ethical issues in human subjects research have received increasing
attention over the last 50 years. Institutional Review Boards for
the Protection of Human Subjects (IRB's) have been established at
most institutions that undertake research with humans. These committees
are made up of scientists, clinical faculty, and administrators
who review research according to the procedures set out in the Federal
Regulations at 45 CFR 46.
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
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 the Belmont Report,
written by The National 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 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
- 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
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 the Institutional 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
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.