Frequently Asked Questions
- Is there an instruction manual for submitting to the IRB?
- Can a student serve as Principal Investigator (PI)?
- How do I know which type of IRB review my project will require?
- How do I submit an IRB application?
- What IRB forms do I need to submit?
- How long does IRB review take?
- May I conduct international research?
- If I have local IRB/another IRB’s approval, do I need Harvard Longwood Medical Area IRB approval?
- What does “reliance on another institution” mean?
- Who needs to complete human research training?
- Does the Harvard LMA IRB accept NIH training?
- As long as I submit my application to the IRB, can I proceed with my research?
- What is the deadline for PIM (Pursuing Inquiry in Medicine) projects/summer projects/etc.?
- How can I be added to the study team of an already IRB-approved project?
- What is meant by “coded” vs. “de-identified” data/specimens?
- My study materials, e.g., survey, interview, etc., are not yet developed. Can I submit these later for IRB review?
- Who can help me?
Yes, students may serve as PI on “Not Human Subjects Research” and “Exemption” Requests. The Principal Investigator of these requests must be a Harvard LMA affiliate; however, a faculty appointment is not required. Any member of the faculty, staff, and/or student body may serve as PI for such protocols.
No, students may not serve as PI on non-exempt Human Subjects Research Applications (i.e., “Expedited” and “Full Board”). The Principal Investigator of such protocols must be a Harvard LMA faculty member. The IRB may make an exception to this policy on a case-by-case basis with appropriate justification (but customarily exceptions are not made for students).
Most student projects do not meet the definition of research with “human subjects” or are eligible for an exemption determination (which must be made by the IRB). Some projects, however, depending on procedures and risk level, are reviewed on an expedited basis or require Full Board review. For help determining which type of review your project will require, call a member of the Quality Improvement Program (QIP) or your department-assigned IRB Review Specialist
The IRB submission process is conducted electronically, through ESTR: Electronic Submission, Tracking, & Reporting. One can log onto ESTR using their HUID and PIN. Click “Create New Study” and follow the system prompts; upload study materials as appropriate. The ESTR support website provides further instruction. For ESTR technical support, email firstname.lastname@example.org.
Harvard LMA IRB forms and instructions are available for download through Harvard’s electronic submission system, ESTR: Electronic Submission, Tracking, & Reporting. You will be prompted as to where they should be uploaded within the ESTR.
IRB review turnaround times may vary depending on the quality of the IRB submission. The below “target” turnaround times assume that the submission is complete and the Principal Investigator/Primary Contact is responsive. Applications requiring review by the convened IRB (“full board review”) should be submitted at least 45 days prior to a scheduled full board meeting. Click here for the list of the HMS and HSPH full board meeting and submission dates.
|Not Human Subjects Research Determination||1 week|
|Exemption Determination||1 week|
|Initial and Continuing Applications||2-3 weeks|
Many Harvard LMA students do conduct international research. Ensure that you contact the host country contacts well in advance as their IRB review process may take longer than that at Harvard LMA. You may not begin your human research procedures (including recruitment) until all IRB approvals have been obtained.
When you are acting as an agent1 and conducting human research, Harvard is considered engaged and Harvard LMA IRB review is required. If, however, another institution is planning to conduct IRB review, it may be appropriate for HSPH/HMS/HSDM to cede IRB review to that institution.
When multiple domestic institutions are engaged in the Human Research, a reliance agreement may be executed (i.e., cede review, or IRB Authorization Agreement) allowing an investigator to designate one institution as the Reviewing Institution (responsible for IRB review). Other engaged institutions would then rely on the Reviewing Institution’s IRB rather than conducting their own concurrent review. Reliance is not automatic, i.e., there is formal process and request form to put such an agreement in place. Click here for more information.
Researchers working directly with human subjects or data/specimens that he or she can link back to individual subjects must fulfill human research training requirements every three years. All Principal Investigators (PIs), Co-Investigators, and those meeting the NIH definition of “Key Personnel” must complete training regardless of whether or not they have access to identifiable data/specimens or contact with subjects.
Harvard’s online human research training curriculum is available through the University of Miami’s Collaborative Institutional Training Initiative (CITI) Program. Those who attend 3 QIP Education Sessions will receive Human Research training refresher credit. Click here for more information on human subjects training requirements.
No, NIH training is not accepted. Harvard’s online human research training curriculum is available through the University of Miami’s Collaborative Institutional Training Initiative (CITI) Program. Click here for more information about CITI including how to access Harvard’s curriculum.
No, official IRB approval/determination must be received prior to conducting any human research activity (including recruitment or identifiable data analysis). A formal notification letter will be available in ESTR and emailed to the Principal Investigator and Primary Contact once IRB review is complete.
The deadline for PIM projects is April 15, 2014.
The IRB has no specific deadline for Non-PIM projects; however, IRB review and approval should be secured before implementing human research activities (including recruitment) in the field. Check with your advisor/department for additional deadlines.
If you will be involved in participant interaction or intervention or have access to identifiable data you should be added to the project’s study team. For existing Harvard LMA IRB-approved studies, the PI will need to open a Modification in ESTR: Electronic Submission, Tracking, & Reporting selecting “Study team member information” where prompted.
For studies in which HSPH/HMS/HSDM is relying on another institution for IRB review please contact the Harvard LMA IRB Coordinator at email@example.com. When contacting the Coordinator, please provide a copy of the original protocol approval letter. Next steps will be determined once the Coordinator can review the other institution’s IRB approval.
“Coded” refers to samples or data labeled with a code (e.g., a number), rather than a person’s name or other personal identifier. Such code can be traced or linked back to the sample donor/data provider by the person who retains the key, e.g., coding system/crosswalk. If such a key is in existence (whether or not the Harvard LMA investigator has access to it, the data/specimens are considered identifiable). To learn of ways in which coded data may become “de-identified,” contact a member of the Quality Improvement Program or your department-assigned IRB Review Specialist.
“De-identified/anonymized” refers to samples or data that may have identified human subjects at one time, but all identifiers or codes have since been removed and destroyed
Where study materials have not yet been developed, note this in your application. If possible, provide draft copies of all study materials even if they may change later. Submit all finalized materials for review/approval via modification before use in the field. As a reminder, no research activities involving human subjects may occur without written approval from the IRB office. If study materials change during the course of your project, these materials must undergo IRB review and determination before implementation in the field.
For questions about an anticipated submission, contact a member of the Quality Improvement Program (QIP) staff.
For ESTR technical questions, email firstname.lastname@example.org.
1 Agent: An individual who is an employee or student is considered an agent of Harvard School of Public Health, Harvard Medical School, and Harvard School of Dental Medicine for purposes of engagement in Human Research when that individual is on-duty in any capacity as an employee or student of HSPH. Specifically, it is an individual who, by agreement or otherwise, may act on behalf of the School and bind it by words or actions; a person who represents the School by its authority or delegated authority.
An individual who is not an employee is considered an agent of HSPH/HMS/HSDM for purposes of engagement in Human Research when that individual has been specifically authorized to conduct Human Research on behalf of HSPH/HMS/HSDM.
The Office of Human Research Administration (OHRA) will consult with the Office of the General Counsel (OGC) to determine whether someone is acting as an agent of HSPH/HMS/HSDM when it is unclear whether the individual meets this definition.