Replacement: After three years, the committee is reconstituted and 30% of the members are replaced. The IEC meeting will take place once the proposals have been received for review. Decisions are made subject to confirmation and notified at the next important meeting of the ethics committee.
All relevant new guidelines or changes must be brought to the attention of the members.
INSTITUTIONAL ETHIC COMMITTEE
NATIONAL INSTITUTE OF MALARIA RESEARCH
ADMINISTRATION AND MANAGEMENT
DEFINITIONS
Data on side effects observed during the clinical use of the drug must be provided together with a report on its effectiveness in the prescribed form. Documents that enable the evaluation of the implementation of the study and the quality of the data obtained. The goal of the GCP is to ensure that studies are scientifically credible and that the clinical properties of the "trial product" are properly documented.
If the study is conducted by a team of researchers at the study site, the designated team leader must be the principal investigator. A collection of data (including the rationale for the proposed study) for the investigator consisting of all clinical and non-clinical information available about the test products that was known prior to the start of the trial. A person appointed by the sponsor or contract research organization (CRO) to monitor and report the progress of the trial and to verify the data.
It refers to all records or certified copies of original clinical and laboratory findings or other activities in a clinical study necessary for trial reconstruction and evaluation. Original documents (or their verified and certified copies) necessary for the evaluation of the clinical trial. The subject identification code is used instead of the subject's name for all matters related to the study.
CONSTITUTION OF ETHICS COMMITTEE CONSTITUTION OF ETHICS COMMITTEE
- Chairman
- Basic Scientists (2)
- Two Clinicians (2) from various institutes 4. A Legal expert / retired judge
- A Social Scientist/ representative of NGO voluntary organization
- Member Secretary from NIMR
- Exemption from review
- Full Review
When, in emergency situations such as severe outbreaks or disasters, a full review of the research is not possible, prior written permission may be obtained from the IEC before using the test intervention. Such research can only be approved for pilot study or preliminary work to investigate the safety and effectiveness of the intervention, and the same participants should not be included in the clinical trial that can be started later on the basis of the results of the pilot study. However, information about the intervention must be given to the next of kin/guardian when it is available later.
It can be periodic, caused by both nature and people, and creates an imbalance between the capacities and resources of society and the needs of survivors or people whose lives are threatened, over a period of time. Research planned to be conducted after a disaster should be substantively culturally sensitive and specific in nature with potential application to future disaster situations. ii.. the participation of the affected community before and during the research is essential and its representative or advocate should be identified. iii. The research undertaken must provide direct or indirect benefits to the participants, the disaster-affected community, or the future disaster-affected population, and an a priori agreement to this effect must be reached, whenever possible, between the community and the researcher. vi.
All international collaborative research in the disaster-affected area must be conducted with a local partner on an equal partnership basis. vii. Transfer of biological material, if any, must be done according to government rules that take care of intellectual property rights issues. If more than this amount has to be drawn, it becomes a risky condition requiring infusion/blood transfusion;.
- Table of Contents
- Background and Introduction
- Study Rationale
- Study Objective(s): (primary as well as secondary) and their logical relation to the study design
- Study Design
- Study Population: the number of Subjects required to be enrolled in the study at the investigative site and by all sites along with a brief description of the nature of the Subject population required is also mentioned
- Subject Eligibility a. Inclusion Criteria
- Study Assessments – plan, procedures and methods to be described in detail
- Study Conduct stating the types of study activities that would be included in this section would be: medical history, type of physical examination, blood or urine testing, electrocardiogram (ECG), diagnostic testing such as pulmonary function tests,
- Study Treatment
- Adverse Events (See Appendix XI): Description of expected adverse events should be given
- Ethical Considerations: Give the summary of
- Investigational Product Management
- Data Analysis
- Registration of Clinical Trial
- Recent curriculum vitae of the Investigators indicating qualification and experience
- Participant recruitment procedures and brochures, if any
- Plan to withdraw or withhold standard therapies in the course of research
- An account of storage and maintenance of all data collected during the trial
- Plans for publication of results - positive or negative - while maintaining the privacy and confidentiality of the study participants
- Agreement to comply with national and international Good Clinical Practices (GCP) protocols for clinical trials
- Details of Funding agency/ Sponsors and fund allocation
- For international collaborative study details about foreign collaborators and documents for review of Health Ministry's Screening Committee(HMSC) or appropriate Committees under other agencies/authority like Drug Controller General of India
- For exchange of biological material in international collaborative study a MoU/ Material Transfer Agreement between the collaborating partners
- A statement on conflict-of-interest (COI), if any
Dosage schedule (dose, frequency and duration of experimental treatment) Describe the administration of placebos and/or sham drugs if these are part of the treatment plan. Supply and Administration of Study Drugs: A statement as to who will provide the study drug and that the study drug formulation has been manufactured in accordance with all regulations. Details of product stability, storage requirements and dispensing requirements should be provided. Blinding procedures: A detailed description of the blinding procedure if the study uses blinding of the investigator and/or subject.
Case Record Form (CRF) completion requirements, including who gets which copies of the forms and any details needed to complete the forms CRF correction requirements, including who is authorized to make corrections to the CRF and how inquiries about study data are handled and how errors, if any, should be corrected, should be stated. Investigational Product Accountability: Describes instructions for receiving, storing, dispensing, and returning the investigational products to ensure a complete accounting of all investigational products received, dispensed, and returned/destroyed. Provide details of the statistical approach to be followed, including sample size, how the sample size was determined, including assumptions made in making this determination, efficacy endpoints (both primary and secondary) and safety endpoints.
Describe the level of significance, statistical tests to be used, and the methods used for missing data; method of evaluating the data for treatment failures, non-adherence and subject withdrawals; rationale and conditions for any interim analysis if planned. Appendices: Provide a study summary, copies of the informed consent documents (patient information sheet, informed consent form, etc.); CRF and other data collection forms; a summary of relevant pre-clinical safety information and any consent form etc.); CRF and other data collection forms; a summary of relevant pre-clinical safety information and any other documents referred to in the clinical protocol. Plans for publication of results - positive or negative - while maintaining the privacy and confidentiality of the study participants.
Compensation for Accidental Injury
Informed Consent Process (Sch Y)
Informed Consent of Subject
Prior to the beginning of the Study the Investigator(s) should obtain the Ethics Committee’s approval for the written informed consent form and all information being provided to the Subjects and / or their legal representatives or guardians as well as an
Essential information for prospective research on subjects
The quality of consent of certain social groups requires careful consideration, as the investigator may unduly influence their consent to volunteer.
Informed Consent in Non-Therapeutic Study
Waiver Of Informed Consent
The IEC must be made aware of the person or persons who must carry out the consent interviews. Each subject (or their legally authorized representative) must be given sufficient time to read and review the consent form, in addition to being informed of the procedures, risks, potential benefits, alternatives to participation, etc. This is often achieved by using the consent form as an outline for the interview process.
The person conducting the consent interview must then sign and date the consent form in the appropriate spaces (PI or designee). It is assumed that in most cases all persons signing the consent form will do so at the end of the consent interview. The regulations also include provisions for the approval of a waiver or modification of part or all of the consent process.
The IEC will consider written requests for a waiver or change of process when accompanied by sufficient justification. Copies of the most recent consent form may be made and should be used until superseded by an amended consent form. The consent form should be reviewed at least annually as part of the ongoing review process.
Selection of Special Groups As Research Subject (Sch Y)
Pregnant or nursing women: Pregnant or nursing women should in no circumstances be the subject of any research unless the research carries no more than minimal risk to the fetus or nursing infant and the object of the research is to obtain new knowledge
Children
Vulnerable groups
Communication/role of the researcher and sponsor with the ethics committee Communication of the researcher with the ethics committee (She Y 3.3.4.).
Communication / Role of Investigator and Sponsor with Ethic Committee Investigator’s communication with Ethics Committee (Sch Y 3.3.4.)
Sponsor’s Role in confirmation of review by the Ethics Committee (Sch Y 3.1.7.)
NATIONAL INSTITUTE OF MALARIA RESEARCH, DWARKA, NEW DELHI
INTIMATION OF START OF STUDY
Project/Trial Code Number
Title of the drug/multicentric trial
Principal Investigator (Name & Department)
Sponsor
Contract Research Organization (CRO) if any
Date of sanction by IEC
Date of start
Signature of Principal Investigator)
Contract Research Organization (CRO) if any 6. Date of sanction by IEC
Objectives of the study
Progress report as per objectives (attach separate sheet)
Serious Adverse Events if any with details (in summary form) 11. Protocol deviation if any with reasons/justifications
NATIONAL INSTITUTE OF MALARIA RESEARCH APPLICATION TO ETHICS COMMITTEE
Code No. of IEC
Proposal Title
Name, Designation & Qualifications
Departmental Tel. Nos
Email ID
Principle Investigator: __________________________
Co- Principle Investigator / Collaborators: 1._____________________
Sponsor Information
- Contact address of sponsor:_________________________________________________
- Budget:___________________________________________________________________
- Status of review: New (_) Revised (_)
- Brief description of the proposal-aim(s) and objectives, justification for study, methodology describing the potential risks and benefits, outcome measures, statistical analysis and whether it is of national significance with
- Subject selection
- Use of biological/hazardous materials
- Will any advertising be done for recruitment of Subjects? Yes(_) No(_) (Posters, flyers, brochure, websites – if so attach a copy)
- Risks & benefits
- Do you have conflict of interest? No(_)Yes(_) If yes, specify__________________________________________
Patient information sheet attached: (check the elements included) Yes (_) No (_) Language understood (_) Alternatives to participation. Yes(_) No(_) (Posters, flyers, brochures, websites – if yes, attach a copy) (Posters, flyers, brochures, websites – if yes, attach a copy). If yes, minimal or no risk (_) More than minimal risk (_) high risk (_) iii. Is there a benefit a) for the subject.
Financial/Non financial)
Check list for attached documents
NATIONAL INSTITUTE OF MALARIA INSTITUTE
UNDERTAKING BY THE PRINCIPAL INVESTIGATOR
NAME AND CODE NUMBER OF THE PROJECT
NAME, DESIGNATION AND DEPARTMENT OF THE PRINCIPAL INVESTIGATOR
OTHER MEMBERS OF THE RESEARCH TEAM
NAME AND ADDRESS OF ANY OTHER MEDICAL COLLEGE, HOSPITAL OR INSTITUTION WHERE PARTS OF THE STUDY WILL BE DONE
NUMBER OF ONGOING PROJECTS/CLINICAL TRIALS IN WHICH YOU ARE PI
STATEMENT OF GENERAL PRINCIPLES
- Principles of essentiality whereby the research entailing the use of human participants is considered to be absolutely essential after a due consideration of all alternatives in the light of the existing knowledge in the proposed area of
- Principles of voluntariness, informed consent and community agreement whereby research participants are fully apprised of the research and the impact and risk of such research on the research participant and others; and whereby the
- Principles of non-exploitation whereby as a general rule, research participants are remunerated for their involvement in the research or experiment; and irrespective of the social and economic condition or status, or literacy or
- Principles of privacy and confidentiality whereby the identity and records of the human participants of the research or experiment are as far as possible kept confidential; and that no details about identity of said human
- Principles of precaution and risk minimisation whereby due care and caution is taken at all stages of the research and experiment (from its inception as a research idea, its subsequent research design, the conduct of the research or
- Principles of professional competence whereby the research is conducted at all times by competent and qualified persons who act with total integrity and impartiality and who have been made aware of, and are mindful of, preferably
- Principles of accountability and transparency whereby the research or experiment will be conducted in a fair, honest, impartial and transparent manner after full disclosure is made by those associated with the research or
- Principles of the maximisation of the public interest and of distributive justice whereby the research or experiment and its subsequent applicative use are conducted and used to benefit all human kind and not just those who
- Principles of institutional arrangements whereby there shall be a duty on all persons connected with the research to ensure that all the procedures required to be complied with and all institutional arrangements required to be made in
- Principles of public domain whereby the research and any further research, experimentation or evaluation in response to, and emanating from such research is brought into the public domain so that its results are generally made
- Principles of totality of responsibility whereby the professional and moral responsibility, for the due observance of all the principles, guidelines or prescriptions laid down generally or in respect of the research or experiment in
- Principles of compliance whereby, there is a general and positive duty on all persons, conducting, associated or connected with any research entailing the use of a human participant to ensure that both the letter and the spirit of these
- principles laid down under Statement on General Principles are common to all areas of biomedical research
Principles of professional competence according to which the research is carried out at all times by competent and qualified persons who act with total integrity and impartiality and who are made aware of, and are aware of, preferably persons who act with total integrity and impartiality and who are made aware of, and are aware of, preferably through training, the ethical considerations that must be kept in mind in respect of such research or experiment. Principles of the maximization of the public interest and of distributive justice whereby the research or experiment and its subsequent appropriate use is carried out and used to benefit all human species and not just those experimenting and its subsequent appropriate use is carried out and used to benefit all people. friendly and not only those who are socially better off, but also the least advantaged; and in particular the research participants themselves and or the community from which they were drawn. Principles of institutional arrangements according to which there will be a duty on all persons connected with the research to ensure that all the procedures that must be observed and all institutional arrangements that must be made to ensure that all the procedures that must be observed and all institutional arrangements to be made in respect of the research and its subsequent use or application are properly made in a bonafide and transparent manner; and to take all appropriate steps to ensure that research reports, materials and data relating to the research are properly preserved and archived.
First, subjects must be provided with sufficient information to decide whether or not to participate, including the research procedure(s), their purposes, risks, and expected benefits. Even if some direct benefit to them is expected, subjects should clearly understand the extent of the risks and the voluntary nature of participation." Incomplete disclosure is justified only if it is clear that: (1) the objectives of the study cannot be achieved are achieved when full disclosure is made; (2) the undisclosed risks are minimal; and (3) when necessary, subjects are interviewed and the study results provided. When involving persons with limited capacity to understand, they should be given the opportunity to choose whether or not to participate to the extent they are able, and their objections should not be overridden unless the research involves offering them a therapy that is not available outside the context of the research.
The principle of beneficence requires both the protection of individual subjects from the risk of harm, as well as taking into account not only the benefits for the individual, but also the social benefits that can be obtained from the research. To determine whether the balance of risks and benefits results in a favorable ratio, the decision should be based on a thorough evaluation of information about all aspects of the research and on a systematic consideration of alternatives. The EC must: (1) determine the "validity of the research assumptions;". 2) identify "the nature, probability, and magnitude of the risk as clearly as possible;" and (3) "determine whether the investigator's estimates of the probability of harm or benefit are reasonable, as judged by known facts or other available studies.".
