NAME :- SARTHAK PRIYANK VERMA

CLASS :- BBA DS (1ST YEAR)

REG NO :- 2220914
SUBJECT :- SEC-3
TOPIC :- REVIEWING ONE CURRENT ARTICLE
 LEGAL AND ETHICAL ISSUES IN
RESEARCH

INTRODUCTION
Legal and ethical issues form an important component of modern research, related to the
subject and researcher. Policymakers, attorneys, scientists, and clinicians have been
concerned for a long time about the ethical and legal issues pertaining to the conduct of
clinical research involving human participants.
In this post, we'll quickly go through the moral and legal concerns that arise when recruiting
people to participate in research, the fundamentals of informed consent, and safety measures
to be taken when publishing results from clinical studies. The protection of human subjects,
defining roles for sponsors and investigators, monitoring and auditing processes, and
defining responsibilities for consent processes are some of the fundamental GCPs in
research.

ISSUES RELATED TO THE RESEARCH PARTICIPANTS

Human participants in research are primarily used as data sources. Protecting the "life,
health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal
information of study subjects" is the responsibility of researchers.
THREE ETHICAL PRINCIPLES :-
• Respect for people - the obligation to recognise autonomy and safeguard those
with weakened autonomy
• Beneficence - is the principle of first doing no harm, then maximising
Benefits and minimising risks.
• Justice - On a personal and societal level, justice.

After this also, there is also a scientific misconduct involving fraud and deception which are
as follows :-
CONSENT, POSSIBILITY OF CAUSING HARM
After receiving full information about the trial that is pertinent to their decision to
participate, subjects voluntarily confirm their willingness to take part through the process of
informed consent. Informed consent forms for clinical trials and research studies must
include additional pertinent information due to the primary purpose being research-centered
rather than patient-centered.

SPECIAL POPULATIONS
If a potential research subject is unable to give informed consent, informed consent may be
requested from a legally recognised representative. Such populations must be included if
they stand to gain from the study's findings. The term "legally authorised representative" can
refer to a spouse, close relative, parent, a power of attorney, or a guardian who has been
appointed by the court. Local regulations should be consulted because the hierarchy of
priority of the representative may vary between nations and between regions even within the
same nation.

SPECIAL CASE: EMERGENCY RESEARCH

Occur when potential subjects are unable to give informed consent due to their incapacity.
INCLUDING a legal authority to give consent should have been the subject of reasonable
efforts. If there is not enough time, a "exception to informed consent" may be used to enrol
the subject after receiving prior ethical committee approval. And I think that it must obtain
deferred informed consent as soon as possible from the subject (when regains capacity), or
their legally authorised representative, for continued participation

COLLECTING PATIENT INFORMATION AND SENSITIVE PERSONAL

INFORMATION, CONFIDENTIALITY MAINTENANCE
The Health Insurance Portability and Accountability Act has standards for electronic
exchange, privacy, and information security, as well as requirements for informed consent
disclosure. Written informed consent must be sought where identifying information is
required for scientific purposes (such as clinical pictures), and the patient must be given the
paper before publishing. It is also important to let subjects know whether any potentially
identifiable information might be accessible through media access.
PROVIDING INCENTIVES
When getting informed consent, participants should be made aware of any financial or other
"in-kind" benefits without placing an undue focus on them.
Benefits may be used to show gratitude or compensate for time and effort, but they shouldn't
be used as an incentive to participate.
The type and quantity of compensation should be compared to social standards, cultural
customs, and ethical committee review.

CONCLUSION
Concerns over ethical and legal difficulties have arisen as a result of the recent growth in
research efforts. Organizations and authorities have developed a number of principles that
act as a roadmap for promoting honesty, compliance, and ethical standards in the conduct of
research. Research fraud degrades the standard of developing evidence-based medicine, and
measures should be taken to stop such behavior. The conduct of research in accordance with
best practises will be made possible by a general understanding of ethical and legal
principles.

REFERENCES
• http://www.ich.org/products/guidelines/efficacy/efficacy-
single/article/goodclinical-practice.html
• http://www.cdsco.nic.in/html/GCP1.html ; http://www.cdsco.nic.in/forms/li
st.aspx?lid=1843&Id=31 .
• http://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
• http://www.councilscienceeditors.org/wp.content/uploads/entire_whitepape
r.pdf . [Google Scholar]
• http://www.cioms.ch/publications/layout_guide2002.pdf
• http://www.legislation.gov.uk/ukpga/1998/29/introduction
• http://www.wame.org/about/recommendations-on-publication-
ethicspolicie#Plagiarism
• http://www.crossref.org/crosscheck/index.html