Summer Recap Article
By Brent Collinsworth
It’s been a busy summer for the IRB Connection! Here’s what readers missed when they were away:
The Central and External IRB Model of Oversight: This article covered the review process of central/external IRB reliance requests, setting up reliance agreements between relying IRBs and IRBs of record, and Principal Investigator responsibilities with a central/external IRB system. This is a must-read for anyone working with central/external IRBs.
Changes to the Continuing Review reminder: When IRB compliance staff do monitoring visits, they sometimes find discrepancies between the number of signed Informed Consent documents and the reported enrollment in their Continuing Review forms. But the correction cannot be made in the HawkIRB system until the next Continuing Review form. To assist researchers with remembering to complete this required action at a later date, we added a reminder to the automated Continuing Review notice.
NIH Single IRB Policy: The National Institutes of Health issued its final policy on the use of a single IRB in late June. The policy takes effect May 27th, 2017. The NIH has issued an FAQ to assist with the policy’s changes. The Human Subjects Office will also be partnering with the ICTS to offer a presentation designed to assist researchers with the changes. This presentation will take place on October 6th, 2016, from 12-1 pm.
Notice of Proposed Rulemaking of the Common Rule: There is no update on the NPRM yet, but the final action on it is still scheduled for September 2016. The 18 departments and agencies that have agreed to follow 45 CFR 46 (“The Common Rule”) will need to endorse it for this final action to take place. OHRP has a series of 6 webinars on the proposed changes available here.
HawkIRB Update-ClinicalTrials.gov: Federal law currently requires certain clinical trials to register with ClinicalTrials.gov to report results. Additionally, the International Committee of Medical Journal Editors now requires registration of clinical trials prior to publishing research. To assist with compliance, we revised Section VII.B.1 of the HawkIRB application to collect the National ClinicalTrials.gov registration number (NCT#) for intervention studies and Phase 1 clinical trials.
Research Subject Compensation: Researchers that compensate participants for being in a study need to make sure they are following all institutional policies that apply to handling cash and cash equivalents (such as gift cards, small toys, etc.). A cash handling approval memo or email should be attached to the HawkIRB application if compensation is provided. Also, remember that researchers are required to maintain records of the distribution of gift cards of $75 or less.
Research in Online Environments: Social media networks, forums, wikis, or other public sites can be effective places to gather data. However, they may also come with their own ethical concerns to address. First, it may be important to determine that the online participant is truly the person they say they are. Researchers should weigh the importance of verifying subjects’ identity, based on study factors like eligibility criteria and risk to subject. If the study is high-risk and/or involves sensitive information, then researchers may use password authentication or identity verification software to ensure the participant is who they say they are. Keep in mind that all the material a researcher uses for conducting the study (including online ads and announcements) must be reviewed and approved by the IRB prior to their use. Terms of Service and Privacy Policies should also be attached to the HawkIRB application. Finally, data security is also a concern, especially if PIs plan to store data using cloud storage.
Ethical Principles in Research-Respect for Persons: This is the beginning of a 3-part newsletter series focused on the three main principles of the Belmont Report. The first, Respect for Persons, is primarily concerned with the autonomy of research participants. Participants should have the right to decide whether they want to participate in research without any pressure or undue influence. Subjects should also be given sufficient information about the study, presented in a way that they can understand. Finally, participation in research should always be completely voluntary.
Policy Updates: Course-Related Student Projects: Do you teach a research-related course with an in-class research project component? If so, you might be interested to know that we recently updated the Course-Related Student Projects policy (the policy that allows students to conduct course-related projects without IRB approval under specific conditions). We have also updated the associated checklist to assist instructors with making decisions about whether IRB approval may be required for a course-related project.
What to Review for Your Continuing Review: This article is about the information that needs to be provided in the Continuing Review form in HawkIRB. When it is time to submit a Continuing Review form, it is important for researchers to report total numbers of subjects enrolled to date, as well as any withdrawals or complaints about the study. Next, the researcher should also disclose any reportable events that may have occurred since the last Continuing Review, and indicate whether they reported these events to the IRB. Lastly, researchers should attach to the application some types of outside correspondence (including progress reports to funding agencies, sponsor monitoring, or Data Safety Monitoring Board reports).
A Measure of Our Performance: The research community is invited to review the updated metrics for the UI Institutional Review Board and Human Research Protection Program. This information is posted on the Human Subjects Office (HSO) website, and also includes past data stretching back to 2012. Researchers can use these metrics to find the average length of the IRB approval process, the types of funding sources associated with UI IRB-approved research, and which colleges and departments submit the most IRB applications.
IRB Advisor is a monthly newsletter from AHC media that contains articles on topics like regulatory issues in research, informed consent, and current events in human subjects protections. Each month, we spotlight an article from IRB Advisor. The featured IRB Advisor articles over the summer include:
- Transparency About Participation Incentives Could Benefit IRBs, Researchers, and Patients
- Reanimation Study a Step Toward Brain-death Breakthrough?
- NIH Clinical Center Riddled With Research Problems
There is a link to current and past issues of IRB Advisor on the Education and Training page of the Human Subjects Office web site. This link provides automatic access to the newsletter from all computers with a University of Iowa IP address. If researchers want to access IRB Advisor from a non-UI computer, they may contact the Human Subjects Office to request the username and password. Contact us by e-mail at email@example.com or call us at 319-335-6564.
IRB Member Recruitment: Seeking IRB Community Members
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)? The UI currently has 57 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
There are current openings for community members and non-scientist members on both the biomedical and social/behavioral research boards. This volunteer opportunity may be of interest to someone interested in 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.
Community members and non-scientists serve a very important role in the review of proposed human subjects research. Community members generally are not from academia and do not have a scientific or medical background. The IRB relies on community members and non-scientists to serve as a “voice” for those who may be approached to participate in research. Within that role, during the IRB meetings, they
- 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
IRB members have a front-row seat to learn about the wide variety of research conducted at the university, from Alzheimer’s and diabetes to early childhood development and driver safety. Board members support the University of Iowa Human Research Protection Program, and by extension society, by reviewing proposals for such research. IRB members can attend one to three meetings per month. They are expected to read the eResearch IRB application (HawkIRB) prior to their scheduled meeting(s).
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. IRB members include people with scientific and non-scientific backgrounds. Unaffiliated community members and non-scientists play a crucial role in reviewing human subjects research and 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.
Qualifications to be an “Unaffiliated” Community or Non-scientist IRB Member
- Applicants and their immediate family must not be employed by (or volunteer at) the UI or VA hospital
- Applicants should have a non-scientific background or training (preferred)
- UI or VA Retirees may qualify as community members after two years post retirement.
- Applicants must be able to attend regular review meetings (one to three times a month)
- 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
The UI IRB Seeks Unaffiliated Community Members
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 through the employment of someone in their immediate family. We are currently trying to replace a long-time IRB Community Member and would like help spreading the word to anyone who might be eligible and interested.
Additional information is available on the Human Subjects Office web site . To apply, contact Michele Countryman, Director of the Human Subjects Office, in one of the following ways:
Human Subjects Office/IRB
Phone: 319-335-6564. Fax: 319-335-7310.
Hardin Library, Office 105
600 Newton Road
Iowa City, IA 52242-1098
Including Everyone: Diversity in Online Research
Patricia Katapol, PhD
From recruiting subjects via Facebook to conducting surveys on iPads, investigators are increasingly taking advantage of information technology to conduct research, such as studying online behavior. While information technology may seem ubiquitous, significant portions of the population are constrained in access to it or in its use, so that subjects in online research may not represent the diversity present in the population.
Diversity is often thought of in terms of race, ethnicity, or gender – that is, having various races, cultures, and genders/sexual orientations represented in everything from the workforce to the government. However, diversity in the United States is more than race and gender and it can be challenging to determine its various nuances. This article encourages diversity in online studies by intentional inclusivity in subject selection and study design. It introduces three areas that broaden the concept of diversity – disability, age, and location.
Disability - Just as there are expanded notions of diversity, expanded notions of disability are developing. As of 2012, 56.7 million people in the US are disabled. Of these, twenty-seven percent of them live with a disability that interferes with daily living. They are more likely to have lower incomes, low levels of education, and are older. Even conditions that are not incapacitating, such as eye strain and vestibular disorders, may be disabilities themselves or may accompany more disabling conditions. Apple’s iOS7 smartphone icons gave some people dizziness and motion sickness due to how the icons moved on-screen. One article suggested, “The words ‘dizziness’ and ‘vertigo’ don’t strike fear into people, but those living with severe cases are in ongoing angst awaiting the next unwarranted attack.” Vestibular disorders affect 69 million Americans over 40 and are an example of one of many conditions that expand the concept of disability.
The disabled may face other barriers to participating in online research. A 2011 study by the Pew Research Center found that the disabled were less likely to use the internet (54 percent vs 81 percent) and more likely to have lower internet speeds, which may restrict the extent to which videos or other streaming media should be part of the research design. Graphics, contrast, and the need for compatibility with screen readers may also affect study design. Navigability (e.g. scroll bars, radio buttons, page layout) may make participating difficult for those with limited or no manual dexterity. Research designed with a significant audio component but no text equivalent may exclude those with hearing difficulties.
Age – Designing information technology for older subjects, such as using high-contrast color combinations and avoiding some fonts are generally well-known by investigators working with this population. Other information about the online habits of older subjects may not be as well known. Internet usage decreases with age; those 65 and older are among the 49 percent of persons who do not use the internet. Older people are also less likely to have high speed/broadband, which may be needed for certain study designs. Investigators needing access to seniors in Iowa may want to use the Seniors Together in Aging Research (STAR) registry, maintained by the UI Center on Aging. The registry can run a preliminary search to find seniors with internet access and who are comfortable using information technology.
Location – By 2010, only 62 percent of rural areas, including farms, had broadband access. Difficulties in getting the technology to people in remote areas, and the increased costs of these services once available, can make broadband a financial hardship for those on fixed incomes, such as many elderly and disabled.
Interestingly, smartphone use has brought lower cost internet services to many people who now access the internet via their smartphones rather than a computer. For blacks, broadband at home went from 62 percent in 2013 to 54 percent in 2015. For this group, a smartphone with no broadband at home increased from 10 percent to 19 percent during the same time. For rural residents in general, broadband at home decreased from 60 percent to 55 percent and smartphone use grew from 9 percent to 15 percent during the same period. With these statistics, researchers may want to consider the constraints of smartphone use when designing the study, such as limits on data usage, the possibility of phone service cancelation, subject dexterity, and screen size.
In addition to the challenges presented above, a less-frequently considered situation where diversity may be an issue is the unbanked. As of 2013, a Federal Deposit Insurance Corporation survey stated that 7.7 percent of households were unbanked and an additional 20 percent were underbanked. The unbanked do not have a bank account or rely on alternatives such as payday loan, check cashing businesses, or money orders for their financial transactions. The underbanked may have a bank account, but also use alternative financial services. Compensation may be problematic for this group as a percentage of the compensation check may have to go towards a check-cashing fee, effectively making them second class as compared to subjects with a bank account.
As investigators consider subject selection, they might also want to make sure that those in rural areas, the disabled, and/or the elderly, are represented in all research, not only in research aimed at these particular populations. When reviewing applications, IRBs could support diversity by considering how the study will make efforts to recruit a more diverse population. Everyone has a story to tell. The quality of research will improve when everyone, able or disabled, young or mature, urban or rural, is represented.
Herky Hints Contact People: Who We Gonna Call
By Sarah Heady
Quick review: anyone who works with subjects OR identifiable subject data (and yes, coded data counts as identifiable even if you can’t access the code) must be listed on the research team, and must complete the appropriate CITI training modules.
When adding an individual to the research team, you have to choose their contact status in Section II of the HawkIRB application—it’s the last bit of adding a new team member to the project.
‘Contact person’ refers to people the Human Subjects Office (HSO) staff or IRB Chairs might call or email with questions about the conduct of the study. Contact people are also included on important automated emails from HawkIRB—the Continuing Review reminders, notifications of questions in workflow, or notices of approval. When I send an intitial notice to schedule a monitoring visit (in my other life as a Compliance and Education Specialist) I email the PI and everyone listed as a contact person. Those are the people I think may need to be included in the visit.
You could think of Contact People as the Ghostbusters of your research team—if the HSO has a question or needs more information, your contacts are who we’re gonna call. Keep this in mind when adding research team members to your HawkIRB application, and choose yes or no according to their role on your team. And never fear, this - like everything else in the HawkIRB form - can be changed.
If things change and a research team member no longer needs to be a contact person, you can revise contact status in a HawkIRB modification. Simply remove the individual from the research team and when you re-add them, select ‘No’ for Contact Person.
Keeping the contacts up to date means the HSO will always know who to call.
And as always, you may contact us with questions, or try the main line at 319-335-6564. We’re happy to help.
Ethics On Demand: IRB Presentations to Suit Your Needs
By Brent Collinsworth
The University of Iowa IRB provides many educational resources to the UI research community. As the Fall 2016 semester begins, we want to highlight a resource that may be especially useful to instructors of research ethics courses. The IRB Education and Outreach program is available upon request to give classroom and group presentations about the ethical conduct of research and the UI IRB review process. These presentations may also be useful for any research-oriented course as well as new faculty, graduate, and professional student orientations or seminars. We can tailor the content to suit your needs, and we are able to present to a wide variety of courses and groups, including evening and online classes.
New for fall 2016 we are offering a full presentation about the ethical conduct of research. It will include an in-depth discussion of the ethical principles of human subjects research that are outlined in the Belmont Report and review examples of unethical research conducted both historically and recently. This presentation is designed to help students apply basic ethical standards to real-world examples of human subjects research. It would be an excellent supplemental lecture for any research methods course.
And we continue to offer a general IRB overview presentation that provides a broad overview of topics that are relevant for students and others who plan to conduct research themselves, whether as a course requirement or as an honors, Master’s or doctoral dissertation. This presentation can cover some or all of the following:
- The definition of human subjects research
- How to ask if you need IRB approval
- Ethical conduct of research (the Belmont Report)
- The research approval process
- Informed consent
- Research off campus or outside the United States
- Course-related student projects
- IRB Resources that are available for UI/VA researchers
This presentation provides a good orientation to the UI IRB and the requirements for IRB approval for faculty, staff and student researchers.
The standard presentation typically fills a 50-minute class period, but we can tailor the length and topic to suit the needs of the class or group. Contact us at firstname.lastname@example.org to request a presentation.
Governor Signs Off on State Law Requiring Oversight of UM Psych Drug Research
By Brent Collinsworth
After the tragic suicide of a research participant in May 2004, the Minnesota state legislature began a long investigation of the University of Minnesota’s psychiatric drug research practices. That process has now ended with Minnesota governor Mark Dayton signing a bill into law that gives broad powers to the state for oversight of UM psychiatric drug research.
The state Office of the Ombudsman for Mental Health and Developmental Disabilities is now charged with monitoring UM’s Department of Psychiatry clinical drug trials, and will be able to recommend corrective action to the University and Board of Regents if problems with compliance are found. The Ombudsman’s office is now able to review any matters that involve unusual death or injury to subjects, manual restraint, and any situations that seem “unclear or inadequately explained.” They also have the power to collect any research records they see fit during an investigation and issue subpoenas to move investigations further. The Ombudsman will also be under strict guidance as well, and will have to make full reports to the governor directly before releasing any findings.
Read the full article in the August issue of IRB Advisor. The August issue also includes articles about:
- Draft OHRP and FDA guidance on preparing and maintaining written policies
- Making IRB education engaging as well as informative
- Use of a direct IRB outreach program between review staff and researchers
- Educating incoming IRB staff members
- Socioeconomic factors and how they affect follow-up and interest in Internet studies
- A finding that nearly half of clinical trial data from four sponsors registered at ClinicalTrials.gov had not been made available to researchers
What is IRB Advisor?
IRB Advisor is a monthly newsletter that contains articles about regulatory issues, informed consent, current events in human subjects protections as well as articles about IRB administrative and management issues. The UI IRB subscribes to this publication as a resource for UI faculty, staff and student researchers as well as for IRB members and Human Subjects Office staff. Each month the IRB Connection Newsletter features an article from the current issue of IRB Advisor.
Current and Past Issues
There is a link to current and past issues of IRB Advisor on the Education and Training page of the Human Subjects Office web site. This link provides automatic access to the newsletter from all computers with a University of Iowa IP address.
The University of Iowa username and password cannot be posted on the Human Subjects Office web site. UI faculty, staff and students and VA researchers may contact the Human Subjects Office to request the username and password to access IRB Advisor from a personal computer. Contact us by e-mail (email@example.com) or call us at 319-335-6564.
Continuing Education Credits
Individual newsletter subscribers can receive 1.5 AMA PRA Category 1 Credits™ or 1.5 nursing contact hours for reading an issue and completing an online test. However, since this is an institution-level subscription, UI researchers must purchase access to an individual issue for $40, or purchase a full subscription, to receive CME/CE credits. Visit the AHC Media web site for information about subscription options.