The document discusses various topics related to medical ethics and research involving human subjects, including:
1. Historical events that shaped ethical guidelines like the Nuremberg Code and Declaration of Helsinki.
2. The structure and functions of Institutional Ethics Committees, including their role in reviewing research proposals and providing oversight.
3. Key principles of ethical research like informed consent, minimizing risks, and protecting participant privacy and welfare.
4. Issues around informed consent processes and the review of research by ethics committees.
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
Presentation on Roles and Responsibilities of sponsor in conducting clinical trials as per GCP-ICH for pursuing a subject in the course of PharmD programme under RGUHS
Lets, just get to know more about safety reporting in clinical trails with some terminologies, reporting requirements of ADR, compensations involved and finally the role of ethics committee in it,
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.
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
Presentation on Roles and Responsibilities of sponsor in conducting clinical trials as per GCP-ICH for pursuing a subject in the course of PharmD programme under RGUHS
Lets, just get to know more about safety reporting in clinical trails with some terminologies, reporting requirements of ADR, compensations involved and finally the role of ethics committee in it,
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.
SAE REPORTING TIMELINE AND COMPENSATION 2019Shweta Lal
This presentation is based on New Drug and Clinical Trial Rule 2019 which was published in 19 march 2019. I have described chapter VI ( compensation) and Seventh Schedule including SAE reporting timeline in India.
Amendments in Schedule Y in 2013,2014 inserted three new rules, new appendix XII: compensation in case of injury or death during clinical trial, amendments in ICD and appendix V inform consent form format.
Role & responsibilities of a clinical research coordinatorRadhika Nagare
Clinical Research Coordinator (CRC) is a specialized research person working with and under the direction of the Principal Investigator .While the Principal Investigator(PI) is primarily responsible for the overall designing, conducting, and management of the clinical trial, the CRC supports, and coordinates the regular clinical trial activities and plays a crucial role in the conduct of the study. By doing these duties, the CRC works with the PI, sponsor ,department, and institution to support and provide guidance on every related aspects of the study.
SAE REPORTING TIMELINE AND COMPENSATION 2019Shweta Lal
This presentation is based on New Drug and Clinical Trial Rule 2019 which was published in 19 march 2019. I have described chapter VI ( compensation) and Seventh Schedule including SAE reporting timeline in India.
Amendments in Schedule Y in 2013,2014 inserted three new rules, new appendix XII: compensation in case of injury or death during clinical trial, amendments in ICD and appendix V inform consent form format.
Role & responsibilities of a clinical research coordinatorRadhika Nagare
Clinical Research Coordinator (CRC) is a specialized research person working with and under the direction of the Principal Investigator .While the Principal Investigator(PI) is primarily responsible for the overall designing, conducting, and management of the clinical trial, the CRC supports, and coordinates the regular clinical trial activities and plays a crucial role in the conduct of the study. By doing these duties, the CRC works with the PI, sponsor ,department, and institution to support and provide guidance on every related aspects of the study.
Ethical Issues in Traditional and Alternative Medicine (TAM) , By Dr. Pathir...Kamal Perera
Invited guest speaker and resource person-
Topic: Ethical Issues in Traditional and Alternative Medicine (TAM)
For Human Subject Protection Course (ER) Colombo , Forum for Ethical Review Committees in Asia and the Western Pacific In Collaboration with the Sri Lankan Medical Association and the National Science Foundation of Sri Lanka, 4-6 August 2014
Introduction
Historical background
Sections
Principles
Ethics committee
Responsibilities of sponsor, investigator and monitor
Investigator brochure
Informed consent process
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines provide internationally recognized standards for the design, conduct, monitoring, recording, analysis, and reporting of clinical trials involving human subjects. These guidelines aim to ensure that the rights, safety, and well-being of trial participants are protected and that the clinical trial data generated is credible and reliable.
Key components of the ICH-GCP guidelines include:
Investigator Responsibilities: The guidelines define the responsibilities of the investigator, who is typically a qualified physician overseeing the conduct of the trial at a study site. This includes ensuring that the trial is conducted in compliance with the protocol, maintaining the confidentiality of participant data, and reporting adverse events and other relevant information promptly.
Ethics Committee/Institutional Review Board (IRB) Oversight: The guidelines stress the importance of independent ethics committees or IRBs in reviewing and approving the trial protocol, providing ongoing oversight, and protecting the rights and well-being of trial participants.
Informed Consent: The guidelines emphasize the importance of obtaining informed consent from each trial participant. Informed consent is a process that involves providing participants with relevant information about the trial, its purpose, potential risks and benefits, and any alternative treatments, enabling them to make an informed decision about participation.
Safety Reporting: The guidelines outline procedures for monitoring and reporting adverse events and any other safety concerns that arise during the course of the trial. Safety reporting ensures that potential risks to participants are identified and communicated appropriately.
Data Integrity: The guidelines emphasize the need for accurate and reliable data collection, recording, and reporting. This includes maintaining source documents and case report forms, as well as implementing data quality control measures.
Quality Assurance and Quality Control: The guidelines highlight the importance of quality assurance and quality control measures to ensure that the trial is conducted in compliance with the protocol, applicable regulations, and Good Clinical Practice.
Monitoring of Clinical Trials: The guidelines stress the need for systematic monitoring of the trial's progress to ensure that it is conducted in compliance with the protocol, applicable regulations, and Good Clinical Practice. Monitoring activities may include on-site visits, source data verification, and assessment of trial conduct.
..
Overall, the ICH-GCP guidelines provide a framework for the ethical and scientific conduct o
Role of IRB and IEC in Safeguarding the Subjects in Clinical TrialsClinosolIndia
In clinical research, the protection of human subjects is of utmost importance to ensure ethical conduct and adherence to regulatory standards. Two key entities responsible for safeguarding the rights, safety, and well-being of subjects in clinical trials are Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs). They play essential roles in the oversight and ethical review of clinical research protocols. Here's a breakdown of their roles in safeguarding clinical trial subjects:
Institutional Review Boards (IRBs):
Ethical Review: IRBs are responsible for conducting an ethical review of research protocols to ensure that the study is designed and conducted in an ethical and morally sound manner. They assess the study's potential risks, benefits, and the protection of subjects' rights.
Informed Consent: IRBs review and approve the informed consent process to ensure that subjects are provided with comprehensive and understandable information about the study, including its purpose, procedures, risks, and benefits. They assess the adequacy of the informed consent document.
Risk-Benefit Assessment: IRBs assess the risks and potential benefits of the research to determine whether they are balanced and reasonable. They weigh the scientific and societal value of the research against the risks posed to subjects.
Subject Recruitment and Selection: IRBs review the methods and materials used for subject recruitment and selection to ensure that they are non-coercive, fair, and do not discriminate against vulnerable populations.
Continual Oversight: IRBs provide ongoing oversight of approved studies. They monitor the progress of research, ensuring that it adheres to the approved protocol and that any deviations or adverse events are appropriately reported and addressed.
Conflict of Interest: IRBs evaluate potential conflicts of interest among researchers, ensuring that financial or non-financial interests do not compromise the rights or safety of research subjects.
Privacy and Confidentiality: IRBs assess how subjects' privacy and confidentiality will be protected, particularly in studies involving sensitive information or data.
Emergency Use of Investigational Products: In cases of emergency use of investigational products, IRBs may provide authorization, ensuring that the use is in the best interest of the subject.
This presentation focuses on Institutional Review Board/ Institutional Ethics Committee, Informed Consent Form and Protocol for a Research. The responsibilities of various personals have also been covered.
Significance and formalities of ethics committees for Clinical ResearchRaktimavaDasSarkar
Clinical research plays a pivotal role in advancing medical knowledge, developing
new treatments, and improving patient care. However, with these advancements
come ethical responsibilities to ensure the safety, dignity, and rights of research
participants are protected.
the all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Assignment on Regulatory Prespectives of Clinical TrialsDeepak Kumar
Assignment on Origin and Principles of International Conference on Harmonization - Good Clinical Practice, (ICH-GCP) guidelines Ethical Committee- Institutional Review Board, Ethical Guidelines for Biomedical Research and Human Participant-Schedule Y, ICMR
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provide assurance that the data and the reported results are credible (able to be believed), accurate and that the rights, integrity and confidentiality of trial subjects are protected.
A well-established hospital is frequently approached by pharmaceutical industry to conduct research on human subjects, for their products and / or for new drug and new formulation.
Even doctors in the hospitals have a keen desire to investigate some of their new ideas by experimenting on the patients.
For all such research involving human subjects in hospital should be routed through an important committee called , 'research and ethics committee' or simply 'independent ethics committee (IEC).
All research involving human subject should be conducted in accordance with ethical principle contained in the current revision of 'declaration of helsinki'.
The declaration is based on three basic considerations namely, justice, respect for persons and to maximize benefits and to minimize harms.
Similar to Institutional ethics committee & informed consent (20)
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LGBTQ+ Adults: Unique Opportunities and Inclusive Approaches to CareVITASAuthor
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The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
5. HISTORY 1000 BC : Charaka Samhita
to 1-2 AD
1947 : Nuremberg Code
1956 : Code of Medical Ethics, MCI
1964 : Helsinki Declaration
1979 : Belmont Report
1980 : Policy Statement on Ethical Considerations
involved in research on Human Subject (ICMR)
1982/1992 : Proposed International Guidelines
(WHO/CIOMS)
1988 : Schedule Y
1997 : Guidelines for Exchange of Human Biological
Material for Biomedical Research Purposes
2000 : Revised ICMR Ethical guidelines
2001 : Indian GCP Guidelines
6. INTRODUCTION
GENERAL STATEMENT
Medical and related research using human beings as research participants must
necessarily ensure
1. PURPOSE - should be directed towards increase of knowledge about the condition
and for betterment of all human beings.
2. CONDUCT - under conditions of professional fair treatment and transparency, in a
manner consistent with dignity and well being of human subjects.
3. EVALUATION - research must be subjected to evaluation at all stages of the study.
7. GENERAL PRINCIPLES
1. Principles of essentiality
2. Principles of voluntariness, informed consent and community agreement.
3. Principles of non-exploitation.
4. Principles of privacy and confidentiality.
5. Principles of precaution and risk minimisation.
6. Principles of professional competence.
7. Principles of accountability and transparency.
8. Principles of the maximisation of the public interest and of distributive justice.
9. Principles of institutional arrangements.
10. Principles of public domain.
11. Principles of totality of responsibility.
12. Principles of compliance.
8. The need for evaluation of research proposals has been emphasized
under the principle of precaution & risk minimisation.
It is mandatory that all proposals on biomedical research involving human
participants should be cleared by an appropriately constituted Institutional
Ethics Committee (IEC), also referred to as Institutional Review Board
(IRB), Ethics Review Board (ERB) and Research Ethics Board (REB) in
other countries, to safeguard the welfare and the rights of the participants.
The Ethics Committees are entrusted not only with the initial review of the
proposed research protocols prior to initiation of the projects but also have
a continuing responsibility of regular monitoring of the approved
programmes to foresee the compliance of the ethics during the period of the
project.
9. INSTITUTIONAL ETHICS COMMITTEE
(IEC)
Committee comprising of medical, non-medical, scientific and
non-scientific members whose responsibility is to ensure the
protection of the rights, safety and well-being of human
subjects involved in the trial and it shall be responsible for
reviewing & approving the protocol, the suitability of the
investigators, facilities, methods & adequacy of information to
be used for obtaining and documenting informed consent of
the study subjects and adequacy of confidentiality safeguards.
10. STRUCTURE OF IEC
Composition:
Multidisciplinary and multi sectorial in composition
Number of persons- 8-12 (not less than 7)
Specific members of IECs:
Chair person should preferably be from outside the
Institution to maintain the independence of the
Committee.
Member secretary, from same institution should conduct
the business of the Committee
11. MEMBERS OF IEC
Chair person
1-2 basic medical scientists
1-2 clinicians from various institutes
One legal expert or retired judge
One social scientist/representative of NG voluntary
agency
One philosopher/ethicist/theologian
One lay person
Member Secretary
12. As per revised Schedule Y of Drugs & Cosmetics Act, 1940, quorum should
consist of:
1. One basic medical scientist (preferably one pharmacologist).
2. One clinician
3. One legal expert or retired judge
4. One social scientist/ representative of non-governmental
organisation/philosopher/ethicist/ theologian or a similar person
5. One lay person from the community.
(EC) can have as its members, individuals from other institutions or
communities with adequate representation of age and gender to safeguard the
interests and welfare of all sections of the community/society.
If required, subject experts could be invited to offer their views. Similarly, based
on the requirement of research area, for example HIV, genetic disorders etc. it is
desirable to include a member from specific patient groups in the Committee.
13. MEMBERSHIP REQUIREMENTS
The members representing medical scientists & clinicians should have post
graduate qualifications.
The duration of appointment is initially for a period of 2-3 years
At the end of 2-3 years, as the case may be, the committee is reconstituted, and
50% of the members will be replaced by a defined procedure.
A member can be replaced in the event of death or long-term nonavailability
A member can tender resignation from the committee with proper reasons to do
so.
All members should maintain absolute confidentiality of all discussions during the
meeting and sign a confidentiality form.
Conflict of interest should be declared by members of the IEC
14. REGISTRATION OF ETHICS COMMITTEE
According to rule 122DD of the recent amendments of Schedule Y – “No ethics
committee shall review and accord its approval to a clinical trial protocol
without prior registration with the licensing authority.”
The registration unless it is suspended or cancelled shall be valid for a period of
three years from the date of issue.
If the ethics committee fails to comply with any of the conditions of registration,
the licensing authority may, after giving an opportunity to show cause, by an
order in writing stating the reasons there for, suspend or cancel the registration
of the ethics committee.
The EC whose registration has been cancelled may within 90 days, appeal to
central govt and central govt after giving an opportunity of being heard, confirm,
reverse or modify such order.
15. FUNCTIONS OF IEC
To provide competent review of all ethical aspects of the research project
Undertake review free from bias and influence
Provide advice to the researchers on all aspects of welfare and safety of
research participants
To protect dignity, rights and well-being of the potential research
participants.
To report all SAE (serious adverse events) to licensing authority.
To provide an opinion on the compensation to research participants, if
any, in case of injury or death during clinical trial
16. DEATH/ SAE REPORTED BY PI LICENSING AUTHORITY
within 24 hr SPONSOR, EC
DEATH
detail report by SPONSOR/ PI (10 DAYS)
EXPERT COMMITTEE Copy to Licensing authority, Head of institution
ETHICS COMMITTEE
detail report by ethics committee (21 days)
CHAIRMAN OF EXPERT COMMITTEE Copy to licensing authority
expert committee recommendations (30 days)
LICENSING AUTHORITY
(3 months)
decides quantum of compensation
to be paid & pass necessary orders
17. SAE other than death
detail report by sponsor/PI (10 days)
LICENSING AUTHORITY, EC
HEAD OF INSTITUTION
detail report by Ethics committee (21 days)
LICENSING AUTHORITY
(may constitute independent expert committee)
within 3 months
decides quantum of compensation
to be paid & pass necessary orders
Sponsor shall pay the compensation as per the order of Licensing authority within
30 days of receipt of such order.
18. IECs should establish standard operating procedures which should include
Functions and duties of the IEC
Determining its composition, quorum requirements.
Scheduling & conducting meetings
Conducting initial & continuing review of trials
Providing according to regulatory requirements, expedited review
and approval of minor changes in ongoing trials that have the
approval of IEC
Specifying that no subject should be admitted to a trial before the
approval of IEC
19. Specifying that no deviation from or changes of the protocol should
be initiated without prior written IEC approval.
Specifying that the investigator should promptly report to IEC
- deviations from the protocol to eliminate the risk to subjects
- changes increasing the risks to subjects
- all ADRs
- new information that may affect the safety of the subjects or
conduct of
the trial
Ensuring that the IEC notifies the investigator concerning
- trial related decision
- reason for its decision
20. SUBMISSION OF APPLICATION FOR RESEARCH TO
IEC
The following documents must be submitted:
- Trial Protocol (in prescribed format)
- Patient Information Sheet and Informed Consent Form and its
translations
- Investigators brochure
- Principal Investigator’s current C.V.
- Insurance policy/ compensation for participation
- Investigators Agreement with the sponsor
21. REVIEW OF PROJECT
Scientific evaluation should be completed before ethical evaluation
Evaluate possible risks to the subjects with proper justification
Expected benefits
Adequacy of documentation for ensuring privacy, confidentiality
and justice issues
The ethical review should be done through formal meetings and
should not resort to decisions through circulation of proposals
Decisions are preferably arrived at by consensus
22. The IEC’s member secretary shall screen the proposals for their
completeness and depending on the risk involved categorize them
into:
- Full review
- Expedited review
- Exempted from review
23. FULL REVIEW
All research proposals presenting with more than minimal risk.
Projects that involve vulnerable population (children, psychiatric
patients etc.,)
Full review is carried out in cases involving
(a) collection of blood samples
(b) Prospective collection of biological specimens eg. Skin
appendages, excreta, saliva, placenta, amniotic fluid, sputum etc.
24. EXPEDITED REVIEW
Those with no more than minimal risk to research participants
may be subjected to this review
1. Minor deviations from originally approved research.
2. Revised proposal previously approved through full review by the IEC
or continuing review of approved proposals
3. Clinical studies of drugs and medical devices only when -
- research is on already approved drugs except when studying drug
interaction or conducting trial on vulnerable population
- adverse Event (AE) or unexpected Adverse Drug Reaction
(ADR) of minor nature is reported.
25. EXEMPTED FROM REVIEW
Proposals with less than minimal risk
Research on educational practices such as instructional
strategies or effectiveness of or the comparison among
instructional techniques, curricula, or classroom management
methods.
26. Following are considered for ethical review
Scientific design and conduct of study
Recruitment of Research Participants
Care and Protection of Research Participants
Protection of research participant confidentiality
Informed Consent Process
27. SCIENTIFIC DESIGN AND CONDUCT OF
STUDY
Appropriateness of study design
Statistical methodology including sample size
calculation
Risk vs anticipated benefits for research participants.
Justification for Controls used
Withdrawal criteria of participants
Criteria for termination of trial
Adequacy of monitoring and auditing the conduct of
research.
Site facilities for handling emergencies.
Reporting and Publication issues
28. RECRUITMENT OF RESEARCH PARTICIPANTS
Study population – demographic characteristics
Means by which participants are contacted and
recruited.
Means by which full information is conveyed to
research participants or their representatives
Criteria for recruitment
Inclusion criteria
Exclusion criteria
29. CARE AND PROTECTION OF RESEARCH
PARTICIPANTS
Suitability of investigator qualifications and experience for
proposed study.
Medical care to be provided to participants during and
after research.
Adequacy of medical supervision
Steps taken if participants voluntarily withdraw from study
Informed consent
Insurance and indemnity arrangements
30. PROTECTION OF RESEARCH PARTICIPANT
CONFIDENTIALITY
Description of persons who will have access to personal data
of research participants, including medical records and
biological samples.
Measures taken to ensure the confidentiality and security of
personal information concerning research participants.
31. INFORMED CONSENT PROCESS
Adequacy, completeness and understandability of written and
oral information given to participants or their legal
representatives
Clear justification for intention to include research
individuals who cannot consent
Assurance that participants will receive any new information
that becomes available
Contact details of persons whom the participants need to
contact for any complaints or queries.
32. DECISION
Out right approval (at most, only very minor changes are
suggested. The application contained all necessary
information.)
Approval with modifications (there is enough
information to judge the study, but clarification or
changes are needed)
Resubmit with more information (there is not enough
information to judge the application appropriately
Outright disapproval (there is no way the researcher can
ethically do study)
33. RECORDS
○ Constitution & composition of IEC
○ CV of all members & records of training
○ SOPs of the IEC
○ National & International guidelines
○ Copies of protocol submitted for review
○ All correspondence with IEC members and Investigators
regarding application, decision and follow up.
○ Agenda of all IEC meetings and Minutes signed by chairperson
○ Copies of decisions communicated to applicants
○ Notifications issued for premature termination of study
○ Final report of the study
○ All records must be safely maintained after
completion/termination of study for 3 years.
34. REVIEW PROCESS
Periodic Review:
Ongoing research may be reviewed at regular intervals of six months
to one year
Continuing Review:
The IEC has the responsibility to continue reviewing approved
projects for continuation, new information, adverse event monitoring,
follow up.
Interim Review:
Interim Review – decide special circumstances for review by sub-
committee – re-examination of proposal already examined by IEC.
35. IEC : CHALLENGES
Inadequate or no standard operating procedures (SOPs)
Noncompliance with the Schedule Y recommendations
Lack of trained manpower
Heavy workload.
Inadequate space allocated for EC operations
Lack of administrative support, and inadequate remuneration offered
to members serving on EC boards.
No legal experts.
Poor record keeping.
Many EC members are ambiguous about their roles and
responsibilities, during a review process
The failure to conduct internal audits
Absence of accreditation
36. ACCREDITATION AGENCIES
AAHRPP
SIDCER
The Association for the Accreditation of Human Research
Protection Programs (AAHRPP) is an independent accrediting body
that works to protect the rights and welfare of research participants
and promote scientifically meritorious and ethically sound research.
The Strategic Initiative for Developing Capacity in Ethical Review
(SIDCER) is a network of independently established regional fora
for ethical review committees, health researchers and invited
partner organizations with an interest in the development of ethical
review.
37. SIDCER- It has developed out of the capacity-building activities of WHO/TDR in
cooperation with the national and international research organizations
SIDCER formally began through the formation of these fora.
FECCIS
FERCAP
FLACEIS
FOCUS
PABIN
Partner organizations
MFES
GCPA
ICMR
WHO/TDR
PATH
38. FERCI
Forum for Ethics Review Committees in India
National chapter of FERCAP
Constituted in 2002
Registered in 2006
Accounts set up in 2007
FERCI operates in close collaboration with important
institutions like the World Health Organization (WHO), Indian
Council of Medical Research (ICMR), Central Drugs Standard
Control Organization (CDSCO), FERCAP, SIDCER
39. INFORMED CONSENT
The concept of “Informed Consent” for participation in research was first
recorded in 1900 but it was Nuremberg code in 1947 that first highlighted the
essentiality of voluntariness of this consent.
Declaration of Helsinki further stated it as being essential but it also allows
physicians under special circumstances to use subjects without giving informed
consent.
Various clinical research guidelines require that every adult volunteer must agree
to participate in writing before enrollment in a trial.
Key elements of informed consent : Information, Comprehension,
Voluntariness, Decision making capacity.
40. INFORMED CONSENT
Written consent is required from each study subject.
Information should be given verbally as well as using a ‘patient information sheet’.
Consent must be obtained in writing using ‘Informed Consent Form’.
Both should have been approved by the ethics committee and furnished to the
Licensing Authority.
Any changes in the informed consent documents should be approved by the ethics
committee and submitted to the Licensing Authority.
Where a subject is not able to give informed consent, the same may be obtained from
a legally acceptable representative
If the Subject or his/her legally acceptable representative is unable to read/write – an
impartial witness should be present during the entire informed consent process.
41. Checklist for study Subject’s informed consent documents
Essential Elements:
Statement that the study involves research and explanation of the purpose
of the research
Expected duration of the Subject's participation
Description of the procedures to be followed
Description of any risks or discomforts to the Subject
Description of any benefits to the Subject
Disclosure of specific appropriate alternative procedures or therapies
available to the Subject.
Statement describing the extent to which confidentiality of records
identifying the Subject will be maintained and who will have access to
Subject’s medical records
42. Trial treatment schedule(s) and the probability for random assignment to
each treatment (for randomized trials)
Compensation and/or treatment(s) available to the Subject in the event of a
trial-related injury
An explanation about whom to contact for trial related queries, rights of
Subjects and in the event of any injury the anticipated prorated payment, if
any, to the Subject for participating in the trial
Subject's responsibilities on participation in the trial
Statement that participation is voluntary, that the subject can withdraw from
the study at any time and that refusal to participate will not involve any
penalty or loss of benefits to which the Subject is otherwise entitled
43. Additional elements
a. circumstances under which the Subject's participation may be terminated by
the Investigator without the Subject's consent.
b. Additional costs to the Subject
c. The consequences of a Subject’s decision to withdraw from the research and
procedures for orderly termination of participation by Subject.
d. Statement that the Subject or Subject's representative will be notified in a timely
manner if significant new findings develop during the course of the research which
may affect the Subject's willingness to continue participation will be provided.
e. A statement that the particular treatment or procedure may involve risks to the
Subject (or to the embryo or fetus, if the Subject is or may become pregnant)
f. Approximate number of Subjects enrolled in the study
44. Informed Consent Form
Study Title:
Study Number:
Subject’s Initials: _______________ Subject’s Name:_______________
Date of Birth / Age: _________________
(Subject)
(i) I confirm that I have read and understood the information sheet
dated ___ for the above study and have had the opportunity to
ask questions. [ ]
(ii) I understand that my participation in the study is voluntary and
that I am free to withdraw at any time, without giving any
reason, without my medical care or legal rights being affected. [ ]
(iii) I understand that the Sponsor of the clinical trial, others
working on the Sponsor’s behalf, the Ethics Committee and the
regulatory authorities will not need my permission to look at
my health records both in respect of the current study and any
further research that may be conducted in relation to it, even if
I withdraw from the trial. I agree to this access. However, I
understand that my identity will not be revealed in any
information released to third parties or published. [ ]
(iv) I agree not to restrict the use of any data or results that arise
from this study provided such a use is only for scientific
purpose(s) [ ]
(v) I agree to take part in the above study. [ ]
Signature (or Thumb impression) of the Subject/Legally Acceptable Representative:_____________
Date: _____/_____/______
Signatory’s Name: ______________________________________________________
Signature of the Investigator: ____________________________ Date: _____/_____/______
Study Investigator’s Name: __________________________________________________
Signature of the Witness ______________________ Date:_____/_____/_______
Name of the Witness: _______________________________________________________
45. CONCLUSION
ECs continue to play an important role in the ethical conduct of
clinical research. However, ECs as a system are facing challenges
with paucity of trained experts and lack of supervising national
body. This calls for a strong need to focus on capacity building and
establishment of an efficient central body to include all ECs under
its umbrella to bring transparency and accountability in their
functioning. Combined efforts by DCGI, ICMR and individual
ECs will definitely promote a sound culture of clinical research.
Council for international organizations of medical sciences
DOH 7th revision 2013
Schedule y 2013
Principle of precaution and risk minimization states that due care and caution must be taken at all stages of research to ensure that research participant and those affected by it including community are put to minimum risk, suffer from no known irreversible adverse effects.
Minimum risk would be defined as one which may be anticipated as harm or discomfort not greater than that encountered in routine daily life activities or during performance of routine examinations or tests.
Association for the accreditation of human research protection programs
Strategic initiative for developing capacity in ethical review