Before You Begin to Prepare Your IRB Application

First, review the following two documents:
 

Harvard University Human Research Protection Program (HRPP) Plan - 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 (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.

3 Levels of IRB Review

levels of irb review
IRB TIP! "Exempt" means exempt from further oversight once approval is given; you still must submit an application.

Other IRB Determinations

List of Other Determinations with explanations

IRB TIP! Take an "In a Perfect World" approach. Unless you know you will need Full Board 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 Full Board Review
    • Applications are due 3 weeks prior to IRB meeting dates
    • IRB Administrators determine whether full 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.

FULL BOARD MEETING OUTCOMES

Approved

Approved – The IRB approves a research proposal when the application is complete and the IRB has determined that the study has met the regulatory criteria for approval.

Modifications Required to Secure Approval

Modifications Required to Secure Approval – The IRB makes the determination of modifications required to secure approval when the proposal meets the regulatory criteria for approval but needs specified changes to the protocol, informed consent document(s), or other supporting materials prior to final approval. Once all contingencies are met, the IRB will issue an approval notice. For initial submissions, no research may be conducted until final approval is released by the IRB.

Action Deferred

Action Deferred The IRB Full Board may vote to defer action on an application when a significant action on the part of the researcher is required before the IRB can consider approval or disapproval of the research. Deferred applications are found to have major deficiencies, such as incomplete procedures and documentation, or major ethical issues, including unreasonable risk to subjects that make it impossible for the IRB to approve the research as proposed. The application is returned to the researcher with a notice that details the issues that must be addressed in the application/materials before it can be reconsidered by the IRB. Upon revision of the application and resubmission to the IRB, the study will be rescheduled for review by the full IRB.

Disapproval

Disapproval – The IRB Full Board may vote to disapprove an application to conduct human subjects research when it determines that the study design does not provide, and is unlikely to be modified to provide, adequate protection to subjects. Disapproval of an application usually follows several attempts by the researcher in conjunction with the efforts of the IRB to modify the study design to afford protection to the subjects. This action can only be taken by the full board at a convened meeting. The researcher will be sent a rationale for the disapproval and may ask that the IRB reconsider the disapproval.

Table

Table – Occurs when the IRB cannot approve the research at a convened meeting for reasons unrelated to the research, such as loss of quorum. Under those circumstances, the research will be reviewed at the next meeting.

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 additional 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 Full Board 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 Single IRB? 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?
 

FAQs

 

Definitions