The Human Subjects Office (HSO) is rebroadcasting the eRA Enhancements notice that went out in the Division of Sponsored Programs (DSP) RAD newsletter as it contains important ClinicalTrials.gov information. The eRA enhancements are directly related to errors you may encounter for federally funded clinical trials that have a Clinicaltrials.gov registration requirement. Please review the article in its entirety on the RAD Archives under “eRA Enhancements (November 12, 2021)”
University of Iowa policies for Clinicaltrials.gov registration and results reporting can be found on the HSO website under the “ClinicalTrials.gov” section. If you need assistance regarding ClinicalTrials.gov registration or reporting, please contact Fozia Ghafoor, UI PRS Administrator, at email@example.com or a University of Iowa departmental ClinicalTrials.gov working group member.
On December 8th, 2021 at 3:00 pm CST, the Human Subjects Office (HSO) will facilitate a virtual training to help research teams become familiar with Western Copernicus Group's (WCG) new online submission system. In this one-hour training, a representative from WCG will provide an overview of the new WCG Connexus online portal, as well as insight and guidance for what to expect from this system. This virtual training was originally scheduled in November, but due to severe weather where the presenter was located, had to be postponed.
Pre-registration is required. Once you are registered, the HSO will send you an email with the Zoom link and calendar invite. If you have questions, please feel free to contact Mayzie M. Tucker, Commercial IRB Application Analyst.
Joanie Hoefer BS, CIP
Recent updates were made to the University of Iowa’s Collaborative Institutional Training Initiative Program (CITI Program) curricula to provide access to additional optional research compliance courses and webinars for the institution. These updates went live in mid-November and are available to all University of Iowa learners, free of charge.
To access these new optional course and webinar offerings, log in to the CITI Program using either your HawkID and password (SSO) or your CITI Program username and password. If you do not have a CITI Program profile, instructions are available in FAQ # 9 on the Certifications in Human Subjects Protections page of the HSO website. If you have a CITI Program profile from a previous institution, instructions are available in FAQ #14 to affiliate your profile with the University of Iowa.
- On the “My Courses” page, click on “View Courses” next to “University of Iowa”.
- Either click on the “Learner Tools” link or scroll all the way to the bottom of the page to see the “Learner Tools for University of Iowa” box.
- Click on “Add a Course”.
- At the bottom of the list on the “Select Curriculum” page are two options—one for Research Compliance training and one for Research Compliance webinar:
Then click on “Next”. Selecting the Research Compliance training option will open a list of optional training courses on topics such as conflict of interest, information privacy and undue foreign influence. Selecting Research Compliance Webinar option will open a list of a number of CITI Program webinars on topics such as clinical research and Good Clinical Practice, grants and blockchain/higher education.
- Select the courses and/or webinars that you would like to review, then click “Next”.
- You will be directed back to the “My Courses” page. You will find these courses under “Courses Ready to Begin”, in alphabetical order.
It is our hope that you find these new optional courses and webinars beneficial to your continued learning and research endeavors. If you have any questions about these updates or the UI’s CITI Program curricula, please contact Joanie Hoefer.
By Kelly O'Berry
Have you ever wondered about the people who review research applications submitted to the University of Iowa Institutional Review Board (IRB)? There are current openings for Community Members, Other Scientist and Non-Scientist members on the UI IRBs. IRB members have a front-row seat to the wide variety of research conducted at the UI, from Alzheimer’s and diabetes to early childhood development and driver safety.
Board members support the UI’s Human Research Protection Program by reviewing proposals for such research. IRB members are asked to attend one to three meetings per month based on their availability. This volunteer opportunity may be of interest to someone who cares about protecting the rights, safety and welfare of individuals who volunteer to participate in research. This is also an ideal position for someone who is interested in learning about research conducted by UI faculty, staff and students and VA researchers.
The UI currently has about 70 board members on the three separate IRBs:
- IRB-01 – reviews biomedical research
- IRB-02 – reviews social, behavioral and educational research
- IRB-03 – reviews research conducted at the VA Health Care System or using VA resources
The Human Subjects Office seeks balanced IRBs made up of UI faculty and staff as well as members of the Iowa City and surrounding area. We also strive for balance in terms of gender, race and ethnicity. IRB members include people with scientific and non-scientific backgrounds. Unaffiliated members, scientists with a non-medical background and non-scientists play a crucial role in reviewing human subjects research and can bring fresh insight and perspective to the review process. No previous experience is necessary. Community Members may include clergy, public servants (police officers, fire fighters), research participants, and others.
As you can imagine, it’s difficult to find people in Iowa City and the surrounding area who are not employed by the University of Iowa themselves and do not have a connection with the institution through the employment of someone in their immediate family. A Community Member may or may not have a scientific or medical background, but they must not have an affiliation with the UI or the VA Health Care System.
The IRB relies on Community Members and Non-Scientist Members to serve as a “voice” for potential subjects who may be approached to participate in research. Within that role, during the IRB meetings, these members are asked to:
- Raise questions (or concerns) they may have with the proposed research
- Make recommendations on how to present the research to subjects in terms that potential subjects can understand.
“I see my role as being an advocate for the potential subject, making sure that what they are asked to do is reasonable and that the explanation of the research is understandable. While I rely on my medical and scientific colleagues to determine if the project is ‘good science,’ I have never been made to feel that my opinion is any less valuable.”
Non-Scientist IRB Member
Qualifications to be a Community Member or Non-Scientist IRB Members
- Applicants and their immediate family must not be employed by (or volunteer at) the UI or VA Health Care System
- Applicants should have a non-scientific or non-medical background or training (preferred)
- UI or VA Retirees may qualify as community members two years post-retirement.
- Applicants must be able to attend regular review meetings (one to three times a month)
- Meetings are generally held during business hours on Monday and Thursday afternoons or Wednesday mornings.
- Applicants should have interest in and general aptitude for reviewing research proposals prior to IRB meetings
- Applicants must complete IRB member training prior to participation
“As a community member my primary task has been to help determine that the information and consents given to participants in clinical trials are accurate and understandable to persons who do not have medical training. As a bonus, I have learned a great deal about human research and new medical advances.”
Dave Schuldt, Former IRB Community Member
We appreciate assistance from the UI research community to spread the word to anyone who might be eligible and interested to serve as a Community Member and/or Non-Scientist Member.
Additional information is available on the Human Subjects Office web site. To apply or recommend a possible IRB member, contact Kelly O’Berry, IRB Education & Outreach Manager, by Phone: 319-335-8477 or Email: firstname.lastname@example.org
By Fozia Ghafoor, MBBS
ClinicalTrials.gov, a web-based registry and results database for federally and industry-supported clinical trials conducted in the US and around the world, was created as a result of the Food and Drug Administration Modernization Act of 1997 (FDAMA) and managed by the National Institutes of Health (NIH)/National Library of Medicine (NLM). ClinicalTrials.gov results database was launched in September 2008 to implement Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). The submission of adverse event information was optional when the results database was first released but was required beginning in September 2009.
For all Applicable Clinical Trials (ACT), the standard submission deadline for results information is no later than one year after the study's Primary Completion Date, as described in 42 CFR 11.44(a) of the final rule. The Primary Completion Date is the date that the last study participant was examined or received an intervention for the purpose of the final collection of data. Recently, the Food and Drug Administration (FDA) started sending warning letters to the responsible parties of clinical trials for not submitting the results within this one-year time frame. Two letters were sent for industry-funded studies and one letter was sent directly to the Principal Investigator (PI) of a research study. This article will provide an overview of how late results submission is considered serious non-compliance in terms of FDA regulations and what consequences are associated with this non-compliance.
Federal law requires that responsible parties register ACTs on ClinicalTrials.gov within 21 days after the first subject is enrolled and submit results information for these trials no later than one year after the study’s primary completion date--unless a deadline extension is submitted. If a responsible party fails to fulfill these timeline requirements related to clinical trial registration and results reporting, the FDA may issue a Pre-Notice of Noncompliance. This Pre-Notice allows 30 calendar days for responsible parties to submit results or address outstanding issues in the record before issuing a Final Notice. The Final Notice allows an additional 30 calendar days to address the situation before the agency imposes any penalties. Failure to submit the required results information for an ACT is prohibited under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 331(jj)(2) and the FDA could pursue civil monetary penalties under 21 U.S.C. 333(f)(3) against the ACT's responsible party. For an ACT that is funded by the NIH or subject to the FDA regulations, failure to submit the required results information by the grant recipient (Responsible Party or the PI) could result in:
- the funding agency not releasing any remaining money for the current grant or
- withholding funding for a future grant in accordance with section 402(j)(5)(A) of the PHS Act (Public Health Service Act).
The FDA issued the first-ever Notice of Noncompliance Notice of Noncompliance 4-27-2021 (fda.gov) in April 2021 to a pharmaceutical company, Acceleron Pharma, Inc., that failed to submit results for a clinical trial within the specified one-year time frame. The Notice related to a study which was completed in June 2017 and results were due in June 2018. Before this warning letter, the company had received a Pre-Notice of Noncompliance in July 2020. The FDA notified the company that they had 30 days to address the outstanding issues in the record for results submission or they would face a fine of up to $10,000 per day. The FDA issued a second Notice of Noncompliance Notice of Noncompliance July-2021(fda.gov) in July 2021 to a Georgia pharmaceutical company for not submitting clinical trial results for a study after they received a Pre-Notice of Noncompliance in October 2020. The third Notice of Noncompliance Notice of Noncompliance August-2021(fda.gov) was sent to an individual clinical trial investigator in August 2021 after the PI failed to publish trial data even after receiving a Pre-Notice of Noncompliance in July 2020.
The warning letters are a part of a broader attempt to hold researchers and industry-related sponsors accountable for submitting results after the completion of clinical trials. The submission and posting of clinical trial information on ClinicalTrials.gov is not only a way to provide information to participants, but also fulfills an ethical obligation to the research community. It also enhances public trust by creating a transparent public record of clinical trials in a standardized format.
If you are a UI investigator of an ACT, and you receive an FDA preliminary notice or a warning letter for non-compliance, contact the PRS Administrator as soon as possible. Should you need assistance with your own clinicaltrials.gov registration or reporting, please contact email@example.com or call the PRS Administrator in the Human Subjects Office at (319)467-3250. Information regarding the University of Iowa ClinicalTrials.gov policies can be found on the Human Subjects Office website under the “ClinicalTrials.gov sub-section.”
- Enhanced Checks for Compliance with Clinical Trial Registration and Reporting in RPRR, NIH Office of Extramural Research
- Retraining the Brain to Treat Chronic Pain, NIH Research Matters
- The Brain Has a Special Kind of Memory for Past Infections, Scientific American
- Fiber: The Hero American Nutrition Deserves, Bill of Health, Petrie Flom Center, Harvard Law