This document discusses several topics related to ethics in research including conflict of interest, informed consent, and confidentiality. It defines conflict of interest as secondary interests that may distort primary research interests. Researchers have a duty to disclose conflicts to prevent harming participants or public trust. Informed consent requires fully informing participants of a study's risks, benefits and alternatives. Consent may be implied in emergencies when patients cannot consent. Confidentiality is a set of rules limiting access to private medical information, though it can be overridden if disclosure protects public health.
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Conflict of interest, Confidentiality, Informedconsent
1. CONFLICT OF INTEREST,
INFORM CONCERNT &
CONFIDENTIALITY
Aman Ullah
B.Sc. Med. Lab. Technology
M. Phil. Microbiology
Certificate in Health Professional Education
Lecturer, Department of Medical Lab. Technology
Institute of Paramedical Sciences, Khyber Medical
University, Peshawar, Pakistan
2. ALERT: THE MATERIALS INCLUDED IN THIS
PRESENTATION WAS ACTUALLY COMPILED BY
DR. TASLEEM AKHTAR
IN THE CONTACT SESSION OF MASTER IN HEALTH
RESEARCH AT KHYBER MEDICAL UNIVERSITY,
PESHAWAR, PAKISTAN
3. Conflict of Interest
Ethical issues can arise when research
activities and other activities conflict.
A conflict of interest occurs when secondary
interests—such as teaching, administration,
political advocacy, or financial or a vocational
pursuits—distort the integrity of
judgments regarding the primary interest-
research.
TRI-COUNCIL POLICY STATEMENT 2010-Canada
4. Failure to disclose and manage conflicts may
impede the informed and autonomous choices
of individuals to participate in research.
Conflicts of interest may also undermine the
respect for participants that is fundamental to
the principle of Justice.
TRI-COUNCIL POLICY STATEMENT 2010-Canada
5. Institutional Conflict of Interest
Institutions involved in research hold trust
relationships with participants, research
sponsors, researchers and society.
These institutions may have financial or
reputational interests that conflict with the
institution’s obligations to protect and respect
human dignity
TRI-COUNCIL POLICY STATEMENT 2010-Canada
6. IERC/B Member Conflict of Interest
The IERC/B, as an entity, or in the persons of
the members who make up the board, also
hold trust relationships with participants,
research sponsors, researchers and society.
IERC/B members must also be aware of their
own potential for real or perceived conflicts of
interest. Contd.
7. For example,
IERC/B members are in a conflict of interest
when:
•their own research projects are under review
by their IERC/B,
•when they are a co-investigator, or
•when they are in a supervisory or mentoring
relationship with a graduate student applicant.
8. Researcher Conflict of Interest
Researchers and research students hold trust
relationships, either directly or indirectly, with
participants, research sponsors, institutions,
their professional bodies and society.
These trust relationships can be put at risk by
conflicts of interest that may compromise
independence, objectivity or ethical duties of
loyalty. contd
9. Researchers’ conflicts of interest may arise
from interpersonal relationships, financial
partnerships, other economic interests,
academic interests or any other incentives that
may compromise integrity or respect for the
core principles of research ethics
Conflicts may arise from an individual’s
involvement in dual and multiple roles within or
outside an institution.
10. Respect for the autonomy of the research
participant/patient would, in common
parlance, mean that the patient has the
capacity to act intentionally, with
understanding, and without controlling
influences
This principle is the basis for the practice of
"informed consent"
11. What is informed consent?
Informed consent is the process by which a fully
informed patient can participate in choices
about her/his health care.
13. Full Informed consent
The most important goal of informed consent
is that the patient has an opportunity to be an
informed participant in her/his health care
decisions.
14. Complete informed consent includes a
discussion of the following elements:
•the nature of the decision/procedure
•reasonable alternatives to the proposed
intervention
•the relevant risks, benefits, and uncertainties
related to each alternative
•assessment of patient understanding
•the acceptance of the intervention by the
patient
15. Basic consent:
Basic consent entails letting the patient know
what you would like to do and asking them if
that will be all right.
Basic consent is appropriate, for example,
when drawing blood.
A low-level of patient involvement is needed
because there is a high-level of community
consensus.
16. What should occur if the patient cannot give
informed consent?
A surrogate decision maker must speak for
her/him.
There is a specific hierarchy of appropriate
decision makers defined by law.
If no appropriate surrogate decision maker is
available, the physicians can act in the best
interest of the patient
17. Is there such a thing as
presumed/implied consent?
The patient's consent should only be
"presumed", rather than obtained, in
emergency situations when the patient is
unconscious or incompetent and no surrogate
decision maker is available.
Contd.
18. The patient's presence in the hospital ward,
ICU or clinic does not represent implied
consent to all treatment and procedures
While the principle of autonomy and the
principle of beneficence have to be balanced
in emergency situations
19. Who has the authority to make
decisions for children?
Parents
This includes the right to refuse or
discontinue treatments, even those that
may be life-sustaining.
20. Parental decision-making should be guided by
the best interests of the child.
Decisions that are clearly not in a child's best
interest can and should be challenged.
21. Confidentiality is a set of rules or a promise
that limits access or places restrictions on
certain types of information
Medical Confidentiality
Confidentiality is commonly applied to
conversations between doctors and patients.
Legal protections prevent physicians from
revealing certain discussions with patients,
even under oath in court
22. Traditionally, medical ethics has viewed the
duty of confidentiality as a relatively non-
negotiable tenet of medical practice.
In the UK information about an individual's
HIV status is kept confidential within the
NHS. This is based in law, in the NHS
Constitution and in key NHS rules and
procedures.
23. A healthcare worker can share personal
information without consent if it is in the
public interest.
These instances are set out in guidance
from the General Medical Council which is
the regulatory body for doctors.
Sometimes the healthcare worker has to
provide the information - if required by law or
in response to a court order.