10.03 Office for Human Research Administration

The Harvard Medical School Office of Human Research Administration is responsible for the approval and oversight of human research conducted at HMS. All such research must receive approval from the appropriate Institutional Review Board (IRB) prior to the start of the study. Details about policy and procedures can be found at http://hms.harvard.edu/departments/office-human-research-administration.

Determining if a Master's Student Needs HMS IRB Approval

  1. If the student is also an employed fellow at an HMS-affiliated hospital and is conducting his Master’s research as part of his fellowship, then usually only hospital IRB approval is needed.  In those cases where HMS is the recipient of a grant or other award which funds the research, HMS approval would be needed.
  2.  If the student is not an employed fellow at an HMS-affiliated hospital but is conducting his Master’s research at an affiliated hospital, he needs to contact the Office of Human Research Administration (Grace Bullock) to determine what type of action may be taken by the HMS/SPH IRB.  Possible actions include: a determination of whether or not the student is actually engaged in human subject research;  a full review by the HMS/SPH IRB; or a ceding to the hospital’s IRB.
  3. If the student is not an employed fellow at an HMS-affiliated hospital and is conducting his Master’s research at an international site, he must contact the Office of Human Research Administration to obtain HMS/SPH IRB approval even if he already has approval from the international site.  (Harvard will not cede to an international site’s IRB.)
  4.  If the student is not an employed fellow at an HMS-affiliated hospital and is conducting his Master’s research at HMS (in a Quad department), he would need HMS/SPH IRB approval for any human subject research or he might just need to be added to an  already approved study.
  5. If in doubt, contact Grace Bullock in OHRA at 617-432-3071 or gbullock@hsph.harvard.edu.

      See also:  http://www.hsph.harvard.edu/ohra/formsinstructions/iaas-and-iias/

Important links

Information and forms for submitting IRB applications for research are available at http://cuhs.harvard.edu/.

IRB Investigator Manual: http://hms.harvard.edu/departments/office-human-research-administration/investigator-manual

Guidelines for Approval of Research Studies

To apply for IRB approval of research

Master’s students must receive approval from their program for their proposed mentored research or capstone projects before applying for IRB approval. Program staff and research mentors are available to assist in the application process.

To begin the application for IRB approval, go to irb.harvard.edu to access ESTR, the Electronic Submission, Tracking, and Reporting System, and use your Harvard ID and password to sign on to the system. Click on “create new study,” and you will see a blank “SmartForm” that includes a series of questions related to your study (Study Title, Personnel, etc.). Depending on your answers, the SmartForm will direct you to fill out additional forms or answer more detailed questions relevant to your study. A research protocol template will also be provided for you to describe the study design, methods, recruitment, and consent process. While you are working on your research protocol document, you can save it on your computer or flash drive, and upload it to your ESTR account when it is completed. Other study documents (such as consent forms, survey instruments, and recruitment material) must also be uploaded to ESTR. When your study documents are ready to go, you will click “submit” and the IRB will begin the intake process.

Guidelines for Research with Students as Participants

Students may participate in any study for which they are eligible; however, in order to prevent any coercion (or perception of coercion) or undue pressure for students to participate, investigators should not specifically recruit students who work directly or indirectly for them, students who work with or for them, or students for whom investigators have any, even indirect, educational oversight, such as grading or assessment.

Participation in a research study may never be a condition of employment, insurance, grades, promotion, or any other benefits or bonuses. The Office of Human Research Administration is particularly mindful of situations that may put undue pressure on students to participate in research projects, and thus recommends that investigators refrain from directly soliciting students as participants. Students with questions or concerns related to participation in a research study should contact the Harvard Office of Human Research Administration. Contact information can be found at http://hms.harvard.edu/departments/office-human-research-administration/contacts-location.