By Michele Countryman
The last of the Office for Human Research Protections (OHRP) 2018 Revised Common Rule regulations under §45 CFR 46 have gone into effect as of January 20, 2020. These changes implement the cooperative research section (§45 CFR 46.114(b)) of the revised regulations for the protection of human subjects that took effect in January 2019. This regulatory change extends the use of a single IRB (sIRB) of record for all multi-center, human subjects research funded by any federal departments and/or agencies that have adopted the Revised Common Rule. The two entities that have not adopted the Revised Common Rule to date are the Food and Drug Administration (FDA) under §21 CFR 50, 56, 312, and 812 and the Department of Justice (DOJ) under §28 CFR 46.
OHRP has issued an exception to the requirement to use an sIRB for the following research:
- Cooperative research conducted or supported by HHS agencies other than the National Institutes of Health (NIH), if an IRB initially approved the research before January 20, 2020.
- Cooperative research conducted or supported by NIH if either:
- the NIH single IRB policy does not apply, and the research was initially approved by an IRB before January 20, 2020, or
- the NIH excepted the research from its single IRB policy before January 20, 2020.
- the NIH single IRB policy does not apply, and the research was initially approved by an IRB before January 20, 2020, or
The Human Subjects Office (HSO) reviewed all applicable research submissions to determine if any are subject to this regulatory change. The HSO is happy to report there were only a few that required further investigation. The VA Research Office has identified all IRB-03 research submissions which may fall under one of these categories and have issued Common Rule Exception Notices.
The HSO will be offering a Spring 2020 presentation on the Single IRB (sIRB) policy update as well as a refresher on the sIRB process at the University of Iowa on Thursday, February 13 from 12:00-1:00 in Braley Auditorium in the Pomerantz Family Pavilion.
If you are not able to attend this presentation and have questions regarding the sIRB review process at the University of Iowa, please contact the External IRB team in the Human Subjects Office at firstname.lastname@example.org. Additional information can also be found on the Human Subjects Office website under “Central and External IRBs (Single IRB of Record).”
By Martha Hedberg
All UI faculty and staff identified as Key Personnel that conduct human subjects research are required to complete an “Annual Disclosure of Outside Professional Activities and Interests” via the eCOI online disclosure portal by April 30, 2020. The Annual Disclosure fulfills the reporting requirements of the following UI policies:
- Policy on Conflicts of Interest in Research,
- Policy on Conflict of Interest in the Workplace,
- Policy on Conflicts of Commitment,
- Policy on Institutional Conflict of Interest in Human Subjects Research,
- UI Health Care Conflicts of Interest Policy, and
- Accreditation requirements for Continuing Medical Education.
Employees may monitor compliance with this annual disclosure requirement via the UI Compliance and Qualifications system accessible through UI Self-Service “My Compliances” tab. Employees who have not completed the requirement will receive reminder emails on April 1, April 25, and April 30. Supervisors and Compliance Administrators will be copied on the final two notifications.
Failure to complete an Annual Disclosure by April 30 in eCOI will result in a hard stop when naming key personnel on both HawkIRB applications and UIRIS Proposal Routing Forms for sponsored research.
Thank you for your assistance in ensuring that UI academic, health care, business, research, and teaching endeavors may be free of potential or actual conflicts of interest.
- Faculty and Executive Questions: Jan Waterhouse, Office of the Provost/University Human Resources, 335-5767 or email: email@example.com. Website: http://provost.uiowa.edu/conflicts-commitment-and-interest,
- Staff Questions: Jan Waterhouse, University Human Resources, 335-5767 or email firstname.lastname@example.org. Website: http://provost.uiowa.edu/conflicts-commitment-and-interest,
- Research-related Questions: Martha Hedberg, Conflict of Interest in Research Office, 384-4256 or email: email@example.com. Website: http://coi.research.uiowa.edu,
- University Official Questions: Martha Hedberg, Conflict of Interest in Research Office, 384-4256 or email: firstname.lastname@example.org,
- UI Health Care Questions: Mary Copper, UI Health Care Conflict of Interest Office at 384-7312 or e-mail: email@example.com. Website: https://uihc.org/conflict-interest,
- Continuing Medical Education Questions: Lori Raw, Division of Continuing Medical Education, 335-8599. Website: http://www.medicine.uiowa.edu/cme.
By Maegan Tyrrell
Spring brings fresh starts, planting new ideas, and cleaning out the old to make room for the new. Like the flowers that bloom every spring, the IRB also has cyclical patterns as a new semester begins. At the beginning of each semester we announce the schedule for HawkIRB Trainings and IRB Presentations.
The IRB offers a four-part, monthly series of trainings on how to use HawkIRB and the forms found within the system. These trainings include:
- How to Complete a HawkIRB New Project Application, Part 1
- How to Complete a HawkIRB New Project Application, Part 2
- How to Complete HawkIRB Modifications, Continuing Reviews, Reportable Event Forms (REFs), and Project Closure Forms
- HawkIRB Training for the Single IRB Model
Follow this link to sign up for HawkIRB trainings.
The IRB presentations this semester will focus on a variety of topics including:
- Single IRB review model
- Key information on consent summaries
- Resources available for researchers arriving and leaving the university
- Top monitoring findings from the past year
- An advanced IRB overview for those that want to learn more about IRB processes.
Check out the descriptions for these presentations and sign up on our website. Topics for IRB presentations are based off of feedback we receive from the research community. Send your ideas to firstname.lastname@example.org. We welcome all suggestions!
By Maegan TyrrellAs the Spring 2020 semester gets started, we want to promote a resource that may be especially useful to instructors of research methods courses, other research-related courses, journal clubs and orientation sessions or seminars for new faculty, graduate and professional students. The IRB Education and Outreach program is available upon request to give classroom and group presentations about the ethical conduct of research, the UI IRB review process and other human subjects research-related topics. We can tailor the length and content of the presentation to suit your needs, and we will present outside normal business hours, including evening and online classes.
IRB Overview Presentation
We 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 or Master’s thesis 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 UI IRB review process
- Informed consent
- Research off campus or outside the United States
- Course-related student projects
- IRB Resources that are available for UI/VA researchers
The purpose of this presentation is to demystify the IRB review process and clarify any questions surrounding human subjects research. Whether you are familiar with conducting research at Iowa or not, you are guaranteed to learn something new with our IRB overview presentation.
Patricia Katopol, PhD
As of December 2016, approximately 6.6 million adults were in the United States’ correctional system. This includes those in correctional institutions, on probation or parole, and in correctional institutions. Historically, this “captive population” was considered an appropriate population for high-risk studies thought to be unsuitable for the general public. This article describes the current regulatory requirements that protect incarcerated persons who participate in research studies.
A variety of research using prisoners was conducted during WWII, including trials for malaria treatments, gas gangrene, and efforts to develop a blood substitute from cattle for use on the battlefield – a study in which a prisoner died. With no federal regulations in place at the time, trials often proceeded without oversight due to the exigencies of the war. The mistreatment of prisoner subjects in these studies was so egregious that Nazi defendants during the Nuremberg trials cited them as examples that a lack of protection and abuse of human subjects was acceptable to American researchers. After the war, American investigators often did not follow the Nuremberg Code because they felt it was directed to the Nazi atrocities and not to American physicians. Other factors, such as the emphasis on scientific progress after WWII also let researchers turn a blind eye toward the protection of human subjects, especially if the subjects were prisoners. It should be noted that although these WWII-era prisoners were not treated in the way that is expected today, many willingly signed up for studies and considered participation as their contribution to the war effort.
After the war, using prisoners as research subjects continued to be popular for investigators as the prison population and environment were seen as a stable and controlled setting for experimentation. Some of the most abusive studies took place at Philadelphia’s Holmesburg Prison, where prisoners were subjected to a variety of trials, including dermatology studies that left some with permanent scars and the testing of psychedelic drugs on a population that often has mental health issues.
In 1966, Henry Beecher’s article presented twenty-two examples of unethical research in the U.S., much of it either without consent or in which subjects were not completely informed about the project. His article, along with publicity about other trials, such as transplanting live liver cancer cells into senile patients, irradiating prisoner’s testicles, and giving institutionalized children hepatitis without telling parents the actual risks, led to increased public awareness about research with institutionalized subjects such as prisoners.
Ethical concerns about research using prisoners are framed by the Belmont Report’s principal of respect for persons, especially respect for people as autonomous decision-makers. Prisoners have limited free choice, are physically isolated and restricted, and are in situations where others can exert control over them. Despite what they are told during consent, they may believe they will be punished or lose benefits if they do not participate.
Where permitted, prisoners should be included in research, however, they also need protection from abuse and exploitation. One element of protection is in the Belmont Report’s concept of Justice, which requires that the benefits and burdens of research be distributed equally. Prisoners should not be subjects in risky or painful trials, such as those at Holmesburg Prison, simply because they are a readily available population.
Investigators should be aware of the regulatory constraints on having prisoners as subjects. The first consideration is, who meets the regulatory definition of prisoner? HHS regulations at 45 CFR 46.303(c) define a prisoner as "any individual involuntarily confined or detained in a penal institution.” This includes those in federal, state, or local institutions as well as those detained in alternatives to incarceration (such as court-ordered substance abuse treatment), involuntary commitment for psychiatric illness, and people detained while awaiting arraignment, trial, or sentencing. Parolees living in the community and those wearing monitoring devices usually do not meet the definition. Where there is uncertainty, the IRB may consult with the Office for Human Research Protections for assistance in determining whether a person is a prisoner.
Under Subpart C of the Code of Federal Regulations for the Protection of Human Subjects (45.CFR 46.306), the following types of studies are permitted for research using prisoners:
- Study of the possible causes, effects, and processes of incarceration, and of criminal behavior; no more than minimal risk and no more than inconvenience to subjects;
- Study of prisons as institutional structures or of prisoners as incarcerated persons, the study must be no more than minimal risk and no more than inconvenience to the subjects;
- Research on conditions particularly affecting prisoners as a class (for example, research on hepatitis, which is much more prevalent in prisons than elsewhere, and research on alcoholism, drug addiction, and sexual assaults). The study may proceed only after the Secretary of the Department of Health and Human Services (HHS) has published notice, in the FEDERAL REGISTER, of the intent to approve such research; or
- Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject. For studies that require the assignment of prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit from the research, the study may proceed only after the HHS Secretary has published notice, in the FEDERAL REGISTER, of the intent to approve such research.
In addition, investigators should note that Iowa Department of Corrections Policies and Procedures provide that, “Normally offenders shall not receive compensation, remunerations, or payment of any kind in connection with a research study.” This could be an issue in a study involving both prisoners and non-prisoners, since the IRB typically requires equal compensation for all subjects that complete the same study activities.
Working with the IRB
IRB review of prisoner research requires a full board meeting that includes the presence of at least one prisoner advocate. In addition to the general requirements of 45 CFR 46.305(a), the IRB must make additional findings to approve prisoner research:
- The research represents one of the categories of research permissible under §46.306(a)(2);
- Possible advantages accruing to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired;
- The risks involved in the research are commensurate with risks that would be accepted by nonprisoner volunteers;
- Procedures for the selection of subjects within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless a justification is provided to the IRB, control subjects must be selected randomly from available prisoners who meet the characteristics needed for that project;
- The information is presented in language understandable to the subject population;
- Adequate assurance exists that parole boards will not take into account a prisoner's participation in the research in making decisions regarding parole, and each prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole; and
- If the Board finds a need for follow-up examination or care of participants after the end of their participation, adequate provision has been made for such examination or care, taking into account the varying lengths of individual prisoners' sentences, and for informing participants of this fact.
If the project was not approved to include prisoners, the PI cannot enroll a prisoner who happens to meet study eligibility criteria. If a subject becomes a prisoner during the course of a study that was not approved to enroll prisoners, all research interactions with the newly incarcerated subject must be suspended immediately, including study interventions, and/or obtaining or working with identifiable information. If the investigator wants to continue to include the prisoner in the study, they need to either submit a HawkIRB modification form so the IRB can review the proposal in accordance with the subpart C OR remove the prisoner from the study.
Prisoners retain the right to participate in research and may choose to do so to amend for their crimes, contribute to society, or out of a sense of altruism. However, because prisoner research historically has been fraught with abuse, it is incumbent upon the researcher to understand the regulatory requirements for including prisoners in research, and to be aware of the protections that must be in place for this vulnerable subject population.
By Maegan Tyrrell
The Secretary’s Advisory Committee on Human Research Protections (SACHRP) used a series of questions in crafting recommendations on the issue of requiring research subjects to “pay to participate.” The unpublished, finalized draft discussed at the SACHRP meeting included the following five questions and committee answers.
- Does the study meet relevant thresholds of scientific quality?
The question of a study’s scientific validity is integral to the IRB Assessment of whether a study’s benefit justifies its risk and burdens. The IRB should be prepared to confirm the scientific validity and value of the proposed study and its design, either directly when they have the expertise to do so, or through reliance on expert consultants or other institutional committees.
- Is the risk-benefit balance justifiable?
Just as payment to subjects is not to be considered a benefit that could balance research risks, payment to participate should not be considered as a harm in the risk-benefit equation. Instead, the IRB should evaluate a study’s risk and benefits first without considering payment.
- Why are traditional research funding sources not used? Could the study potential be funded by means other than charging subjects?
The IRB should require investigators to specifically explain and justify the rationale for charging subjects, including whether traditional funding was sought and why other funding sources are not available or appropriate.
- Will requiring payment for participation influence equitable subject selection?
Investigators should try to mitigate concerns regarding generalizability and equitable subject selection, potentially considering efforts to include some subjects who cannot pay their own way (e.g., a sliding payment scale or an approach where economically disadvantaged subjects are subsidized by those who can pay).
- Is requiring payment from subjects likely to exacerbate the possibility of therapeutic misconception? If so, how can that concern be mitigated?
When subjects are charged for participation, they may regard trial participation as a means of gaining further access to a promising new treatment. This raises concerns about their adequate consideration of and reflection about important study features, such as risk, burdens, discomforts, and uncertainty. IRBs should pay special attention to whether the informed consent process will provide clear and complete information about the study and support adequate consideration and comprehension of that information. Similar consideration should be given to any recruitment materials.
To read the full article, go to the ICON course available on the Human Subjects Office website.
Other articles in the November issue of IRB advisor include:
- “New SACHRP Guidelines on ‘Pay-to-Participate’ Research”
- “Preparation Needed to Follow Common Rule Exemption Changes”
- “Suggestions for Improving Exempt Determinations by IRBs”
- “Bioemergency Research Might Weigh Risk-Benefit Ratio Differently”
- “Bioengineered Organ Research on the Recently Deceased”
Current and Past Issues
IRB Advisor (a publication of Relias) is a monthly newsletter with articles about issues facing IRBs and individuals involved with human subjects research. The University of Iowa subscribes to this publication as a resource to UI faculty, staff and student researchers as well as for IRB members and Human Subjects Office staff.
Current and past issues of IRB Advisor are posted in the “IRB ICON Course for Researchers” which is accessible to anyone with a UI HawkID and password. You must access this ICON Course from the Education and Training page of the Human Subjects Office web site. Due to our licensing agreement, we are no longer able to post a link to this publication on the Human Subjects Office website.
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