Ethics Committee

Sir Ganga Ram Hospital

Standard Operating Procedure (SOP) submission of research

proposal

1. All research projects (Clinical studies, drug trial, trials of medical devices) shall
first be submitted to the Research committee for evaluation of scientific content
and study design.

1.1. The research committee shall meet once a month. Their responsibilities will
include:
A) Evaluation of all new projects
B) Help investigators in improving the study design
C) Monitor the progress of the ongoing research projects. This will be by a
progress report to be submitted by the investigators every 6 months.

1.2. The Research Committee shall communicate its decision on a new proposal
(Approval or rejection) within 3 weeks of submission.

1.3 All drug trials (including post-marketing surveillance studies) or trials of

medical devices, all such proposals shall necessarily be submitted to Ethics
Committee for approval before the trial is initiated.

2.1. Submission of application to Ethics Committee: The investigator is expected to

Submit a complete set of documents to the Ethics Committee (15 copies should be
submitted).Incomplete applications will not be accepted. Investigators may take the
assistance of the Secretary, Ethics Committee in this regard. All proposals should be
submitted at least three weeks beforehand for consideration in the committee meeting
.The documents required to be submitted include:

1. A brief statement of the objectives and rationale for undertaking the study and the
existing knowledge on the subject. The statement must briefly outline the study
design and methodology; subject recruitment procedures; inclusion and exclusion
criteria and safety or risk factors associated with the study.
2. A complete investigation protocol giving details of the protocol title, identification
number and date (including all amendments with date), name of CRO, name of
principal investigator must be submitted. The protocol must include a complete
investigator brochure including the details of the drug/device under study, study
design, randomization procedure, inclusion / exclusion criteria, handling of
products, assessment of efficacy, assessment of safety, statistical methods etc.

3. All necessary documents showing that the appropriate regulatory clearances have
been taken must be enclosed. All drug trials must have prior DCGI clearance.

4. The method of taking informed consent must be clearly defined. A copy of the
informed consent form (in at least two languages, English & vernacular must be
included.

5. All financial aspects of the study must be clearly enclosed. This should include
information about the sources of economic support, payment to subjects,
payments to the investigator or other members of the research team. A statement
on conflict of interests, if any, must be included.

6. A publication policy should be clearly defined. This should include plan for
publication of results-positive or negative, while maintaining the privacy and
confidentiality of the study participant.

7. The investigator must submit an unequivocal undertaking from the sponsor of the
proposed compensation and reimbursement in case of study-related injury,
disability or death. The sponsor shall indemnify the investigator and the institution
against such mishaps and adequately compensate the subject. In case of insurance
cover a copy of the same must be included.

8. The principal investigator shall ensure that the identity and data of patients
remains private and confidential.

2.2. The investigator is obliged to inform the Ethics Committee immediately of the
following

1. Any amendment of the study protocol

2. Any adverse event relating to the study in the institution concerned, or in any
other center, in cases of a multi-center trial.

3. Premature termination of the study, and reasons thereof

2.3. The Principal Investigator shall not recruit any subjects in the trial till the
Ethics Committee approval has been obtained.
2.4. Upon completion of the trial the Principal Investigator must submit a
conclusion report to the Ethics Committee within four weeks of completion.
2.5. The investigator must submit a statement agreeing to comply with the national
and international GCP protocols for clinical trials, and the guidelines of the
national regulatory bodies.

2.6. The Ethics Committee shall undertake to communicate to the investigator its
decision on the submitted proposal not later than 2 months from the time of
submission. The Ethics Committee shall not give conditional approvals. The onus
of providing the necessary explanations to queries raised by the Ethics Committee
shall rest with the investigator and the sponsor of the study .

2.7. The Ethics Committee shall operates in accordance with the Indian Council of
Medical Research guidelines and International Conference on Hormonisation of
technical requirements for registration of pharmaceuticals for human use and
Good Clinical Practice (ICH-GCP)/Declaration of Helsinki (amendments)
guidelines.

2.8. The Ethics Committee shall meet once in a month. The quorum of the
meeting shall consist of at least five members present.

2.9. Incase the Chairman is unable to attend the meeting, a non-institutional

Member may be requested to take the chair.

2.10. The Hospital shall charge 10% of the total financial budget as an
administrative fee
 Ethics Committee
Sir Ganga Ram Hospital

Check list for Drug Trials

Name of research proposal :

Details of protocol : Protocol No. --------------------- Dated ----------------
1. New molecule Already marketed drug
2. Name of sponsor of drug trial
1. Name of Contract Research Organisation (CRO) , if any
2. Phase of trial proposed to be conducted
Phase II
Phase III
Phase IV
5. Phase of trial on which published data is available
Phase I
Phase II
Phase III
6. Expected benefits of drug
7. Expected adverse reactions, if any
8. Known adverse reactions of drug (particularly teratogenic , carcinogenic)
9. Does the investigator have the unqualified right to publish date of the study Yes/No
10. Does the sponsor commit to the following :-
Compensation to the subjects for any injury, disability due to drug Yes/No
Indemnify investigator and hospital against legal action related to trial
Yes/No
11. Documents enclosed :-
Copy of approval letter of DCGI Yes/No
 Copy of informed consent form Yes/No
Copy of details of funding /financial arrangements Yes/No

Certified that the information provided above is true to the best of my knowledge and
nothing has been concealed.