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Organization Policy OHSR.4 JHM Policy Governing Use of Human Biospecimens to Derive Immortalized or Pluripotent Stem Cell Lines
The U.S. federal regulations governing human subjects research establish ethical standards for collecting and using human biospecimens (“biospecimens”). These standards generally require voluntary and informed consent from biospecimen “donors” or “sources”.
In the past, researchers have derived cell lines from previously collected clinical samples and/or from samples collected under general biomedical research protocols, without explicit consent from donors for this use. JHM recognizes that there are many valuable biospecimen repositories that were derived before these potential uses were contemplated. JHM also recognizes that it may be impossible or impracticable to obtain reconsent from some donors or sources of these biospecimens.
JHM believes it is important to provide guiding principles for the ethical use of biospecimens to derive immortalized or pluripotent stem cell lines. These principles apply to biospecimens with identifiers and those that have been de-identified.
- Prospective biospecimen collection: For the prospective collection of biospecimens from which immortalized or pluripotent stem cell lines may be derived, a research application with a consent form explicitly describing this use must be submitted to the JHM IRB and approved. A sample consent form template is available on the JHM IRB website at http://www.hopkinsmedicine.org/institutional_review_board/forms/.
- Existing biospecimens:
- Research specimens: For the use of existing biospecimens to derive immortalized or pluripotent stem cell lines where this use was not described explicitly in the research consent form, a research application should be submitted to the JHM IRB and approved. The application should describe whether (i) reconsent will be obtained, or (ii) provide justification for not obtaining reconsent (e.g., impracticability). If reconsent will be obtained, a copy of the form to be used for reconsenting should be submitted with the application.
If the researcher does not plan to obtain reconsent, copies of the consent forms under which the biospecimens were obtained should be included with the application. The JHM IRB will determine whether the proposed use is consistent with the intent of the original consent form, in which case reconsent may not be required.
- Clinical specimens: Immortalized or pluripotent stem cell lines may not be derived from biospecimens that were obtained under general consent provided for routine clinical care, unless reconsent for research use of the biospecimens is obtained.
- Commercial Source: If a commercial source provides biospecimens that will be used to derive immortalized or pluripotent stem cells, the planned use at JHM should be (i) consistent with the consent form under which the biospecimens were obtained, and (ii) not in conflict with any restrictions on use in the purchase agreement. This may be confirmed through a specific statement from the commercial source with the purchase, or through information made available on the source website.
- Incoming MTA: A Material Transfer Agreement (“MTA”) is required for biospecimens transferred to Johns Hopkins from outside entities. When immortalized or pluripotent stem cells will be derived at JHM from transferred biospecimens, the MTA should include a statement from the transferring entity confirming that this use is consistent with the consent under which the biospecimens were obtained, and any restrictions on such use.
- Outgoing MTA: An MTA and Biospecimen Information Transfer Sheet (“Info Sheet”) will be required for biospecimens transferred from JHM to outside entities. When immortalized or pluripotent stem cells derived at JHM are being transferred to outside entities, or biospecimens are being transferred for the derivation of immortalized or pluripotent stem cells by the recipient, the Info Sheet must include this information. The Info Sheet will be reviewed to determine whether such derivation is consistent with the consent under which the biospecimens were obtained, and any restrictions on such use. Any restrictions on use will be included in the outgoing MTA.