Human Subject Training Policy

Required Training Overview: Research Involving Human Subjects

MIT policies require that all personnel directly involved in human subjects research complete appropriate human subjects training in the ethical conduct of human research. This requirement applies to all types of human subjects research activities, including Exempt, Expedited and Full Board studies. 

Human subjects training is required for: 

  • All MIT Faculty, Staff, Undergraduate, Graduate Students, Study Coordinators, Visiting or Affiliate Appointees, and any other study personnel who, for the purposes of a research project: 
    • Obtains or access data about the participants of the research through intervention or interaction with them 
    • Obtains or access identifiable private information about the subjects of the research
    • Obtains the informed consent of human subjects for the research 
    • Engaged in research under OHRP guidance.
    • Obtains or analyze data, either identifiable, de-deidentified or anonymous, for the purpose of a clinical investigation. Please see here for more information. 
  • Faculty Sponsors who provide direct oversight to study personnel by serving as Principal Investigators, Co-Investigators, or carrying out other study roles as listed on the COUHES application
  • Non-MIT Researchers collaborating on an MIT research study 
  • Non-MIT International Enumerators
  • Investigators and all key personnel who will be involved in the design or conduct of NIH-funded human subjects research

Human subjects training is mandatory for those who are directly involved in conducting human subjects research. However, we recommend that anyone else indirectly involved with human subjects complete CITI training or similar human subjects training.

CITI Refresher Training Requirement

Personnel must undergo recertification in human subjects research training, such as taking the CITI refresher course, every three years from the date of original approval.

Responsibilities of Principal Investigators and Faculty Sponsors

Principal Investigators are responsible for confirming that all study personnel have taken and passed human subjects training, and are "certified" to participate in studies involving human subjects. In addition, Principal Investigators are also responsible for identifying and complying with any additional training requirements that apply to the study and ensuring that all staff are appropriately qualified to carry out their designated role in the study. 

The Principal Investigator and Faculty Sponsor must manage the status of all personnel involved in their research in COUHES Connect (this includes both exempt and non-exempt research), such as adding and removing personnel. Principal Investigator and Faculty Sponsor are responsible for ensuring that all study personnel are trained, and that any person whose training has lapsed no longer participates in the research and is removed as study personnel. 

Investigators involved in human subjects research must maintain their training throughout their engagement in the research. Principal investigators and faculty sponsors have a responsibility to ensure that all study personnel maintain their training until the research is complete.

To learn how to complete training and view study personnel compliance, see Training: Research Involving Human Subjects.

COUHES Training Requirement by Role

MIT Faculty, Staff, Undergraduate and Graduate Students, Visiting or Affiliate Appointees, Faculty Sponsors; OR Non-MIT Collaborating Researchers

May complete one of the following: 

  • MIT Users (Active Kerberos account) and Non-MIT Users:CITI (Collaborative Institutional Training Initiative) online training *
  • CITI training Basic Course and, if applicable active Refresher course certificate that is still valid from a previous institution (must be comparable training and at the discretion of COUHES) **

Other equivalent ethics training (determination of equivalency is at the discretion of COUHES) **

Non-MIT International Enumerators

May complete one of the following: 

  • Non-MIT Users: CITI (Collaborative Institutional Training Initiative) online training **
  • Paper based training Guide through Harvard: Link
  • Other equivalent ethics training (determination of equivalency is at the discretion of COUHES) 

Additional Study Specific Training Requirements 

Additional training and resources available through VPR

Researchers on NIH-Sponsored Clinical Trials or Conducting Clinical Investigations

Individuals involved in the conduct, oversight, or management of NIH-sponsored clinical trials or clinical investigations are required to complete training in Good Clinical Practice (GCP). The GCP training is an additional requirement and does not replace the Protections of Human Participants basic course training.

Additional Training Requirements

Study sponsors might have their own training requirements. It is the responsibility of the Principal Investigator to identify and comply with all applicable training requirements. 

COUHES Protocol Role Qualification Requirements

The PI should ensure that all staff are appropriately qualified to carry out their delegated role in the study. Each study team member’s role and associated qualifications must be described within the study application. Personnel conducting clinical assessments are encouraged to provide an up to date CV or relevant professional certificate or licensure. 

What Is Adequate Training?

The investigator should ensure that research team:

  • Are familiar with the purpose of the study and the protocol
  • Have an adequate understanding of the specific details of the protocol and attributes of the investigational product needed to perform their assigned tasks
  • Are aware of regulatory requirements and acceptable standards for the conduct of clinical trials and the protection of human subjects
  • Are competent to perform or have been trained to perform the tasks they are delegated
  • Are informed of any pertinent changes during the conduct of the trial and receive additional training as appropriate