Conducting Human Subjects Research at MGH IHP

All human subjects research projects conducted by MGH IHP faculty in connection with their MGH IHP faculty appointment must be submitted to the MGB IRB for review through the MGB 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 MGB IRB for review. The Program Director’s signature signifies that the MGH IHP faculty member has the expertise and resources to conduct the research and that the research project is acceptable for IRB review.

When MGH IHP faculty conduct research under the auspices of another non-MGB institution, they must consult the MGB IRB to determine whether the MGH IHP is engaged in human subjects research, and if so, whether the MGH IHP is willing to rely on the non-MGB IRB for IRB approval. In such cases, reliance agreements must be executed between the relying institution and the reviewing IRB organization. The MGB 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-MGB IRBs.

All student human research projects must be carried out under the direct supervision of at least one MGH IHP faculty member. MGH IHP 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. MGH IHP 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 MGB IRB through the MGB Insight system. The MGH IHP 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 MGB IRB for review. The Program Director’s signature signifies that the MGH IHP faculty member and student have the expertise and resources to conduct the research and that the research project is acceptable for IRB review.

When MGH IHP students conduct research under the auspices of another non-MGB institution, they must consult the MGB IRB to determine whether the MGH IHP is engaged in human subjects research, and if so, whether the MGH IHP will rely on a non-MGB IRB for IRB approval. The MGB 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-MGB IRBs, refer to the Reliance Agreements page in Research Navigator or contact Laura Kea or Maria Sundquist.

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

Recruitment of Students of the MGH IHP Faculty Member: As an academic institution, MGH IHP 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 MGH IHP faculty proposes to recruit their own students, the MGB 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 MGH IHP 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 Institute/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 MGB Human Research guidance on Education Research (still in draft).

Most of the information needed to apply to the MGB 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

• MGB Protocol Summary and/or Detailed Protocol
• MGB 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 MGB 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 MGB IRB submissions, contact:

IRB Help Line, 857-282-1900

%20IRB [at] partners.org (subject: IRB%20Questions) (MGB 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:

• MGB HRA Clinical Research Boot Camp (2.5hrs)
• MGB HRA Good Clinical Practice Guidelines (1.5hrs)