Policies Relating to Human Subjects Research at URMC

University of Rochester Medical Center

			Research Use of Electronic Patient Information: URMC Policy Statement Appendix 1: Policies Relating to Human Subjects Research
	Research Subjects Review Board:		The RSRB must review all research where the investigational procedures involve human subjects. This definition includes...research on medical records, collection of data through surveys or observation...(U of Rochester Research Subjects Review Board. Investigator's Handbook, September 1997, p. 3). The RSRB recognizes some categories of research as exempt studies, and provides expedited review for others. However, in either case, applications must be reviewed to determine that exemption is appropriate. Most research covered by this policy will qualify either for expedited review or for exempt status. Applicable sections from the RSRB manual are reproduced below. The RSRB guidelines are available online at http://www.urmc.rochester.edu/urmc/rsrb/rsrbhome.htm. Exempt Review: Applies to "the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. (p. 6, no. 4) Exempt research is reviewed by the RSRB office to confirm exempt status. Exempt studies may include activities conducted with patient information that are not research studies, and studies that employ anonymous patient data. Expedited Review: Research activities involving no more than minimal risk and in which the involvement of human subjects will be in one or more of the following...The study of existing data, documents, records, pathological specimens or diagnostic specimens. (p. 7, no. 8) Expedited review is performed by the RSRB chair, experienced RSRB members, or alternates. Expedited review studies may include those which involve extraction of patient information that includes identifying elements. To obtain RSRB approval, the investigator submits an application for research review or a study exemption. This includes a cover sheet/application plus a study protocol that includes the following elements: Title & purpose of the study Characteristics of the requested information (e.g., number of records, types of information to be captured) Methods & procedures The approximate duration of the study Procedures used to maintain confidentiality of the information, including security from unapproved access List of people who will have access to the datafile Proof of appropriate signed releases and/or approvals if HIV or alcohol/drug abuse related information is requested.

			Back to URMC Electronic Patient Information Policy Statement
			Scenarios and Test Questions
			Appendix 2: Rationale and Context for the URMC Policy

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Jul98; jd