HSPP/IRB Bulletin
October 28, 2021
Hot Off the Press
With Sincere Appreciation to Our Retiring Board Members
As your time on the Rutgers Institutional Review Board draws to a close, we wanted to express our sincere gratitude for your service. IRB service is one of the toughest volunteer roles at an Academic Medical Center.  Thank you all for your contributions and the expertise you brought to our deliberations. 

Clifford Weisel
2016-2021
5 Years of Service

Interested in becoming an IRB Member?
Contact Training and Communications Manager Michelle Watkinson
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Consent Form Revisions 

All consent templates are updated with revised IRB Contact Information and are available online, then under Section B click on "Consent Templates": 

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HSPP Website Updates

1.      Under Clinical Trials.gov link under “Helpful Resources” link to ClinicialTrials.gov Registration and Results Reporting Decision Tree fixed. 

2.      Under HSPP/IRB Education: https://research.rutgers.edu/researcher-support/research-compliance/human-subjects-protection-program-irbs/hsppirb-educational  removed hyperlink, “Required Monthly Training for IRB Board Members”.  


4.      Under Guidance Topics (https://research.rutgers.edu/researcher-support/research-compliance/human-subjects-protection-program-irbs/hspp-guidance-topics), there is a subsection, “ Revised 2018 Common Rule area of Website” broken links fixed. 

5.      Under Guidance, Data Retention and Record-Keeping subsection, removed missing link: Regulatory Binder Instructions (PDF). 

6.      Under Guidance, "Data Security" in “Rutgers University Policies” added “Minimum security standards for data protection” with a link to Rutgers OIT’s policy. 

7.      Under Guidance, "Data Security" in "Traveling with Electronic Devices section:" provided link to Rutgers' IT Security Guidelines for Domestic and International”. 

8.      Under the Resources page, add a new box entitled “FAQs for Researchers” and add a link to the IRB’s FAQs. 

9.      Under Guidance Topics in the “Data Use Agreements" section, updated information for “Sponsored Research Agreements” plus included the following under “Help”:  
a.      Change hyperlink of HIPAA Business Associate Agreement to https://uec.rutgers.edu/forms/   
b.       Add a link to Sponsored Research Agreement staff: https://research.rutgers.edu/staff-directory/all?field_staff_directory_unit=1116   
  1. Add link to Sponsored Research Agreements FAQs link: https://research.rutgers.edu/researcher-support/researcher-faqs/sponsored-research-agreements-faqs  

10.  Under Guidance Topics in under “Health Insurance Portability and Accountability & Protected Health Information” updated a link to University Ethics & Compliance webpage: https://uec.rutgers.edu/. 

11.  Under Guidance Topics in “Emergency Use of an Investigational Drug or Biologic”/ “Related Forms” section fixed link to Emergency Permission Consent Template document. 

12.  Under Guidance Topics in under “Genomics Research" section link updated: Genomic Research that meets the definition "Human Subjects Research" requires IRB Approval. Plus, fixed broken links to - 
  1. NIH Funded dbGaP Study IRB Requirements (PDF)  
  2. NIH Funded NIDDK Studies / GWAS IRB Requirements (PDF) 
  3. NIH IRB and Institutional Considerations When Reviewing Genomic Studies (PDF) 

13.  Under Guidance Topics in under “Informed Consent" section fixed link to Consent templates and fixed links to OHRP informed consent guidance. Also, the contact information for the IRB was updated. Fixed typo, "For FDA Regulated Research”. 

14.  Under Guidance Topics in “Non-English Speaking Subjects” an updated link for interpreter/translator services is offered by Rutgers Procurement. 

15.  Under Guidance Topics in “Certificate of Confidentiality (CoC)” section updated IRB's contact email. 

16.   Under Guidance Topics in “Data and Safety Monitoring” section,  
  1. updated "IRB Reporting Requirements" to inform users to see the following guidance topic, Reportable Events 2: Unanticipated Problems and Adverse Events for more information.”  
  2. Updated link to NIH Policy for Data and Safety Monitoring. 

17.  Under Guidance Topics in "Quality Assurance" the contact information for the IRB was updated. 

18.  Under Guidance Topics in “Quality Activities” section the following PDFs have been restored:   
  1. Reference Guide: Quality Assurance [PDF]  
  2. Reference Guide: Quality Improvement/Continuous Quality Improvement [PDF]  
  3. Reference Guide: Program Evaluation [PDF]  
  4. Reference Guide: Evidence-Based Practice [PDF]  
  5. Reference Guide: Benchmarking [PDF]  
  6. Under Guidance Topics in “Genomic Research” section: 
a.      Added, IRB and Institutional Considerations When Reviewing Genomic Studies (PDF). 
b.       Removed reference to HRP-309 Worksheet: Quality Activity. 

20.  Updated IRB's contact email: IRBOffice@research.rutgers.edu  

21.  Under Guidance Topics in “Revised Common Rule 2018 (Human Subject Regulations)”: 
a.  Updated IRB's contact email: IRBOffice@research.rutgers.edu  
b.  Updated hyperlink for Forms and Templates to our Toolkit page. 

21.  Under Guidance Topics in “More Guidance Topics …from Federal Agencies” section, added, “FDA Conduct-of-Clinical-Trial-During-COVID 19-QA Updated 01-27-21” (PDF).
22.  Under Guidance Topics in “Research Repositories (Banks, Registries, etc.)” section: updated hyperlink to “Identifying Human Subject Research”. 

23.  Under Repository Documents-updated links to Toolkit items and 4th bullet:  
a. Change the header to NCI’s Glossary of Terms and added a hyperlink to  https://biospecimens.cancer.gov/bestpractices/got/#H. 

24.  Fixed broken link to “SACHRP’s Updated FAQs on Informed Consent for Use of Biospecimens and Data”. 

25.  Under Guidance Topics in “Students & Employees as Research Subjects” section: 
a.    Removed Appendix A Use of Rutgers Students as Subjects as this form is no longer. 
b.    Added reference to Worksheet HRP-331 FERPA Compliance 
  1. Added link to Rutgers UEC's FERPA guidance 
  2. Under Guidance Topics in "Study Management Tools” section, fixed broken links to:
a.      Study Staff Delegation Log  
b.      Study Staff Training Log  
c.      Subject Enrollment Log  
d.      Monitoring Log,  
e.      Drug Accountability Log   
f.       Device Log  
g.      Unanticipated Problem or AE Log   
h.      Protocol Deviation Log    
  1. Added notation that additional clinical research study logs may be obtained from NIH’s NCCIH Clinical Research Toolbox : https://www.nccih.nih.gov/grants/toolbox or https://www.nimh.nih.gov/funding/clinical-research/clinical-research-toolbox/nimh-clinical-research-toolbox  
  2. Under Guidance Topics in “Waiver of Informed Consent” section fixed: 
  3. Broken link to OHRP’s Consent FAQs.  

27.  Removed “For HealthSci IRBs” and made a new header, “Criteria for Alternate Method/Waiver of Consent for Research & Privacy of Individually Identifiable Health Information (HIPPA)”. 

28.  Under Guidance Topics in “Data Retention and Record-Keeping” section added Department of Education best practices for data destruction. 

29.  Under Guidance Topics in “Surrogate consent with Adults Lacking Capacity to Consent” added a link to our Toolkit items. 

30.  Under Guidance Topics in “Subject Recruitment” section added 2 new hyperlinks, “Recruiting Study Subjects” & “SACHRP Recruitment Recommendations”. 

31.   Under Guidance Topics in “Site Authorization/Approval” under Forms section added a link to our Toolkit items. 

32.  Under Guidance Topics in “Reportable Events 1: Protocol Deviations and Violations” section added a link to our Toolkit items. 

33.  Under Guidance Topics in “Non-English-Speaking Subjects” section added a link to our Toolkit items. 

34.  Under eIRB section removed “Submission Instructions for Current IRB Paper Studies Not Using eIRB” as paper submissions for new studies were discontinued several years ago. 

35.  Under Research Roles, then under Principal Investigator in Individuals who cannot be a Rutgers Principal Investigators removed reference to HealthSci or ArtSci and revise to “Rutgers Biomedical Health Sciences (RBHS) Units or “Other Rutgers Schools/Depts”.
36.  Under Federalwide Assurances, then under “HHS Registration Numbers” removed reference to HealthSci/ArtSci. 

37.  Under External IRBs then under Western IRB (WIRB): 
a.      updated link to WIRB Forms and templates 
b.      Removed “the Newark IRB” and replaced with Rutgers IRB  
  1. Updated contact for IRB's email - IRBOffice@research.rutgers.edu  

37.  Under "Identifying Human Subjects Research" in Types of Studies Which May Require Review section removed hyperlinks to define "Social Psychology", "Educational Research" etc. 

38.  Under Closing a Study in “Closure Instructions” section-removed reference to both HealthSci and ArtSci. Updated information For Studies Initiated in eIRB: Close your study via eIRB by submitting a Continuing Review: Final Report. For Paper Studies: Submit a paper Final Study Report/Study Closure Form to the IRB.  

39.  Under  IRB Paper Forms, then under View Converting your study...-removed reference to both HealthSci and ArtSci. Updated information on how to convert a paper study into eIRB. 

40.  Under the IRB Submission Process, in “Making A Change to Your Previously Approved Study“ then under Instructions:  Updated hyperlink to our Toolkit and changed instructions to “email your modification for existing paper-study to the IRB: IRBOffice@research.rutgers.edu.   

41.  Under the IRB Submission Process, in Submitting a Status Report, then under Submission Instructions: Corrected eIRB hyperlink & Update hyperlink to our Toolkit.  

42.  Under the IRB Submission Process, then under “Post IRB Approval Responsibilities “ then under “responsibilities after your study is Closed, Learn More” updated information for user to seek Data Retention and Record-Keeping under Guidance page. 

43.  Under the IRB Submission Process, then under “Post IRB Approval Responsibilities “ then under “Submit a Reportable Event, Learn More”, then under “Another Type of Reportable Event: Data & Safety Monitoring Reports updated information for user to seek Data Safety and Monitoring under Guidance page. 

New HSPP Staff Spotlight

Kathleen Villapiano

Hello, my name is Kathleen Villapiano. I recently re-joined the Human Subjects Protection Program (HSPP) as a Compliance Administrator. I am returning to HSPP after some time staying home with my twin girls.
 
I have over 15 years of experience working in research administration. I started out my career as a study coordinator at the University of Medicine and Dentistry of New Jersey (UMDNJ). After moving to Colorado, I accepted a job at the University of Colorado Health Science Center at the Colorado Multiple Institutional Review Board (COMIRB). Here I gained experience working in an IRB office learning the regulations from an IRB perspective. After a couple of years at the IRB, I was asked to join a newly developed Regulatory Affairs Team at the Colorado Cancer Center. Here I worked with many different phases of research studies, obtained new regulatory affairs experiences this time pertaining to the PI’s and the entire study team. Upon returning home to New Jersey, I started my career in the HSPP office as a Research Analyst where I worked for eight years in compliance and quality assurance.
 
I hope to utilize my knowledge to help support Rutgers University to continue to conduct ethical research.
IRB Member Spotlight


Meet one of the IRB Vice-Chairpersons for all Rutgers IRB Committees 
 
Nora Cosgrove, RN
 
Nora Cosgrove, RN, is a clinical research coordinator for the Cardiovascular Institute at Rutgers Robert Wood Johnson Medical School. In addition to her role with Rutgers, Nora has contributed to many peer reviewed journal articles related to cardiovascular issues. Her commitment to health care and research have made her an integral member of the Rutgers IRB. 

In 1999, Nora became a member of the IRB at the request of a colleague. Then, in 2004, Nora took on the role of Vice-Chairperson and a member of the IRB Executive committee. Nora’s dedication to protecting clinical trial subjects motivates her to serve in her role with the IRB. Nora enjoys learning about the research discoveries that will contribute to peer-reviewed, medical science. For Nora, it is an honor to be part of team that witnesses first-hand the innovative potential new treatments and devices that may improve and extend a person's quality of life.

Meet our New IRB Members

Braishna Khattak, DDS (she/her/hers) has recently joined the Rutgers IRB as an expedited reviewer. She is in a Master's program at Rutgers for Clinical Research Management–Drug Safety and Pharmacovigilance. She is American Dental Board certified (NBDE 1, II) with Bachelor of Dental Surgery (DDS from Khyber Medical College, Peshawar, Pakistan). Dr. Khattak also spent seven years as a research coordinator for an Internist in Fresno, CA. We welcome Dr. Khattak onto the IRB and look forward to working with her.

Kristen Krause, PhD, MPH (she/her/hers) has joined the Rutgers IRB as an expedited reviewer. Dr. Krause is an instructor of Urban Health in the Department of Urban-Global Public Health at the Rutgers University School of Public Health (SPH) and the Deputy Director of the Center for Health, Identity, Behavior, and Prevention Studies (CHIBPS), a leading training ground for LGBTQ scholars. She has expertise in HIV/AIDS, aging, resilience, and broader LGBTQ health disparities. More specifically, her work examines resilience as it relates to biological, psychological, and social health status among older gay HIV+ men. Previously, she was the recipient of a TL1 Pre-doctoral fellowship at the Clinical and Translational Science Institute at NYU Langone Health and more recently received the Stuart D. Cook Excellence in Research Award for her dissertation work from the Rutgers SPH. Dr. Krause also serves as the founding Deputy Editor of a new journal geared towards the health and well-being of sexual and gender diverse communities called Annals of LGBTQ Public and Population Health and she is also the Deputy Editor of Behavioral Medicine. We welcome Dr. Krause onto the IRB and look forward to working with her.

Aidan Ziobro, PharmD, R.Ph., MBA (he/him/his) has joined the Rutgers IRB as an expedited reviewer. Dr. Ziobro is a Clinical Pharmacy Specialist (Investigational Drug Services) at the University Hospital (Newark), who provides investigational drug services to New Jersey Medical School Clinical Research Center (CRC) and associated clinical trial units, and oversight over several pharmacists and ancillary staff. Also, he serves as preceptor for pharmacy students and newly graduated pharmacists.  Dr. Ziobro manages about 40 actively enrolling studies, with the majority being within the NIH Division of AIDS (DAIDs) research networks: AIDS Clinical Trial Group, HIV Prevention Trials Network, HIV Vaccine Trials Network, and COVID-19 Prevention Network with remaining studies being industry-funded studies, investigator-funded, or cooperative-group studies (e.g., NCI, NIDA). Dr. Ziobro serves as the hospital’s Medication Safety Officer (MSO) and is an active member of Patient Safety, Pharmacy and Therapeutics, and Nursing-Pharmacy interdisciplinary committees. We welcome Dr. Ziobro onto the IRB and look forward working with him.

Interested in being featured in an upcoming issue of this bulletin?

Please contact Donna Hoagland.
eIRB System Announcements
Stay tuned for updates to the eIRB System! 
AAHRPP Accreditation Updates

Step 1 application is currently under committee review with the AAHRPP council. For more information, please contact Swapnali Chaudhari and Malica Dock.
ClinicalTrials.gov News

Under the FDAAA801 law and Rutgers policy, the Responsible Party/ Principal Investigator is held accountable for study registration and results reporting on ClinicalTrials.gov.

One of the common mistakes when entering study results on ClinicalTrials.gov is the Inconsistent Outcome Measure Data. A problem is often identified when the title, description, measure type (e.g. mean, median, number, count of participants, etc), unit of measure (e.g. participants, scores on a scale, mL/min, hours, percent, etc.), and/or the numerical data entered into the outcome measure data table do not make sense when reviewed together. 

· Problem Example: The Outcome Measure title and description indicate that the measure to be reported is “Participant a1c levels”, but the Unit of Measure is “participants” not “mg/dL”. 

· Problem Example: The Outcome Measure title and description indicate that the measure to be reported is “Change in BMI from Baseline at Week 6”, but the numbers reported in the data table appear to be the BMI score measured at baseline, rather than the value of the change in scores. 

Avoiding common mistakes such as the examples above when entering study results on ClinicalTrials.gov will enhance the accuracy of data and eliminate the possibility that the PRS reviewers reject results submission.
Quality Assurance/Quality Improvement

The HSPP Quality Assurance team provides guidance to the Rutgers research faculty and study team by providing study management tools to guide the team in conducting quality research.

The Study Management Tools are intended to be used as an aid to help the researcher and research team. These templates provide a general format applicable to all types of research. After choosing the appropriate template, it should be modified to reflect the unique attributes of the study.
Single IRB News

Effective January 1, 2022, the submission process at Rutgers IRB (Institutional Review Board) for Advarra submissions will be revised. All Advarra submissions must be submitted directly to the Rutgers IRB office for a preliminary review.  

WCG IRB made a few procedural changes to the Translations process. If you are supplying your own translations to WCG IRB for review and approval, effective immediately, the following will apply to your submissions:

1. Consent forms must be submitted in Word format to the IRB 
  • Submissions made in PDF or other formats will not be accepted.

2. When you receive approved versions of revised documents, and if non-English speaking participants are active on your trial, it is WCG IRB’s expectation that you will submit updated translated versions of those materials within 30 days for IRB review/approval accompanied by an updated Certificate of Translation (CoT). 

3. Translated materials that are submitted prior to the approval of the corresponding English material(s) will no longer be accepted.

  • The Board often requires changes to the English material(s) during the review that will then need to be applied to the submitted translation(s).

4. Translated Consent Forms, Subject Materials, and/or Advertisements must be submitted with appropriate identifiers on the document or accompanying the documents so that the translated items can be easily matched to their already approved English counterparts.

  • Submissions made without the appropriate identifiers will not be accepted, as WCG IRB utilizes this information for version controlling purposes.
 
The provided link includes the updated Translation Request Submission form: https://www.wcgirb.com/how-to-submit/irb-forms/?k=translation
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HSPP / IRB Education

eIRB Virtual Training Workshops

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.
  
  • 10/28/2021 at 2:30 pm 
  • 11/9/2021 at 11 am 
  • 11/18/2021 at 2:30 pm 
  • 12/7/2021 at 11 am 
  • 12/16/2021 at 2:30 pm
Stay Tuned!

In the works:

  • Additional Consent Form Revisions

  • IRB Orientation Workshops