Conducting Human Subjects Research at MGH Institute of Health Professions (MGH IHP)
Additional sections are still being drafted by the MGB IRB as indicated. This document will be revised to include the additional sections when available.
1. Policies and Procedures for Research
Institutional policies and procedures for research are overseen by the Office of the Provost.
Scholarly research is conducted by both MGH IHP faculty and students. As educators, the MGH IHP faculty may conduct research on a broad range of topics including new educational approaches/methods. As part of some MGH IHP educational programs, students are required to complete a scholarly project in order to graduate.
Scholarly projects can be research projects, literature reviews, scholarly case presentations, or quality improvement projects. Systematic research projects conducted on new educational methodologies with the intent to disseminate findings to develop or contribute to generalizable knowledge meets the definition of human subjects research, but may be exempt from the regulatory requirements in the Common Rule (45 CFR 46). The IRB must review all human subjects research and make all exemption determinations. For more information, refer to MGB Human Research guidance on Education Research (still in draft).
Literature reviews and scholarly case presentations do not meet the definition of human subjects research and do not require MGB IRB approval. Quality improvement projects do not require MGB IRB approval if the results will only be used to improve quality at the institution and are not intended to be published in the literature or otherwise be used to contribute to generalizable knowledge in the field of education research. For more information on Quality Improvement activities or activities that do not require IRB review, see Clinical Quality Improvement Checklist and Guidance on Activities Not Requiring IRB Review (still in draft).
The MGH IHP relies on the MGB IRBs (also known as the MGB IRBs) for review and oversight of human subjects research projects conducted by MGH IHP faculty and students. MGB IRB policies and procedures are available on the MGB Research Navigator website.
1.1. Faculty Research
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, firstname.lastname@example.org, 857-282-1902 or Laura Kea, email@example.com, 857-282-1896 for more information on reliance on non-MGB IRBs.
1.2. Student Research
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.
1.3. Use of Institute Students/Employees as Research Subjects (adapted from the Harvard Medical School policy)
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).
1.4. MGB IRB Information
Most of the information needed to apply to the MGB IRB can be found in Research Navigator. To access the Navigator public page, go to http://navigator.partners.org. To access the Navigator private page, scroll down the public page. On the right you will see the EMPLOYEE LOGIN button. Click on EMPLOYEE LOGIN and follow the instructions below:
- Enter your primary email address
- Click the box Keep Me Logged In.
- Enter your MGB User Name.
- Enter your Password on the secure logon screen.
- Bookmark the private page.
Please be sure to log into your Navigator account before trying any of the links below:
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
Line (Lynne) Papin, Protocol Administrator, 857-282-1908
Rosalyn Gray, Administrative Director, 857-282-1903
Insight Help Desk, 857-282-1959, firstname.lastname@example.org (for technical issues)
Research Navigator, email@example.com (for access to Research Navigator)
1.4.1. Human Research Training
All faculty and student researchers must complete training in human subjects research (HSR). This training must be renewed every three years. MGH currently subscribes to online HSR training courses offered by the Collaborative Institutional Training Initiative (CITI). When registering, MGH IHP faculty and students should affiliate with MGH as the account holder and complete the HSR courses through the MGH affiliation. Information about HSR training requirements and instructions on how to access and complete the CITI online training courses can be found here: CITI Human Subjects Training.