Submitting New Research for Approval
- Download this walkthrough (includes step by step guidance, tips & screenshots)
The following documents may also be required for initial submission:
In Addition to IRB review, submission to other Penn entities may be required to gain full approval of your study. The IRB has developed a new tool to help researchers find out what other reviews are needed.
Is IRB Review Required?
The IRB must review all human subjects research conducted at the University of Pennsylvania
Human Subject: a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information.
Research: the systematic investigation of materials and sources in order to establish facts and reach new conclusions with the intention of contributing to generalizable knowledge.
If your project does not meet both of the above criteria you do not need to submit for IRB approval to conduct your research.
Not sure about the criteria? Download and review this detailed guidance - Is IRB Review Required?
If your project requires IRB review and is Minimal Risk the IRB will conduct either an Exempt or Expedited review...
Exempt level of review
"Exempt" means review by one IRB member, sometimes in consultation with others. A research activity may be declared exempt if it is considered low-risk and the only involvement of human subjects will be in the categories briefly described below:
1.Research conducted in established or commonly accepted educational settings, involving normal educational practices.
2.Research using anonymous or no-risk tests, surveys, interviews, or observations.
3.Most research involving pubic officials.
4.Research involving the collection or study of existing data if it is publically available or if subjects cannot be identified.
5.Research examining public benefit or service programs.
6.Taste and food quality evaluation and consumer acceptance studies.
Although subject consent is always needed, signed consent forms are typically not recommended if they are the only identifying variable in an otherwise anonymous project. Approval for exempt projects does not expire, unless the researchers decide to change the protocol. Most exempt level reviews are completed within two weeks after being received by the IRB from the department chair.
Expedited level of review
Projects not eligible for an exempt review may be eligible for an expedited review. "Expedited" means review by the IRB chair and one or more experienced reviewers. In general, research may qualify for expedited review if it is judged to involve only minimal risk, does not include intentional deception, does not employ sensitive populations or topics, and includes appropriate informed consent procedures. For example, the collection of physical data through non-invasive procedures is eligible for an expedited review, including:
- Height and weight
- ECG, MRI, Ultrasound
- Moderate exercise
- Blood or other bodily fluids
The full list of categories of research that may be reviewed as expedited can be found on the DHHS website. Most expedited reviews are completed within approximately three weeks after being received by the IRB from the department chair.
If your project does not qualify for expedited review due to being Greater Than Minimal Risk, the IRB will schedule a Full Board review...
Research that does not qualify for expedited or exempt review and/or presents more than minimal risks to subjects will receive review by a fully convened board. The Penn IRB has 8 boards that meet once a month. Each board has various areas of expertise and is comprised of physicians and other community members.
The following are examples of research requiring full board review:
- Studies for which the level of risk is determined by the IRB Chair to be greater than minimal.
- All sponsored and non-sponsored-driven Clinical Trials (investigational drug or device) subject to FDA regulations.
- Studies that involve the intentional deception of subjects, such that misleading or untruthful information will be provided to participants.
- Studies that involve sensitive or protected populations (such as children or cognitively disabled individuals).
- Studies that plan to use procedures that are personally intrusive, stressful, or potentially traumatic (stress can be physical, psychological, social, financial or legal).
Guidance Documents for Initial Submissions
- Electronic Data Protection / Storage / Transmission Requirements - For use in developing plans to protect PHI
- Companion Guide to Electronic Data Protection / Storage / Transmission Requirements
- Is IRB Review Required?
- Minimal Risk Research FAQ document
- Initial Submission Completeness Guidance
- Greater than minimal risk research where pregnancy is exclusionary