09/10/2019 Ethical Issues in Clinical Research
4:30-6:30
Research
T
LDT 408
Euniel Don A. Solinap, M.D.
OUTLINE
I. Clinical Research
II. Overview of Research Ethics
III. Conflict of Interest
IV. Precis’
V. Sources
CLINICAL RESEARCH
 To understand the pathophysiology of illness and to improve
clinical care
o Research with human participants is essential to better
understand the pathophysiology of illness to improve clinical
care
 Risks and inconvenience primarily to advance scientific
knowledge
o The key words: RISK AND BENEFITS
o How high is the risk or how great is the risk compared to the
benefits we are acquiring
o There is an ethical tension between protecting those research
participants and gaining new knowledge to benefit the society
 Protecting the wellbeing of research participants and gain new
knowledge
Clinical Research attempts to address a relatively straight
forward and extremely important challenges. In the case of
animal research, it raises important clinical issues of
their own since potentially new interventions will
eventually be tested/ must be tested in humans.
Participants in research accept these risks and inconvenience
primarily to advance scientific knowledge and to benefit others.
Epigenetics is geared toward treating the gene of interest.
Ethical Principles for Clinical Research
1. Respect for Persons
 Obtain informed and voluntary consent
o participants should be very well informed
o all aspects of the research should be given to the
participants
 Protect participants with impaired decision-making capacity
o There are participants in research who will not be able to
decide for themselves like if you are trying to research
schizophrenia, who will give the informed consent or like in
children? The parents or caregiver are the ones who will
give the consent. But do you think it will represent subject’s
choice?
 Maintain confidentiality
o Research participants are passive sources of data.
 Rights and welfare be respected
2. Beneficence
 Research design is scientifically sound
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 The risk of research versus likely benefits- physical and
psychological harm
o Risk should be minimal and acceptable
o In any intervention, you always have to expect result may
be beneficial or risky
o In clinical research the benefits should always outweigh the
risk
o The risk for participants include both physical harm
(research intervention) and psychosocial harm (breaches of
confidentiality, stigma and stipulation) stigma of having no
more dignity I entering the research study
o Breach of confidentiality, especially in those cases when
you are doing a qualitative research wherein you personally
probe
 Minimize risk by screening and monitoring
o exclude those likely to suffer adverse effects
o Different individuals will react to different kind of treatment
 Clinical research is regarded as beneficial; it provides access
to potentially life- saving new therapies
o In cases of Cancer, HIV and organ transplantation
3. Justice
 The benefits and burdens of clinical research be distributed
fairly
o Vulnerable population such as people with poor access to
health care
o Impaired decision making capacity, those who may not
have the capacity to make informed choices about
participating in research (mental institutions, children who
will not be able to give their full consent)
o Institutional population are attractive to study because
access and follow up are convenient
o Need to be careful with subjects of our research. We have
to see to it if they are homogenous. If they will represent all
aspects of the population
 Also requires equitable access to the benefits of research
o Children, women and members of ethnic minorities
historically have been under represented in research. So if
you only choose a particular group, you will be under
representing other groups
OVERVIEW OF RESEARCH ETHICS
 It is required that research with human subjects be approved by
Institutional Review Board (IRB).
o In-charge in ensuring that the research is ethically acceptable
and the welfare and rights of the research participants are
protected
Informed and Voluntary Consent
 Respect for persons and their autonomy
 Informed and free consent
 Participants are not as sources of data
 Respect for the welfare and rights of the participants
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  Issues that Prospective subjects need to understand to give
informed consent:
1. The Nature of Research Project
 The prospective subject should understand that the
research is being conducted, understand the purpose, how
it differs from standard care, and how participants are being
recruited including the process of sampling
 How did you arrive from your sampling design should also
be given to your subjects
 Any financial interest of the investigator should also be
disclosed. For example, you are involved in this particular
company and you are also the person who is going to do
the research
2. The Procedures of the Study
 Participants need to know what will they do in the study
 They should be told how much time will they be required,
how often are they going to be examined
 Procedures that are not standard care should be identified.
Sometimes researches deviate from the standard of care. If
the study involves blinding or randomization, these
concepts must be explained to patients esp. in doing a
double blind placebo control study, the outcome will be
different in two subsets or cohorts
3. Risk and Potential Benefit of the Study
 Medical, Psychosocial and Economic risk and benefits
should be described in layman’s term. This includes
physical harm, probable complications of the test/treatment.
Psychosocial harm such as loss of privacy and
inconvenience
4. Assurance that participation in research is voluntary
 Participants can withdraw anytime
5. Misconception about research
 Research can provide direct therapeutic benefit to the
participants
 Participants do not understand how research differs from
clinical care. Participants believe that the study can provide
them personal benefits if the choice of intervention will be
placed on their needs. This is not the ideal clinical care.
 Sometimes in doing research we deviate from what is the
normal. Subjects might assume that it will be beneficial to
them
Selection of Participants in Research
 Potential benefits and harms of participation in research should be
equitably
o
o
 No particular group should be overrepresented in dangerous
studies nor underrepresented in trials of promising new therapies
 Patients who lack decision making capacity
o Cannot give informed consent to research studies
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o Research is essential to improve therapies for their conditions
o Surrogates may give permission for them to participate in
research
o Ethical controversy: surrogate decisions often are not based
on patients' wishes or best interest
o "Informed consent by proxy, an issue in research with elderly
patients"
 31% of surrogates who believed that the patient would refuse
to participate in the study nonetheless gave consent
 20% of surrogates who would not enroll in the study
themselves nevertheless allowed the patient to participate in
the research. best interest in this case is very subjective
 Treating physicians and investigators role is to assure the
participation in research by persons who lack decision
making capacity is appropriate
 Patients whose consent might not be free
o Some potential participants in research are vulnerable because
their consent might be constraint.(ex. persons in institutions,
persons in nursing homes, etc)
o These persons might be dependent on the physician-
researchers for ongoing medical care
o Dependent populations are recruited because recruitment and
follow up are easier
o However, such patients might not feel free to refuse to
participate
o They or their surrogates might fear that their physicians will be
upset, and they will not get a good medical care
o Fairness requires that vulnerable populations- not be used if
other populations would also be suitable for the study
CONFLICT OF INTEREST
Conflicting Interest for Treating Physicians
 The goal of carrying out important and valid research might
conflict with the goal of acting in the best interest of individual
patient.
 Finder's Fee
o Is payment for clinicians for referring patients to a research
project
 We don’t own all patients
 We need to refer these patients to be a part in other
researches that falls on their criterion
o Facilitate the timely completion of enrollment of subjects in
clinical trial
o Give the impression that physicians refer patients to clinical
trials for their own interest
o Analogous situation of kickbacks for referring patients to
another physician for clinical care
o Unethical
Responding to Conflict of Interest
 Disclose Conflicting of Interest
o Should disclose to patients any financial interest in a research
project
o California Supreme Court: " Disclose personal interests
unrelated to patient’s health, whether research or economic
that may affect the physician’s professional judgment"
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 o Patients should be told if referring physicians receive finder's
fee
o "Patients views on financial conflicts of interest in Cancer
Research Trials" - Hampson, Agrawal, Joffee N Engl Med,
2006
 70% of respondents would still have enrolled in the clinical
trial even if the researcher had financial ties to the drug
company sponsoring the trial.
 Only 31% wanted disclosure of the researcher’s financial
interest.

PRECIS’

1. Rigorous clinical research is essential to evaluate promising new

therapies
2. Treating physicians, should also help assure that participants
appreciate the key features of the research study. To make sure
that there are no special considerations that would make it unduly
risky for the patient to participate in research.
3. Conflict of interest might impair objectivity and erode trust in
research

SOURCES

 Doc’s PowerPoint Presentation

 Lecture recordings

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