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Welcome to Human Subjects Research at Harvard

We at the Harvard University Area Institutional Review Board (HUA IRB) are happy to assist as you submit your project for review. Our goal is to ensure you have all the resources and information you need to create a comprehensive and compliant research study at Harvard University. Below are some things to know that will help facilitate our work together.

Our Guiding Principles

Human subjects research at Harvard University is guided by the ethical principles set forth in the Belmont Report (Ethical Principles and Guidelines for the Protection of Human Subjects of Research). The minimum standards are set by the Department of Health and Human Services regulations at 45 CFR part 46 and the Food and Drug Administration’s regulations at 21 CFR part 50 and 21 CFR part 56.

Consider Your Tools and Timing

Knowing what resources are available as well as how long a review might take are important to consider. See below for information on these aspects.

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We’re happy you found the HUA IRB website which is your first stop for all things that involve human subjects research.

Quick Access Resources

Not sure where to start or if your research even requires IRB review? Check out our IRB Lifecycle Guide which takes you through the IRB review process step-by-step.

Consider perusing the IRB News tab and signing up for our Newsletter.

Deep Dive Resources

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  - This is your comprehensive guide - Keep it close by! The Investigator Manual covers all topics here on our website plus many more, including: 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.

 

ESTR is the Electronic Submission Tracking and Reporting tool that researchers and the IRB use for all study submissions. You will need to be a Harvard Researcher to access it. Resources for using ESTR are:

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Timing is of great concern for many researchers. HUA IRB reviews studies on a first come, first served basis. We do our best to honor urgent needs however, it is best to allow a minimum of 4 to 6 weeks from the time of submission to a complete review. The time of review is impacted by many factors: the complexity of the study, the need for ancillary reviews, and the office workload. 

What is an Ancillary Review?

As you begin to plan your research project, consider that your study may require reviews beyond just the IRB. Below are a few factors to keep in mind that may add time to your overall IRB study review timeline:

Reliance Agreements/Collaborations - These are managed by our office and involve collaboration with another institution. 

Ancillary Reviews – Below are a sample of reviews that happen outside of the IRB office.

Upon receipt of your submission, the IRB will conduct an initial review and refer any ancillary reviews to the appropriate office. Only once these reviews are completed can the IRB reviewer complete the human subjects review

IRB Office Metrics

Interested in knowing how long a particular type of review might take? The Harvard IRB office publishes metrics and other key performance activities on our website. You can access the Report on Operations here.