Policy Contacts Shannon Sewards Director of IRB Administration for the Committee on the Use of Human Subjects, Harvard University Ara Tahmassian Chief Research Compliance Officer, Harvard University
Human subjects research comprises a broad spectrum, from testing of new drugs and therapeutics to surveys and questionnaires (in person or online), observation studies, and research with human tissues or data about human beings. It may or may not include direct contact with people.
Anyone performing human subjects research at Harvard, including faculty, staff, and students, must obtain the requisite approvals prior to beginning the project, regardless of funding source.
Harvard has two IRB offices that oversee human research activities:
- Committee on the Use of Human Subjects in Research (CUHS), Harvard University-Area (HUA), reviews projects from FAS, GSE, HKS, HBS, HLS, SEAS, GSD, HDS, and the Radcliffe Institute.
- The Office of Regulatory Affairs and Research Compliance: Longwood Medical Area, (ORARC), handles projects that are reviewed by the HMS/HSDM IRB, the Committee on Human Studies, and the HSPH IRB.
Harvard’s IRBs are governed by the Statement of Policies and Procedures Governing the Use of Human Subjects in Research at Harvard University.
The Harvard IRBs share a common Electronic Submission, Tracking and Reporting ESTR which is a web-based system where all researchers submit their applications including completed forms and sample documents.
While the IRBs are the first line of contact for any human-research-related question, human subjects research may require approvals beyond that given by the IRB:
- Research that involves the use of biological, chemical, or radioactive materials in humans may require the approval or signoff from the appropriate area in Lab Safety
- Research performed in collaboration with another institution may require approvals from the collaborating institution.
- Research in foreign countries may require government and/or local research ethics committee approval.
- Research involving genomic data and sharing should comply with the Harvard GDS Policy and Procedures
- Use of stem cells requires the review and approval of the Embryonic Stem Cell Research Oversight (ESCRO) Committee.
- Research must comply with the the Harvard Research Data Security Policy (HRDSP).
- Some research involving patients and/or medical information may require compliance with HIPAA.
Multi-center research may be eligible for the Common Reciprocal Reliance Agreement, which can allow investigators who are conducting a multi-center clinical study to request that participating IRBs rely on the review of one center’s IRB. Please see the Harvard Catalyst’s cede review website for more information.
Researchers should be aware of the Financial Policy on Human Subjects Payments.
Guidance: Clinical and Medical Services During Clinical Research
This guidance is intended to provide Harvard faculty who conduct clinical research and those who administer and oversee research projects uniform criteria for the conduct of research with a clinical care component.
Because Harvard does not have a teaching hospital, providing clinical care is outside the mission of the University (the exception being the teaching clinic at the Dental School). With no teaching hospital, Harvard lacks the administrative infrastructure that hospitals have to comply with regulations that apply to clinical care – the treatment of patients. Clinical research, on the other hand, is supported across the University.
The Guidance is intended to clarify what clinical projects are appropriate to carry out at the University, and set out procedures for review and oversight of those projects. In addition to the guidance, there is a flow chart to describe the sequence of review of clinical research projects, and a set of scenarios to illustrate application of the Guidance principles in a variety of contexts, at different Schools.