Before You Begin to Prepare Your IRB Application
First, review the following two documents:
Harvard University Human Research Protection Program (HRPP) Plan (PDF) - This is the "30,000 foot view" document that ties all of the pieces of our program together. It defines roles and mission and includes a complete outline of the regulatory requirements that must be met. Please also see the HRPP Overview page for more information.
Investigator Manual (PDF) (IM) - This is your comprehensive guide. In addition to topics covered here on our website, the IM covers many more, such as reporting financial interests, consent considerations, conflict of interest, data management/ security, research in schools, secondary data analysis, deception and incomplete disclosure, subject pools, additional requirements for federally funded research, HIPAA privacy rule, Principal Investigator responsibilities and assurance statement, Provostial review, and more.
Next, review the following information:
There are 3 Levels of IRB Review and Other IRB Determinations
During review, IRB Administrators will determine which level of review is required.
Convened IRB
- More than minimal risk to subject
- Not covered under other review categories
Example: Interventions involving physical or emotional discomfort
Expedited
- Not greater than minimal risk to subjects
- Fits one of 9 categories
Example: Collection of biospecimens by non-invasive means
Exempt
- Less than minimal risk to subjects
- Fits one of 6 categories*
*Harvard has not implemented categories 7 & 8 which involve broad consent
Example: Research with de-identified records; anonymous surveys
Other IRB Determinations
IRB TIP! Take an "In a Perfect World" approach. Unless you know you will need Convened IRB Review, don’t worry about category of review or deadlines. Keeping in mind the regulations and ethical concerns that you learned about in your ethics training, design the study as you envision it. If revisions are needed, your IRB Administrator will let you know and will assign the review level accordingly.
Submission Deadline Dates
- Submissions for the following types of review/determination have no deadline date. They are conducted by IRB staff on behalf of the IRB on a rolling basis.
- Exempt review
- Expedited review
- Not human subjects research determination
- Not engaged in research determination
- .118 determination
- Submissions for Convened IRB Review
- Applications are due 3 weeks prior to IRB meeting dates
- IRB Administrators determine whether convened board review is needed, assign the study to the next possible meeting date and inform the researchers of any requirements prior to review.
- The IRB meets once monthly, generally on the 3rd Thursday.
- At these meetings the IRB has the authority to Approve, Require Modifications to Secure Approval, Defer, Disapprove, or Table a study. More on these outcomes may be found below.
Convened IRB Meeting Outcomes
Last, consider the following:
Required Ethics Training
Harvard institutional policies require that all individuals who are involved in human subjects research complete training in the ethical conduct of human research. This includes:
- Investigators and all study team members who have contact with human subjects or their identifiable data and
- Faculty sponsors of non-exempt research.
- Note that NIH-funded clinical trials have NIH training requirements.
Collaborating with Another Institution (Including HMS, HSPH and HSDM)
When Harvard investigators will collaborate with another institution on non-exempt research (i.e., requiring Expedited or Convened IRB review) involving human subjects, it may be possible to establish an IRB Authorization Agreement (IAA) allowing one institution to rely on IRB review conducted by the other institution. This helps avoid duplicative review and streamlines the review process across research sites. The IAA delineates the responsibilities of both the relying and reviewing institutions regarding research review, reporting, and oversight.
Navigate to the Collaboration tab on the CUHS main page to learn about this process.
Who is Eligible to be a Principal Investigator?
PI eligibility criteria is generally determined by the Schools who have developed eligibility criteria for their faculty, as well as specific procedures for granting exceptions to their criteria. Of note:
- PI eligibility is grounded in who may receive funds through a grant, contract, or other funding mechanism on behalf of the University.
- Those who are not PI eligible may still serve as a PI on an IRB application if they have a faculty sponsor listed (most notably, students).
Receiving NIH Funding?
- Please see NIH training requirements for additional requirements.
