The Research Ethics Consultation Service is available to assist researchers or research participants at UAMS (and affiliated sites) with any ethical concern that arises at any stage of research. Consultants can help researchers think through potential ethical issues in the design of their studies, or they can help resolve concerns that arise in the conduct of the research. They can also assist in communicating and discussing ethical matters in the study report. The service is collaborative in nature and is not an oversight or regulatory body.
How Can I Learn More About Ethical Issues in Research?
The Division of Medical Humanities maintains a library with volumes on both clinical ethics and research ethics. You may browse in the library and ask about checking out books.
The RECS and the IRB
One purpose of the RECS is to help investigators identify and proactively address issues that might impede approval by the UAMS Institutional Review Board (IRB). In this way it can speed up, rather than slow down, the approval process. It can also help resolve concerns that arise on IRB review. The RECS is here to help in a timely manner and will impose no additional processes or requirements.
What is a Research Ethics Consultation?
A consultation is simply a request for help or advice from someone trained to help, in this case, with an ethical concern about research. It may consist of a brief conversation to get feedback or clarify options, or it may involve a more thorough investigation of solutions to a particular problem. You may also ask for an ethics review to be sure your proposal does not raise unforeseen ethical issues.
Some studies raise ethical concerns by virtue of their design or subject population. You might consider a consultation if:
The Study Will Involve Special Populations
- Subjects who lack or may lack decision making capacity (e.g., children, persons with dementia, persons with addiction or substance abuse)
- Subjects who may be enrolled without consent (e.g., emergency research)
- Children in a study that poses more than minimal risk
- Subjects who will be enrolled by surrogates
- Subjects who may lose decision making capacity during the study (e.g., a long-term study of people with early stages Alzheimer Disease)
- Pregnant women or fetuses
- Prisoners or persons under court supervision
- Students, residents, fellows, employees
- Subjects who have no viable treatment options outside of research
- Stigmatized populations
- Subjects who lack access to basic goods and services
- Subjects who have limited English proficiency
The Study Design Will Involve
- Interventions with unknown or unusually high risks
- Questionable risk-benefit ratio
- Incentives that may be unduly influential
- Unusual confidentiality issues
- Storage of blood, tissue, or other biological samples
- Potential to generate information that may be clinically significant
- Potential to generate information about illegal activities
- Subject selection that raises questions of fairness (for example, populations may be targeted or excluded by sex, race, income, or linguistic proficiency)
Examples of Questions the Consultation Service Can Help Answer
- I want to include only active drug users in my study and exclude any who are trying to quit. Can I do this ethically? Should I offer treatment, treatment referral, or at least encouragement to quit?
- During screening we discovered that a potential subject has HIV infection. What should I do with this information?
- I am doing a survey of attitudes of adolescents about different contraceptive methods. Do I need their parents’ permission or consent before I can proceed with recruitment of participants?
- Most of the subjects in my study will be recruited from a low-income clinic, and I will be paying them $500 to participate. Might this be considered an undue inducement?
- My study involves a long-term follow-up of drug users, and some of my subjects may go to prison. May I continue to collect data while they are incarcerated? When they are released?
- My co-author and I have a disagreement about who should be lead author. Can you help us resolve this matter?
- Potential subjects for my drug trial will have failed all available standard therapies. How do I make sure they understand this is a safety trial and not another treatment?
- I would like to collect leftover tissue from gynecological surgeries to establish a tissue bank for future genetic studies. What are the ethical concerns with tissue banking?
- I want to pass out a research survey to my class. I will explain it to them and tell them they may leave if they don’t want to participate. Is this an acceptable consent process?
- We are conducting a Phase 3 trial of an oncology drug on 7-17 year old children. Should we enroll any of the children who refuse assent but whose parents request and give consent for it?
Who Can Ask for a Research Ethics Consultation?
Anyone involved with research or its regulation at UAMS may request consultation, including:
- Clinical Investigators (the PI, or anyone on the research team)
- Research Coordinators
- Institutional Review Board members
- Basic scientists interested in translational research
- Research study participants or their legally authorized representatives
How Would Someone Request a Consultation or Ask for More Information?
To contact a research ethics consultation, email firstname.lastname@example.org and we will get to work.
Where are the UAMS Research Ethics Consultation Service and Research Ethics Library located?
The service and library are located at 5800 W. 10th Street in the Freeway Medical Tower, Suite 500. You may come to the office in Freeway or request that the consultant visit you in your office.