Updates from the Director
Biomedical researchers using Gadolinium for research purposes should review the following safety risk concerns here. The IRB will expect these concerns are addressed as part of the IRB application.
Central and External IRB Models
Written by Martha Hedberg, MPA
The University of Iowa Human Subjects Office is developing reliance relationships with other Institutional Review Boards (IRB). There are various IRB models for this kind of collaboration. Some models are driven by research sponsor requirements, whether public or private funds are the source of support. Some models are driven by a desire to collaborate with colleagues at multiple institutions. In some instances, the University of Iowa IRB will be the “IRB of Record,” meaning that the UI IRB agrees to oversee and monitor the research conducted at multiple sites. Typically, the lead Principal Investigator would be from the University of Iowa. In other situations, the UI IRB may agree to rely on another, external IRB.
In some cases, multiple institutions may come together and develop an overarching Reliance Agreement and accompanying Standard Operating Procedures. Under these types of agreements, multiple research protocols may be proposed. These kinds of agreements may be the result of a proposal funded at a specific academic institution, such as StrokeNet at The University of Cincinnati, which is funded by the National Institutes of Health (NIH). Another example is the Great Plains Collaborative funded by the Patient-Centered Outcomes Research Institute (PCORI) which allows for the possibility of one of eleven institutions to serve as the IRB of Record. Other arrangements may be entered into whereby an agency central IRB will serve as the IRB of record, such as the NCI CIRB.
Researchers also have the opportunity to utilize an external, commercial IRB such as WIRB or Quorum, in a central IRB model.
Other scenarios include opportunities to create smaller research consortiums with a more localized purpose. These types of proposals are weighed by the Human Subjects Office and the UI IRB on a case-by-case basis in accordance with the External and Central processes outlined on the Human Subjects Office website found here.
Whatever model investigators are exploring, staff of the Human Subjects Office are here to help. HawkIRB is now equipped to receive electronic submissions of external and central IRB model proposals. Contact the Human Subjects Office at UIRB-External@uiowa.edu or call 319-335-9915 to speak with the External IRB Coordinator.
Developing Your Data Management Plan
Written by Patricia Katopol, PhD
Many funders now require researchers to explain how they will manage the data produced by their study – these data management plans help studies of all sizes track their data and determine what can be shared and with whom. For example, you may want to look at the DMPTool to see data management plan requirements of funders across a variety of disciplines.
The Researcher Handbook, Section 6g. Data Management: Research Records provides information on relevant University of Iowa information data management policies. When formulating your plan, Purdue University suggests that you think of your data as a story – who is the audience, what do you want to tell about the data, and how do you want to tell the story of your data? You also need to consider whether the dataset has a lifespan? Do you expect it to grow, and at what rate? Does the data include sensitive information? Have any publications come from the data? How will people access your data? For example, to make your data easier to find and cite, you may want to use the services of a company such as DataCite which creates methods to “locate, identify and cite data and other research objects.” And last, but not least - if you want to license the data, who owns it?
There are many options to pursue Research Data Services support on the University of Iowa campus to help provide assistance in developing a data management plan. To name a few:
- The University of Iowa Libraries subject guide on data management focuses on the roles and responsibilities of research team members regarding the plan; description of data and metadata; storage, backup and security; privacy, confidentiality, and intellectual property rights; data access and sharing. For assistance, contact a librarian at Hardin Libreary here.
- The Clinical Trial Statistical and Data Management Center (CTSDMC) provides assistance in study design and data management. Contact information available here.
- The Institute for Clinical Translational Science (ICTS) offers data management tools such as RedCap to better manage the data collection process. Contact information available here.
- The Iowa Social Science Research Center (ISSRC) offers data access and management services to UI Social Science Researchers. Contact information available here.
Finally, regardless of how you construct your data management plan, remember that if your research involves human subjects, respecting subjects’ privacy and confidentiality is still essential. Make sure that the plans you have for disseminating findings or study data are referenced in your IRB application and consent forms so that subjects know how the information you receive from them may be used in the future. For more information, researchers are directed to Part 15: Section X Privacy & Confidentiality of the UI Investigator’s Guide.
HawkIRB Hints: Breaking Down the Details, VIII.1-2 Risks
Written by Sarah Heady, CIP
Principal Investigators and research team members tend to view research protocols as a whole, the big picture, so to speak. In accordance with the Office of Human Research Protections regulations under 45 CFR 46 and the Food and Drug Administration regulations under 21 CFR 50, the HawkIRB application asks that descriptions of the research process be extremely focused on elements, the detail oriented view of research. In ethical research (and life), both big picture thinking and detail oriented thinking are essential, two halves of a
Question VIII.1 asks that all known potential risks be listed—that’s it. (No foreseeable risks is a much more accurate response than ‘no risks!’ No one can say with complete certainty that a study is entirely without risk.) And risks aren’t limited to physical risks, although physical harm is often the first consideration—any emotional, psychological, financial, even legal or social risks must be considered and described in this section. Don’t forget to describe risks to confidentiality. This is where the response to VIII.1 should halt—just the list of risks. It seems so tempting to jump in and explain how the risks of participation will be alleviated, but be patient!
Question VIII.2 asks for a description of how risks to subjects will be minimized—what can be done to decrease the effects for research participants? This can be something as simple as offering breaks from computer tasks, to rest tired eyes, or skipping survey questions if the participant doesn’t want to respond. Risks are not always dire, as the Help Message in HawkIRB VIII.2 reminds us, “Depending on the type of study, some risks may be better described as things that could make the subject “uncomfortable” – such as fatigue or embarrassment.” Risks described in all of Section VIII should match risks included in the informed consent document and the study protocol.
If the research project involves more than minimal risk to the subjects, there may be a Data Safety Monitoring board required to review the research periodically. The remaining questions in Section VIII address the data monitoring board and process. Make sure this is described in the rest of the risk section, and remember to include safety reports with your Continuing Review submissions.
In short:
- Respond to each question in HawkIRB (use the Help feature if you get stuck),
- Avoid getting ahead of yourself,
- Match consents and protocols to the application, and
- Include safety monitoring reports at the point of Continuing Review, sooner if there is a safety concern.
