U.S. Department of Health & Human Services
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Can records or databases be reviewed to identify potential subjects without obtaining informed consent or parental permission?
Yes, under certain circumstances. Although the HHS regulations do not specifically reference this type of activity, sometimes referred to as “preparatory to research,” such an activity must be reviewed and approved by an IRB in accordance with HHS regulations at 45 CFR 46.109(a) when:
- The activity involves human subjects research, as defined by the regulations at 45 CFR 46.102(f);
- The research does not meet the criteria for exemption under HHS regulations at 45 CFR 46.101(b).
In general, informed consent of the subjects, or parental permission for children involved in research, must be sought and documented in accordance with, and to the extent required by, HHS regulations at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116">45 CFR 46.116 and 45 CFR 46.117 respectively.
However, an IRB may approve a consent or parental permission procedure that does not include, or that alters, some or all of the elements of informed consent, or may waive the requirements to obtain informed consent (45 CFR 46.116(c) or (d)). In order to permit investigators to obtain and record identifiable private information for the purposes of identifying potential subjects, OHRP expects that IRBs routinely will waive the requirement for informed consent for such activities. In assessing the level of risk to determine whether a waiver of informed consent or parental permission is permissible for the identification of potential subjects, the IRB need only consider the risk of investigators accessing the subjects’ identifiable private information, not the risks of the research in toto.
Last Reviewed: 01/20/2011
Related Questions:
- How can the consent and parental permission processes be designed to facilitate understanding?
- Can an electronic signature be used to document consent or parental permission?
- Is a faxed copy of the signed consent or parental permission form acceptable to document informed consent?
- Who must sign the informed consent or parental permission document?
