January 2022 IRB Connection Newsletter

Index

 

Reminder: Pre-Grant Submission Survey for Single IRB Model

FAUCI & the Importance of Representation in Research: A Film Screening and Discussion

New Exempt Application Rollout

Protocol Outline Template

Medical Ethics Advisor Newsletter, December 2021

In the News

 

 

Reminder: Pre-Grant Submission Survey for Single IRB Model

By Kelly O’Berry, BS, CIP

Federal agencies require the use of a single IRB (sIRB) for federally funded research conducted at multiple sites. This means one IRB oversees research conducted at some or all of the study sites. The budget must include the fees for this type of IRB review and this type of research may require some additional approvals and agreements. Researchers can access information about UI IRB fees for budget planning.


If you are planning to submit a grant proposal to the National Institutes of Health (NIH) or any other federal agency that requires the sIRB model, complete the Pre-Grant Submission Survey as soon as you become aware of the award notice. Plan ahead and complete this survey well in advance, especially if the Iowa IRB is either serving as a lead IRB or relying on an external IRB as an expectation of the grant!

If you have questions or need any assistance, contact the External IRB Team at uirb-external@uiowa.edu.

 

FAUCI & the Importance of Representation in Research: A Film Screening and Discussion

January 27, 2022 at 6:00pm ET


Join us for a special screening of FAUCI (2021), the National Geographic Documentary Films’ revealing portrait of one of our most dedicated public servants.  After the film, hear from longtime AIDS activist and survivor Michael Manganiello in a discussion about the importance of participation in medical research.

To register for the live screening and discussion, or to watch the film on demand (1/27 to 1/31), go to the UI Events Calendar for more information and to preregister.

The film and discussion will both have closed captioning in English and Spanish. This special event was made possible by Picture Motion, NIH All of Us Research Program, Network of the National Library of Medicine, and Center on Halsted.

 

More about this event and NNLM

This event is supported by funds from the National Library of Medicine, National Institutes of Health under cooperative agreement number UG4LM013729 at the University of Iowa, Hardin Library for the Health Sciences.

The mission of the NNLM is to advance the progress of medicine and improve public health by providing all U.S. health professionals with equal access to biomedical information and improving the public's access to information to enable them to make informed decisions about their health. The Program is coordinated by the National Library of Medicine and carried out through a nationwide network of health science libraries and information centers.

 

New Exempt Application Rollout

By Joanie Hoefer, BS, CIP


As the new year and a new semester gets underway, the Human Subjects Office (HSO) is pleased to announce the late January rollout of the highly anticipated exempt new project application in HawkIRB! This is the culmination of extensive work by HSO and IRB leadership and Research Information Services (RIS) programmers on a major update to the HawkIRB system for projects that qualify for exempt status.

Currently, about 24% of all IRB-02 (Social/Behavioral) and 3% of all IRB-01 (Biomedical) approvals qualify for exempt status. These revisions to the HawkIRB application will allow UI researchers and the IRB to take full advantage of the new exemptions to the federal regulations for human subjects research that went into effect in 2019, including:

  • Research in educational settings using common educational practices
  • Research involving surveys, interviews and observation of public behavior
  • Research with a benign behavioral intervention
  • Retrospective record reviews

Since retrospective record reviews can qualify for exempt status, the new exempt application will significantly increase the number of biomedical studies that are eligible for exemption, subsequently reducing the regulatory burden on researchers and the IRB.

In addition to the regular HawkIRB training series offered every semester, the HSO is offering several HawkIRB training sessions during the Spring 2022 semester. These trainings will demonstrate the updated exempt application form and provide guidance on how to use this form for new and existing projects. For more information, visit the Education and Training page of the HSO website. Recordings of all HawkIRB training sessions, including the new exempt application, are posted in the IRB’s ICON Course for Researchers.

 

Protocol Outline Template


A protocol is a detailed plan of every aspect of the research study. It outlines the following information:

  • Scientific basis for the project
  • Study objectives
  • Subject population(s)
  • Methodology (study procedures)
  • How data will be managed (data security plan)
  • Evaluations and analysis plan
  • Safety management and regulatory issues

The IRB provides a template protocol as guidance for what to include in a study protocol. The revised template includes prompts to provide specific information that will be requested in the HawkIRB New Project form.

Template Options

The Human Subjects Office Protocol Outline Template can be used for Phase I or non-clinical trials

Phase II-IV clinical trials should use the FDA/NIH Clinical Trial Protocol Template. There is also a Behavioral and Social Science Research protocol template on this page of the National Institutes of Health (NIH) website.

Separate Protocol Note Required

The IRB does not usually require researchers to create a separate, written protocol. The description of the study design and procedures in the HawkIRB application is usually sufficient. Applications for IRB-01 (biomedical) and IRB-03 (VA Health Care System) have a question (Section VII.B.11) asking whether there is a study protocol. If so, it must be attached to the HawkIRB application in the appropriate attachment category. If the project is a clinical trial, the IRB may request a separate, written protocol.

The IRB-02 (social/behavioral/educational research) application does not have Section VII.B, so there is no question about a separate, written protocol. However, researchers can still attach a protocol in the Miscellaneous attachment category.

 

Medical Ethics Advisor Newsletter, December 2021

Kelly O'Berry, BS, CIP


Medical Ethics Advisor (a publication of Relias, LLC) is a monthly newsletter with articles about human subjects research and medical ethics. Current and past issues of Medical Ethics Advisor and IRB Advisor are posted in the “IRB ICON Course for Researchers.” The portal to this ICON Course is on the Education and Training page of the Human Subjects Office website. This month we are spotlighting some articles about human subjects research from the December 2021 Medical Ethics Advisor Newsletter.

IRBs Scrutinizing Remote Consent, Screening, and Participation in Protocols

Remote recruitment, consent and study participation raise ethical concerns for investigators and IRBs. Where this used to be a somewhat rare occurrence, now researchers are proposing it more often and with novel methods. The article includes some good questions for investigators to address when they propose remote study procedures:

  1. How will you confirm (authenticate) the identity of the participant?
  2. What system are you using for eConsent?
  3. If this study has Food and Drug Administration (FDA) oversight, is your method of eConsent and electronic data capture 21 CFR Part 11 compliant?
  4. How will you confirm that children are not accidentally enrolled (unless the study is approved to enroll minors)?

IRBs Face Unique Ethics Questions About Big Data Research

Some examples of big data include: social media data, sensors, wearables, consumer data and medical data. This article outlines some weaknesses in the ethics review of big data research. IRB considerations about consent, use of secondary data, privacy and confidentiality protections and communal harms are more complicated with the use of big data.

Paying Participants? Incentives Should Be Reasonable for Research Activities Involved

Payment alone does not make a study unethical, especially when it is to reimburse for expenses, compensate for time and effort and incentivize participation. But IRBs have concerns when payment is an “undue inducement,” where the offer is so appealing it might affect the judgement of the potential subject. The safety catch for this is the regulatory requirement that the IRB can only approve research that has a favorable risk-benefit ratio, so the risks of participating do not outweigh the benefits. Another ethical concern is for “unjust inducement,” where the payment is more attractive to certain subjects so they bear more of the burden of participation in research. IRBs look at both the amount and method of compensating research subjects. They should consider whether researchers are paying too much OR too little compensation to subjects.

IRBs Often Reluctant to Approve Inclusion of Pregnant Participants in Research

This article provides a summary of survey research conducted with 93 IRBs and 39 IRB Administrators to learn about reluctance to approve the involvement of pregnant women in HIV/AIDS research and in other research contexts. The issue of including pregnant women in research also came up with COVID-19 research, with the American College of Obstetricians and Gynecologists (ACOG) advocating for their inclusion. IRBs often consult with maternal/fetal experts during the review process. The ethical principle of justice is the basis for including, or at least not excluding, pregnant women and women of childbearing potential in human subjects research.

Articles in the December 2021 Issue:

  • Medical Providers’ Views Vary on Refusals of Life-Sustaining Treatment
  • Many Ethics Consults Involve “Unbefriended” Patients
  • Decisional Capacity is Most Common Issue in Neuro-oncologic Consults
  • Moral Distress When Caring for Patients on Mechanical Circulatory Support
  • Data Show Larger-Than-Expected Market for Ethics Consultation Training
  • Positive STI Test Results Not Always Shared with Study Participants
  • Novel Ethics Curriculum for Neonatal-Perinatal Medicine

 

In the News, January 2022