• The primary expectation is that biospecimens subject to transfer will have been obtained using a research consent, that the consent includes information about sharing with collaborators and that the planned use outlined in the transfer will align with any research consent obtained.
• Sharing with commercial entities typically requires explicit consent. The JHM IRB has developed template consent language that can cover this sharing. (i.e., Your data and/or biospecimens may be shared with researchers at Johns Hopkins and other institutions, for-profit companies, sponsors, government agencies, and other research partners.) If you wish to share with a commercial entity and the consent form signed by participants does not contain this language, be prepared to consider a plan for re-consent.

• If you are planning to transfer samples from a Hopkins IRB-approved protocol that had multiple consent versions, you will need to specify the versions of the consents that were used to consent individuals whose biospecimens are part of the proposed for transfer. This will assist the committee in considering the appropriateness of sharing and use language for each version of multiple/varying consent documents.
• For your convenience, please see the Example Table for Consent Variations. Please feel free to download this table and adapt it to your unique biospecimen transfer request. If you have specific questions about how to complete the table, please reach out to BTC staff at [email protected]. 

If biospecimen donors were minors at the time of donation, but have since reached the age of majority, they should be reconsented for the use and transfer of their biospecimens for research purposes.

• If donors are known to be deceased at the time of the transfer request, the BTC may request that you create a plan for potential recontact/reconsent from family members who can provide permission for the transfer of their loved one’s/next-of-kin’s biospecimens for research purposes. Each situation for recontacting/reconsenting family members of deceased participants is unique and the BTC will review and advise on a case-by-case basis. Please contact us at [email protected] if you have questions about utilizing specimens from participants who are now deceased.

• Next-of-kin consent/reconsent may be appropriate when next-of-kin were involved in the initial biospecimen donation process (e.g., in circumstances when a participant agreed to a research autopsy and ultimately a family member had to approve the autopsy after the individual passed away).

Examples of what the BTC considers to be “absence of consent” include:

• Specimens originally used for research purposes under a waiver of consent 
  OR
• Specimens collected under a clinical/research consent that did not inform participants about future data/biospecimen sharing but did not explicitly prohibit sharing. (If the consent form specifies that biospecimens will be used only by the investigator/institution and will not be shared, permission to transfer will not be granted without reconsent.)

In the absence of consent, the BTC considers the following:

• Is consent or reconsent practicable? This can be accomplished by contacting the patient/participant to sign a new consent form or requesting permission by telephone (waiver of documentation of consent, including phone script).

   

• If reconsent is not practicable, is there an alternate source of consented specimens available? For example, is there another IRB-approved Hopkins study with appropriately consented specimens available from participants with a similar disease/condition that could be used? Investigators are expected to provide a detailed justification as to why an alternate source of consented specimens is not available.

   

• If reconsent is not practicable AND an alternate source of consented specimens is not available, the BTC considers the risk/benefit ratio of the proposed transfer, whether the risk/benefit ratio is favorable, and given the risk/benefit ratio, whether it is reasonable to transfer specimens when participants did not have a choice. For more information regarding these considerations, please see the Risk/Benefit Ratio section.

   

  • In these instances, the BTC also takes into consideration whether the disease cohort is rare, and if so, how rare it is at Hopkins (e.g., How many patients with the rare diagnosis are seen at Hopkins per year?).

Identifying potential benefits is a major factor in determining whether specimens can be transferred outside of Hopkins, especially when consent is absent. The BTC considers, for example, whether the knowledge to be gained will benefit Hopkins patients, the local Baltimore community, or will address a specific local clinical need. 

The BTC must consider potential risks and how those can be minimized in the process of transferring biospecimens outside of Hopkins. The following factors are important to address in the BTI Form so that the BTC can appropriately assess and determine that potential risks have been mitigated.

• Confirmation that specimens/data will not be retained by recipient for unspecified future use and that any unused specimens will be returned to Hopkins
• Assurances that specimens/data will not be contributed to a repository or shared in an uncontrolled manner by the recipient
• Characterization of risk of re-identification based on data associated with specimens (e.g. genomic data) that could be considered identifiable 

Please visit the Route an Agreement for Review webpage for information about submitting MTA requests.

• If biospecimens were originally sent to Hopkins from another entity (Sender), and the Hopkins PI wants to transfer some/all of those specimens outside of Hopkins to a third party (Recipient), the original MTA documenting Hopkins’ acquisition of specimens must be reviewed by appropriate offices to assess any potential restrictions on the use/transfer of specimens per the original agreement between the Sender and Hopkins.
• If you are unsure as to whether your biospecimens would fall under this consideration, please contact us at [email protected]. 

The BTC meets once per month to discuss biospecimen requests that require convened committee review. However, expedited transfer requests are reviewed on an ongoing basis. 

Although there are a variety of factors that may affect the review type for each unique biospecimen transfer request, below are some of the most common indicators that a transfer request will require convened BTC review:

• Biospecimens collected under a waiver of consent or under a consent without biospecimen sharing language
•  Biospecimens collected under clinical consent with no biospecimen sharing language
• Biospecimen transfers where there is a financial or institutional conflict of interest documented by the investigator which may be impacted by the transfer
• Biospecimens collected from minors who have now reached age of majority/adulthood
• Transfer to for-profit corporations/companies with the potential for drug or device development/marketing
• Umbrella biospecimen transfer protocols