Conducting Human Subjects Research at Mass General Brigham University

All human subjects research projects conducted by Mass General Brigham University faculty in connection with their faculty appointment must be submitted to the Mass General Brigham IRB for review through the Mass General Brigham Insight system.

New submissions that involve an intervention or an interaction with research participants (e.g., participants are asked to complete instruments/questionnaires, surveys or participate in specially designed lab exercises) must be reviewed and signed off in Insight by the Program Director before the submission can be accepted by the Mass General Brigham IRB for review. The Program Director’s signature signifies that the Mass General Brigham University faculty member has the expertise and resources to conduct the research and that the research project is acceptable for IRB review.

When Mass General Brigham University faculty conduct research under the auspices of another non-Mass General Brigham institution, they must consult the Mass General Brigham IRB to determine whether the University is engaged in human subjects research, and if so, whether the University is willing to rely on the non-Mass General Brigham IRB for IRB approval. In such cases, reliance agreements must be executed between the relying institution and the reviewing IRB organization. The Mass General Brigham IRB will consult the Director of Research Programs in the Office of the Provost on any proposed new reliance arrangements. Contact Maria Sundquist, msundquist [at] partners.org (msundquist[at]partners[dot]org), 857-282-1902 or Laura Kea, lkea [at] partners.org (lkea[at]partners[dot]org), 857-282-1896 for more information on reliance on non-Mass General Brigham IRBs.

All student human research projects must be carried out under the direct supervision of at least one Mass General Brigham University faculty member. University faculty members are responsible for reviewing student research projects to ensure adequacy of the specific aims, study design, study procedures, outcome measures and methods of analysis prior to submission to the IRB review. Mass General Brigham University faculty may consult other faculty members with research expertise or the Director of Research Programs, as needed, on project development.

All student human research projects must be submitted to the Mass General Brigham IRB through the Mass General Brigham Insight system. The faculty member must be listed as the Principal Investigator and the submission must be reviewed and signed off in Insight by the PI faculty member and, when applicable, the Program Director before the submission can be accepted by the Mass General Brigham IRB for review. The Program Director’s signature signifies that the faculty member and student have the expertise and resources to conduct the research and that the research project is acceptable for IRB review.

When Mass General Brigham University students conduct research under the auspices of another non-Mass General Brigham institution, they must consult the Mass General Brigham IRB to determine whether the University is engaged in human subjects research, and if so, whether the University will rely on a non-Mass General Brigham IRB for IRB approval. The Mass General Brigham IRB will consult the Director of Research Programs in the Office of the Provost on any proposed new reliance arrangements. For more information on reliance agreements with non-Mass General Brigham IRBs, refer to the Reliance Agreements page in Research Navigator or contact Laura Kea or Maria Sundquist.

Recruitment of Mass General Brigham University Students: For the mutual protection of the student, investigator, and the University, any protocol in which researchers outside Mass General Brigham University or Mass General Brigham plan to recruit Mass General Brigham University students must be submitted to the Mass General Brigham IRB for administrative approval. The Mass General Brigham IRB, in consultation with the Director of Research Programs in the Office of the Provost, will determine whether recruitment of Mass General Brigham University students is appropriate and, if so, whether further review by Mass General Brigham IRB is needed.

Recruitment of Students of the Mass General Brigham University Faculty Member: As an academic institution, Mass General Brigham University faculty are engaged in the scholarship of teaching and conduct research on new educational approaches/methods to determine whether these new methodologies have a positive impact on learning outcomes. When University faculty proposes to recruit their own students, the Mass General Brigham IRB will consider issues of coercion or undue influence, informed consent and confidentiality. Prospectively conducted research will require informed consent (written, verbal or implied by completion of surveys). Student participation must be voluntary and students must be given the option to opt out with the understanding that opting out will have no impact on grading, educational opportunities or attitudes of the University faculty.

Review of Student Education Records: When the research is limited to review of students’ educational records (e.g., tests, journals, written assignments, etc.) protected by the Family Educational Rights and Privacy Act (FERPA), faculty must obtain the written informed consent (signed and dated) of the students OR request de-identified copies for their research. Student records must be de-identified by an official of the school with legitimate access to the records (other than the researcher). Student records are considered de-identified when all personally identifiable information is removed from the records such that the University/IRB has determined that the student cannot be reasonably identified from the record. The school official may assign a code to the records when the researcher needs to match information from multiple sources provided that the school official does not disclose to the researcher the basis for the codes and how they were generated and the codes do not include elements of the student’s social security number or other personal information. For more information, refer to Mass General Brigham Human Research guidance on Education Research (still in draft).

Most of the information needed to apply to the Mass General Brigham IRB can be found in Research Navigator. 

The pages in Navigator where you can find requirements for most studies are as follows:

Intervention/Interaction Studies (includes survey research):

The following documents are required for studies that involve an intervention or interaction with subjects

• Mass General Brigham Protocol Summary and/or Detailed Protocol
• Mass General Brigham Research Consent Forms (or Information/Fact Sheet when requesting a waiver of documentation of informed consent).

Health/Medical Records Studies (studies limited to the use of medical/other records)

Excess Human Material Studies (studies limited to the use of leftover tissue/samples)

Secondary Use Research Samples/Data (studies limited to use of samples/data collected as part of another research study (source study))

Note: Access to Research Navigator is based on your license to Office 365. Most of the Mass General Brigham research community has Office 365. If you are unable to login using your primary email address, click the button ‘REQUEST ACCESS’ to get your Office 365 license activated.

For assistance with Mass General Brigham IRB submissions, contact:

IRB Help Line, 857-282-1900

%20IRB [at] partners.org (subject: IRB%20Questions) (Mass General Brigham IRB Mailbox)

Insight Help Desk, 857-282-1959, insighthelpdesk [at] partners.org (insighthelpdesk[at]partners[dot]org) (for technical issues)

Research Navigator, researchnavigator [at] partners.org (researchnavigator[at]partners[dot]org) (for access to Research Navigator)

All faculty and student researchers involved in the conduct of human subject research must complete training in human subjects research (HSR). This training must be renewed every three years and is comprised of two courses:

• Mass General Brigham HRA Clinical Research Boot Camp (2.5hrs)
• Mass General Brigham HRA Good Clinical Practice Guidelines (1.5hrs)