Doretha Walker, PhD, MPH

Doretha Walker, PhD, MPH (she/hers) has joined the Rutgers IRB as an expedited reviewer. Dr. Walker is the Chief Mission Officer at YWCA Central Alabama, whose mission is to eliminate racism, empower women and promote peace, justice, freedom, and dignity for all. Dr. Walker is also a non-Rutgers research scholar and has done extensive research on Public Policy, Racial Justice, Driving Inclusivity and Justice in Human Ethics Review, Return of Data (Results Reporting), Healthcare Disparities for African American Women, Mental Health as well as having worked with military veterans. We welcome Dr. Walker onto the IRB and look forward to working with her.  

Emily McDaniel, BA, CCRA

Emily McDaniel, BA, CCRA (she/hers) has joined the Rutgers IRB as an expedited reviewer. Ms. McDaniel is a non-Rutgers Clinical Trials Project Manager and has experience in FDA-regulated drug and device clinical trials. Ms. Daniels is working on Clinical Research with IDEs/INDs plus Oncology Research in Phases 2 through 4. We welcome Ms. McDaniel onto the IRB and look forward to working with her.

NIH to Implement Requirement to Post Study Results to ClinicalTrials.gov in Response to HHS OIG Report

As reported by eight member institutions of the national Clinical Trials Registration and Results Reporting Taskforce, NIH has issued possible non-compliance letters to their investigators requesting results reporting for their NIH-funded research studies. A redacted version of this letter from NIH can be viewed here.

NIH’s action appears to be an implemented procedure in response to the recent HHS OIG Report: The National Institutes of Health Did Not Ensure That All Clinical Trial Results Were Reported in Accordance With Federal Requirements that came out August 2022. See Report in Brief or Full Report.

In written comments, NIH concurred with the OIG recommendations and described actions it has taken or plans to take in response. NIH indicated that it is implementing activities that will enhance NIH’s ability to take compliance actions against responsible parties that are late in submitting trial results or do not submit results. In addition, NIH stated that it has implemented significant improvements related to working with responsible parties to understand the challenges they face in submitting their results to ClinicalTrials.gov and that it has implemented procedures to address these challenges. Check out Appendix B of the Full Report for NIH’s comments, and NIH Policy Statement on Dissemination of NIH-funded Clinical Trial Information.

For assistance completing results reporting responsibilities or if you have any ClinicalTrials.gov questions, contact Rutgers ClinicalTrials.gov Support at rutgersctgsupport@research.rutgers.edu. 

On July 1, 2022, OHRP posted a draft guidance document for public comment entitled “Use of a Single Institutional Review Board for Cooperative Research.” The draft guidance remained open for public comment until August 30, 2022.

The recently posted draft guidance provides further detail on the 2018 Requirements (45 CFR 46.114(b)(1)) for the use of a single IRB in cooperative (multisite) research projects. Topics addressed in the draft guidance include clarification on when an institution must rely on a single IRB, exceptions to the single IRB requirement pursuant to 45 CFR 46.114(b)(2), the process of determining which IRB will be the IRB of record for a specific project, and whether a single IRB can be used for projects not required to follow the 2018 Requirements.

In addition, the draft guidance explores whether a local IRB can conduct a review in addition to the single IRB review, documentation requirements for single IRB review, and an analysis of best practices & responsibilities of the reviewing IRB in a single IRB review.

The full draft guidance document can be found at Use of a Single Institutional Review Board for Cooperative Research | HHS.gov.

HSPP Website

In order for Rutgers IRB to serve as the IRB of Record for an external institution(s), a Single IRB (sIRB) eIRB application must be submitted for IRB review. The Single IRB Submission Guidance is now available on the HSPP Website! Direct access is available in the provided link below:

Single IRB Submission Guidance (1).pdf (rutgers.edu)

In order for Rutgers IRB to cede review to an external IRB, an Administrative Review eIRB application must be submitted for IRB review. The Administrative Review Submission Guidance is now available on the HSPP Website! Direct access is available in the provided link below:

Administrative Review Submission Guidance.pdf (rutgers.edu)

Mysteries of Post Approval Monitoring (PAM)

While many researchers have experienced the Quality Assurance (QA) team’s visit to monitoring the conduct of ongoing studies, we wanted to share the other responsibilities of the QA Team for the review and documentation of Human Subjects Research (HSR).

There are some common regulatory requirements, between HHS-OHRP and HHS-FDA (drugs/devices) in the review of HSR, and there are also differences in guidance, of how federal agencies look at certain circumstances, as well as NJ State Law and Rutgers institutional policies and procedures.

In addition to PAM, the QA team reviews how the IRB members and staff document the HSR they review, documentation of reviews in meeting minutes and reviewer checklists and forms. We also look at whether the intake of HSR studies is handled according to institutional policy and procedure. 

For assistance please contact:

Barbara LoDico, Quality Improvement Senior Analyst  

Barbara.lodico@research.rutgers.edu

Kathleen Villipiano, Compliance Administrator

Smithk6@research.rutgers.edu