewed similarly whether the study is subject to Common Rule provisions or not. As a result, the committee has recommendations in this chapter that are similar to those in the Chapter 3.
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From page 72... ...
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 offunding source even though they are not legally required to do so.
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From page 73... ...
These practices include using codes, rather than identifiers such as Social Security numbers or names, to locate a record and a variety of measures to reduce the likelihood that individuals can be identified by inference. In particular, the committee recommends the following observations from the previous chapter to institutions that do HSR and similar work that is not subject to federal regulations.
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From page 74... ...
Recommendation 4-3. Health care organizations that conduct projects applying the methods of HSR to personally identifiable health information for purposes such as QA or QI, disease management, and core business functions as well as for research should have comprehensive policies, procedures, and other structures to protect privacy when personal health information is used for research or other purposes.
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From page 75... ...
The IISC is also responsible for determining whether projects from the ambiguous area in the middle of the health care operations/research spectrum should proceed to seek IRB review. Finally, the IISC generates and recommends data security policies to the Board of Trustees of the company and then helps implement these policies and procedures throughout the organization, thus enhancing confidentiality protections at the operations end of the continuum.
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From page 76... ...
IHC terminates employment because of privacy infractions. Many of the provisions in Recommendations 4-3 and 4-4 are consistent with the recommendations regarding organizational practices discussed in For the Record (NRC, 1997)
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From page 77... ...
Comprehensive policies for all uses of personal health information will avoid issues of how to oversee activities that are in the gray zone between research and QA or QI. If a comprehensive policy is in place, a QA or QI project will have strong confidentiality safeguards that make the risk to patients minimal.
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