TABLE 42–12. Questions to consider regarding the
ethical acceptability of psychiatric research protocols
the study scientifically valuable?
the hypotheses be tested adequately?
the design yield meaningful data?
the protocol employ accepted scientific methods?
team and institutional issues|
the investigative team have enough expertise and institutional and
other support to successfully complete the experiment?
the researchers aware of research ethics issues and potential problems
related to the protocol?
they in good standing within the scientific and professional communities?
conflicting roles and conflicts of interest exist in relation to
this protocol? How will they be dealt with?
the documentation features of the protocol adequate to monitor procedures
and the professional accountability of the research team?
issues related to risk and benefit|
the design minimize experimental risks to participants? Do alternative
designs pose less risk?
the protocol pose excessive risk to individual participants, the
community, and/or larger society?
participants are likely to have emerging symptoms as a result of
protocol involvement, have appropriate mechanisms for following
symptom progression been developed? Are there clear criteria for
disenrollment, and have alternative mechanisms for treatment been
benefits exist for participants? Is the likelihood of benefit accurately
it expected that any benefits derived from the protocol will be
applicable to the specific population being studied?
participant information carefully safeguarded during the collection,
storage, and analysis stages of the study?
the participant aware of potential disclosure obligations of the
research records kept separate from clinical records? If not, is
there a sound justification for this practice?
there important "overlapping relationships" between
investigative staff and participants? How will these be dealt with
in terms of confidentiality protections?
exclusion, and recruitment issues|
the process of selection, exclusion, and recruitment ensure that
members of vulnerable populations are included in a manner consistent
with federal guidelines and only if essential to the study's
understudied populations inappropriately excluded from participation
(i.e., are selection and recruitment practices potentially biased)?
the recruitment process itself noncoercive?
consent and decisional capacity issues|
the consent form concise, readable, accurate, and understandable?
the informed consent disclosure process include all relevant information,
study's purpose and the nature of the illness or the phenomenon
is responsible for the scientific and ethical conduct of the study
the individual may be eligible for participation
proposed intervention and its associated risks and benefits and
their relative likelihood
study design features (e.g., placebo use, randomization, medication-free
intervals, frequency of visits, confidentiality, plans for use of
there reasonable assurance of adequate decisional capacity of participants
with respect to the ability to understand, analyze, and appreciate
the meaning of the research decision?
a participant has (or is at risk for) diminished decisional capacity
at any time during protocol participation, are efforts to identify
and follow the participant's capacity in place? Have specific
interventions intended to enhance or restore the diminished capacity
been built into the protocol?
the protocol include an appropriate mechanism for advance decision
making by the participant or for identifying an alternative decision
maker for the participant? Is it clear when the advance directive
or alternative decision maker should be put into effect?
there reasonable assurance that individuals will not experience
coercive pressure to participate in the project or continue in the
incentives for participation sufficient and timed so that they compensate
research participants without being coercive?
health care is an incentive, how will the patient's health
care needs be met if disenrollment becomes necessary?
and peer/professional review issues|
the institutional context sufficient to allow the research to be
the protocol undergone appropriate scientific and ethical review?
the protocol undergo any additional review steps (e.g., by community
the protocol have features (e.g., very high-risk, very vulnerable
participants) that merit ongoing external monitoring?
the presentation of the data describe the ethical safeguards employed
in the protocol?
the presentation of the data meet current ethical standards (e.g.,
authorship, accurate disclosure of conflicting roles and conflicts
participants' identities be adequately protected in data