Written by Michele Countryman, CIP
The Human Subjects Office\IRB is making a series of enhancements to the electronic research application (HawkIRB) in Fall 2015. These enhancements are designed to:
- Clarify study design information important for FDA regulated research;
- Enhance the University of Iowa human subjects research protections reporting portfolio;
- Ensure compliance with NIH ClinicalTrials.gov and Certificate of Confidentiality policies;
- Directly associate funding awards in UIRIS under the Division of Sponsored Programs with HawkIRB research applications;
- Launch the External IRB Reliance module (including automating WIRB submissions); and
- Separate research occurring at the UI and VA into two separate HawkIRB research applications.
These enhancements will be split into phases. The first set of enhancements to the HawkIRB application were activated on 9/2/15. All Principal Investigators, research team members, delegates, and contacts received an email describing these changes. Ongoing enhancements will continue this fall; email notifications will continue as will posting of this information on our website.
Phase 1 changes require a Principal Investigator to respond to two new lead questions on IRB applications (IRB-01, IRB-02, and IRB-03). These lead questions include a new question(s) addressing a NIH Certificate of Confidentiality (CoC) application and categorization on the HawkIRB attachments page for CoC specific attachments.
In conjunction with the above rollout to all IRB applications, IRB-01 and IRB-03 (Biomedical Research) applications will include an additional enhancement listed below. (IRB-02 Social\Behavioral Research applications will not be affected by this enhancement.)
- Revise VII.B.1 to specifically identify the study type.
- Identify Clinical Trial phases, Repositories, Registries, or other study design specific information.
- Identify the National Clinical Trial # as assigned by Clinicaltrials.gov.
Responses will be required as part of the next submission made to the HSO\IRB for review. These submissions could be in the form of a new IRB application, modification, or modification + continuing review.
This pdf outlines the initial enhancements to the HawkIRB Application. The blue “i” near each question can be used to review HawkIRB help content for additional information on IRB expectations.
If you have any questions, please feel free to call the Human Subjects Office at (319) 335-6564 or firstname.lastname@example.org
Written by Patricia Katopol, PhD
For some time now, researchers have known that pain and drugs affect women differently than men, resulting in a push for more women to participate in clinical trials so that more can be learned about these differences. Similar concerns have been raised about minorities, especially blacks, as participants in clinical trials. Not only are there fewer trials focusing on medical issues related to this population, but fewer minorities participate in trials in general. This is the case, even though it has been shown that blacks respond to drugs differently. For example, older drugs such as diuretics, work well for blacks, who are likely to be salt sensitive. And in 2005, the FDA approved the first race-specific medication, BiDil, for blacks with heart failure.
It can be difficult enough for clinical trials to find participants in general, and even more difficult finding black participants. Much of this is attributable to the notorious history medical research has among blacks in the United States. Early surgeries and experiments often held blacks up to public examination as they received treatment or failed to use anesthetics or sedation in the belief that black people did not feel pain in the same way as Caucasians or that it was not ‘worth’ taking the effort to make blacks comfortable.
The Tuskegee Syphilis Experiment traced the course of untreated syphilis in poor, uneducated black men from 1932 – 1972, even after a treatment was found for the disease and causing needless pain and suffering to the subjects and their families, all with the approval of the US Public Health Service. More recently, information about the HeLa immortal cell line, used without consent from a black woman (Henrietta Lacks) with cervical cancer, has hit the public consciousness and provides another example of the medical community ignoring, mistreating, and often profiting from, black people. These historical events live on in black community consciousness and have led to a lack of trust in clinical trials and medical research. According to the FDA, blacks are only 5 percent of clinical trial participants, despite being 12 percent of the population. While low participation is problematic, low numbers of blacks and other minorities in the STEM fields adds to the challenge. Researchers tend to do research on those problems of interest to them and it makes sense that minority researchers would tend to examine minority medical issues more than others. Unfortunately, minority researchers also tend to get less funding, so that even if they wanted to pursue minority health issues, they may not be able to do so.
The United States is a diverse society both in terms of its people and their health needs. Populations such as blacks, women, the elderly, and transgender persons should be treated as primary participants in health research, not as afterthoughts.
Image with permission from the Centers for Disease Control and Prevention, US Public Health Service Syphilis Study at Tuskegee, http://www.cdc.gov/tuskegee/
Written by Sarah Heady, CIP
Unanticipated events are just that: unanticipated—no one can predict every single potential adverse outcome for research subjects. Yet the most common reportable event, over-enrollment of subjects, is entirely preventable. Over-enrollment occurs when the number of participating subjects exceeds the number approved for enrollment by the IRB. Once enrollment exceeds the approved number of subjects, a PI must submit both a modification, to increase the approved number of subjects, and a Reportable Event Form for noncompliance. Save yourself the hassle and prevent the problem!
Tips for preventing over-enrollment:
- Communicate, and track enrollment centrally. Research team miscommunication can happen if enrollment numbers are not tracked in a single place. If more than one research team member is enrolling subjects, over-enrollment may be discovered after it has happened.
- Be sure to set a limit for the number of participants when initiating use of web applications. Failure to set enrollment limits when using MechanicalTurk or other web applications can lead to participation rates that exceed approval numbers.
- Allow room for attrition when designing your project. The IRB counts any subject who consents to be enrolled, regardless of continued participation, as counting toward the approved number of subjects. Some subjects may fail post-consent screening, and there are always subjects who decide not to continue with study procedures.
- Be sure your application describes your project accurately, and if something needs to be adjusted, submit a modification before over-enrolling. Misunderstanding IRB approval can lead to over-enrollment. The number of subjects in HawkIRB is the enrollment limit, not the minimum number of subjects you may consent. Typos can also lead to over-enrollment; if the approved number of subjects is 300, and you intended to indicate you would enroll 3000, the board may consider that serious and/or continuing noncompliance when 3000 subjects participate.
Image courtesy of Herky Hints cover, new student orientation manual, 53 93 [Subject Vertical file Collection (RG 01.15.03, Miscellaneous category, folder "Freshman orientation," University Archives, Department of Special Collections, University of Iowa Libraries]