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“Human biological materials” include, but are not limited to, blood, urine, saliva, or other bodily fluids; tissues; hair or nails; placentas and umbilical cords; sperm, oocytes, and products of conception; excess pathology tissue; and waste surgical tissue.
A. The Department of Health and Human Services (DHHS) defines human subject research to be the “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” (45 CFR 46.102(d).) As per July 20, 2004 DHHS/NIH guidance, “research” includes the creation of a database or repository for use in future research.
B. The FDA definition of “research” includes any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the FDA, or is not subject to requirements for prior submission, but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing permit.
Note: Clinicians who study biological materials obtained from a single patient, for patient-care purposes only, are not conducting research.
The collection or use of any human biological materials for research is subject to the oversight of the JHM IRB and must comply with the policies of the IRB and of the institution or department from which tissue is obtained (e.g., Department of Pathology, Dept. of Surgery, Maternal and Fetal Medicine Committee, etc.).
Whenever human biological materials will be obtained for research in connection with a research protocol, the investigator must obtain specific consent for collection and for each use of the biological materials for research purposes. For example, if blood or tissue are drawn for routine laboratory analysis during research, the patient’s specific informed consent must be obtained t (1) perform genetic analyses, or (2) for the investigator or sponsor to archive the materials, even if identifiers are removed, unless the subject is informed that de-identified materials may be used in future research. The alteration of any clinical procedure to accommodate research (e.g., collecting additional tissue during a biopsy), requires IRB approval and the patient’s specific informed consent.
“Existing” materials include any materials collected solely for clinical purposes that are no longer needed for patient care, and any materials in a pre-existing repository. Materials added in the future to an established, IRB approved, repository are considered to be “existing.”
The requirements for use of “existing” materials for research depends upon whether or not that research is regulated by the Food and Drug Administration. The FDA has its own rules for research involving an FDA test article and human biological materials.
FDA-Regulated Research. As stated in “Organization Policy on Review of In Vitro Diagnostic Device Protocols” (Policy No. 50.1) ” FDA regulations do not permit exemptions for the use of existing materials; all FDA-regulated research involving existing human biological materials must be conducted under an IRB-approved protocol, even when the research involves only de-identified excess clinical or surgical specimens. Informed consent is also required unless the research meets the criteria specified in the IVD Policy. Investigators conducting such research must submit a New Application to the IRB, along with HIPAA Form 4 (Application for IRB Waiver of Privacy Authorization).
All Other Research
Under Maryland law, all other research involving existing (as defined above) identifiable human biological materials must comply with DHHS human subjects regulations.
Materials are “identifiable” if the investigator has access to any identifying information associated with the materials, even when such information is coded, unless the researcher has signed a written agreement that prohibits disclosure of the code key to the investigator (e.g., the JHM Data Use Certification).
Except as described below, investigators using materials that are identifiable, or that are coded or linked to any identifying information (e.g., any HIPAA identifier) must submit a New Application to the IRB, along with HIPAA Form 4 (Application for IRB Waiver of Privacy Authorization ).
The research may qualify for an exemption from IRB review if the investigator or the study team do not use or record identifiers (i.e., data fields listed among the 18 HIPAA identifiers), OR codes linked to identifiers, for the research. In this case the investigator should submit the Exempt Application to the IRB.
If the investigator/staff will access JHM records but will remove or will not record identifiers or codes other than those permitted in a HIPAA limited data set [see: http://www.hopkinsmedicine.org/dev/irb/forms/ldsdef.doc], the investigator should sign the JHM Data Use Certification, retain the original, and submit one copy along with the Exempt Application to the IRB. If the investigator intends to share the limited data set with a researcher outside of the covered entity, the investigator should complete a HIPAA Data Use Agreement with that outside investigator. If the investigator receives materials along with a limited data set of identifiers from an entity outside of JHM, the investigator should complete the Data Use Agreement provided by that outside source.
Research that does not involve FDA-regulated products, where the investigator will receive and use materials that have been fully de-identified (all 18 HIPAA identifiers have been removed) by an entity not associated with the research (e.g., Dept. of Pathology, or an external tissue bank), does not require submission of an application to the IRB. Any codes associated with the materials may not be derived from identifiers (e.g., no codes based upon SSN or medical record numbers). Written policies or a written agreement between the investigator and the source of the materials must specify that neither the code key nor any identifiers may be disclosed to the investigator. Consult OHSR staff for assistance in determining whether the requirements for de-identification are satisfied.