ADDRESSING ETHICAL
ISSUES IN CLINICAL
RESEARCH.
PREPARED BY;- MS.QURATULAIN
WASEEM
Ethical issues in clinical research
INTRODUCTION
Ethical issues in clinical research refer to
moral challenges and concerns that
arise during the design, conduct, and
reporting of studies involving human
participants. These issues revolve
around ensuring participant safety,
informed consent, data integrity,
and fairness while balancing scientific
progress with ethical responsibility.
Ethical issues in clinical
research
Ethical issues in clinical research,focuses
on balancing scientific progress with the
protection of human subjects. Here are
some key ethical concerns they address:
Informed Consent
Risk-Benefit Analysis
Selection of Participants
Conflict of Interest
Institutional Review Board (IRB) .
Data Integrity and Scientific
Misconduct
Special Considerations in Global
Research
1. Informed Consent
1. Informed Consent
One of the fundamental ethical principles in clinical research is
ensuring that participants provide informed, voluntary, and
comprehensible consent. Challenges include:
Understanding: Patients must receive clear explanations of the study’s
purpose, risks, benefits, and procedures. However, complex medical
jargon can make this difficult.
Vulnerable Populations: Special attention is required for individuals
unable to give full consent (e.g., children, cognitively impaired
individuals, prisoners). Surrogate decision-makers may be required.
Coercion and Undue Influence: Offering excessive financial
incentives or making participation a condition for medical treatment
may compromise voluntary consent.
CONT.
Solutions:
Use plain language in consent forms.
Provide interpreters and patient advocates for
non-English speakers.
Ensure independent review of consent procedures
by ethics committees.
Risk-Benefit Analysis
Risk-Benefit Analysis
Researchers must balance the potential benefits of a
study with the risks participants face. Ethical concerns
include:
Unnecessary Risks: Studies should not expose
participants to risks unless scientifically justified.
Overestimating Benefits: Researchers may
exaggerate potential benefits to encourage
participation.
Therapeutic Misconception: Participants may
misunderstand research as personal treatment rather
than an experiment.
CONT.
Solutions:
Conduct rigorous ethical review by
Institutional Review Boards (IRBs) to
assess risk-benefit balance.
Ensure participants understand that
research is not guaranteed treatment.
Use continuous consent processes
where participants are updated on risks
throughout the study
3. Fair Selection of Participants
Fair Selection of Participants
Ethical research requires that participant recruitment
be just and equitable, avoiding exploitation or
unfair burden on certain populations. Concerns
include:
Overuse of disadvantaged populations: Poor
and marginalized groups are often targeted for
high-risk studies because they are easier to
recruit.
Exclusion of certain groups: Historically, women,
minorities, and older adults were often excluded
from research, leading to biased medical findings.
CONT
Solutions:
Follow fair selection guidelines (e.g.,
Belmont Report, CIOMS).
Ensure that recruitment reflects the
broader patient population.
Avoid placing excessive burdens on
vulnerable communities without
equitable benefits
4.Conflict of Interest
(COI
Conflict of Interest (COI)
Researchers and institutions may face financial or
professional pressures that bias research. Ethical
concerns include:
Industry Funding: Pharmaceutical companies may
fund studies that favor their products, leading to
biased results.
Dual Roles: Physicians involved in research may
pressure patients to participate.
Personal Gains: Researchers with patents or
financial stakes in a treatment may have
incentives to manipulate results.
CONT.
Solutions:
Full disclosure of conflicts of interest
in publications.
Independent data monitoring
committees to oversee research.
Separation of research and clinical
care roles to prevent physician coercion
5. Institutional Review Board (IRB) Oversight
Institutional Review Board (IRB)
Oversight
IRBs (also called Ethics Committees) review and
approve research to ensure it meets ethical and legal
standards. Ethical concerns include:
Inadequate Review: Some IRBs may conduct
superficial reviews or lack expertise in complex cases.
Regulatory Loopholes: International studies may
bypass strict regulations by operating in countries
with weak oversight.
Delays and Bureaucracy: Overly strict IRB
requirements can slow critical research.
CONT.
Solutions:
Strengthen IRB training and
independent audits of research.
Encourage community representation
in ethics committees.
Streamline ethical reviews while
maintaining high standards.
6. Data Integrity and Scientific Misconduct
6. Data Integrity and Scientific
Misconduct
Maintaining accurate, honest, and transparent data is critical in research. Ethical concerns include:
Fabrication and Falsification: Manipulating or inventing data to produce favorable results.
Selective Reporting: Only publishing positive results while hiding negative findings (publication
bias).
Plagiarism: Using others’ research without proper attribution.
7. Global Research Ethics
When conducting clinical trials in low-resource settings, researchers must ensure ethical fairness,
cultural sensitivity, and local benefit. Key issues include:
Exploitation of Developing Countries: Studies are sometimes conducted in countries with lax
regulations and poor legal protections.
Lack of Post-Trial Access: Participants often cannot access the tested drug after the study ends.
Informed Consent Challenges: Language barriers, low literacy, and different cultural norms
complicate informed consent.
Solutions:
Ensure trials are beneficial to the local population (e.g., capacity building, affordable access to
treatment).
Obtain community consent alongside individual informed consent.
Conduct independent ethical reviews in both the home and host countries.
CONT.
Solutions:
Enforce strict peer review and data
transparency policies.
Require researchers to pre-register
trials to prevent selective reporting.
Impose severe penalties for
misconduct (e.g., funding bans,
professional disqualification).
7. Global Research Ethics
Global Research Ethics
When conducting clinical trials in low-resource settings,
researchers must ensure ethical fairness, cultural
sensitivity, and local benefit. Key issues include:
Exploitation of Developing Countries: Studies are
sometimes conducted in countries with lax
regulations and poor legal protections.
Lack of Post-Trial Access: Participants often cannot
access the tested drug after the study ends.
Informed Consent Challenges: Language barriers,
low literacy, and different cultural norms complicate
informed consent.
CONT.
Solutions:
Ensure trials are beneficial to the local
population (e.g., capacity building,
affordable access to treatment).
Obtain community consent alongside
individual informed consent.
Conduct independent ethical reviews
in both the home and host countries.
