HRPP/IRB Bulletin

February 28, 2023
Hot Off the Press

Quality Assurance vs. Human Subject Research


A flowchart has been developed as a tool for investigators who are unsure if their planned project is quality assurance or human subjects research. 


  • The QA vs. HSR Flowchart was developed, reviewed, and approved by a multidisciplinary group. This resource should be used to assist an investigator in determining if a project is human subject research or a quality activity and provides guidance on when IRB review and approval is required. 


  • This flowchart is a self-service tool, and IRB staff should be consulted to provide subject matter expertise if a proposed activity falls into a gray area or if there are any uncertainties with how to interpret and apply this guidance.


Find the flowchart at:


https://research.rutgers.edu/researcher-support/research-compliance/human-subjects-protection-program-irbs/identifying-human-subject-research


If you have questions, please contact the staff at IRBOffice@research.rutgers.edu


We would like to acknowledge the following individuals for their role on the multidisciplinary group that developed this resource:


Vice Chancellor for Population Health Team: Ethan Halm, Jack Hemphill, and Joyce Porter


NJACTS Team: Farah Anwar and Nancy Reilly


Human Research Protection Program Team: Hila Berger, Angela Cartmell-McGlyn, and Jason Lin


New Regulatory News 


The 2023 NIH Data Management and Sharing Policy. Previously, the NIH only required grants with $500,000 per year or more in direct costs to provide a brief explanation of how and when data resulting from the grant would be shared. 


The 2023 NIH policy is entirely new. Beginning January 25, 2023, ALL grant applications or renewals that generate Scientific Data must include a robust and detailed plan for managing and sharing data during the entire funded period. This includes information on data storage, access policies/procedures, preservation, metadata standards, distribution approaches, and more. You must provide this information in a data management and sharing plan (DMSP). The DMSP is similar to what other funders call a data management plan (DMP). 


The policy does not state specific requirements for how you share your data. When you share your data, you should address the NIH’s goal of making data as accessible as possible. The NIH expects all shareable data to be made available, whether or not it is associated with a publication. All data used or generated as part of a grant must be managed, but not all data should be shared. You should not share data if doing so would violate privacy protections or applicable laws. You may share data related to human subjects, but your plan should address how data sharing will be communicated in the informed consent process (e.g., consent forms, waivers of consent). For more information, please see https://libguides.asu.edu/NIH-2023-DMS#s-lg-box-29379406 


Planning to Submit to the IRB? Check out These Helpful Tools

 

The Rutgers' Human Research Protection Program (HRPP) offers several interactive resources to provide guidance and recommendations to investigators preparing a submission to the Rutgers IRB. 


  • The IRB Review Type and Template Recommendation Tool is a Qualtrics-based tool developed by the Rutgers IRB. 

These Qualtrics-based tools utilize branching logic to:


  • Recommend which Rutgers Templates to utilize and indicate the level and type of IRB review that a study may qualify for.


  • Determine a non-Rutgers site’s degree of involvement and/or engagement in research within a Rutgers research study.


  • Provide a self-certification mechanism to evaluate whether a project or activity may qualify as non-human subjects research or a quality assurance/quality improvement (QAQI) activity. 


A Rutgers Net ID is required to access these tools. 


To report broken/expired links, please email irbprereview@research.rutgers.edu.


Learn more at: https://research.rutgers.edu/researcher-support/research-compliance/human-research-protection-program/interactive-irb-resources


Upcoming Changes to the eIRB system for Committee Members 

 

  • Our electronic submission system, eIRB, has been updated for changes to the Committee member "Submit Designated Review" activity area to now include regulatory-required checklists (e.g., research involving children as subjects) instead of these being separate documents to be completed and uploaded per each submission. In addition, the Submit Designated Review activity will include a new area for the review of Reportable Events: Unanticipated Programs (UAPs).  


  • All individual COI-management plans are available in eIRB for currently active studies. Specifically, COI management plans are now present in the attachments section of the eIRB record for that study. All IRB committee members will need to regularly to view the status of COI disclosures in the eIRB system to complete their review(s). HRPP IRB Staff will provide updates at IRB meetings and through email communications. 


NJ ACTS Needs Assessment Survey


The NJ ACTS team is looking to conduct a needs assessment of barriers researchers commonly encounter while conducting their translational research. They hope to help establish feasible institutional solutions and initiatives for overcoming these commonly experienced barriers.

 

  • The survey also aims to identify at what stages in the translational research process these barriers most often arise. This survey should take approximately 5-10 minutes to complete and consists of three sections – Demographics and Background, Self Reporting of Barriers, and Comments and Feedback. Upon completion of the survey, participants can enter a raffle for a $25 Starbucks gift card.

 

  • The link to the survey is included below, if you have any questions or concerns, please contact sm2097@scarletmail.rutgers.edu and ag954@rbhs.rutgers.edu. Please feel free to share this survey with other investigators at your institution and within your research community.


Translational Research Needs Assessment Survey

 

If you have trouble with the link above, please copy and paste this link into your browser; https://redcap.link/zf8san6p



Pre-Review Service Announcement


Are your documents ready for IRB review? The Pre-Review Service may be just what you need to confirm your readiness for review.


The Rutgers’ Human Research Protection Program (HRPP) offers a Pre-Review Service to all investigators. This service is designed to improve submission outcomes and cut down on the back-and-forth between the IRB and the investigative team.


Use of the Pre-Review Service is optional* and easy to use.


When you engage in Pre-Review Services, you will have the assistance of highly knowledgeable IRB and HRPP staff, as well as key Committee Members on the IRB. All Pre-Review services include feedback for all study documents, access to individuals with subject matter expertise, and education on best practices for a successful submission and review.


Have questions? Contact the team at: irbprereview@research.rutgers.edu or visit our informational site at: https://research.rutgers.edu/researcher-support/research-compliance/human-research-protection-program/irb-pre-review-service


In some instances, the IRB may require that the study team consult with the Pre-Review Team prior to re-submitting to the IRB.

eCOI+

Do you have eCOI+ questions? or Need help with your disclosure forms?

New Departmental Approvers

The following have completed eIRB Departmental Approver (RBHS) training and been included online under the IRB's eIRB Departmental Approvers Listing:          

New HRPP Team Member


Andrea Dragan, MPH, CIP


Andrea comes to us from University of Maryland. Andrea served in a multitude of roles within the Human Research Protection Program (HRPP) of the University of Maryland, College Park, most recently as the IRB Manager. While at Maryland, Andrea elevated the overall performance and efficiency of the IRB through improvements to the reliance agreement process and through creation of the IRB Liaison program, providing faculty with a more comprehensive understanding of the IRB process to assist researchers within their department. This program increased knowledge across campus regarding IRB policies and procedures, and notably improved turnaround times and collaboration between the IRB office and departments across the University. Additionally, she co-led the effort to obtain initial accreditation and reaccreditation of Maryland’s HRPP from the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Andrea earned her Master of Public Health degree in Behavioral and Community Health from the University of Maryland School of Public Health and is certified as an IRB professional (CIP®).
IRB Member Spotlight


Celine Thompson, PhD, MS.Ed


Celine Thompson, PhD, MS.Ed (she/hers) has joined the Rutgers IRB as an expedited reviewer. Dr. Thompson is a Research Developmental Psychologist and a Senior Education Project Administrator at the Senator Walter Rand Institute for Public Affairs (RU-Camden). Dr. Thompson has research experience with Education-based Research with children. Dr. Thompson’s research interests include gendered-racial identity development in Black women and scale development. In her spare time, she enjoys crafting and learning about the rich cultural history of the Frankford community in Philadelphia. We welcome Dr. Thompson onto the IRB and look forward to working with her.     




Seema Husain, PhD, FACMG 


Seema Husain, PhD, FACMG (she/hers) has joined the Rutgers IRB as an expedited reviewer. Dr. Husain is a Research Associate in the Clinical and Research Genomics Laboratory and an Assistant Professor in the Department of Microbiology, Biochemistry and Molecular Genetics (RU-N). Dr. Husain has both genetic and clinical research experience. We welcome Dr. Husain onto the IRB and look forward to working with her.  
Interested in Becoming an IRB Member

Do you (or someone you know) have an interest in biomedical or social science research? Or do you know someone from the community that might be interested in serving as a community member on the Rutgers IRB? Would you (or they) like to be involved with protecting the rights, safety, and welfare of individuals who volunteer to participate in research?


Please read more information online about IRB Membership or by contacting our Training and Communications Manager, Michelle Watkinson, CIP.



Interested in Being a Featured Board Member in a Future Issue of this Bulletin?


Share your background, interests, and area(s) of expertise by being a featured board member in an upcoming issue of the HRPP/IRB Bulletin


Please contact Claribel Vega @claribel.vega@rutgers.edu or Angela Cartmell-McGlynn if interested.

HRPP Website


Website Revisions



Updates to the IRB Pre-Review Service | Rutgers Research for clearer instructions and layout of information (plus revised contact information of the Pre-Review Team). 


Updates to the Reliance area Reliance - External IRBs | Rutgers Research for a clearer layout of information.


Updates to the Reliance’s IRB Fees | Rutgers Research for Commercial IRBs Fee Resources (Requires a Rutgers Net-ID login). 



Updated the Reliance area’s Administrative Review Submission Guidance.pdf (rutgers.edu)
AAHRPP Accreditation Updates
 

The Rutgers University has earned full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

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ClinicalTrials.gov News


Uploading Documents to ClinicalTrials.gov

 

In some cases, you may be required to upload documents to ClinicalTrials.gov.


These include:

 

  • The study Protocol and Statistical Analysis Plan (SAP) (often included in the protocol) - Required if results are required. Must be posted when results are posted.


  • The Informed Consent Form - Required for federally-funded clinical trials IRB approved on or after January 21, 2019. Must be posted after enrollment closes but within 60 days of the last study visit by any subject.

 

To post documents to ClinicalTrials.gov, follow these instructions.

 

  1. First, prepare a Cover Sheet with official title, NCT number and document date to be included in each document.
  2. Convert your document(s) to a PDF/A format by following these instructions.
  3. Next, log in and open the record (the Organization is "RutgersSUNJ", case sensitive).
  4. The record will open to the Record Summary Page. Scroll down the page to the Upload Documents section and click "Open".
  5. Click the “+ New Document” button.
  6. Click “Continue”, if prompted
  7. Select the Document Type and enter the Document Date. The date must be included on the first page. If your document has a version date AND an IRB approval date on the first page, use the IRB approval date.
  8. Click “Choose File” and browse for your document. Remember to select the version that you saved as a PDF/A (this will still be a pdf file type).
  9. Click “Upload” to upload your document.
  10. Don’t forget to go back to the Record Summary page and click the green “Entry Complete” button when done!

 

For assistance with your record or any ClinicalTrials.gov questions, contact Rutgers ClinicalTrials.gov Support at rutgersctgsupport@research.rutgers.edu.
Single IRB News


Be on the Lookout:

SMART IRB

  • Ambassadors are experienced IRB/HRPP professionals available to assist institutions in joining and implementing the SMART IRB Agreement. Connect with an ambassador in your region or contact an ambassador at large for assistance in a key focus area. The following link includes the list of ambassadors and their contact details: Ambassadors | SMART IRB

 

Rutgers University Pre-Consultation Team

  • Rutgers Principal Investigators are highly encouraged to contact the Rutgers Institutional Review Board (IRB) Pre-Consultation Team to discuss the options available for IRB review to process a multi-site or collaborative study where Rutgers will serve as the IRB of Record. The Pre-Consultation Team can be reached at irbrelianceadmin@research.rutgers.edu.



All Things Reliance
  • There are upcoming revisions to the Reliance section of the HRPP website.



  • Reliance In-Service being offered during Spring 2023! 

Quality Assurance/Quality Improvement
 


QA/QI Announcement

 

Our HRPP QA/QI Team is excited for the upcoming 2023 with new plans on the horizon to support our researchers, IRB reviewers, and IRB team members as we work to continue improvements and maintain our accreditation with AAHRPP. 

 

First, we would like to introduce and welcome our new HRPP QA/QI Director, Andrea Dragan to our team. We are very excited to have Andrea working with us and are looking forward to implementing new projects with her.

 

As we closed this past year out, we are wrapping up the QA/QI projects we have told you about. Our Team will be reporting on the following work for the first quarter of the year before moving on to some new projects:

 

  • Presenting the outcome of the IRB Meeting Minute Review Report (Part 2), to ensure that documentation meets federal reporting requirements and AAHRPP standards, to the IRB Executive Committee.

 

  • Completing Part 2 of our Reportable Events Project. Our Team has been conducting a review on how the newly implemented online IRB Reviewer Unanticipated Problem (UAP eForm) has been integrated into eIRB to document that review criteria has been met. In addition, we will be continuing to monitor the effectiveness of this update to the UAP section in eIRB both from the IRB Reviewer and Principal Investigator perspective.   

 

Please keep a lookout for new QA/QI projects in the future! 

 

As always, please feel free to reach out with any questions or concerns, or any help you may need. The QA webpage provides information for the support services we provide.


The Quality Assurance web page has a new location on the Rutgers Human Research Protection Program website: https://research.rutgers.edu/researcher-support/research-compliance/human-research-protection-program/hrpp-quality-assurance


For assistance please contact:


Barbara LoDico, Quality Improvement Senior Analyst  

Barbara.lodico@research.rutgers.edu


Kathleen Villipiano, Compliance Administrator

Smithk6@research.rutgers.edu  
Education and Training Opportunities


eIRB Virtual Training Workshops Sessions will include a step-by-step tutorial on the electronic submission system, eIRB and Q&A.



These workshops are open to Rutgers faculty, staff, and/or students regardless of campus location or specific Rutgers IRB of Record.




Upcoming eIRB Workshops (all dates available online):   


  • Monday, March 6th at 11:30am
  • Tuesday, March 14th at 2:30pm
  • Wednesday, March 22nd at 11:30am
  • Thursday, March 30th at 2:30pm
  • Tuesday, April 4th at 11:30 am 
  • Monday, April 17th at 2:30 pm 




Education Items

 

(some articles might require subscription access) 

 

The articles below highlight the importance of Belmont Report's Ethical Principles of Respect for Persons (operationalized by informed consent), Beneficence (operationalized by minimalization of harms while increasing benefits), and Justice (which is meant to promote equitable representation in research in terms of fairly distributing the risks and benefits of research):    

 

The Most Compelling Science Graphics of 2022 (Scientific American) Words alone cannot capture the full wonder (or horror) of all the stories science had to tell this year. That’s where graphics come in. Whether visualizing the most important data emerging around the COVID pandemic, explaining some mind-bending idea in quantum physics or synthesizing the incredible journey of a parasite through three different hosts, Scientific American’s graphics editors have helped cover a plethora of fascinating topics this year. Here is just a tiny sampling of our favorites. https://www.scientificamerican.com/article/the-most-compelling-science-graphics-of-2022/  

 

NASA Science Directorate Wants Help Prioritizing What Digital Resources It Should Open-Source First (NextGov) NASA’s Science Mission Directorate plans to give the broader research community access to its data, software, computing resources and collaboration tools. But that effort will take time and its own resources, prompting the agency to ask the open-source science community for its opinions on where to start.   https://www.nextgov.com/analytics-data/2023/01/nasa-science-directorate-wants-help-prioritizing-what-digital-resources-it-should-open-source-first/381501/ 



‘Disruptive’ science has declined — and no one knows why (Nature) The number of science and technology research papers published has skyrocketed over the past few decades — but the ‘disruptiveness’ of those papers has dropped, according to an analysis of how radically papers depart from the previous literature 1. Data from millions of manuscripts show that, compared with the mid-twentieth century, research done in the 2000s was much more likely to incrementally push science forward than to veer off in a new direction and render previous work obsolete. Analysis of patents from 1976 to 2010 showed the same trend.  https://www.nature.com/articles/d41586-022-04577-5 


Eleven science stories likely to make big news in 2023 (Science) Big funders to get new leaders: Two of the world’s largest biomedical research sponsors—the U.S. National Institutes of Health (NIH) and the Wellcome Trust—will likely get new directors this year. Researchers have grown impatient waiting for the White House to nominate a successor to Francis Collins, who stepped down as director of the $47.5-billion-a-year NIH in December 2021. The agency’s next leader, who will require Senate confirmation, will oversee NIH’s efforts to boost diversity in the research workforce and likely face a grilling by Republican lawmakers over the agency’s response to the COVID-19 pandemic.   https://www.science.org/content/article/eleven-science-stories-likely-make-big-news-2023 


Diversity Mandate for Clinical Trials Aids Review Boards’ Role (Bloomberg Law) New clinical trial diversity requirements should help panels charged with ethics reviews of human studies, even if they don’t have to review the plans directly, research specialists said. Drug and device companies and other clinical trial sponsors must submit a diversity action plan in the studies the Food and Drug Administration uses to decide whether to approve a medical product. The new requirement came about in the  DEPICT Act (Public Law 117-164), which Congress enacted late in 2022.  https://news.bloomberglaw.com/pharma-and-life-sciences/diversity-mandate-for-clinical-trials-aids-review-boards-role 

 

Health Emergency’s Demise Restores Mandate on Research Boards (Bloomberg Law) Research institutions must revert to using the same ethics board when collaborating on studies once an exception tied to the the Covid-19 public health emergency ends in May. The Health and Human Services Office for Human Research Protections issued a statement Friday to clarify how the  White House decision to end the public health emergency on May 11 will affect the human research regulations it administers known as the Common Rule (45 C.F.R. 46). The rule implements safeguards for research volunteers, largely through ethics panels known as institutional review boards charged with ensuring participants are enrolling voluntarily and understand the risks and benefits of enrolling in that research. https://news.bloomberglaw.com/pharma-and-life-sciences/health-emergencys-demise-restores-mandate-on-research-boards 

 

FDA to require diversity plan for clinical trials (Nature) The US Food and Drug Administration (FDA) will soon require researchers and companies seeking approval for late-stage clinical trials to submit a plan for ensuring diversity among trial participants… The diversity requirement arrives in the wake of a 2022 report from the US National Academies of Sciences, Engineering and Medicine, which found that, although the representation of white women in clinical trials has improved, progress has “largely stalled” for minority racial and ethnic groups. Older adults, pregnant people and individuals with disabilities remain severely under-represented — and, in some cases, excluded — from US clinical research, the report found. https://www.nature.com/articles/d41586-023-00469-4 
 
 
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