Designing ethical

research studies.
RESEARCH ETHICS
Cont…
 The primary concern of the investigator should
be the safety of the research partricipant.The
investigator must be prepared to stop the
study if serious unanticipated risk manifest.
 The investigator must obtain informed consent
from each research participant..\
 Researchers must protect the subjects’ privacy
and confidentiality (data).
 Ethically valid informed consent for researc
h>>: CONT
Components of ethically valid
informed consent for research
 Disclosure:the informed consent document must
make clear that the study is a research study and
not a clinical therapy, the nature and purpose of
the study must fully be informed to participant,
the expected benefits and pontential foreseeable
risks and discomforts.The informed consent
document must disclose what compensation and
medical treatment are available incase of
research injury and whom to contact.
Cont.

 Understanding: participant must understand

what has been explained and must be given
the opportunity to ask questions fully
answered by one conversant with study
particulars. Participant must be able to read
and understand the language in which the
the consent form has been written .Consent
forms of multinational research must be
translated into respective language.
Cont. Voluntariness:
 Consent to participate in the research must
be voluntary, free from coercion, or inflated
promise of benefit from participation.
 Competence: participant must be competent
to give consent.
 Consent: human subject must authorize his
participation preferably in writing:
 As a general rule deception is not acceptable
when doing re search with humans.
IRB review of research

 Clinical trials that expose subject to more

than minimal risk must be reviewed by the
IRB.
HISTORY TAKING AND P/E

 Clinical practice are acquired throughout lifetime

of practicing, change as new techniques and
concept arise.
 Introduce yourself and greet the patient.
 Observe response with care ,if smile,frightened,
shortness of breath.
 If a patient doesn,t want to discuss certain topics
or examined, this must be respected.
 In some patients the nature of the problem will be
observed, eg CHF, STROKE, PARKINSON,S
DISEASE
 Principles of Medical Ethics
 I. A physician shall be dedicated to providing competent medical care, with compassion and respect
for human dignity and rights.
 II. A physician shall uphold the standards of professionalism, be honest in all professional interactions,
and strive to report physicians deficient in character or competence, or engaging in fraud or
deception, to appropriate entities.
 III. A physician shall respect the law and also recognize a responsibility to seek changes in those
requirements which are contrary to the best interests of the patient.
 IV. A physician shall respect the rights of patients, colleagues, and other health professionals, and shall
safeguard patient confidences and privacy within the constraints of the law.
 V. A physician shall continue to study, apply, and advance scientific knowledge, maintain a
commitment to medical education, make relevant information available to patients, colleagues, and
the public, obtain consultation, and use the talents of other health professionals when indicated.
 VII. A physician shall recognize a responsibility to participate in activities contributing to the
improvement of the community and the betterment of public health.
 VIII. A physician shall, while caring for a patient, regard responsibility to the patient as paramount.
 IX. A physician shall support access to medical care for all people.
 VI. A physician shall, in the provision of appropriate patient care, except in emergencies, be free to
choose whom to serve, with whom to associate, and the environment in which to provide medical
care.
  Patient-physician relationships
 Building relationships of trust with patients is
fundamental to ethical practice in medicine.
ent- Responsibilities of physicians & patients
sician
 The relatioDoctor-patient relationships are
tions strengthened by the practice of medical
ethics, which can help you create better
tor- communication and health care decisions.
ent  nship between a
tions
 VII. A physician shall recognize a responsibility to
participate in activities contributing to the improvement
of the community and the betterment of public health.
 VIII. A physician shall, while caring for a patient, regard
responsibility to the patient as paramount.
 IX. A physician shall support access to medical care for
all people.
 VI. A physician shall, in the provision of appropriate
patient care, except in emergencies, be free to choose
whom to serve, with whom to associate, and the
environment in which to provide medical care.