Activities that require Harvard Longwood Campus (HLC) IRB review
The IRB is required to review studies that meet the regulatory definition of human subjects research. Research involving the following will likely require IRB review before the project can begin:
What are common examples of projects that are not research?
- A project with a narrow scope that does not contribute to generalizable knowledge.
- Quality improvement
- Program evaluation
- Case studies
The intent to publish or present the findings of a study does not automatically require HLC IRB review for that study. The project must meet the definition of research, as stated above.
1. Can I make my own IRB determination?
Investigators may self-determine when their activities do not meet the definition of human subjects research. When an investigator determines that their activities do not meet these definitions, an HLC IRB application is not required.
Investigators may use the HLC IRB Decision Tool to help determine if their activities meet the regulatory definition of research, if their research involves human subjects, and/or if they need to submit an IRB application. A decision will be rendered at the end of the tool with the required next steps. Feel free to also refer to WORKSHEET: Human Research Determination and OHRP Decision Charts.
See Question #6 if you do need to submit an IRB application.
2. What do I need to know if I hold an appointment elsewhere?
It is common for Harvard students and faculty to hold an appointment elsewhere, in addition to their Harvard affiliation. If that is the case, their human research activities may require IRB oversight by another, non-Harvard, organization.
Please see the IRB Tip Sheet website for more detailed guidance on what it means to be a Harvard dual-affiliate, as well as an agent of Harvard. A reliance arrangement between institutions may be appropriate whereby the HLC IRB cedes IRB review to another institution or another institution cedes review to a HLC School. See our Reliance Support website for more information.
Keep in mind that if the research you are conducting is in fulfillment of a Harvard role, requirement, or responsibility (e.g. teaching responsibility, course or degree requirement, job requirement), you will need to submit an application to the HLC IRB (or enter into a reliance agreement).
3. What if I collaborate with non-Harvard individuals?
Oftentimes, students and faculty collaborate with non-Harvard researchers. Before starting any research project, each researcher should check in with their home institution to determine research requirements.
There are options for one IRB to review one study for all researchers – for more information on when that is possible and examples, see our Reliance Support website.
4. What if I am conducting research internationally, or collaborating with international researchers?
The IRB recommends that any investigator conducting international research first consult the OHRP International Compilation of Human Research Standards to understand and comply with the applicable local human subjects protections laws, regulations, and guidelines in the country/countries where their research will take place. If local IRB/ethics review is required, it must be obtained before any human subjects research activities are conducted locally, in-country.
If students collaborate with international collaborators – for example, they co-create the study design, study documents, and implement research activities together – those collaborators will need to obtain in-country ethics approval. If the extent of the collaboration is the transfer or sharing of data, and the analysis will take place by Harvard researchers at Harvard, the Harvard study team does not need to obtain any in-country approvals.
The HLC IRB does not provide review and oversight for international study team members, and international reliance agreements are not allowed.
5. Who can I contact if I am a new researcher, student, or scholar, and/or first time PI, and I need tailored research support?
The Quality Improvement Program is a unit within the Office of Regulatory Affairs and Research Compliance, which is independent of the HLC IRB, but offering complimentary human research support service. These services include regulatory consultation, IRB submission assistance, and focused training/education. QIP service is available to any HLC agent. To receive customized support for your research, please submit a Quality Improvement Program Service Request.
- Pre-submission support and consultation: Complete a Quality Improvement Program Service Request.
- Post-submission questions: Contact your department-assigned IRB Review Specialist.
- The Investigator Manual provides guidance on preparing and submitting materials to the HLC IRBs.
- The ESTR Submission Support website provides instructions on using the IRB’s online submission system.