Sponsor Contracted Third-Party Collaborators

September 2022

If a Sponsor requires investigators to utilize the services of a third-party entity in a research study and the activity conducted by the entity constitutes engagement in human subject research, Hopkins requires documentation that the activities conducted by the third-party entity have been approved by an external IRB.

Investigators are responsible for understanding the requirements associated with utilizing a third-party entity and sharing them with Sponsors. When contemplating the use of a third-party entity in a research study, investigators must consider the following:

1) Is the third-party entity engaged in human subject research?

Maryland law requires that all human subjects research be conducted in accordance with the federal regulations.  Accordingly, to ensure a consistent approach, Johns Hopkins Medicine applies the Common Rule/DHHS definition of engagement to all federally funded and non-federally funded human subject research. See OHRP guidance: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-institutions/index.html. The determination of engagement depends on the specific facts of the individual study.

A third-party entity is considered engaged in human subject research if any of the following are applicable:

(a) The entity solely provides services for research purposes;

(b) The activity of the third-party entity includes the administration of an investigational product; OR

(c) The entity conducts activities not otherwise considered routine in the scope of their business.

The IRB requires documentation of outside IRB approval for third-party entities engaged in human subject research.  See also 3 below.

Alternatively, the IRB may determine that an entity is not engaged in human subject research if all of the following are correct:

(a) the services performed are typically performed by the entity for non-research purposes;

(b) the services performed do not merit professional recognition or publication privileges; and

(c) the entity’s employees or agents do not administer any study interventions being tested or evaluated under the protocol. 

For studies involving services provided by a third-party entity, investigators should upload a document to eIRB Section 20, item 2, providing a rationale for why the services do or do not engage the entity in human subject research.   Documentation of outside IRB approval is not required if the IRB determines that the third-party entity is not engaged in human subject research. 

PLEASE NOTE: The determination of engagement is study specific.  Investigators are urged to consult the aforementioned OHRP guidance as it provides multiple examples of activities that do and do not constitute human subjects research and include scenarios not included in this guidance.  

2) Will the Sponsor permit the study team or a Hopkins affiliated entity to conduct the activity?

For example, if the Sponsor is requesting that a third-party home health agency provide services to subjects in their home, the investigator should consider whether those services may be conducted by a Hopkins study team member or the Johns Hopkins Home Care Group (JHHCG). This is the preferred option as the JHM IRB may provide oversight of the JHHCG activities and that entity is covered by the Hopkins FWA.  Additionally, no additional IRB approvals or contractual considerations are required. Investigators should reach out to [email protected] to seek arrangements. For more information, please review the JHHCG guidance at the following link: https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/research_requiring_home_care_services_at_JH.html

3) Does the entity have IRB approval?

If an entity is determined to be engaged in human subject research, Hopkins requires documentation that the research activities conducted by the entity are reviewed and approved by an external IRB.

(a) Commercial IRBs may agree to act as the IRB of record for a third-party entity engaged in human subject research. Documentation that an external IRB reviewed a protocol describing the planned activities of the third party entity is not sufficient. In cases where a third part entity is engaged in human subjects research, the JHM IRB requires documentation that an external IRB is providing IRB oversight for the activities of the third party entity. This is typically accomplished via adding the third party entity as a “site”.  Documentation of IRB approval for the third party must be supplied before the JHM IRB can agree to the use of the third party entity for our site. The investigator is encouraged to discuss these requirements with the Sponsor and reach out to the JHM IRB if the sponsor has questions regarding the required documentation.

(b)Documentation confirming the entity has IRB approval to conduct the research activities should be uploaded into eIRB Section 20 (Supplemental Documents), item 2./p>

(c) The entity’s role in the research must also be described in the protocol and consent.

4) Has ORA been notified? 

Investigators must contact the Office of Research Administration to confirm that the activities conducted by the third-party entity are clearly reflected in a JHU Research Contract; most often the research sponsor has retained the third-party, and this relationship should be documented in the main study contract with the research sponsor, but a separate agreement with the third-party may be appropriate in some circumstances. Either way, the agreement should be clear that neither JHU nor the PI may take responsibility for oversight of the third-party entity. Contact information for the Contracts Specialist that supports your department/division is available here for commercial sponsors, or here for noncommercial sponsors.