I want to access administrative records to develop a sample frame for a health survey. What are the key issues related to consent for this and other studies?
A. Investigators sometimes want access to existing records in order to identify potential subjects or in order to conduct research. If the investigator will record subjects’ names (either for further record review or for personal contact), this activity requires IRB review. The IRB will determine whether the consent of subjects should be sought before the researcher gains access to the records; in some cases, a waiver can be granted. When determining whether it is appropriate to waive the requirement to obtain consent from these subjects, the IRB considers the sensitivity of the information being recorded, the vulnerability of the subject population, and other risks to the subject. The IRB also considers whether the rights or welfare of the subjects would be adversely affected by the waiver, the purpose for which the investigator wants access to the information, and the practicability of conducting the research without the waiver. In some cases, consent cannot be waived. For example, t
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