What are the main ethical issues in human subjects

research?
There are several ethical issues that must be considered when
designing research that will utilize participants who are human
beings.
The primary concern of the investigator should be the
safety of the research participant. This is accomplished
by carefully considering the risk/benefit ratio, using all
available information to make an appropriate assessment
and continually monitoring the research as it proceeds.
The scientific investigator must obtain informed consent
from each research participant. This should be obtained
in writing (although oral consents are sometimes
acceptable) after the participant has had the opportunity
to carefully consider the risks and benefits and to ask any
pertinent questions. Informed consent should be seen as
an ongoing process, not a singular event or a mere
formality.
The investigator must enumerate how privacy and
confidentiality concerns will be approached. Researchers
must be sensitive to not only how information is
protected from unauthorized observation, but also if and
how participants are to be notified of any unforeseen
findings from the research that they may or may not
want to know.
The investigator must consider how adverse events will
be handled; who will provide care for a participant
injured in a study and who will pay for that care are
important considerations.
In addition, before enrolling participants in an
experimental trial, the investigator should be in a state of
"equipoise," that is, if a new intervention is being tested
against the currently accepted treatment, the investigator
should be genuinely uncertain which approach is
superior. In other words, a true null hypothesis should
exist at the onset regarding the outcome of the trial.
What are the main ethical principles that govern
research with human subjects?
There are three primary ethical principles that are traditionally
cited when discussing ethical concerns in human subjects
research. (A more complete enumeration of these principles is
available in theBelmont Report, written by The National
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Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research in 1979.)
The first ethical principle cited by the influential
Belmont Report is autonomy, which refers to the
obligation on the part of the investigator to respect each
participant as a person capable of making an informed
decision regarding participation in the research study.
The investigator must ensure that the participant has
received a full disclosure of the nature of the study, the
risks, benefits and alternatives, with an extended
opportunity to ask questions. The principle of autonomy
finds expression in the informed consent document.
The second ethical principle is beneficence, which refers
to the obligation on the part of the investigator to attempt
to maximize benefits for the individual participant and/or
society, while minimizing risk of harm to the individual.
An honest and thorough risk/benefit calculation must be
performed.
The third ethical principle invoked in research with
human subjects is justice, which demands equitable
selection of participants, i.e., avoiding participant
populations that may be unfairly coerced into
participating, such as prisoners and institutionalized
children. The principle of justice also requires equality in
distribution of benefits and burdens among the
population group(s) likely to benefit from the research.
What are the components of an ethically valid
informed consent for research?
For an informed consent to be ethically valid, the following
components must be present:
Disclosure: The potential participant must be informed
as fully as possible of the nature and purpose of the
research, the procedures to be used, the expected benefits
to the participant and/or society, the potential of
reasonably foreseeable risks, stresses, and discomforts,
and alternatives to participating in the research. There
should also be a statement that describes procedures in
place to ensure the confidentiality or anonymity of the
participant. The informed consent document must also
disclose what compensation and medical treatment are
available in the case of a research-related injury. The
document should make it clear whom to contact with
questions about the research study, research subjects'
rights, and in case of injury.
Understanding: The participant must understand what
has been explained and must be given the opportunity to
ask questions and have them answered by one of the
investigators. The informed consent document must be
written in lay language, avoiding any technical jargon.
Voluntariness: The participant's consent to participate
in the research must be voluntary, free of any coercion or
promises of benefits unlikely to result from participation.
Competence: The participant must be competent to give
consent. If the participant is not competent due to mental
status, disease, or emergency, a designated surrogate
may provide consent if it is in the participant's best
interest to participate. In certain emergency cases,
consent may be waived due to the lack of a competent
participant and a surrogate.
Consent: The potential human subject must authorize
his/her participation in the research study, preferably in
writing, although at times an oral consent or assent may
be more appropriate.
Is informed consent required by law?
According to 21 CFR 50.20,
"no investigator may involve a human being as a subject in
research covered by these regulations unless the investigator has
obtained the legally effective informed consent of the subject or
the subject's legally authorized representative."
The potential participant must be given the opportunity to give
full consideration regarding the decision whether or not to
participate in the research study without undue influence from
his or her physician, family, or the scientific investigator. No
informed consent may contain any exculpatory language by
which the participant waives any legal rights or releases the
investigator or sponsor from liability for negligence.
Can I use deception when doing research?
As a general rule, deception is not acceptable when doing
research with humans. Using deception jeopardizes the integrity
of the informed consent process and can potentially harm your
participants. Occasionally exploring your area of interest fully
may require misleading your participants about the subject of
your study. For example, if you want to learn about decision-
making practices of physicians without influencing their
practice-style, you may consider telling them you are studying
"communication behaviors" more broadly. The IRB will review
any proposal that suggests using deception or misrepresentation
very carefully. They will require an in-depth justification of why
the deception is necessary for the study and the steps you will
take to safeguard your participants.
I'm just doing a simple survey! Do I need IRB
approval?
Some research with humans is eligible for "exempt" status from
theInstitutional Review Board (IRB). If your research is part of
a routine educational experience, or if your participants will
remain completely anonymous (with no identifying code to link
them to their identity), you may apply to the IRB for a
certificate of exemption. Your study proposal will still be
reviewed by a member of the IRB, but the application process is
considerably shorter.
Your study may also qualify for "expedited review" if an IRB
reviewer determines that it meets assessment criteria for
minimal risk, and involves only procedures that are commonly
done in clinical settings, such as taking hair, saliva, excreta or
small amounts of blood. A study that qualifies for expedited
review is still held to the same standards used in full board
review, but the approval process may take less time. Contact the
University IRB if you have questions about the eligibility of
your study.