The Office of Human Research Administration (OHRA) at Harvard Longwood Medical Area is a comprehensive administrative office designed to review, approve, assist, and oversee all human research projects conducted by Harvard T. H Chan School of Public Health, Harvard Medical School, and Harvard School of Dental Medicine faculty members and students. OHRA is the primary component of Harvard Longwood Medical Area’s Human Research Protection Program (HRPP). There are two major units within OHRA; The Institutional Review Board Operations (IRB) and the Quality Improvement Program (QIP).
IRB Operations is responsible for managing and supporting the IRB’s scientific and ethical review of research studies submitted by Harvard T. H Chan School of Public Health (Harvard Chan School), Harvard Medical School (HMS), and Harvard School of Dental Medicine (HSDM) faculty and students. The HSPH and HMS/HSDM IRB meets once a month to conduct Full Board reviews. Submissions eligible for expedited review are accepted on a rolling basis and reviewed by designated review specialists.
An IRB submission is done so through our Electronic Submission Tracking and Reporting system (ESTR). You will need to provide your HUID and password to log into the system. If you have forgotten your HUID PIN/Password, please click here to reset it or request a new PIN. If you do not have an HUID, one can be requested for you by a HLC Sponsor (i.e. HLC affiliate/primary contact or Principal Investigator) by completing the ID Request Form. Please click here for additional information.
The Quality Improvement Program (QIP) is a unit within the Office of Human Research Administration (OHRA), independent of the IRB. QIP’s mission is two fold: 1) To liaise between investigators and the IRB and 2) To provide institutional regulatory compliance.
QIP can assist investigators and their study staff by:
1. Providing general guidance or study specific services at study startup or throughout the course of a study. These services can include Routine On-site Review, Study Consultation, Educational service, IRB Submission Assistance, External Audit Preparation, and Study Management Tools.
2. Drafting/Editing the human subjects portion of grant applications.
3. Providing temporary research coordinator/ project manager support at no cost.
4. Providing investigators with quality improvement recommendations to ensure that research is conducted in accordance with best practices.
5. Providing training and education to the research community.
6. Providing confidential discussion and correspondence which does not become part of the IRB records or file.
QIP ensures institutional regulatory compliance by:
Conducting Directed (for-cause) Audits at the request of the Harvard Chan School, HMS/HSDM Institutional Officials. Directed Audits focus on areas of concern that may have been identified by a variety of entities, i.e., federal, state or institutional.
Recommending action to the IRB, based on onsite observations during Directed (for-cause) Audits.
Investigating allegations and findings of non-compliance.
Reporting potential serious or continuing non-compliance to the IRB and/or HSPH, HMS/HSDM Institutional Officials and proposing corrective actions.
For more information about the Office of Human Research Administration please visit our website at http://www.hsph.harvard.edu/ohra/