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?
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
Here are just a few examples of questions the
consultation service should be able to help answer:
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?
screening we discovered that a potential subject has HIV infection. What
should I do with this information?
doing a survey of attitudes of adolescents about different contraceptive
methods. Do I need their parentsí 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
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?
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
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?
to pass out a research survey to my class. I will explain it to them and
tell them they may leave if they donít 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)
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
Call the RECS office at (501) 661-7970. You may also
to send an email message. There is no charge for a research ethics
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.