ClinicalTrials.gov Registration Tool
A new tool is available for University of Iowa investigators planning to register or report results on ClinicalTrials.gov. The tool, ‘ClinicalTrials.gov Checklist’ helps investigators determine when a specific regulation may apply to their study, what materials are needed to register and report results, and provides links to a number of useful planning materials. The checklist is available on the Human Subjects Office ClinicalTrials.gov webpage here.
Hardin Library Exhibit about Human Subjects Research
You are invited to view the new exhibit, “Humans in Medical Experiments: Issues of Social Justice” that will be posted through June on the third floor of the Hardin Library for the Health Sciences. One section of the exhibit highlights examples of human experimentation that were conducted between 1796 and 2013, including:
- Early experiments on digestion and x-rays
- WWI experiments by the Nazis and Japanese
- Experiments for the Manhattan Project, Atomic Energy Commission and Holmesburg Prison
The other section of the exhibit highlights significant milestones and landmark events in the past, present and future of the protection of human research subjects. Panels cover:
- Nuremberg Code
- Declaration of Helsinki
- Belmont Report
- Federal Regulations for the Protection of Human Subjects
- UI Human Research Protection Program (HRPP)
- IRB review process
- AAHRPP accreditation
- 2018 revisions to the Common Rule.
New International Listing of Social/Behavioral Research Standards
When researchers go to another country to conduct human subjects research, they must follow the regulations for research in that country in addition to the University of Iowa IRB policies for research by UI faculty, staff and students. To assist researchers in finding relevant regulations, the US Department of Health and Human Services’ Office of Human Research Protections (OHRP) annually issues an International Compilation of Human Research Standards. The listing briefly outlines regulations, committees, and laws researchers will need to be aware of before they go abroad to conduct research.
Most countries only have regulations for biomedical research, so it can be challenging for social/behavioral researchers to identify the regulations that apply to their research. On February 6, 2018, OHRP posted a separate and detailed listing of research standards for social/behavioral research in 27 countries around the world as well as in The United Nations Educational, Scientific and Cultural Organization (UNESCO). The listing (found here) provides detailed information about each country’s ethical principles, exempt categories, and frequently asked questions. Researchers who plan to conduct social/behavioral research internationally can refer to this resource to learn about the ethical standards and principles in that country.
Using UI Mass Email for Study Recruitment: The Top 5 Things Researchers Should Know
By Wendy Daubert and Jorie Schmit
In recent years, it has become more common for researchers to recruit for research studies using UI mass email. This can be an effective tool to advertise widely in a short amount of time. Information Technology Services (ITS) is responsible for processing and sending the mass emails. The Human Subjects Office (HSO) is responsible for verifying that both the recruitment strategy and the content of the email message are approved by the IRB.
Here are the top 5 things you should know to use UI mass email as a recruitment method:
- Select “Email” as a recruitment method in Section VII.D.1 of the HawkIRB application and describe the use of UI mass email in Section VII.D.29/VII.D.30. Attach the text of the message in the attachment category for “E-mail correspondence used to recruit subjects.” The HSO will only approve a mass email request form if this information is in your application. To add mass email as a recruitment method for an IRB-approved study, submit a HawkIRB modification to revise these two sections and attach the text of the message in the proper attachment category.
- Include the IRB-approved text of the email message in the Mass Email request form. The HSO will only approve a mass email request if the message content and proposed subject line are identical to the email message attached to the HawkIRB application. To ensure the use of IRB-approved text, go to the Project Summary page, click on the Attachments tab and copy and paste the text from the document into your request.
- Complete and submit the ITS Mass E-mail Request form. Send copies of the request form and the message confirming the submission to the HSO via one of these methods:
- Campus mail (Campus mail: 600 Newton Rd. Iowa City, IA 52242 (105 HLHS)
- Email scanned documents (email@example.com)
- Fax (319-335-7310)
- HSO staff will verify the request within two business days and forward the approval to ITS.
- If you have any questions about the use of mass email for research study recruitment, contact the Human Subjects Office at 319-335-6564 or firstname.lastname@example.org. If you have questions about the mass email policy and process that are not addressed on the ITS or HSO website, contact the ITS E-mail Team (email@example.com).
Expressing Appreciation and Reporting Concerns
By Kelly O’Berry
Feedback from the research community lets us know to continue services or practices that are appreciated and make changes to address complaints or concerns. Do you know how to express your appreciation for a staff member or report a concern about one of the Compliance Units in the UI Human Research Protection Program (HRPP), including:
- The Human Subjects Office (HSO)
- Conflict of Interest in Research Office (COIR)
- The Division of Sponsored Programs (DSP)
- Environmental Health and Safety (EHS)
Of course, you can call us on the telephone, send us an email or talk to us in person. But there are ways to thank a staff member or report a concern online.
Thank a Staff Member
You can share positive feedback when something goes well or when a staff person is particularly helpful. The Office of the Vice President for Research and Economic Development (OVPRED) offers a way to “Thank a Staff Member.” The web pages of each unit that reports to the OVPRED provides a link with a ‘thumbs up' icon that allows you to nominate a staff member in these units for a job well done.
According to Wendy Loney, Senior Human Resources Manager in the OVPRED who coordinates this staff recognition program, the office receives 2-3 nominations per week across all of the research administration and OVPRED reporting units. Nominating a staff member calls the attention of senior leadership to staff in the organization who are doing an exceptional job or providing noteworthy services to the research community.
The online nomination form includes the following fields
- Name (but you may choose to remain anonymous)
- Name of the person you want to thank
- A brief description of why you want to thank them.
The nominated staff member receives a card signed by the Vice President for Research and Economic Development that includes the text you provide in the online nomination. The supervisor of the staff member is also notified about the recognition.
Report a Concern
Customer service is very important to all of the OVPRED Compliance Units, including the Human Subjects Office. We want to hear if something is not working well in our systems or processes. We routinely solicit feedback from researchers who attend HawkIRB trainings or IRB presentations, IRB Office Hours or read the IRB Connection newsletter. We also welcome concerns about the conduct of a research project, the actions of a Principal Investigator or research team member or any other events related to human subjects research.
You can report concerns from the HSO website. In the “Contact Us” section of the yellow menu bar, there is a sub-menu for reporting a concern. It is always an option to report a concern by phone (319-335-6564), email (firstname.lastname@example.org) or by campus mail (mark it “Confidential” and address it to the IRB Compliance Program, 105 HLHS).
There are two additional ways to report a concern:
- Click here to access an online reporting page. These concerns are reviewed by the IRB Compliance Program.
- Contact Jennifer Lassner, Senior Assistant Vice President for Research by phone (319-335-3710) or email (Jenniferemail@example.com).
In the online reporting system for complaints and concerns, it is preferable (but not required) that you identify yourself so we can contact you to gather additional information, if necessary. Providing your contact information also allows our office to notify you about the resolution of the issue. Your confidentiality will be protected to the extent that it is legally possible to do so and consistent with the steps required to resolve the concern. You always have the option to report a concern anonymously.
The Human Subjects Office strives to establish and maintain constructive working relationships with the research community and we are open to making improvements in our processes and policies wherever possible. When members of the research community raise concerns, it encourages us to explore ways to improve our procedures, forms and services. In some cases, dialog about concerns can further understanding on both sides and can also lead to a resolution.
We welcome your concerns, constructive comments, suggestions, questions and your words of thanks and praise when you appreciate the work of the extremely knowledgeable and dedicated staff in the HSO and other OVPRED Compliance Units.
Genetics and Research: New Frontiers, New Challenges
by Brent Collinsworth
The contents of the human genome have intrigued researchers for almost 150 years now, ever since Friedrich Miescher discovered DNA in the nucleus. In 2015, President Obama attempted to push applied genetics research ahead further when he announced the Precision Medicine Initiative. Research utilizing genetic information to improve people’s lives has become very popular. It has changed the lives of many already, and may revolutionize medicine in the future. However, it has also opened up new ethical issues for human subjects research.
The first unique ethical issue that researchers may face when working with genetic information is the fact that so-called “de-identified genetic data” might not be de-identified at all. Every person has their own unique genome, tied to every cell in their body. Researchers using de-identified genetic data of people with a specific disease may be able to identify them through genotyping, resulting in a loss of confidentiality about their medical condition. This would be very difficult with today’s technology, but technology might advance to the point where this is a more realistic risk.
The Office for Human Research Protections (OHRP), a division of the U.S. Department of Health and Human Services (HHS) is responsible for issuing regulations for human subjects research. This office is taking steps to address this issue. The revised Code of Federal Regulations for the Protection of Human Subjects (45 CFR 46.102(e)(7)), scheduled to take effect in July 2018, includes a requirement for federal agencies to meet every 4 years and re-evaluate what techniques or technologies may produce identifiable information. OHRP instituted this process to keep the regulations up-to-date with current technology, especially as it pertains to genetic data(45 CFR 46.102(b)(9)). According to the Preamble to the revised Code, the first technology they plan to evaluate is Whole Genome Sequencing.
Researchers may also find clinical results from participant genetic information that might directly affect those participants’ future health, income, and work life. For instance, researchers might find a mutation in the BRCA gene of a participant, a mutation directly linked to a much higher risk of breast and cervical cancer. Disclosing this to subjects can inform appropriate treatment decisions, but it may cause participants undue emotional distress, especially if nothing can be done about it. Additionally, the participant may also disclose this risk to their personal physician and have it become a part of their permanent medical record. While the Genetic Information Nondiscrimination Act of 2008 protects people from discrimination because of their genetic data, this Act only protects discrimination for the purposes of employment and health insurance. Groups like life insurance and disability insurance companies may still legally discriminate based on genetic information.
Researchers should consider whether it is appropriate to disclose this information to participants. If the research testing is done in a facility that is not certified by the Clinical Laboratory Improvement Amendments (CLIA) Program, the researcher will have certain limitations on the data regarding disclosure. If the research team plans to disclose this information to participants, they must also describe their plans in HawkIRB about how they will communicate this information to subjects and in what settings. It may also be appropriate for researchers to give subjects a choice about whether to receive the results.
There are historic examples of researchers inappropriately using genetic information and data without consent from the participants. In 1981, researchers at Arizona State University (ASU) collected genetic information of members of the Havasupai Tribe, located near the Grand Canyon. Researchers had IRB approval to use this information to study tribe members’ risk of diabetes, and they kept the genetic data for future use with ASU and tribal IRB approval. Other ASU researchers used these samples for research on schizophrenia, tribal migration origins, and potential tribal inbreeding. While the ASU IRB approved of the secondary research, the tribe did not. Topics related to mental health and inbreeding are taboo in Havasupai society. In their lawsuit, the tribe asserted that they would not have consented to such research had they been properly informed.
This case is unique in that there are some additional requirements for approval of research involving Native American subjects. Non-Native American participants in other studies may also not want their genetic information used in future research. To avoid inappropriate use of study data, researchers must disclose to participants whether they plan to store genetic data for future use. It may also be appropriate for researchers to give participants a choice about whether to allow storage of their data for future research. If the participant does not agree to this storage, the research team must destroy the sample(s) upon completion of the project. In addition, if researchers plan to use data for a specific research topic or if the topic of future research is unrestricted, they must disclose this to participants in the Informed Consent Document.
Herky Hints: How to Get Your HawkIRB Applications Approved Quicker
By Joanie Neyens
One of the most common questions that Human Subjects Office reviewers get is "how much should I write in my HawkIRB application?" HSO reviewers typically want applications to be both concise and detailed.
Wait! Don’t go! Hear me out! The one thing that most consistently delays the IRB review process is not providing enough detail about the study procedures in response to questions in the HawkIRB application. The IRB needs certain information to verify that the study meets all regulatory requirements for IRB approval. This includes evaluating the risks subjects may encounter during their participation.
During the review process, Application Reviewers in the Human Subjects Office (HSO) work with researchers to clarify and remove discrepancies between the responses to questions in HawkIRB and the attached documents. HawkIRB applications with discrepancies or a lack of detail in the description of study procedures will be returned to the researcher through Workflow for corrections and clarification. The plain, honest truth is that the more complete the initial application is, the less time the application will spend in Workflow prior to IRB approval.
What level of completeness are we looking for? Some HawkIRB applications read like a dissertation. (Too much.) Others take less than 10 minutes to read from beginning to end, including the attachments. (Not enough.) There is a happy medium in there somewhere. Here are a few hints to help you find that middle ground:
- Responses should thoroughly address the question – The best guidance we can give for filling out a HawkIRB application is to read the question carefully and provide a response that fully addresses the question. Be concise and thorough. If there are bulleted items in the question, be sure you provide information for each bullet as part of your response. Be careful not to provide more information than requested because the eResearch application is designed to act as a “smart form” which means based on your responses, the HawkIRB form will request additional information in response to other questions. Providing more information than is requested may lead to redundant responses throughout the eResearch submission. There are no duplicate questions in HawkIRB forms. Also, there are very few questions for which Not Applicable (N/A) is an appropriate response.
- Detailed description of study procedures - If a section has anything to do with the actual human subject (e.g. who they are, how you will be interacting with them, what they will do, etc.), it is going to need plenty of details. You should provide a detailed description of your subject population (Section VI.1-VI.13), how you intend to recruit and consent subjects (Section VII.D.29), the study procedures (Section VII.E.6) and the risks of participation in the study (Section VIII). It is a red flag to staff reviewers when there are not enough details in these sections.
A rule of thumb in getting the level of details right in these sections is to pretend that the IRB will need to run the study visits for you based entirely on what you describe in the HawkIRB application. We will need to know the target population and who is eligible, how we should recruit them and conduct the consent process and what study procedures we will ask them to complete. When these sections of the HawkIRB application are thoroughly completed, the IRB can easily make determinations regarding the protection of the human subjects and compliance with federal regulations.
- Be Consistent – It is guaranteed that inconsistencies in the application, between responses or in the attached documents, will need to be corrected before the application can be forwarded to an IRB Chair or scheduled to an IRB meeting. The HSO reviewer will have to send the application back in Workflow for you to update responses and documents to be consistent. We strongly recommend that researchers check for insufficient details and inconsistencies before submitting the HawkIRB application.
- HawkIRB Help Content – There are several ways you can prepare for completing the IRB application and learn why the IRB asks for specific information. Each section of the carousel index for a HawkIRB application includes a link to “What you need to get started.” These messages can help the person filling out the HawkIRB application to know what information they need to be able to complete each section. Each section of the carousel index also includes a link to “Why we need this information.” These messages provide references to federal regulations, institutional policies and other explanations for the questions in the HawkIRB application. Click here to learn more about the carousel index.
There are also Help Messages associated with most of the questions in the HawkIRB application. Look for the symbol next to the section number. These Help Messages are intended to help researchers know what content to include in their thorough, detailed responses to each question. While there is no data to back up this next statement, these are likely one of the most underutilized tools provided by the HSO for researchers. I strongly encourage you to use these Help Messages if you ever wonder ‘What does the IRB need in the response to this question?’ HSO staff wrote these Help Messages to help you prepare HawkIRB forms that go through the review process as quickly as possible.
- Make detailed plans and describe them in HawkIRB - This is not really a hint. I want to dispel the myth, “Just put something down and the IRB will tell you what they want.” Please. Don’t do that. We are not the experts regarding your research—you are. We may sometimes ask for specific wording in responses or attachments but only for the purposes of providing thorough, detailed descriptions of the study procedures. The PI is the best person to give us details about the proposed research. If we have to guess or make assumptions about your research, it is a guarantee that we will have to return the application through Workflow before your project can be approved.
- Use the Printer-Friendly View – The printer-friendly view opens in a new browser window and can be printed or saved as an html file. This view lets you read the full application rather than clicking from screen to screen in the form itself. This view does not show all of the choices for questions that include a list of options (such as Section VII.D.1, recruitment methods); it only shows the options you selected. You will also have to open the attachments separately on the Attachment page. This is an excellent resource to identify and correct discrepancies between questions before you submit the HawkIRB application.
Nothing warms an Application Reviewer’s heart more than reading a new application once and thinking, ‘Holy cow! I don’t have any questions! This is ready for [approval/the Chair/ full board review]!’ And nothing will blast an application through the review process quicker than a complete, thorough, detailed and concise application!