Index
New Guidelines for Posting Informed Consent Documents for Federally Funded Research
HawkIRB Carousel Index: A Wealth of Information at Your Fingertips
Division of Sponsored Programs Rebroadcast: Revised Workflow Form for PI Departure, Grant Transfers, and VPR Request for Approval to serve as Adjunct, Visiting or Emeritus PI
Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD)
Medical Ethics Advisor Newsletter, May 2022
In the News
New Guidelines for Posting Informed Consent Documents for Federally Funded Research
By Fozia Ghafoor, MBBS
New Guidance
At the end of March 2022, the Office of Human Research Protections (OHRP) released guidance and posting instructions to clarify the regulatory requirement to post the Informed Consent Document (45 CFR 46.116(h)). This guidance provides clarification via a Frequently Asked Question format. Federally funded clinical trials must post one version of an IRB-approved consent document used to enroll study participants on a publicly available federal website.
Posting Locations
Currently, there are two locations available for posting the informed consent document: ClinicalTrials.gov and Regulations.gov
- For clinical trials that meet the FDAAA definition of an Applicable Clinical Trial (ACT), the informed consent document can be uploaded to the relevant ClinicalTrials.gov record.
- For clinical trials that do not fulfill the criteria of an “Applicable Clinical trial”, but meet other clinicaltrials.gov registration requirements (e.g. NIH Funding), the informed consent document can be uploaded to ClinicalTrials.gov, but the investigator needs to first register the record with ClinicalTrials.gov.
- For all other studies that do not have a ClinicalTrials.gov registration requirement, the informed consent document can be uploaded to a docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021).
UI researchers may post in the applicable site to fulfill this regulatory requirement.
Tracking the Posting Deadline
The consent form must be posted to a designated federal website after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject.
To better track the timing of the posting requirement, there is a question for federally funded clinical trials in HawkIRB under section VII.B.1.c to document the estimated date of the last visit by any subject as required by the protocol. This should be the best guess of the date of the last visit by any subject enrolled in the study as specified by the protocol.
While it is possible to post a consent form before the final study visit or the close of the recruitment period, it will not satisfy the regulatory requirement for posting the document. If a consent form is posted before a clinical trial closes recruitment, the investigators would have to re-post the document after the clinical trial closes recruitment. If a clinical trial closes recruitment 61 or more days after the last study visit by any subject as required by the protocol, OHRP recommends that posting should occur within 60 days of the clinical trial recruitment closure.
In a scenario where research study visits overlap with the clinical visits for a routine care, the OHRP considers the “last study visit by any subject” as the last study visit that occurs only as a part of a research project required by the protocol and not as part of routine clinical care.
Instructions for Posting
General information on the format for documents to be uploaded to ClinicalTrials.gov, including informed consent documents, can be found here:
- The ClinicalTrials.gov final rule information page, which provides information related to the implementation of the ClinicalTrials.gov final rule
- The ClinicalTrials.gov Results Data Element Definitions document, which describes how to format documents (including consent forms) and upload them to ClinicalTrials.gov
The OHRP website contains instructions for uploading a consent form to the designated docket folder on Regulations.gov. The informed consent document should be a blank copy of the IRB-approved document. Investigators should not post documents that were signed by a research subject or that contain names of individual research participants. No personally identifiable information or other patient information should be on this form.
If a federal department or agency conducting or supporting a clinical trial determines that certain information should not be made public on a federal website, the federal department or agency may permit or require redactions to the information posted (45 CFR 46.116(h)(2)). Researchers should only post redacted forms if the federal department or agency conducting or supporting a trial permitted or required the redactions.
The regulations do not specify a language for a posted consent form. OHRP recommends that if an English language consent form is available, that version of the form should be posted. Note that the ClinicalTrials.gov Protocol Registration and Results System (PRS) User’s Guide states that all clinical trial information must be submitted in English. Clinical trial informed consent forms written in a language other than English may be submitted to the Regulations.gov docket folder.
Questions?
Should you have any questions or need assistance with the submission of an informed consent document, please contact ct-gov@uiowa.edu or call the PRS Administrator in the Human Subjects Office at (319) 467-3250.
HawkIRB Carousel Index: A Wealth of Information at Your Fingertips
By Kelly O’Berry, BS, CIP
In April 2022, the IRB Education and Outreach Program offered a presentation about information and guidance available in the HawkIRB Carousel Index. This article provides an overview of the layout and features in the index of a HawkIRB New Project form.
The Ribbon Index
HawkIRB forms are “smart” forms. The form opens or closes sections of the application based on the respondent’s answers. The ribbon index across the top indicates sections to complete and the status of completion:
Gray – Section “closed.” These sections may open when the researcher responds to questions in the form OR the section may not be required for that type of study.
White – Section “open,” but the researcher has not yet responded to any questions.
Yellow – Section “open” and the researcher has responded to some, but not all, of the questions.
Green – Section “complete.” The researcher responded to all questions in this section. Note: HawkIRB cannot tell if the researcher put a note to themselves to come back and answer the question OR a thorough, detailed response about the study.
You can click a box in the ribbon to advance the Carousel Index (see below) to the appropriate section, but you cannot open the form itself from the ribbon index.
Help Messages
There are little blue circles with “i” for “information” associated with most of the questions in the HawkIRB application. The Help Message on the index page provides a lot of information:
- Overview of the HawkIRB system
- Template Consent Forms and Other Attachments
- Resources for assistance with preparing HawkIRB applications
- About the Help Messages
- Resources on the Human Subjects Office website
- Principal Investigator (PI) Responsibilities
- HawkIRB Delegates
- Guidance for Community-Based Research
Other Help Messages provide guidance for what information to include in response to specific questions in the HawkIRB form.
Links to Other Pages of the Application
Below the ribbon index, there are links to the following pages:
Consent Forms and Other Attachments
This link takes you to the Attachments page. Take a moment to read the notes and information about expected attachments at the top of the page. The first section is for Consent/Assent Documents. There is a dropdown menu for UI IRB templates.
Other Committee Review
This link takes you to a page that shows any other Human Research Protection Program (HRPP) committees that will be involved in the review process. This is based on the way you answer questions in the form and could change if you change responses while you prepare the application. There may be forms, links and documents that you need to complete for these other committees.
Final Submission Page
This page shows unanswered questions in the form. If you have answered all of the questions, you will not see anything on this page.
The Carousel Index
The Carousel Index consists of the white boxes on the index page. This is where you actually access the application to answer questions to describe the study. Each box has a section heading and links to sub-section headings. To help researchers see where they left off, there will be a green check mark to the left of a sub-section heading when there is a response to all questions in that section.
Each white box in the Carousel Index contains the following links:
What you need to start
With one click the PI or their HawkIRB Delegate can see what information they will need to respond to the questions in that section.
Why we need this information
If the PI or their HawkIRB Delegate wonder why certain questions are in the HawkIRB application, this link includes references to federal regulations and guidance, the Belmont Report, UI IRB policies, and institutional policies that are the basis for the questions in that section.
We hope this information assists UI researchers with preparing HawkIRB forms. The recorded presentation is posted in the IRB ICON Course for Researchers. The recording includes several case examples of when researchers could benefit from using the links in the Carousel Index.
Division of Sponsored Programs Rebroadcast: Revised Workflow Form for PI Departure, Grant Transfers, and VPR Request for Approval to serve as Adjunct, Visiting or Emeritus PI
The Division of Sponsored Programs recently launched a revised PI Departure, Request for Grant Transfer, or Request for Approval of Adjunct, Visiting, Emeritus or Retired Faculty as PI Workflow form. This form is required for Principal Investigators who have federal or non-federal sponsored projects (fund 500 or 510) for which they plan to take any of the following actions:
- Transferring a grant to a new institution
- Ending/early termination with PI’s departure
- Requesting a change in PI for the project to stay at the UI
- Requesting VPR approval to serve as a PI in an adjunct, visiting, or emeritus appointment
A separate Workflow form is required for each project:
It is recommended that the department initiate the PI Departure, Request for Grant Transfer, or Request for Approval of Adjunct, Visiting, Emeritus or Retired Faculty as PI at least 90 days prior to the PI's departure or effective date of the requested change.
PDFs of the prior forms will no longer be accepted for any of these actions. This revised Workflow form contains information previously requested on the individual PDFs.
Workflow path and approvals:
The form will be initiated by the PI's department through Workflow. The form is located on the DSP e-Forms page. The form will automatically route to the PI, Departmental Research Administrator, Departmental Executive Officer, and Dean for approval before submission to Grant Accounting Office (GAO) for review.
GAO approval is only an indication that the form has been completed accurately and appropriate documentation is attached to proceed with the requested action. This will prompt DSP to take the appropriate and necessary action based upon the request and information contained on the form. Additional offices may contact you based on the nature of your project and answers to questions on the form.
More information is available on the Division of Sponsored Programs website page about PI Transfer/Departure/Change of Status.
For assistance with HawkIRB modifications related to PI departure, grant transfer or change of status, contact the Human Subjects Office (PH: 319-335-6564, Email: irb@uiowa.edu, IRB Office Hours).
Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD)
By Kelly O’Berry, BS, CIP
This site has information about:
- Investigational New Drug (IND) – what this is, exemptions, IND submissions, FDA responses and Type B meetings, maintenance of an IND, and drug development. There is a link to the ReGAARD training modules on IND Sponsor and Investigator Responsibilities.
- Investigational Device Exemption (IDE) – what this is, exemptions, significant/nonsignificant risk determinations, initiating an IDE submission, FDA responses/meetings, and maintenance of an IDE. There is a link to ReGAARD training modules on IDE Sponsor and Investigator Responsibilities.
- Resources – helpful links, frequently asked questions, and regulatory forms and templates. There is also an Informed Consent Checklist with information that should be included in consent documents.
- Training and Events – educational videos, CTSA and other educational events, past events and institution training resources
- About – the collaborating sites, the ReGARDD Regional Regulatory Forum (which meets quarterly) and contact information for the regulatory contact people at each site and for the ReGARDD Forum (regardd@unc.edu).
Even though the UI ICTS is not part of the group that created the website, these publicly available resources may be useful for UI researchers. This can be another tool in your toolbox for conducting research with investigational drugs and devices.
Medical Ethics Advisor Newsletter, May 2022
Rachel Kinker, MPA
Ethical Concerns Persist Over Reporting Bias in Clinical Trials
Reporting bias is fairly common in clinical trials. There is often the perception that publications prefer to publish studies with positive outcomes and statistically significant findings. Publication bias and outcome reporting bias are two types of reporting bias. Often in cases of publication bias, trials that have negative or no effect are not published. In cases of outcome reporting bias, unfavorable data is omitted, only a portion of data is included, or the primary outcome is altered. These reporting biases can result in inaccurate and incomplete data that can skew perceptions, ultimately impacting clinical decision making and patient outcomes.
Proposed solutions:
- Enforcement of penalties for delays in reporting trial results
- Prioritizing accuracy between published results and the original study protocols in publications and reporting
- Addressing the problem of selective registering, publication, and reporting on ClinicalTrials.gov
What can IRBs and researchers do?
- IRBs can require study investigators to register studies and require a data-sharing plan prior to IRB approval
- Confirm that study results have been published transparently before ending continuing review
- Note that FDA package inserts may not paint the full picture, ask investigators to submit any relevant unpublished studies that they feel might impact the research
IRBs May Need to Seek Outside Expertise; More Data are Needed
During the review process, IRBs may need to consult with outside individuals with expertise in specific areas that are not currently represented on the IRB. There are a variety of reasons why an IRB does not seek an outside consultant. They may be concerned that it implies the IRB is not adequately composed.
When seeking outside experts, the IRB should identify someone who has the necessary risk expertise.
Articles in the May 2022 Issue:
- Greater Awareness of Reporting Bias on Antidepressants, Yet Problem Persists
- Efforts to Improve Ethics Education for Nurses
- Ethical Controversy Persists Over Organ Procurement Method
- Use Caution if Machine Learning Models Are Used to Predict Mortality
- Plastic Surgery Poses Unique Ethical Considerations
- Ethics Training for Community-Engaged Research in Latino Community
- Investigators Make Ethical Commitment for Neuroscience Research in Humans
- New Guidance to Promote Diverse Populations in Cardiovascular Trials
- Informed Consent Considerations if Surgeon Delegates Portion of Operation
In the News, June 2022
- The Essentials of Single IRB Review, Harvard Catalyst
- Addressing Racial Gaps in NIH Grant Funding, EurekAlert!
- This Tick Can Make You Allergic to Meat, and It’s Spreading, Scientific American
- Monkeypox outbreaks: Here’s Everything you Need to Know, Live Science
- Study Links Synthetic Chemicals to Liver Damage, NIH
- Zinc is a metal essential to life-scientists have discovered a protein that helps keep cells alive when zinc levels are low, The Conversation
- Complete Responses in 100% of dMMR Rectal Cancer With Neoadjuvant PD-1 Inhibition, Medpage Today
- Introducing resources to support diversity and inclusion in clinical research oversight, Ampersand, The PRIM&R blog
- NIH-supported study links poor sleep to increased risk of COPD flare-ups, NIH
- Just how accurate are rapid antigen tests? Two testing experts explain the latest data, The Conversation
