Herky Hint for HawkIRB: Reducing Workflow Regarding Data Collection Materials
Sponsor Monitor Access to Epic
AAHRPP Accreditation Review – Domain III. Researchers
50th Anniversary of the National Research Act
2024-25 Grant Proposals Seminar and Workshop
LGBTQIA+ Inclusive Language for Research Participants
In the News
Updates for the UI Research Community
IRB Educational Resources for July
Herky Hint for HawkIRB: Reducing Workflow Regarding Data Collection Materials
By Rachel Kinker, MPA
All surveys, questionnaires, or written materials for data collection, need be listed, described, and uploaded in the HawkIRB new project application. Missing one of the steps is a common error that could lead to increased workflow and longer review times.
HawkIRB question VII.E.4 asks that the investigator “List all questionnaires, surveys, written assessments and ATTACH each one to the application.” To expedite the review process and reduce the number of workflow requests, please review the application prior to submission and make sure you are following these best practices:
Best Practices
If it’s listed, upload it. If it’s uploaded, make sure it’s listed.
If a data collection method is listed in question VII.E.4, it should also be attached in the application. If a data collection document is attached to the application, it should also be listed in question VII.E.4.
Make sure that items listed in section VII.E.4 are also described in section VII.E.6
Section VII.E.6. asks for “a detailed description in sequential order of the study procedures following the consent process.”
If an online survey will be utilized, make sure to provide both the URL and attach a document containing the survey questions to the application.
If you are using a Qualtrics (or similar platform) survey, the URL and a pdf of the survey need to be included in the application.
Use file names that are descriptive of what they contain and refer to them in the description.
When listing the documents in VII.E.4. and describing them in VII.E.6., please refer to the documents by their file name.
Where to describe in HawkIRB
In HawkIRB, section VII. E 3-6 refer to the data collection materials. Because HawkIRB is a smart form, if ‘no’ is selected for question VII.E.3, question VII.E.4 will not appear, and the application will not prompt the attachment and listing of data collection materials.
List all questionnaires, surveys, and written assessments in Section VII.E.4. After listing these items, they should also be attached in the attachments section of the application. Best practice is to refer to the file name of the attached document in answering question VII.E.4.
Provide a detailed description of study procedures in section VII.E.6, taking care to address each bulleted item in the question, and that the description agrees with the consent document. If an item was listed in section VII.E.4, it should also be explained in section VII.E.6
Please reach out to irb@uiowa.edu if you have any questions regarding this process.
Sponsor Monitor Access to Epic
By Kelly O’Berry, BS, CIP
During the COVID-19 pandemic, University of Iowa Health Care began using CareLink to allow sponsor monitors to access Epic remotely and during on-site monitoring visits. There are separate contact persons, but the procedures are the same for cancer research and non-cancer related research.
Step 1
Contact one of the following people to initiate the process:
For the Holden Comprehensive Cancer Center (HCCC), contact Erik Sieg in the Cancer Center Research Services at erik-sieg@uiowa.edu or 319-335-1068.
For all other UI Health Care research, contact Kristy Mahan in the Institute for Clinical and Translational Science (ICTS) at kristy-mahan@uiowa.edu or 319-384-5232.
Step 2
Complete the Remote Monitoring Priority form and return it to the HCCC or ICTS contact. They will provide additional instructions and a Confidentiality Agreement.
Step 3
Send the Confidentiality Agreement to the sponsor monitor. They will complete the form, sign and date, and route it back to the study coordinator. Submit the completed agreement to the HCCC or ICTS contact.
Step 4
The HCCC or ICTS contact person will request a CareLink monitor ID from Health Care Information Systems (HCIS). This usually takes at least 5-7 business days from the date of the request.
If possible, submit the request at least 7 days before the site visit.
If necessary, the HCCC or ICTS contact person can request a temporary monitor ID. This can be generated within a day, but then it is only valid for the date of the visit.
Step 5
The HCCC or ICTS contact will send a welcome letter and tip sheet to the study coordinator to pass along to the sponsor monitor.
Questions
Reach out directly to the HCCC or ICTS contacts listed above if you have questions about remote sponsor monitoring.
By Emily Shultz, CIP
As the University of Iowa Human Research Protection Program (HRPP) prepares for its reaccreditation site visit with the Association for the Accreditation of Human Research Protection Programs (AAHRPP), this article is part of a series outlining the certification process and requirements. In previous articles, we introduced the three domains of the AAHRP accreditation review:
I. The organization
II. The institutional review board or ethics committee
III. Researchers and research staff members
March and April articles presented Information about the Organization Domain. In May, we examined the Institutional Review Board (IRB) or Ethics Committee (EC) Domain. This month we are focusing on Domain III, which is specific to researchers.
Researchers and research team members have the most direct interaction with participants and, therefore, have the most impact on how human research is implemented. Because of this, they have a direct opportunity to provide the best protections for research participants.
The Standards and Elements of this Domain focus on the AAHRPP requirements that evaluate and support the competence of researchers and research staff. The UI IRB Standard Operating Procedures and Researcher Guide and within the HawkIRB forms outline the expectations for meeting these requirements for researchers.
The two Standards under Domain III are:
STANDARD III-1: In addition to following applicable laws and regulations, researchers and research staff adhere to ethical principles and standards appropriate for their discipline. In designing and conducting research studies, researchers and research staff have the protection of the rights and welfare of research participants as a primary concern.
STANDARD III-2: Researchers meet requirements for conducting research with participants and comply with all applicable laws, regulations, codes, and guidance; the organization’s policies and procedures for protecting research participants; and the IRB’s or EC’s determinations.
The seven Elements under Standard III-1 consist of the following:
ELEMENT III.1.A.: Researchers and research staff know which of the activities they conduct are overseen by the Human Research Protection Program, and they seek guidance when appropriate.
ELEMENT III.1.B.: Researchers and research staff identify and disclose financial interests according to organizational policies and regulatory requirements and, with the organization, manage, minimize, or eliminate financial conflicts of interest.
ELEMENT III.1.C.: Researchers employ sound study design in accordance with the standards of the discipline. Researchers design studies in a manner that minimizes risks to participants.
ELEMENT III.1.D.: Researchers determine that the resources necessary to protect participants are present before conducting each research study.
ELEMENT III.1.E.: Researchers and research staff recruit participants in a fair and equitable manner.
ELEMENT III.1.F.: Researchers employ consent processes and methods of documentation appropriate to the type of research and the study population, emphasizing the importance of comprehension and voluntary participation to foster informed decision-making by participants.
ELEMENT III.1.G.: Researchers and research staff have a process to address participants’ concerns, complaints, or requests for information.
Researchers meet most of these requirements through their new project application in HawkIRB. For example, the descriptions of the recruitment and consent processes in the application provide confirmation of the researcher’s focus on the protection of the rights and welfare of research participants.
The four Elements under Standard III-2 consist of
ELEMENT III.2.A.: Researchers and research staff are qualified by training and experience for their research roles, including knowledge of applicable laws, regulations, codes, and guidance; relevant professional standards; and the organization’s policies and procedures regarding the protection of research participants.
ELEMENT III.2.B.: Researchers maintain appropriate oversight of each research study, as well as research staff and trainees, and appropriately delegate research responsibilities and functions.
ELEMENT III.2.C.: Researchers and research staff follow the requirements of the research protocol or plan and adhere to the policies and procedures of the organization and to the requirements or determinations of the IRB or EC.
ELEMENT III.2.D.: Researchers and research staff follow reporting requirements during a research study in accordance with applicable laws, regulations, codes, and guidance; the organization’s policies and procedures; and the IRB’s or EC’s requirements.
Researchers demonstrate their fulfillment of the requirements under Standard III-2 through the assurance document that is uploaded to HawkIRB, through the completion of CITI training and through the information provided in the HawkIRB application.
Next month’s article will focus on the AAHRPP accreditation site visit and what members of the University of Iowa research community can expect if they are selected for an interview.
The information for this article was adapted from the AAHRPP website.
50th Anniversary of the National Research Act
On Friday, July 12th, the Office of Human Research Protections (OHRP) will be hosting a virtual event to commemorate the 50th anniversary of the National Research Act.
The National Research Act was passed in 1974 in response to public outcry over a research project funded by the U.S. Public Health Service (PHS) that allowed hundreds of Black men in rural Alabama to go untreated for syphilis to study the impact of the disease on the human body. The Act created federal rules to protect human participants in research and established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to identify ethical standards to guide human research, which led to the publication of the Belmont Report.
This OHRP commemorative event will reflect on what happened following the passage of the National Research Act, showcase the diverse role research participants play in contemporary research, and consider what future scientific advances may mean for research participants and public trust in research.
For a link to the livestream, visit https://www.hhs.gov/ohrp/education-and-outreach/national-research-act-50th-anniversary/index.html Registration is not required.
(Agenda times are provided in CDT)
What Followed the National Research Act (11:15-11:50 pm)
1. Reflections on the Work of the National Commission
Speaker: Patricia A. King, JD
Professor Emerita, Georgetown Law
2. The Evolution of the Regulations for Human Research Protections and the Establishment of OHRP
Speaker: Ivor A. Pritchard, PhD
Senior Advisor to the Director of the HHS Office for Human Research Protections
3. A Brief History of Public Responsibility in Medicine and Research (PRIM&R) – A Response from the Research Community
Speaker: Ivy Tillman, EdD
Executive Director of PRIM&R
From Research Subject to Research Partner (11:50-12:45 pm)
Fifty years after the passage of the National Research Act, people are no longer seen as merely “subjects” in research but are now regarded as integral partners. This session will showcase the different ways the public may be engaged in the research process to advance science and further their interests as individuals and members of a community.
1. Why I Participated in Research - A Participant’s Voice
Speaker: Rey Calabrese
Former Research Participant and Current Research and Community Coordinator at Fenway Health
2. Participants as Investigators: Participatory Action Research and Community-led Studies
Speaker: Basaime Spate
Community Research Coordinator, Center for Justice Innovation
3. Respecting Cultural Values: Doing Research with Indigenous Populations
Speaker: Karina L. Walters PhD, MSW
Director of the NIH’s Tribal Health Research Office (THRO)
4. Listening to the People: Community Ethics Review Boards
Speaker: Ella Greene-Moton
Member of a Community Ethics Board in Flint, MI, and President of the American Public Health Association
5. Engaging the Community in Research: The Insight of an Investigator
Speaker: Sergio Aguilar-Gaxiola, MD, PhD
Founding Director of the Center for Reducing Health Disparities at UC Davis Health and the Director of the Community Engagement Program of the UCD Clinical Translational Science Center (CTSC)
Contemplating the Future 12:45-1:30 pm
Speakers in this panel discussion will explore the potential impact of scientific advances in the coming decades, the challenges they may present to the notion of “human research protection,” the stress they may present on public trust, and what the scientific community can do and prepare for it.
Moderator:
Laura Ruse Brosch, RN, PhD, COL, AN, USA (ret)
Assistant Vice President for Research Initiatives and Compliance, Office of the Vice President for Research, Uniformed Services University of the Health Sciences
Panelists:
Jodi Halpern, MD, PhD
Chancellor's Chair and Professor of Bioethics, UC Berkeley
Misha Angrist, PhD, MFA
Associate Professor of the Practice, Social Science Research Institute. Senior Fellow, Duke Initiative for Science & Society. Visiting Associate Professor of the Practice, Sanford School of Public Policy
Lee McIntyre, PhD
Research Fellow, Center for Philosophy and History of Science, Boston University and Senior Advisor for Public Trust in Science at the Aspen Institute
Aaron F. Mertz, PhD
Director, Science and Society, Aspen Institute
2024-25 Grant Proposals Seminar and Workshop
It’s never too early to start strategizing about how to write a grant proposal that will draw attention and bring in research funding. A long-respected program that helps faculty and other research team members do just that, the Write Winning Grant Proposals seminar (Phase I), will be held on Friday, September 20, 2024. The event will be presented by John D. Robertson, PhD, a managing member of Grant Writers' Seminars & Workshops. The Phase I seminar is a pre-requisite to the Phase II intensive workshop, which is scheduled for January 7-8, 2025. This is sponsored by the Research Development Office in the Office of the Vice President for Research sponsors this program.
Registration for the Phase I seminar is open until Sunday, September 8, 2024.
When and Where: 8:30 AM – 4:30 PM, Friday, September 20, 2024, at the IMU (Virtual option available)
Eligibility: This seminar is open to faculty members, postdoctoral researchers, and administrative staff who have had some exposure to writing grant applications, either through training, mentoring or personal experience.
Registration Fee: $150 (includes seminar, workbook, supplemental materials, and lunch for in-person participants). A limited number of college-specific sponsored registrations complimentary to faculty are available on a first-come, first-served basis. The seminar will not be recorded.
To attend: Register here by Sunday, September 8, 2024.
Phase II Intensive Workshop (pre-requisite: Phase I Seminar)
When and Where: January 7-8, 2025, UCC
Consultations: The workshop includes a ½ day in-person seminar, a follow up in-person consultation, and 4-6 months of ongoing virtual consultations.
Eligibility: This seminar is open to faculty members who attended the Phase I seminar last fall (2023) or are registered to attend this fall (2024). To be considered for participation in the workshop, candidates must be approved by their associate dean for research and submit the required pre-proposal via registration. Workshop registration is capped at 25 participants.
Registration Fee: $4,400/participant (tuition is split equally between the participant's college, department, and the OVPR)
To attend: Faculty should discuss sponsorship with their ADR and DEO, and then complete the registration here by Monday, September 30, 2024.
For questions or more information, email the Research Development Office.
LGBTQIA+ Inclusive Language for Research Participants
The Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard has created an Inclusive Language Checklist to provide recommendations for the use of language that is respectful to and inclusive of LGBTQIA+ populations. The checklist can be used when creating participant-facing documents (e.g., recruitment materials, informed consent forms), drafting study protocol eligibility criteria, and speaking with participants face-to-face.
In the News, June 2024
Updates to the VA Researcher Guide
IRB Educational Resources for July
Monthly Information Session
The Human Subjects Office invites the UI research community to attend monthly information sessions about the IRB Efficiency Initiative on the fourth Wednesday of the month from 12-1 pm, via Zoom. We will discuss the changes and demonstrate HawkIRB enhancements being implemented to streamline the IRB review process. The monthly sessions will cover upcoming enhancements and expected roll out dates. Pre-register to receive the Zoom link.
Wednesday, July 24, 2024
12:00 PM-1:00 PM
Office Hours
Human Subjects Office staff host IRB Office Hours via Zoom to provide assistance with electronic IRB applications (in HawkIRB) and to discuss study proposals prior to submission. All researchers are welcome to attend. No appointment is necessary.
Summer office hours run June 5th through August 28th.
Wednesdays (2:00 PM-4:00 PM) via Zoom
Visit the Human Subjects Office website for complete information about IRB Office Hours and the Zoom link.
Recorded Training
The IRB ICON Course for Researchers HawkIRB training sessions provide an orientation to the electronic IRB application and review system. These sessions are for anyone preparing to submit a HawkIRB application for the first time and for those who would like guidance about the proper completion of HawkIRB forms. Five recorded trainings are available 24/7.
The recorded trainings are available on ICON at IRB ICON Course for Researchers.
Note: HawkIRB training Parts 1 and 2 satisfy the Student PI Training Requirement.