External Members and Engagement in Research 

Summary

Purpose: Occasionally, external research personnel perform services that would not qualify them to count as officially part of the “research team.” However, situations are not always clear when those personnel communicate or interact with potential participants. This guidance provides some clarity around when external members count as “engaged” in the research.

Full Description

Engaged or not? 

Per OHRP, “in general, an [person] is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain: 

1. data about the subjects of the research through intervention or interaction with them 
2. identifiable private information about the subjects of the research;  
3. the informed consent of human subjects for the research."

If an individual is functioning within their regular work responsibilities and their involvement in the research is limited to those work responsibilities only, without further contribution to the research, then they are generally not considered study team members. 

I. The personnel/researcher is engaged if:

1. The institution/researcher receives a direct Federal award through a grant, contract, or cooperative agreement for human subjects research, even where all activities involving human subjects are carried out by employees or agents of another institution;
   
2. Employees or agents
   • Intervene for research purposes with any human subjects of the research by performing invasive or noninvasive procedures or by manipulating the environment; or
   • Interact for research purposes with any human subject of the research (if yes, see point 4 in Section II for exceptions); or
   • Obtain the informed consent of human subjects for the research; or
     
   • Obtain for research purposes identifiable private information or identifiable biological specimens from any source for the research. Obtaining identifiable private information or identifiable specimens includes, but is not limited to:
     • observing or recording private behavior; or
     • using, studying, or analyzing for research purposes identifiable private information or identifiable specimens
     • provided by another institution; or
     • using, studying, or analyzing for research purposes identifiable private information or identifiable specimens already
     • in the possession of either institution or the investigators.

Example: A translator obtains informed consent from a prospective participant on behalf of the researcher. The W&M researcher is not present during the consent process.

II. The personnel/researcher is NOT engaged if:

1. Assisting with the recruitment of subjects by
   
   • informing prospective subjects about the availability of the research; or
     
   • providing prospective subjects with information about the research (which may include a copy of the relevant informed consent document and other IRB approved materials) but do not obtain subjects’ consent for the research or act as representatives of the investigators; or
     
   • providing prospective subjects with information about contacting investigators for information or enrollment; or
2. Obtaining coded private information or biological specimens from another institution, provided that the recipient investigators will be unable to readily ascertain the identities of the subjects to which the coded information or specimens pertain (for example, by having a written agreement prohibiting the release of the key to the code)
3. Authoring a paper, journal article, or presentation describing a human subjects research study without obtaining access to identifiable private information
4. Performing commercial or other services for investigators provided that all of the following conditions also are met:
   • the services performed do not merit professional recognition or publication privileges; and
   • the services performed are typically performed by those personnel for non-research purposes; and
   • the institution’s employees or agents do not administer any study intervention being tested or evaluated in the study

Example: A translator employed by a translating service assists researchers with interpreting participant responses. The translator will not have access to the interview data and will not be listed on the publication materials.

Requirements for Engaged Personnel 

1. Take Required Human Subject Research Training Course: The external member must chose to take OHRP or CITI training to complete this requirement. W&M accepts CITI training of other US institutions. 
   • OHRP Human Subjects Training
     When accessing the webpage, please click the green circle with two arrows to access the course that will allow you to generate a certificate for each lesson. 
     If your external collaborator chooses to complete the OHRP training, please attach their certificate of completion to the research protocol. 
   • IRB CITI Course: IRB External Members 
     External members can use their own professional email to sign up for courses. They do NOT have to have a W&M email to access the courses. External members can follow the same instructions to sign up for the course.
   • CITI Export Controls (if conducting research internationally or researcher is based outside the US
2. Review of FAQs of “investigator” responsibilities from OHRP.  
3. External personnel must be listed on protocol with their role on the project defined within the protocol submission 
4. Research Agreement/Contract: An IRB Authorization Agreement (IAA), Individual Investigator Agreement (IIA), Data Use Agreement (DUA), Cooperative Research & Development Agreements (CRADA) and/or Memorandum of Understanding (MOU) may be needed depending on the type of research, data being accessed, etc.
5. International Research Guidance: If working in a non-US location, please make sure to familiarize yourself with W&M guidance about international research requirements.  
   • External personnel are required to follow all applicable laws and regulations to both the U.S. and the country hosting the research