The document discusses ethics in clinical trials and outlines several key principles:
1) Research should be essential and benefit patients, health care, and the environment.
2) Participants must provide informed consent and can withdraw at any time without penalty.
3) Participants should not be exploited and must be compensated for any risks.
4) Privacy and confidentiality of participant data must be maintained.
5) Precautions must be taken to minimize all risks to participants.
ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTSjyothibhat21
This presentation highlights the regulations on Ethical requirements for conducting clinical research in India. This is the guiding regulation for the Ethics Committees in India.
The viewers are requested to give their feedback on the utility of the presentation.
ETHICS COMMITTEE
MEMBERS OF ETHICS COMMITTEE
SOME ETHICS COMMITTEE AROUND THE WORLD
What authority does EC/IRB have?
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.
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An overview of ICH-GCP guidelines of clinical trials.
Good clinical practice (GCP): a standard for the design , conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
ICH-GCP is an International Conference on Harmonization Good Clinical Practice.
The guideline was developed with consideration of the current good clinical practices of the European union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the world health organization
ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTSjyothibhat21
This presentation highlights the regulations on Ethical requirements for conducting clinical research in India. This is the guiding regulation for the Ethics Committees in India.
The viewers are requested to give their feedback on the utility of the presentation.
ETHICS COMMITTEE
MEMBERS OF ETHICS COMMITTEE
SOME ETHICS COMMITTEE AROUND THE WORLD
What authority does EC/IRB have?
.
.
.
FOR ENROLLMENT CALL US ON - 9028839789
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
FACEBOOK- https://www.facebook.com/pristynsolutions
INSTAGRAM- https://www.instagram.com/pristyn_res...
TWITTER- https://twitter.com/Pristynresearch
SLIDESHARE- https://www.slideshare.net/azherkhan5916
LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
An overview of ICH-GCP guidelines of clinical trials.
Good clinical practice (GCP): a standard for the design , conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
ICH-GCP is an International Conference on Harmonization Good Clinical Practice.
The guideline was developed with consideration of the current good clinical practices of the European union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the world health organization
Describes in detail definition, purpose, participants and goal of good clinical practices (GCP). Gives history of GCP staring form Nuremberg code in 1948 to implementation of GCP guidance via WHO handbook in 2005. Also describes Nuremberg's code, declaration of Helsinki and Thirteen principles of GCP.
Roles and Responsibilities of sponsor, CRO, and investigator MOHAMMEDSALEEMJM
This slide mainly includes Roles and responsibilities of sponsor CRO and Investigator in Ethical conduct of Clinical Research as per ICH GCP Guidelines
Required mainly for Regulatory affairs students
“CSR is a detailed regulatory document which gives the information about the methods and results (related to efficacy and safety) of a clinical trial. CSRs are created as a part of the process of submitting applications to the Regulatory Authorities for new medical treatments and for its approval. CSRs can be full, abbreviated, synopsis, supplementary, observational etc as per the results and requirements”.
Investigator: A person responsible for the conduct of the study at the trial site.
Investigator is a person responsible for the rights, health and welfare of the study subjects.
This presentation is a brief overview of ICH-GCP guidelines. Although ICH-GCP is a very vast topic, still this presentation will cover almost all the points. The reader will be able to discuss about the roles and responsibilities of various personnel in clinical trials.
Describes in detail definition, purpose, participants and goal of good clinical practices (GCP). Gives history of GCP staring form Nuremberg code in 1948 to implementation of GCP guidance via WHO handbook in 2005. Also describes Nuremberg's code, declaration of Helsinki and Thirteen principles of GCP.
Roles and Responsibilities of sponsor, CRO, and investigator MOHAMMEDSALEEMJM
This slide mainly includes Roles and responsibilities of sponsor CRO and Investigator in Ethical conduct of Clinical Research as per ICH GCP Guidelines
Required mainly for Regulatory affairs students
“CSR is a detailed regulatory document which gives the information about the methods and results (related to efficacy and safety) of a clinical trial. CSRs are created as a part of the process of submitting applications to the Regulatory Authorities for new medical treatments and for its approval. CSRs can be full, abbreviated, synopsis, supplementary, observational etc as per the results and requirements”.
Investigator: A person responsible for the conduct of the study at the trial site.
Investigator is a person responsible for the rights, health and welfare of the study subjects.
This presentation is a brief overview of ICH-GCP guidelines. Although ICH-GCP is a very vast topic, still this presentation will cover almost all the points. The reader will be able to discuss about the roles and responsibilities of various personnel in clinical trials.
When a new drug/device/surgical procedure/treatment or other potential medical innovation is developed it must be thoroughly tested to ensure that it is safe and does what it is supposed to be.
This presentation will provide a basic overview of clinical research process.
The Declaration of Helsinki is a set of ethical principles and guidelines for medical research involving human subjects. It was first adopted by the World Medical Association (WMA) in 1964 and has been revised multiple times, with the most recent version released in 2013. The Declaration provides a framework to protect the rights, safety, and well-being of individuals participating in research studies. Here are the key elements of the Declaration of Helsinki:
Respect for Autonomy and Informed Consent: The Declaration emphasizes the importance of respecting the autonomy of individuals and their right to make informed decisions about participating in research. It requires researchers to obtain informed consent from participants or their legally authorized representatives, ensuring they have been adequately informed about the study's purpose, procedures, potential risks and benefits, and their right to withdraw at any time.
Beneficence and Risk Assessment: Researchers have a responsibility to maximize potential benefits and minimize potential harm to research participants. The Declaration states that research protocols should be based on a thorough scientific assessment of risks and benefits and should prioritize the well-being of participants.
Ethical Review and Approval: The Declaration highlights the necessity of independent ethical review of research protocols by an appropriate research ethics committee or institutional review board (IRB). The committee should ensure that the study is scientifically valid, ethically sound, and compliant with relevant regulations and guidelines.
Privacy and Confidentiality: The Declaration emphasizes the importance of protecting the privacy and confidentiality of research participants. Researchers should ensure that participants' personal information is kept confidential, and data should be anonymized or pseudonymized whenever possible to protect participant identities.
Data and Safety Monitoring: The Declaration emphasizes the importance of ongoing data monitoring and safety assessments during the research study. Researchers should have plans in place to detect and manage any adverse events or unanticipated risks that may arise during the study.
Vulnerable Populations: Special protections are outlined for vulnerable populations, such as children, pregnant women, prisoners, and individuals with impaired decision-making capacity. Researchers should take extra precautions to ensure their well-being, and their involvement in research should be justified based on the potential benefits to their own population.
Publication and Dissemination of Results: The Declaration emphasizes the responsibility of researchers to publish and share the results of their research in a timely manner. The results should be accurately reported, and negative or inconclusive results should also be disseminated to prevent publication bias.
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In the ethics section, you'll gain insights into crucial principles like fairness, letting people choose, doing good, and ensuring research is managed properly. These principles—justice, respect for autonomy, beneficence, and research governance—are particularly important for individuals involved in coordinating clinical trials or academic research. It's not just about being skilled; it's about doing things right and knowing why.
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The Declaration of Helsinki is a set of ethical principles and guidelines for conducting medical research involving human subjects. It was adopted by the World Medical Association (WMA) in 1964 and has been revised multiple times since then, with the most recent revision occurring in 2013.
The Declaration of Helsinki outlines several key principles and considerations for researchers and physicians involved in human research, with a focus on protecting the rights, safety, and well-being of research participants. Some of the core principles and points covered in the Declaration of Helsinki include:
Informed Consent: Research participants must provide voluntary, informed, and written consent to participate in a study. They should be fully informed about the nature of the research, its purpose, risks, benefits, and alternatives.
Beneficence and Non-Maleficence: Researchers should aim to maximize the benefits of research while minimizing harm to participants. The well-being of the research subjects should be the primary concern.
Research Ethics Committee Review: All research involving human subjects should undergo ethical review by an independent committee. This review ensures that the study meets ethical and scientific standards.
Scientific Validity and Ethical Conduct: Research should be scientifically rigorous and designed to answer important questions. Researchers must conduct their work with integrity and honesty.
Privacy and Confidentiality: Participants' privacy should be protected, and their data should be kept confidential. Personal information should not be disclosed without informed consent.
Equitable Distribution of Benefits and Burdens: Research should benefit society, and the selection of research subjects should be fair, without exploitation or discrimination.
Continuing Review: Ethical review of research should continue throughout the duration of the study, with particular attention to any new information that may affect the research's ethical considerations.
Access to Medical Care: Participants should have access to medical care and treatment, and they should be compensated for any injuries resulting from their participation in research.
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects.
Source: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
Addressing Data Security and Privacy Concerns in Clinical ResearchClinosolIndia
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Ethics in clinical trials
1. ETHICS IN CLINICAL TRIALS
Dr Urmila M. Aswar
Department of Pharmacology, SIOP, Narhe
2. Principle of essentiality
• The research being carried out should be
essential for the advancement of knowledge
that benefits patients, doctors and all others
in aspects of health care and also for the
ecological and environmental well being of the
planet.
3. Principles of voluntariness, informed
consent and community agreement
The research participant should be aware of the
nature of research and the probable consequences
of the experiments and then should make a
independent choice without the influence of the
treating doctor, whether to take part in the research
or not.
When the research treats any community or group of
persons as a research participant, these principles of
voluntariness and informed consent should apply to
the community as a whole and also to each
individual member who is the participant of the
research or experiment.
4. Principle of non-exploitation
Research participants should be remunerated for
their involvement in the research or experiment.
The participants should be made aware of all the
risks involved irrespective of their social and
economic condition or educational levels
attained.
Each research protocol should include provisions
of compensation for the human participants
either through insurance cover or any other
appropriate means to cover all fore seeable and
hidden risks.
5. Principle of privacy and
confidentiality
All the data acquired for research purpose
should be kept confidential to prevent
disclosure of identity of the involved
participant and should not be disclosed
without valid legal and/or scientific reasons.
6. Principle of precaution and risk
minimization
• Due care and caution should be taken at all stages
of the research and experiment (from its
beginning as a research idea, formulation of
research design/ protocol, conduct of the
research or experiment and its subsequent
applicative use) to prevent research participant
from any harm and adverse events.
• EC has to play an active role in risk minimization.
7. Principle of professional competence
Clinical research should be carried out only by
competent and qualified persons in their
respective fields.
8. Principle of accountability and
transparency
• The researcher should conduct experiments in
fair, honest, impartial and transparent manner
after full disclosure of his/her interests in
research.
• They should also retain the research data, subject
to the principles of privacy and confidentiality, for
a minimum period of 5 years, to be scrutinized by
the appropriate legal and administrative
authority, if necessary.
9. Principle of the maximization of the
public interest and of distributive
justice
The results of the research should be used for
benefit of all humans, especially the research
participants themselves and/or the
community from which they are drawn and
not only to those who are socially better off.
10. Principle of institutional
arrangements
It is required that all institutional
arrangements required to be made in respect
of the research and its subsequent use or
applications should be duly made in
transparent manner.
11. Public domain
The results of any research work done should
be made public through publications or other
means. Even before publication, the detailed
information of clinical trials should be made
public before start of recruitment via clinical
trial registry systems that allow free online
access
like: www.ctri.in/; www.actr.org.au/; www.clin
icaltrials.gov/ or www.isrctn.org/.
12. Principle of totality of responsibility
All those directly or indirectly connected with
the research should take the professional and
moral responsibility, for the due observance of
all the principles, guidelines or prescriptions
laid down in respect of the research.
13. Principle of compliance
All those associated with the research work should
comply by the guidelines pertaining to the specific area
of the research.
For research to be conducted ethically we need to
follow general principles laid down by the ICMR.
In order to follow these principles one should be
aware about the informed consent process, vulnerable
population, therapeutic misconception, post trial
access and structure and role of ethics committees.
These concepts hold special importance in developing
countries like ours, as most of the research participants
are uneducated and economically backwards.
14. Informed Consent Form (ICF)
• A well-documented informed consent is the hallmark of any
ethical research work.
• It is the responsibility of the investigator/researcher to
obtain the informed consent of the prospective participant
or in the case of an individual who is not capable of giving
informed consent, the consent of a legal guardian.
• Informed consent respects individual's autonomy to
participate or not to participate in research.
• Adequate information about the research is given in a
simple and easily understandable vernacular language in a
document known as the ‘Participant/Patient Information
Sheet’ attached along with the ‘Informed Consent Form
(ICF)’.
15. ICF should include
• A statement that the study involves research;
• An explanation of the purpose of the research and the expected
duration of the subject's participation;
• A description of the procedures to be followed and identification
of any procedures which are experimental;
• A description of any reasonably foreseeable risks or discomforts
to the subjects;
• A description of any benefits to the subjects or to others which
may reasonably be expected from the research;
• Trial treatment schedule(s) and the probability for random
assignment to each treatment (especially in randomized placebo
controlled trials);
• A disclosure of appropriate alternative procedures or courses of
treatment
16. ICF
• For research involving more than minimal risk,
an explanation as to whether any
compensation and an explanation as to
whether any medical treatments are available
if injury occurs and, if so, what they consist of,
and where further information may be
obtained; an explanation of whom to contact
for answers
17. ICF
• It involves a statement that participation is
voluntary and refusal to participate will
involve no penalty or loss of benefits to which
the subjects are otherwise entitled, also the
subjects may discontinue participation at any
time without penalty or loss of benefits.
18. ICF
• The ICF should specify that the participant has
read and understood the patient information
sheet.
• The results arising from the study can be used
only for scientific purposes and he voluntarily
agrees to take part in the study.
• ICF should have space for signature/thumb print
of the participant, the principal investigator, a
witness and a legally acceptable representative
when required.
19. VULNERABLE POPULATION
Defn: Persons who are relatively or absolutely
incapable of protecting their own interests are
termed as vulnerable research population.
• Egs: The very poor, illiterate
patients, children, individuals with
questionable capacity to give consent
(including psychiatric
patients), prisoners, foetuses, pregnant
women, terminally ill
patients, students, employees, comatose
patients, tribals and the elderly.
20. Cont..
• It is the responsibility of the EC to see whether
the inclusion of vulnerable populations in the
study is justifiable, shd not be exploited.
• EC should consult the representative of
vulnerable population,
• Research is only justified if it is responsive to the
health needs and priorities of vulnerable
population or community and if population or
community would be benefited from the
research.
21. THERAPEUTIC MISCONCEPTION
• A patient coming to a physician may misinterpret and
enrol in a research study .
• He may think it to be routine medical care without
understanding the experimental nature of the
treatment given.
• He may misinterpret the information given about the
research, such that he believes that aspects of the
research will directly benefit him.
• Duty of Investigator to avoid therapeutic
misconception.
• IC should clarify every aspect.
22. Cont…
• The purpose of randomized controlled trials
(RCTs), random selection of treatment,
masking of treatment, meaning and rationale
of placebo, restrictions on treatment flexibility
and how treatment decision making differs in
RCTs compared with routine medical care.
Thus to safeguard the ethical rights of the
participants therapeutic misconception needs
to be taken care of.
23. POST-TRIAL ACCESS
• The concept of post trial access holds special
importance for clinical research works in the
less developed countries.
• The Helsinki Declaration states that at the end
of the trial, every participant should be
assured of access to the best proven
prophylactic, diagnostic and therapeutic
methods identified by the study.
24. Cont….
• it is necessary during the study planning
process to identify post-trial access by study
participants to prophylactic, diagnostic and
therapeutic procedures identified as beneficial
in the study or access to other appropriate
care. Post-trial access arrangements or other
care must be described in the study protocol
so that ethical review committee may
consider such arrangements during its review.
25. Cont….
• Benefit in indirect way through improving
their living conditions, establishing counseling
centers, clinics or schools and giving education
on maintaining good health practices.
26. ETHICS COMMITTEE
• The first appearance of need of ethics committee
(EC) was made in Declaration of Helsinki in 1964,
while in India it appeared in 1980 in the ICMR
Policy Statement
• Institutional Review Board/ Ethics Review Board
stands as the bridge between the researcher and
the ethical guidelines of the country
• Every institute, where research is going on should
have its own EC with its head preferably from
outside the institute.
27. • The ECs should have independence from
political, institutional, professional, and
market influences, in their
composition, procedures, and decision-
making.
• As there are no laws governing the
registration, formation or working of ethics
committees in India, each ethics committee
should have their own standard operating
procedures for proper functioning.
28. Responsibilities: EC
• Review of proposed research before the
commencement of the research
• Independent, competent and timely review of
all ethical aspects of the project proposals
received.
• Safeguard the dignity, rights, safety and well-
being of all actual or potential research
participants
29. Responsibilities
• The appropriateness of the study design in
relation to the objectives of the study.
• The statistical methodology (including sample
size calculation).
• The potential for reaching sound conclusions
with the smallest number of research
participants should be assessed.
30. Responsibilities
• The EC should also look into matters like Informed
consent process.
• Qualifications of Principal investigator and supporting
staff, adequacy of infrastructure and facilities,
• Risk benefit ratio, plans to maintain confidentiality and
plans for post trial access and compensations.
• They also need to ensure that there is regular
evaluation of the ongoing studies.
• EC is the most important check point for promoting
ethical research in the country.
31. Members of EC
• The establishment of EC requires 5-15 members with at
least 1.
• one basic medical scientist (preferably one
pharmacologist),
• one clinician,
• a legal expert,
• a social scientist / representative of NGO / philosopher
or theologian and
• a lay person from the community.
Poor science is Poor ethics
32. Some related issue in India
• India have formulated many ethical guidelines for
clinical research, are we adequately following them?
The answer is ‘No’.
• This is because the ethical guidelines in India are just
the recommendations and not a law.
• Guidelines sd be made in law, as has been done in US
and other countries of the world.
• Another issue lies with the training of doctors and
research scientists in our institutions. Doctors are
specially trained to be good clinicians but are never
taught even the fundamentals of ethical clinical
research.