New rules created to protect patient records
Ensure procedures are in place
The Institute of Medicine (IOM) of the National Academy of Sciences has recommended several steps for sponsors of clinical research and institutional review boards (IRBs) to take in order to protect the privacy of patients’ medical records. Ethics committees, as a result, should ensure that the proper policies and procedures are in place.
The 12-member committee, headed by Bernard Lo, MD, of the University of California at San Francisco, suggests that investigators involved with health services research "should have all health services research reviewed by an institutional review board or other review board with sufficient expertise in privacy or confidentiality protection."
Investigators also should "educate themselves to be aware of the best available techniques for confidentiality protection, including being careful to collect and retain only those fields that are truly needed."
Institutions funding or sponsoring such research should "have comprehensive policies, procedures, sanctions, and structures to protect health data confidentiality throughout the organization when personally identifiable health information is used for research or other purposes," the committee recommends. Research sponsors also should "ensure adequate administrative support and funding for their IRBs."
The committee says that to carry out valuable health services research and protect patient confidentiality requires adequate funding "to support dedicated, trained IRB members and staff, establish organizational confidentiality policies and electronic security practices, educate researchers, and provide statistical and computer expertise."
The IOM committee advises research sponsors to "provide more specific guidance to IRBs, clarifying the range of discretion that local IRBs have to interpret federal regulations."
Among other suggestions, the report recommends that sponsors "encourage holders of personally identifiable health information to make this information available to researchers as public use files after suitable application of techniques to minimize the risks of identifiability."
They also should "ensure that the data provided for health services research use are prepared in a manner that protects confidentiality adequately, including covering the cost of pre-paring government-held personally identifiable health information, so that confidentiality can be adequately protected in health services research."
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