Biomedical Research

Biomedical Research

New & Updated Guidance

 

*New Guidance* New Jersey State Law

 

A new guidance on NJ state laws that are applicable to research is now available on the IRB website. The PA state law guidance and NJ state law guidance are both available under Applicable State Laws in Human Subjects’ Research online.

 

Researchers planning to conduct research at any of the following sites should review this guidance prior to conducting research in NJ:

 

  • Penn Medicine Princeton Health (and Behavioral Health)
  • Penn Medicine Cherry Hill
  • Penn Medicine Woodbury Heights
  • Penn Medicine Mount Laurel
  • Clinical Health Care Associates of New Jersey
  • Virtua Health

 

Updated 2018 Common Rule Guidance

 

The IRB has recently updated the guidance on the 2018 Common Rule. Notably, the following changes were made:

 

  1. A section was added on Elimination of Grant Review.
  2. The section on Revised Informed Consent Requirements was extensively revised to:
    1. Align with the most recent Informed Consent Form template. If you are familiar with the Penn ICF template, this information should not be new.
    2. Update the section on Clinical Trial Informed Consent Form Posting [§46.116(h)] to note that the Penn HRPP recommends posting unsigned, IRB-approved stamped copy on either ClinicalTrials.gov or Regulations.gov.
  3. Federal Agency Harmonization was updated to reflect that DOJ and FDA have not harmonized with the 2018 Common Rule.

 

This also serves as a reminder that posting of Clinical Trial consent forms is required for all federally funded clinical, educational, and social-behavioral research meeting the NIH Definition of a Clinical Trial. This applies to The prime awardee is responsible for compliance. A clinical trial is defined by NIH as: “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.”

 

Updated Remote Consent Guidance

 

The IRB’s Guidance on Remote Consenting has been updated for all Penn schools as of June 2022. Both guides were updated to align with the IRB SOPs that were updated in January 2022. Likewise, the Penn Medicine / Dental guidance was updated to reflect the discontinuation of the University’s Blue Jeans account, announced in June 2022.

 

*New Guidance* Suicidal Ideation and Behavior: Risk Mitigation

 

The IRB has issued a new guidance regarding mitigating risk to participants who may be at risk for suicidal ideation and behavior. Participants at risk of suicidal ideation and behavior are a vulnerable population group. Therefore, additional measures may be warranted to ensure their protection while they are enrolled in research studies. Additionally, participants in FDA-regulated clinical trials (including otherwise healthy volunteers) may also be at risk for suicidal ideation and behavior, when they are being administered certain drug products. When a research team is made aware of immediate suicide risk in a participant, there is an obligation and responsibility for timely and appropriate follow up to ensure participant safety. The intent of this document is to provide guidance on ensuring the safety of research participants who may be at risk of suicidal behavior. The IRB would like to express thanks to Dr. Yvette Sheline for reviewing and providing feedback on this guidance.

 

Updated Data & Safety Monitoring (DSM) Guidance

 

The IRB has updated guidance on data and safety monitoring as a resource to study teams. This includes more details surrounding when the IRB requires a Data and Safety Monitoring Plan (DSMP), what the plan should entail, when a DSMB may be necessary, and when DSMB reports should be submitted.