IRB Review FAQs

The IRB Office processes ~12,000 submissions per year. The IRB does its best to process submissions in a timely manner. Below are review timeline goals for the IRB office. IRB Metrics for last fiscal year are linked below.

Minimal Risk Submissions Qualifying for Exempt, Limited, or Expedited Review

Submissions Requiring Convened Review

According to Penn policy, researchers are not permitted to self-exempt. Submission to the IRB is required for initial review to confirm the exempt status of the study.

The IRB does not expect research teams to be experts in IRB levels of review as well as exempt and expedited review categories. Please do your best to select a level of review and category of review that seems to best apply. The IRB is the final arbiter as to level of review, category of review, and risk level for a study. NOTE: If you mistakenly submit an exempt application for a study that requires full committee review, your submission will be returned to you with additional questions to answer within the HSERA application. The exempt application is abbreviated and may not be used for research requiring convened board review.

Informed consent should never be waived for convenience, nor waived solely for reasons of cost or speed, if doing so dilutes the protection of subjects’ rights and welfare. A waiver of informed consent may be granted by the IRB if all of the following criteria are met:

• The study or portion of the study where the waiver is proposed poses no more than minimal risk to participants;
• The research could not be carried out practicably without the waiver;
  
  • Scientific validity would be compromised if consent was required.
  • Ethical concerns would be raised if consent were required.
  • There is a scientifically and ethically justifiable rationale why the research could not be conducted with a population from whom consent can be obtained.
• The waiver would not adversely impact subjects’ rights and welfare;
  
  • Consider other Federal, state, or local laws that safeguard rights:
  • Consider whether the subject population, in general, would consider that the waiver/ alteration has the potential to cause adverse consequences for their welfare or general well-being.
• Where appropriate, the subjects or their legally authorized representative will be provided with additional information about their participation. This may be appropriate in the following situational examples:
  • A subject is included in research that exposes them to situations or conditions to provoke a response for research purposes, and the situation would not have ordinarily occurred; or
  • Information is obtained during the course of the research that directly impacts on the safety or welfare of the subject;
• [NEW – 2018 CR] If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format.

A waiver of documentation of consent reflects that no signature will be obtained. Participants should still be offered a copy of the consent information for their records. The IRB still expects a consent script or information sheet to be provided for review. One of the following 3 criteria must be met for a waiver of documentation of consent:

1. The only record linking the subject and the research would be the informed consent form AND the principal risk would be potential harm resulting from a breach of confidentiality.
   • Each subject (or LAR) should be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern.

2. The research presents no more than minimal risk of harm to subjects AND involves no procedures for which written consent is normally required outside of the research context;

3. [NEW 2018 CR] The subjects or LARs are members of a distinct cultural group or community in which signing forms is not the norm, the research presents no more than minimal risk of harm to subjects, AND there is an appropriate alternative mechanism for documenting informed consent.

A case report for 1-3 patients does not require IRB review. As case reports are not considered to be human subjects’ research, the IRB always advocates for informed consent but does not require it. If 4 or more patients are included, the IRB considers this a medical record review and it should be submitted to the IRB under exempt category 4, with either a plan to obtain informed consent and HIPAA authorization, or a request for a waiver of informed consent and HIPAA authorization.

The IRB does not require the submission of case report forms.

Supporting Documents That DO Require IRB Review

• Device brochures and FDA approval / marketing information for research with devices
• Informed consent forms and scripts
• Investigational drug brochures and/or package information for approved drugs
• Interview scripts
• Questionnaires, inventories, surveys, tests, assessments that are not validated or were created for the purposes of the study. NOTE: If you have multiple of these types of documents, please consider combining into 1 PDF as opposed to uploading each document separately to facilitate IRB review.
• Recruitment materials (flyers, scripts, letters, advertisements, videos, brochures, social media posts, etc.)
• Standalone protocol / protocol addendums

It depends. Modifications to exempt studies are typically not required. If the IRB has determined the study to meet criteria for exemption, the study team can make non-significant changes to their protocol and study documents without notifying the IRB or requesting formal approval. However, there are circumstances under which modifications must be submitted to the IRB.

• The determination letter from the IRB indicates that the study qualified for Limited Review.
• Changes to a medical record review that impact the PHI collected under a HIPAA waiver, including new disclosures, new unaffiliated personnel, changes to the PHI being collected, changes to the data confidentiality plan, etc.
• Removal of the consent process, or use of deception or incomplete disclosure.
• Addition of a vulnerable population (e.g., children, pregnant women, prisoners)
• Adding sensitive questions to a survey or interview process (e.g. questions regarding illegal activities; traumatic events such as childhood, sexual, or domestic abuse; suicide; or other probing questions that could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation).

The above list is non-exhaustive. If you are unsure, you may submit the modification for an exempt study or consult with a senior analyst.

If the IRB acknowledges a modification to an exempt study, it means that submission was not required, but we recognized the administrative change.

Yes, please submit all participant facing materials to the IRB for review and approval. Some materials may be submitted later prior to use if they are not ready at the time of initial review (e.g., recruitment materials).

All participant facing materials must be submitted to the IRB for review and approval.