Aravind Eye Care System Standard Operating Procedure

26 Pages·2011·0.42 MB·English

Aravind Eye Care System 
Institutional Review Board 

Standard Operating Procedure 

Version 1 
2011 

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Table of contents 

1. Introduction ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 3 

2. Scientific Committee‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 4 

3. Members of Scientific Committee‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 5 

4. Institutional Review Board (IRB)‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 6‐8 

5. Members of IRB‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 9 

6. General principles in Biomedical research involving human Subjects‐‐‐‐‐‐‐‐ 10‐11 

7. Working Procedure of the IRB‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 12‐14 

8. Informed Consent process‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 15‐18 

9. Amendment submission‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐19 

10. Monitoring and reporting adverse reactions or events‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 20 

11. Submission of Application to IRB‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 21‐22 

12. Expeditors review projects  
(Observational studies, Questionnaires, Survey, interview,  
historical studies, Epidemiological studies)‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 23‐25 

13. Documents to be kept‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐26 

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Introduction 

The objective of this SOP is to contribute to the effective functioning of the Institutional Review
Board (IRB) so that a quality and consistent ethical review mechanism for health and biomedical
research is put in place for all proposals dealt by the committee as prescribed by the Ethical
guidelines for biomedical research on human subjects of ICMR.

All proposals on Biomedical research involving human participants should be cleared by an
appropriately constituted Institutional Review Board (IRB). 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. Such an
ongoing review shall be in accordance with the international guidelines wherever applicable and
the Standard Operating Procedures (SOP) of the WHO available at www.who.int

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Scientific Committee 

Investigators who wish to submit their project proposals would route it thru Scientific
Committee, IRB. The Scientific committee, a responsible body of clinicians from various
departments and basic researchers, who are external to the particular research, examine and
approve the scientific content and technical appropriateness of the proposal. After ensuring the
scientific soundness, it is cleared by an appropriately constituted Institutional Review Board
(IRB).

Aravind faculty members would be designated to take the responsibility of coordinating the
activities of the scientific committee. Scientific committee chair designates primary reviewer for
project. Scientific committee will approve the protocol and forward it to the Ethics committee
along with checklist for the basis of recommendations.

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ARAVIND EYE CARE SYSTEM 
SCIENTIFIC COMMITTEE ‐ MEMBERS LIST 
No Name Highest Designation/ Title Position
Degrees earned
1 Dr.VR.Muthukkaruppan M.Sc., Ph.D Director-Research Member
Aravind Medical Research Secretary
Foundation, 1, Anna Nagar, Madurai
2 Dr.M.Srinivasan MS DO Director (Emeritus) Member
Aravind Eye Care System, Madurai
3 Dr.SR.Rathinam MNAMS Ph.D Professor of Ophthalmology Member
Aravind Eye Care System, Madurai
4 Dr.SR.Krishnadas DO DNB Chief Medical officer Member
Aravind Eye Care System, Madurai
5 Dr.N.V.Prajna DO DNB Clinician Scientist Member
Aravind Eye Care System, Madurai
6 Dr.Usha Kim DO DNB Chief-Orbit clinic Member
Aravind Eye Care System, Madurai
7 Dr.Lalitha Prajna MD DNB Chief Microbiologist Member
Aravind Eye Hospital, Madurai
8 Dr.P.Sundaresan M.Sc.,Ph.D Senior Scientist Member
Aravind Medical Research Foundation,
No.1, Anna Nagar, Madurai
9 Mr.R.D.Thulasiraj M.B.A Executive Director Member
Lions Aravind Institute of Community
Ophthalmology, Madurai
10 Dr.R.Revathi MS DO Chief Medical Officer Member
Aravind Eye Hospital, Coimbatore
11 Dr.Sivakumar Chandrasekar MS (Oph) Medical Officer Member
Aravind Eye Hospital, Tirunelveli
12 Dr.R.Venkatesh DO DNB Chief Medical Officer Member
Aravind Eye Hospital , Pondicherry
13 Mr.V.Venkatesa Kannan M.Sc (Chemistry) Manager– Department of Pharmacy Member
Aurolab, Madurai
14 Dr.R.Kim DO DNB Chief Medical consultant Member
Retina & Vitreous services
Aravind Eye Hospital , Madurai
15 Dr.R.Muralidhar MD Medical Officer Member
(Ophthalmology) Paediatric Ophthalmology
Aravind Eye Hospital , Madurai

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Institutional Review Board (IRB) 

The Institutional Review Board should review every research proposal on human subjects. It
should ensure that a scientific evaluation has been completed before ethical review is taken up.
The committee should evaluate the possible risk to the subjects with proper justification, the
expected benefits and adequacy of documentation for ensuring privacy, confidentiality and
justice issues.
The responsibility of an IRB can be defined as follows:
1. To protect the dignity, rights and well being of the potential research participants.
2. To ensure that universal ethical values and international scientific standards are
expressed in terms of local community values and customs.
3. To assist in the development and the education of a research community responsive to local
health care requirements.

The Institutional Review Board of Aravind Eye Care System is established in compliance with
ethical guidelines for biomedical research on human participants formed by Indian Council of
Medical Research (ICMR Code) 2006.
Registration of the IRB: 
The Institutional Review Board of Aravind Eye Care System is approved by the Office of
Human Research Protection, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville,
MD 20852, USA.
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The FWA number is FWA 00004084, Assurances relying upon IRB00002999 and parent
organization: IORG 0002442
COMPOSITION

The IRB should be multidisciplinary and multisectorial in composition. Independence and
competence are the two hallmarks of an IRB. The number of persons in an ethics committee
should be kept fairly small (8 - 12 members). It is generally accepted that a minimum of five
persons is required to form the quorum without which a decision regarding the research should
not be taken. The IRB should appoint from among its members a Chairman who should be from
outside the Institution and not head of the same Institution to maintain the independence of the
Committee. The Member Secretary should be from the same Institution and should conduct the
business of the Committee. Other members should be a mix of medical/ non-medical, scientific
and non-scientific persons including lay persons to represent the differed points of view.
The composition may be as follows:-

1. Chairperson
2. One - two persons from basic medical science area
3. One - two clinicians from various Institutes
4. One legal expert or retired judge
5. One social scientist/ representative of non-governmental voluntary agency
6. One philosopher/ ethicist/ theologian
7. One lay person from the community
8. Member Secretary

As per revised Schedule Y of Drugs & Cosmetics Act, 1940, amended in 2005, the ethics
committee approving drug trials should have in the quorum at least one representative from the
following groups:

1. One basic medical scientist (preferably one pharmacologist).
2. One clinician
3. One legal expert or retired judges
4. One social scientist/ representative of non-governmental organisation/philosopher/ ethicist/
theologian or a similar person
5. One lay person from the community.

The Ethics Committee (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, for instance, a pediatrician for pediatric conditions, a cardiologist for cardiac
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disorders etc. 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.

Recruitment of Members:

• The members for IRB will be recruited by the Chairman of Aravind Eye Care System for
a period of 3 years.

• A copy of letter of acceptance, CV and the confidentiality agreement signed by all the
members will be kept for the records of EC.

• Ethics committee to preferably not have more than 2 members from the Institute

• Scientific committee will comprise of all faculty of the institute.

Responsibilities of EC Members

Review the protocols
Attend the EC meetings (3-4 times per year)
Opine on the new project provided
Monitoring of approved projects, with special reference to Adverse events
Survey of execution of the projects, as and when required
Maintain confidentiality

TRAINING

The EC members should be encouraged to keep abreast of all national and international
developments in ethics through orientation courses on related topics by its own members or
regular training organized by constituted body (ies), so that they become aware of their role and
responsibilities. For drug trial review it is preferable to train the IEC members in Good Clinical
Practice. Any change in the regulatory requirements should be brought to their attention and they
should be aware of local, social and cultural norms, as this is the most important social control
mechanism. .
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Members – Institutional Review Board 
S.No Name Qualification/ Designation IRB position
1. Ms.Shobhana Ramachandhran M.A Chairman
Managing Director
TVS Sri Chakra Ltd, Madurai
2. Dr.Lalitha Prajna MD DNB Member-Secretary
Chief Microbiologist
Aravind Eye Hospital, Madurai
3. Dr.C.Srinivasan M.Sc.,Ph.D Member
UGC Emeritus Professor
Department of Chemistry
1, Subhash Street, Kalvi nagar
Theni Main Road, Nagamalai
Madurai
4. Dr.L.Thayumanavan MD.DM Member
Sr.Consultant, Gastroenterologist
Vadamalayan Hospital
Madurai - 625002
5. Dr.T.S.Chandrasekaran MS DO Member
Ophthalmologist, Gandhi Nagar,
Madurai
6. Mr.M.Mariappan B.Sc.,B.L Member
Advocate, Plot No.355, Anna Nagar,
Madurai
7. Mr.M.Senthilkumar M.A., B.L Member
Advocate
Plot No.32, Sindanayalar Nagar,
Senthamil Nagar
Karuppayoorani East, Madurai
8. Mr.R.Raja Govindasamy M.A., M.A (USA) Member
Former Principal, Thiagarajar college
169-1, 2nd cross street
I main Road, Gomathipuram
Madurai - 625020
9. Dr.R.Muralidhar MD (Ophthalmology) Member
Medical Officer
Paediatric Ophthalmology
Aravind Eye Hospital, Madurai

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GENERAL PRINCIPLES IN BIOMEDICAL RESEARCH INVOLVING HUMAN
SUBJECTS

The committee will ensure a strict concordance with the statements of General principles on
Research using Human Subjects in Biomedical Research as well as the Statement of Specific
Principles on Research using Human subjects in specific areas of biomedical Research, as laid
down by Indian Council of Medical Research (ICMR).

The general statement includes:

• The Purpose of the research should be directed towards the increase in knowledge about
human beings

• Research is conducted under conditions that no one person/persons become a mere means
for the betterment of other.

• Research is subjected to a regime of Evaluation at all stages on proposal, i.e. design,
experimentation, statistical validity, declaration and use of results thereafter.

To ensure that the research protocols that are carried out at Aravind Eye Care System are in
accordance to the guidelines laid down by Indian Council of Medical Research ICMR/ GCP

Do not compromise the safety of the procedure

Are conducted under the supervision of medical persons with the required expertise.

Include solely patients who have given voluntary and informed consent

The committee will review approved research projects as and when thought necessary and will
maintain a list of projects submitted, approved, disapproved and outcome required expertise
paramount importance.

Any research using the human beings as subjects of medical or scientific research or
experimentation shall bear in mind the following principles.

1. Principles of essentiality whereby, the research entailing the use of human subjects is
considered to be absolutely essential after a due consideration of all alternatives.

2. Principles of voluntaries, informed consent and community agreement whereby,
research subjects are fully apprised of research subject and others.

3. Principle of non-exploitation whereby, as a general rule, research subjects are
remunerated for their involvement in the research or experiment; and, irrespective of the
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