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Transferring Human Biospecimens to Outside Organizations
Human biospecimens obtained for clinical and/or research purposes at any Johns Hopkins Medicine (JHM) facility are the property of the applicable JHM entity under whose authority the samples were collected. JHM is dedicated to thoughtful and responsible stewardship of those human biospecimens. To that end, any transfer of human biospecimens must meet the institution’s policy and procedural requirements.
Q1. Is there a policy outlining the requirements for transfer of human biospecimens?
Yes, the policy, ADMIN015: Transferring Human Biospecimens to Outside Organizations (JHED login required) went into effect in February 2019. While there has historically been a process for review of human biospecimen transfers, this policy sets forth the specific requirements for transfer of human biospecimens that are the property of JHM.
Q2. Who is responsible for the review of human biospecimen transfer requests?
The JHM Human Biospecimens Transfer Committee (“Committee”) is responsible for the review of transfer requests and will consider information provided in corresponding IRB applications submitted by the Principal Investigator requesting the transfer.
Q3. Who makes up the Human Biospecimens Transfer Committee and how will they review transfer requests?
The Committee, made up of the Vice Dean for Clinical Investigation, the Vice Dean for Research (or their designees), a representative of the JHM Institutional Review Board (IRB), and at least one additional faculty member with appropriate expertise is responsible for reviewing human biospecimen transfer requests. The Human Biospecimens Transfer Committee may conduct reviews by convened session or by an individual reviewer, as applicable.
The Committee will consider a number of factors in its decision to approve a biospecimen transfer, including but not limited to: (i) that the biospecimens are utilized for the highest and best use; (ii) whether human biospecimens collected at JHM are managed in compliance with applicable regulatory, ethical and privacy standards; (iii) whether the transfer involves a true research collaboration; and (iv) whether conflicts of interest are managed. The Committee will consider information provided in corresponding IRB applications and coordinate review with the execution of Material Transfer Agreements (MTAs) by the Office of Research Administration (ORA) and the Johns Hopkins Technology Ventures (JHTV) office.
Q4. How do I submit my request for human biospecimen transfer for review?
Requests to transfer human biospecimens outside of the organization must be submitted in a JHM eIRB application. Requests may be included in a new application that includes a transfer, a Change in Research for a new transfer within a previously approved application or a Not Human Subjects Research (NHSR) application, as applicable. The protocol should include a description of the nature of the research collaboration with the external entity and the rationale for the transfer, along with supporting documentation (addressed in Q6 below).
Q5. Is my IRB-approved repository/banking protocol sufficient for new projects that involve transferring biospecimens collected under the initial IRB application?
Each new project that involves transferring biospecimens collected under a banking protocol generally requires a new eIRB application. In addition to a specific use of the biospecimens, the new project may involve different objectives, funding, collaborations and/or conflicts of interest.
As of 01/03/2019, a repository/banking protocol should be described in an eFormR protocol format, designed to cover the creation of a research resource. An eFormS protocol format should be used to describe all secondary research projects. The eFormS may be brief and may draw from information included in the scope of work. See https://www.hopkinsmedicine.org/institutional_review_board/forms/ for protocol templates.
Q6. What are the supporting documents required for review of human biospecimen transfers?
Supporting documents that must accompany the human biospecimen transfer request include:
- A completed JHM Outbound Human Biospecimen Transfer Information sheet;
- De-identified Human Subject Certification (or a Data Use Agreement);
- Unsigned consent form(s)* used to obtain informed consent of the donors of the human biospecimens.
- *Where applicable, JHM Institutional Review Board application numbers may be referenced instead of uploading consent documents.
- Associated Institutional Review Board approval letter(s) where the JHM IRB was not the reviewing IRB for the protocol under which samples were collected;
- JHTV online submission form (https://ventures.jhu.edu/technology-transfer/material-transfer-agreements/) or a copy of the COEUS PD, if a concurrent MTA request has been initiated with either office;
- If the proposed research collaboration at the receiving institution qualifies as human subjects research, a copy of the receiving institution’s IRB approval or Institutional Review Board exemption determination should be provided.
Q7. What is a JHM Outbound Human Biospecimen Transfer Information (BTI) sheet?
A JHM Outbound Human Biospecimen Transfer Information sheet is a form designed to capture relevant details about the proposed transfer of human biospecimens. It is available on the JHM Institutional Review Board Forms page at https://www.hopkinsmedicine.org/institutional_review_board/forms/index.html.
Q8. How should I submit supporting documents to the Human Biospecimens Transfer Committee?
The Supporting documents (outlined in Q6) should be uploaded into an eIRB application at Section 20, Item 2 (Supplemental Documents). This will allow the transfer request to be available for concurrent preliminary reviews by the IRB, ORA and JHTV, as applicable.
Once the information is determined to be complete, the Committee will review the submission and will determine whether to approve the transfer.
Q9. If this transfer is related to a new or ongoing JHM Institutional Review Board approved protocol, does Human Biospecimens Transfer Committee approval have to occur before the IRB approves the plan?
Yes, similar to other ancillary reviews, Committee approval is a condition for final Institutional Review Board approval. The Committee must review and approve any human biospecimen transfers related to new or existing JHM IRB applications. If the transfer was not previously described in the application, a change in research needs to be submitted to the IRB with the request and supporting documents to facilitate the review prior to transfer of any human biospecimens.
Q10. What does it mean to have a true collaboration that necessitates transfer of a JHM derived human biospecimen?
A true research collaboration means that a JHM investigator must make a significant intellectual contribution to the design of the research study, analysis and sharing of resulting data and must participate in the planned publications.
Q11. What is required if you are sharing samples originally collected under someone else’s study?
A statement is required from the investigator who originally collected the human biospecimens confirming that s/he is aware of the transfer and does not object. The investigator (who collected the human biospecimens or who will transfer them) must confirm that s/he has a signed copy of the consent form for each individual whose human biospecimens are being transferred or an Institutional Review Board waiver of consent and that the described sharing is consistent with the consent of donors. This includes confirmation from the transferring investigator that opt in/opt out options for future sharing are followed.
Q12. If I have an MTA do I still need to meet these requirements?
Yes. The existence of an MTA does not eliminate the requirement for human biospecimen transfer review. In addition, a new Committee review and a new MTA or MTA amendment may be required for an existing MTA if the terms or uses of the biospecimens change.
Q13. Do I still need an MTA after my request to transfer materials is approved by the Committee?
Q14. Are there exceptions to the policy?
Yes. Approval for transfer of human biospecimens maintained or collected at JHM need not be (additionally) approved through the policy under the following two exceptions:
- Where the human biospecimens are contained in, or transferred to, a National Institutes of Health (NIH) funded tissue bank specifically designed to provide samples to qualifying research parties, and the requesting party fits within the conditions for access to the bank; and
- Where human biospecimens are collected and transferred as part of a clinical trial agreement, with the use of the samples limited by the terms of the clinical trial agreement and informed consent.
Q15. Is Biospecimens Transfer Committee review required if samples are sent for analysis through a service agreement only?
No. Committee review is not required for use of “vendors” who do not obtain/retain any rights to use data/specimens except as needed for the performance of the services.
Q16. Is Biospecimens Transfer Committee review required if samples to be transferred are obtained from human biospecimens but are not “human” samples.
No. The transfer of microbes isolated from human sputum, for example, does not require Committee review if the isolates are washed/cleared of information from the human cells that could identify the donor.
Q17. I used to send my requests to JHTV. How are they involved?
Johns Hopkins Technology Ventures will continue to provide administrative support to the Human Biospecimens Transfer Committee. In addition, JHTV and the Office of Research Administration (ORA) will still prepare Material Transfer Agreements (MTAs) as described on the JHTV website (See: https://ventures.jhu.edu/technology-transfer/material-transfer-agreements/.)
Q18. Are there any other requirements related to research with human biospecimens?
If you plan to derive human immortalized or pluripotent stem cell lines, please see requirements related to creation and transfer of these cell lines in the JHM Policy Governing Use of Human Biospecimens to Derive Immortalized or Pluripotent Stem Cell Lines.
Q19. Whom should I contact for additional questions/guidance?
Contact Suzanne Damaré, JHM Biospecimen Program Administrator at firstname.lastname@example.org.