The Ethics committee Asha Hospital (Institute of medical psychology counselling and psychotherapy) was constituted in 1996. It is responsible for reviewing the ethics of hospital medical research involving human participants and their personal data. The Institutional Ethics Committee (EC) is intended to ensure a competent review of scientific and ethical aspects of the project and proposals received as per ICMR, New Drugs and Clinical Trial Rules 2019 and ICH GCP Guidelines.
The EC is setups to ensure that the research protocols that are carried out at ASHA HOSPITAL are sound in scientific design, have statistical validity and are conducted according to the parameters of the ICH-GCP as well as New Drugs and Clinical Trial Rules 2015 and other regulatory requirements. Do not compromise the safety, rights and wellbeing of the patients participating in the research study. Are conducted under the supervision of medical persons with required experience/expertise. Include solely patients who themselves or through their legally acceptable representative have given informed consent for participation in the research study.
The Ethics committee will comprise of 12 members who have the qualifications, to allow a quorum of at least 5 members at review meeting as per ICMR guidelines and Schedule Y New Drugs and Clinical Trial Rules 2019 in order to provide expertise ensuring a comprehensive review (scientific and ethical) of the projects submitted to it.
The chairperson of the committee will be elected from outside the Institution (Asha Hospital). The Member Secretary, who will be from the institution (Asha Hospital), shall conduct the business of the committee. Other members will be a mix of medical, Non- medical, Scientific and Non- scientific persons including general public to reflect the different viewpoints.
The composition may be as follows:
- Basic Medical Scientist
- Legal Expert
- Social scientist/ representative of Non- Governmental voluntary agency
- Educated person from the community
- Member Secretary
EC shall have majority of its members from other institutions. They could be drawn from any public or private institutions.
2. Conduct of meeting:
The chairperson will conduct all the meetings. The Member secretary designed by the chairperson, will record the minutes of meeting and circulate the same to the members within 2 weeks of the meeting. Study personnel may be called to the meeting to present the study or answer specific queries. However, He / She will not participate in the decision making / Voting process of that study even if he/she is a regular member of the EC. A Study team member including the Principal Investigator will be deemed an interested party with regard to the review. The Study team member non-participation in the decision making/voting process will be recorded in the response letter from EC.
3. Review Procedure:
Meetings of the Ethics Committee shall be held at scheduled intervals as prescribed (once in 2 months). Additional meetings will be held as and when necessary.
4. Decision Making:
The decision of the committee will be taken by a majority. vote after quorum requirements is fulfilled to recommend/reject/suggest modifications for a repeat review or advice appropriated steps. If the subject’s experts are invited to offer their views, they will not take part in the voting process.
5. Protocols approved by Ethics Committee Asha Hospital:
- MYL-1802N-1001 – BE study on INVEGA TRINZA
- R092670PSY3015- Palperidone palmitate study
- 17775A – Brintellix study
- NOPRODSCH4001- Observational study
- 0567-18- Clozapine study
- 0851-17- Palperidone study
- 618/19- Quetiapine study
- NW-3509- Evanamide studies
- RC-GX-103 – Riseperidone study
- 0124-21 – Endoxifen study
- Deksel in depression- Vitamin D study
- Dementia- Observational study
- PALI-ISR-1001- BE – Paliperidone study
- PALI-ISR-1003- BE- Paliperidone study
- C2A01319- BE- Aripiprazole study
- C2A00006- INVEGA SUSTENNA