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Study of Existing Data or Human Biological Specimens for Non-genetic Research

Existing Material/Data

Federal regulations stipulate that "research involving 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" may qualify as exempt from HSPC review. (Please see the previous section of this chapter, "The HSPC Review Process, Exempt from HSPC Review, Exemption Category #4" for more information).

For example, research using medical records would be exempt from HSPC review under the federal regulations if the records

1. exist prior to the initiation of the research project; and if
2. the investigator records the information in such a manner that subjects cannot be identified directly or through identifiers.

For example: Dr. Smith requests records from the State Department of Health regarding people who have used a specific service. The research may qualify for a Claim of Exemption if the investigator receives records from the agency that do not include any subject identifiers, such as names, social security numbers, addresses, etc.

If Dr. Smith receives the data from the State with social security numbers, the identifying numbers pose a potential breach of privacy and confidentiality, are no longer anonymous, and require review by the HSPC.

Archived pathology or diagnostic specimens that are considered residual biological material and are destined to be destroyed can be used in research and are considered exempt from HSPC review if there are no patient identifiers linked to the specimen and if the data is not intended to be used in the diagnosis or treatment of a patient. If either of these conditions apply, consent of the research subject is required and the study is not exempt from HSPC review. (Please see the previous section of this chapter, "The HSPC Review Process, Exempt from HSPC Review," for more information.)

Research which includes review of private records involving access to and/or recording of identifiable information is not exempt from HSPC review and requires prior written consent from the subject. The review of pre-existing public records does not require prior consent of subjects.

Records considered private based on federal and State statutes, including medical, insurance, and educational records, require written release by the individual subject or by the custodian of the record and prospective HSPC review to be used in research.

Extra Material

Specimens received as extra material or extra specimens requested from a physician conducting a clinical procedure are not pre-existing or "archived" and thus require written informed consent from the subject and review by the HSPC. If there is a link to the patient’s identity and a possibility that the patient may be contacted in the future, an informed consent document is required. Furthermore, informed consent is required if there is a link to the patient’s identity and a possibility that the research may result in commercial or economic value.