sop ethics committee ihbas

Institutional Biomedical Research Ethics Committee IHBAS

Standard Operating Procedures

SOP Title: Standard Operating Procedures: Institutional Biomedical

Research Ethics Committee, IHBAS

¨ SOP Author(s). IHBAS, Ethics Committee Members

¨ SOP Status: Current

¨ Version: February 5, 2008

Pages 23 pages

Approval 1: Ethics Committee

Approval 2: The Director

Developed by: Dr. Sangeeta Sharma

Member Secretary

IHBAS Ethics Committee

Page 2 of 23

SOPs Ethics Committee, IHBAS. Status Current Version 1 dated February 5, 2008Prepared and issued by: Ethics Committee, IHBAS Approved by Director, IHBAS

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CONTENTS

1.0 OBJECTIVE_____________________________________________________________2.0 PROCESS FLOW

3.1 Application Procedure3.2 Pre Meeting Procedure3.3. Meeting Procedure3.4. Post Meeting Procedure

_____________________________________________________________3.0 SOP - APPLICABLE TO

3.1 All Members of Ethics Committee3.2 All personnel of the Ethics Office3.3 All personnel submitting an application

_____________________________________________________________4.0 DEFINITIONS_____________________________________________________________5.0 PROCEDURES

5.1 Composition of Committee5.2 Term of appointment5.3 Conditions of appointment5.4 Functions of Committee5.5 Responsibilities of Committee5.6 Meeting Procedures5.7 Application procedure5.8 Committee Review Procedure5.9 Decision making5.10 Communicating a decision 5.11 Record keeping

_____________________________________________________________6.0 INVESTIGATORS RESPONSIBILITIES

6.1 Notification of Amendments6.2 Notification of Adverse Events6.3 Annual Review and Renewal6.4 Patient Information Leaflet6.5 Patient Consent6.6 Final Report

_____________________________________________________________7.0 Appellate Authority


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1.0 OBJECTIVE

To ensure effective functioning of the Ethics Committee so that a quality and consistent ethical review takes place as prescribed by the Ethical Guidelines for Biomedical Research on Human Participants, ICMR, 2006 and that the content of the clinical trial documentation is relevant and accurate, the submissions are prepared and progressed in a consistent manner.

2.0 PROCESS FLOW

2.1 APPLICATION PROCEDURE

Post Meetin


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Inquiry to Ethics Office for submission procedures.

Ethics office to forward 1. Application Form. 2. SOP Available in both Hard copy or disc

Submission must be received by Ethics Officeat least 1 month prior to next review meeting.

All details of1. Application form 2. Summary of the proposal & Justification for study, drug developmental history in case of drug

trials3. Permission of the HOD & Head of the Institute4. Protocol 5. Questionnaires6. Informed consent form (Hindi and English)7. Patient Information Leaflets (Hindi and English)8. Investigator’s Brochure, in case of clinical trial9. Approval of DCGI in case of clinical trial10. Agreement/ Undertaking by the Principal Investigator11. Signed Indemnity bond12. Insurance13. Financial disclosure: Details of Funding agency/sponsors and fund allocation for the proposed

work.14. Curriculum vitae of all the investigators 15. Any other voluntary disclosure

All documents must be bound & sent to Ethics Committee office for processing.

When all the above requirements are processed.1. Log Proposal on Database.2. Include on Agenda for next Committee Meeting.

of 232.2 PRE MEETING PROCEDURE


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Notify all committee members of next meeting date.

Each protocol is allocated to all committee member for detailed review.

Log all amendments, adverse events and notifications for review at next meeting

Each member is circulated with Agenda, Previous Meeting Minutes and a copy of all proposals, protocols, Investigators Brochure and appendices for review.

Inform each Chief Investigator required to attend the meeting at a appointed time for presentation or clarification, if any for their proposal presentation.

Confirm date, time and agenda with the Chairperson & book the meeting room

Ensure that the meeting will be properly constituted –at least quorum of 5.

of 232.3 COMMITTEE MEETING PROCEDURE


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Previous Minutes andMatters arising are discussed.

Each submission is discussed in detail and a list of queries is compiled

A quorum of at least 5 members must be present.Vice chairman. may act as Chairman in his/her absence

Each Investigator in turn answers any queries the committee may have.

Decision mostly by consensus recorded in the minutes of the meeting. If no consensus could be reached, dissent with reasons to be recorded.If any of the members are participating in a study that is under review by the Committee, he/she must not participate in the discussion on that submission and must absent him/herself from the decision making.

of 232.4. POST MEETING PROCEDURE


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Recorded minutes are maintained.

All Investigators of protocols submitted for review are informed of the committee’s decision in writing including any modifications or conditions within 2 weeks.

Investigators who submitted Amendments or Adverse events for review will be notified of the committee’s decision in writing.

All correspondence must be signed by the Member Secretary

All Ethically Approved Studies/Trials Must Include:1. Application form 2. Summary of the proposal & Justification for study, drug

developmental history in case of drug trials3. Permission of the HOD & Head of the Institute4. Protocol 5. Questionnaires6. Informed consent form (Hindi and English)7. Patient Information Leaflets (Hindi and English)8. Investigator’s Brochure, in case of clinical trial9. Approval of DCGI in case of clinical trial*10. Agreement/ Undertaking by the Principal Investigator*11. Signed Indemnity bond*12. Insurance*13. Financial disclosure: Details of Funding agency/sponsors and fund

allocation for the proposed work.14. Curriculum vitae of all the investigators 15. Any other voluntary disclosure

* Where Applicable

of 233.0 SOP APPLICABLE TO

3.1 All members of the Ethics Committee3.2 All personnel of the Ethics Office3.3 All investigators submitting an application

4.0 DEFINITIONS

EC, IHBAS: Ethics Committee, IHBASICH GCP: International Conference on Harmonisation of Good

Clinical Practice. (Harmonized Tripartite Guidelines for Good Clinical Practice.)

Sch Y: Schedule Y, Regulatory Requirements for Clinical Trials in IndiaDCGI Drugs Controller General of India

5.0 PROCEDURES

5.1 Composition of Committee.

The Institutional Biomedical Research Ethics Committee, IHBAS is constituted by the Executive Council of the Institute. The EC, IHBAS was established in 1996. A panel of members will be proposed by the Director in consultation with the Chairperson and Vice Chairperson, Ethics Committee and Heads of the departments for selection by the Executive Council of IHBAS. The Ethics Committee will comprise of a minimum 11 members and up to 15 members. Appellate authority will be the Director. Majority of the members should be external. A quorum of at least five members must be present at each meeting. See Appendix A for current list of Members and their qualifications. All members of the Committee, including ex-officio members, are voting members.

5.2 Term of Appointment

The term of office of each member is three years (renewable for one term). Any change to membership of the Ethics Committee must be done by the Director from a panel of approved members. The Ethics Committee can have as its members, individuals from other institutions or committees, if required. If required, experts could be invited to offer their views. The members be preferably trained in bioethics or person should be conversant with ethical guidelines and laws of the country.


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Replacement procedure

The members may be replaced at the discretion of the appointing authority for the same.

Removal procedure

A member may be relieved of his/her membership in case of a conduct unbecoming for a member of the Ethics Committee or inability to participate in the three consecutive meetings on any grounds.

5.3 CONDITIONS OF APPOINTMENT

Name, age, gender, profession, and affiliation will be publicized whenever the committee is reconstituted or there is a change in the membership.

Conflict of interest to be disclosed if any exists.

Members must apprise themselves of the relevant documents, codes, GCP, ICH guidelines and the ICMR code.

An investigator can be a member of the EC; however, the investigator-as-member cannot participate in the review and approval process for any project in which he or she has a present or potential conflict of interest.

5.4 Functions

5.4.1. To review and approve research protocols, including surveys and other data collecting instruments, if human subjects are involved or must verify that the research needs criteria for exemption. To consider the justification for conducting the proposed trial/study and the circumstances under which proposed trial/study is to be conducted and, where the committee considers that the proposed trial is justified and it is satisfied with those circumstances, it shall give its approval to the conducting of the proposed study and the person who is arranging for the conducting of the proposed study in compliance with ICMR guidelines 2006 and Drugs & Cosmetics Rules, 1945, amended 2005, Schedule Y, Regulatory Requirements for Clinical Trials in India, Central Drugs Standard Control Organization, DGHS, Ministry of Health & Family Welfare, Government of India.


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5.4.2. The committee will not consider the proposed clinical trial/study ethical unless it is satisfied that there is little risk of injury to participants and that what risk their may be is justifiable. Risks incurred by participants are few and justified by virtue of the potential benefits to the individual participant and or future recipients of the trial/study drug.

5.5 Committee Responsibilities

5.5.1. To safeguard the rights, safety and well being of all trial/study subjects.

5.5.2. Obtain the following documents:

For thorough and complete review, all research proposals should be submitted with the following documents:

i. Name of the applicant with designationii. Name of the Institute/Hospital/Field area where research will be

conductediii. Approval of the Head of the Department and institution.iv. Protocol of the proposed researchv. A brief statement of the objectives and rationale for undertaking

the study in his/her own words along with 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.If the study/clinical trial is a continuation of the previously approved proposal summary of the results of the proposal along with its status should be submitted with the new proposal.

vi. Ethical issues in the study and plans to address these issues.vii. Proposal should be submitted with all relevant enclosures like

proformae, case report forms, questionnaires, follow up cards etc.viii. Informed Consent process, including patient information sheet and

informed consent form in local language(s).ix. For any drug/device trial, all relevant pre-clinical animal data and

clinical trial data and available Safety reports from other centres within the country/countries, if available.

x. Curriculum vitae of all the investigators with relevant publications in last five years (Signed and dated)

xi. Copy of signed Indemnity Form, approval of the DCGI, insurance etc, where applicable.


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xii. Proposed compensation and reimbursement of incidental expenses.xiii. Details of Funding agency/sponsors and fund allocation for the

proposed work. 5.5.3. To review proposed study with regard to the following:

i. The objectives and element of public goodii. Scientific design and conduct of the studyiii. The sample size calculationiv. The subject inclusion and exclusion criteriav. The exposure of participants to riskvi. Justification for the use of control arm vii. The extent of medical and laboratory examination proposedviii. The storage of data and laboratory samplesix. The proposed analysis of datax. The procedures proposed to achieve informed consentxi. The proposed mechanisms to ensure confidentialityxii. Informed Consent formxiii. A statement on the proposed method for recruitment of study

subjects including all advertisements, probable ethical issues and steps taken to tackle the same

xiv. The qualification and competence of the investigatorsxv. The adequacy of provisions made for monitoring and auditing the

conduct of the research including the constitution of a Data Safety Monitoring Board in case of clinical trials.

xvi. The adequacy of the site, including the supporting staff, available facilities and emergency procedures.

xvii. The manner in which the results of the research will be reported and published

xviii. Proposed compensation and reimbursement of incidental expenses.xix. Details of Funding agency/sponsors and fund allocation for the

proposed work along with allocation for institutional overhead charges for different types of funding agencies – Government agencies (e.g., ICMR, DBT), Not for profit organizations and pharmaceutical companies. While for government agencies it could be as per policy of the government but for pharmaceutical companies it should be at least 15% and for Not-for-profit organization could be at least 5%.

xx. All other relevant documents relating to the study protocol including regulatory clearance, Agreement between PI & sponsor, Insurance, Indemnity Bond, Agreement to comply with national and international GCP protocols for clinical trial


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In addition, EC has responsibility within the Institution for the following objectives:

a. Education of professional, administrative and support staff about ethical issues

b. Continuing education and training programmes that assure that EC members are qualified to perform their specific duties within the Ethics Committee.

5.6 MEETING PROCEDURES

The Chairperson will conduct all meeting of the EC. If for reasons beyond control, the Chairperson is not available, the Vice-Chairperson nominated by the Executive Council will conduct the meeting. Professor Kusum Saigal is nominated as Vice Chairperson. The Member Secretary is responsible for organizing the meetings, maintaining the records and communicating with all concerned. He/she will prepare the minutes of the meetings and get it approved by the Chairman before communicating to the researchers.

5.6.1i. A minimum of four meetings to be held per annum. The Committee

will meet once in three months and additional meetings may be held as and when the proposals are received at the discretion of the Chairman. Project applications must be submitted at least one month prior to each meeting.

ii. All members to be notified of meetingsiii. Agenda, previous minutes and application forms to be circulated to

the committee two weeks prior to the meetingiv. Minutes of the meeting to be recordedv. All meetings must consist of at least a quorum i.e., five.vi. All proposals received on or before the cut-off date will be put up by

the Member Secretary for review at any one meeting. If a large volume of applications is received for a meeting, the applications may not all be dealt with and some may have to be postponed to a subsequent meeting. The applications will be taken on a first come, first served basis or at the discretion of the Chairman.

vii. As part of the review process, an individual on the committee may be assigned the task of acting as the primary reviewer.


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of 235.7 Application Procedures

i. All proposals should be submitted in the prescribed application form, the details of which are given under Documentation. Only complete proposals to be put up for review by the Committee. Incomplete proposals to be returned by the Member-Secretary.

ii. All relevant documents should be enclosed with application form.iii. All necessary documents showing that the appropriate regulatory

clearances have been taken must be enclosed. In case of drug trials recruitment of subjects will be initiated only after clearance form the Drugs Controller General of India (DCGI).

iv. Investigator initiated proposals to be reviewed by Internal Review Committee before submission to the Ethics Committee.

v. Required number of copies of the proposal along with the application and documents in prescribed format duly signed by the Principal Investigator (PI) and Co-investigators/Collaborators should be forwarded by the Head of the department(s)/Institution to the Ethics Committee.

vi. The date of meeting will be intimated to the investigator, to be present, if necessary to offer clarifications.

vii. The decision will be communicated in writing. If revision is to be made, the revised document in required number of copies should be submitted within a stipulated period of time as specified in the communication or one month before the next meeting.

5.8 COMMITTEE REVIEW PROCEDURE

5.8.1 When protocols involve more than minimal risk to human subjects, meaning a greater risk than that found in ordinary daily life, they must be reviewed by the Ethics Committee. A review of the Ethics Committee is defined as a regular meeting of a quorum (5 or more) of the committee members.

5.8.2. TYPES OF REVIEW BY EC

Full Board review: Review of proposed research at a convened meeting at which a valid quorum of EC members is present. For the research to be approved, it must receive the approval by consensus. All clinical trials should undergo full board review.

Expedited review: Review of proposed research by the EC Chair or a designated voting member or group of voting members or by one or more experienced reviewers designated by the chairperson from among members of the EC rather than by the entire EC.


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Expedited review may be taken up depending on the discretion of the Chairperson for certain kinds of research involving no more than minimal risk and for minor changes in approved research. Expedited review may also be taken up in cases of nationally relevant proposals or post-graduate teaching programme (thesis/dissertation) requiring urgent review.

Proposals for expedited review to be submitted on separate application form clearly mentioning the reasons for expedited review. A brief summary and review decision of the protocol will be placed before the EC members in the next meeting.

The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review, expedited or convened.

Exemption from Review

Proposals which present less than minimal risk fall under this category as may be seen in following situations:

i. Research on educational practices such as instructional strategies or effectiveness or the comparison among instructional techniques, curricula, or classroom management methods.

ii. Research involving the collection or study of existing data, documents, records, specimens, that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis) and if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

Exceptions:a. recorded in such a manner that human subjects can be identified,

directly or through identifiers linked to the subjects; andb. any disclosure of the human subjects' responses outside the

research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.


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5.8.3 An investigator cannot decide that her/his protocol falls in the exempted category without approval from the Ethics Committee. All proposals to be scrutinized by the Member Secretary to decide under which of category it will be considered.

5.8.4 The Investigator/ Co-investigator to attend the meeting to make a presentation and answer any queries, if any on the protocol. The committee then discusses the protocol until a consensus is reached. Following each Ethics committee meeting the investigator will be informed of the protocol status in writing.

5.9 Decision Making

Decision may only be taken when sufficient time has been allowed for review and discussion of an application in the absence of non-members (e.g. the investigator or representative of the sponsor, independent consultant) from the meeting, with the exception of EC staff.

i. Decision will only be made at meetings where a quorum is present. No proposal will be approved by circulation of study proposals.

ii. The documents required for a full review of the document should be complete and the relevant elements considered before a decision is made.

iii. Members of the Committee must be sensitive to the potential for real or perceived conflict of interest and advise the rest of the Committee whenever there is potential for either (e.g. as in the case of current or past research collaborations). In addition, members must not participate during the portion of a meeting that involves ethics review decisions of projects on which they are listed as principal investigators or co-investigators, or of projects of students they supervise. Any conflict of interest will be recorded in the meeting minutes.

iv. Only members without any direct or potential conflict of interest, who participate in the review, will participate in the decision. The experts will only offer their opinions.

v. The Committee strives to reach decisions concerning ethics review and clearance of applications by sufficient discussion to reach a consensus. In cases, however, when a consensus is not possible or a vote is required, a simple majority of the quorum of those present is required. The vote and dissent recorded if required.

vi. Detailed proceedings and minutes of the Committee's deliberations and decisions will be securely maintained by the Office Ethics Committee and will be considered strictly confidential.


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vii. In cases of conditional decisions, clear suggestions for revisions and the procedure for having the application re-reviewed will be specified.

viii. A negative decision on an application will be supported by clearly stated reasons.

ix. Member Secretary will communicate the decision in writing.

5.9.1 Approval

If full ethical approval is granted, the investigator may only begin the research proposed in the protocol when it has been outlined in a letter.

5.9.2 Conditional Approval:

Conditional approval of a protocol may be granted, requiring modifications in the protocol and/or patient information sheet and/or patient consent form before initiation or responses to specific inquiries by the Ethics Committee. In this case, the investigator should submit a cover letter along with a modified submission form, protocol, consent form or supplemental information as requested with the changes highlighted.

No research may be started until all conditions have been met and full approval has been obtained.

Where conditional approval is granted the Chairman and Member Secretary may review the modified submissions and grant approval subject to the affirmation of the committee at its following meeting.

5.9.3 Deferral

A deferred protocol must be revised and resubmitted to the Ethics committee within 2 months. If not resubmitted within stipulated time, the proposal will be considered as withdrawn.

5.9.4 Rejection

Protocols may be rejected by the Ethics Committee. This may occur if a protocol has been deferred three times and the Ethics Committee feels that the proposed research is not justified and/or poses severe or unnecessary risk to the subjects. The Ethics Committee will not accept any further revisions to a rejected protocol.


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5.9.5 Amendments

All amendments to approved protocols to be submitted to the Ethics Committee for review.

Amendments to approved protocols may not be initiated until Ethics Committee approval has been obtained.

Amendments to approved study will be reviewed by the Chairman and Member Secretary if amendments do not affect study protocol and patient information sheet involving only or are related to logistical or administrative aspects of the study and approval issued as appropriate subject to affirmation by the committee at its following meeting.

5.10 COMMUNICATING A DECISION

A decision will be communicated in writing to the applicant, preferably within two weeks’ time of the meeting at which the decision was made.

The communication of the decision will include, but is not limited to, the following:

i. the exact title of the research proposal reviewed;ii. the clear identification of the protocol of the proposed research or

amendment, date and version number (if applicable).iii. the names and specific identification number version

numbers/dates of the documents reviewed, including the potential research participant information sheet/material and informed consent form;

iv. the name and title of the applicant;v. the name of the site(s);vi. the date and place of the decision;vii. a clear statement of the decision reached;viii. any advice by the EC;ix. in case of a conditional decision, any requirements by the EC,

including suggestions for revision and the procedure for having the application re-reviewed;

x. in the case of a positive decision, a statement of the responsibilities of the applicant; for example, confirmation of the acceptance of any requirements imposed by the EC; submission of progress report(s); the need to notify the EC in cases of protocol amendments; the need to notify the EC in the case of amendments to the recruitment material, the potential research participant information, or the informed consent form; the need to report serious and unexpected adverse events related to the conduct of the study; the need to report unforeseen circumstances, the termination of the study, or


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significant decisions by other EC; the information the HEC expects to receive in order to perform ongoing review; the final summary or final report;

xi. In the case of a negative decision, clearly stated reason(s) for the negative decision;

xii. Signature (dated) of the Member Secretary of the EC.

5.11 RECORD KEEPING

i. Written Proceduresii. Membership Listiii. List of membership qualifications & their CVsiv. Agendas and Minutes of meetingsv. All Correspondencevi. All reports/summariesvii. All submitted documentation must be retained for at least ten years

after completion of trialviii. Archival of documents – is the responsibility of the office.

6.0 INVESTIGATORS RESPONSIBILITIES

The Investigator of the study must attend the Ethics Committee Review.

It is the responsibility of the Investigator to provide the Ethics Committee with the appropriate information on the research protocol including initial information, notification of subsequent modifications, terminations and adverse reactions.

It is the responsibility of the Investigator to ensure that all equipment used in trials has the appropriate certification of compliance for the Year.

6.1 Notification of amendments

When any revision to an approved research protocol or written consent form is proposed the amendment must be brought to the attention of the ethics committee for approval.

Amendments to approved protocols may not be initiated until Ethics Committee approval has been obtained.


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6.2 Notification of Adverse Events

All adverse events which may be related to the trial drug must be brought to the attention of the sponsor within 24 hours and to the ethics committee attention within 7 days.

All adverse events must be accompanied by an explanatory letter from the Company or Principal Investigator involved.

6.2.1. SERIOUS ADVERSE EVENT (SAE) REPORTING

When a subject who is participating in a research study experiences an unexpected or serious adverse event, the PI must promptly report the incident to the sponsor’s Data and Safety Monitoring Committee and the EC. A summary of the adverse event must be submitted along with whether such events have been observed at our site. For adverse events or reactions that occur at IHBAS the following apply:

i. Death and hospitalization for any reason must be reported immediately to EC

ii. If the adverse event or reaction was anticipated in the protocol and the subject was informed about the possibility of the event in the consent form, there is no need to inform the EC unless the adverse event was unexpectedly serious, life threatening, or fatal.

iii. If the adverse event or reaction was unanticipated, unexpectedly serious, life-threatening or fatal, the adverse event must be reported to the Sponsor within 24 hours and should be sent within 7 days to the Secretary Ethics Committee.

iv. If the research study is being supported by an industry sponsor, the PI is also responsible for notifying the sponsor. The sponsor must then notify the regulatory authorities within 7 days.

v. If the PI holds the Investigational New Drug (IND) or Investigational New Device Exemption (IDE) in his/her name, he/she is required to notify the regulatory authorities of the adverse event or reaction within 24 hours, in addition to notifying the EC.

vi. Within 15 working days, the PI must submit a written confirmatory report of the adverse event or reaction to the EC.

vii. For industry sponsored research trials of drugs or devices, sponsors are required to inform investigators of adverse events or reactions that occur at other sites. When PIs are informed of the adverse events in sponsor safety memos and other correspondence, the PI must review the adverse event report and then notify the EC. This should be done within 2 weeks of receipt of the report from the sponsor.


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viii. PI in consultation with the Head of the Department and Institute & the Member-Secretary may take the initiative to temporarily stop the project in view of the life threatening SAEs reported even if from sites other than IHBAS, whenever required.

6.3 ANNUAL REVIEW AND RENEWAL

i. Updated reports of all trials/studies must be forwarded to the ethics committee on an annual basis and interim reports on biannual basis. The committee must be notified when trials are completed or terminated. The committee will prepare an annual report of activity.

ii. EC will follow-up progress of all studies for which a positive decision has been reached, from the time the decision was taken until the termination/completion of the research.

iii. The follow-up review intervals will be determined by the nature and the events of research projects, though each protocol will undergo a follow-up review at least once a year.

iv. A decision of a follow-up review will be issued and communicated to the applicant, indicating a modification, suspension, or termination of the EC’s original decision or confirmation that the decision is still valid.

v. In the case of the premature suspension/termination of a study, the applicant must notify the EC of the reasons for suspension/termination.

vi. A summary of results obtained in a study prematurely suspended/terminated should be communicated to the EC.

vii. EC should receive notification from the applicant at the time of the completion of a study

viii. EC should receive a copy of the final summary or final report of a study.

6.4 PATIENT INFORMATION LEAFLET

Patient information leaflet should be in English and in the language understandable by the patient. Patient information leaflet must include the following elements:

i. A statement that the protocol involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed and identification of any procedures, drugs or devices, which are experimental.

ii. Description of any reasonably foreseeable risks or discomforts to the subject.


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iii. Description of any benefits to the subject or to others that may reasonably be expected from the research, including payment or free treatment.

iv. A disclosure of appropriate alternative procedures or courses of treatment, if applicable, that might be advantageous to the subject.

v. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.

vi. Have the title of the project/trial and the names of the investigators clearly printed on the top of the form.

vii. Have space for signature/name/date of both the patient and witness/guardian and the investigator (or investigator’s nominee).

viii. Include the statement “I’ve read over, explained and understand the attached patient information leaflet.”

6.5 INFORMED CONSENT

Informed consent should be in English and in the language understandable by the patient. The following points must be included in the written patient informed consent:

That the trial involved research The purpose of the trial The trial treatment (s) and the probability for random assignment to

each treatment The trial procedures to be followed including all invasive procedures The subject’s responsibilities The reasonably foreseeable risks The reasonably expected benefits The alternative procedures / treatments available That subject’s participation is voluntary and may withdraw at any

time That the records identifying the subject will be kept confidential The expected duration of the subject’s participation in the trial

Compensation/ treatment available in event of trial related injury.

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6.6 FINAL REPORT

A copy of the final report should be sent to the Committee as soon as it is available.

7. Appellate Authority

In case there are any disputes regarding decision of the Ethics Committee , the appellate authority will be the Head of the Institution. In case the project belongs to the Head of the Institution, Chairperson IHBAS will be the appellate authority.


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Appendix A

Good Clinical Practices for Clinical Research in India, ICMR 2006

The Ethics Committee is constituted and operates to the standards laid down in the ICMR guidelines published in 2006.

COMPOSITION

S.No.

Name & designation Address

1. Prof. S.M. ChannabasavannaChairman

194, 10th Cross, Wilson GardenBangalore – 560 027Tele: 080-22222726Fax – 080 28432840

2 Prof. M. Gourie DeviMember

Flat 9, Doctors’ ApartmentsVasundhara EnclaveDelhi – 110 096

3. Drugs Controller of Delhi or his nomineeMember

Delhi SachivalayaNew Delhi

4. Dr. R.K. Chadda, Prof. of Psychiatry, AIIMSMember

Pocket E, Flat No. 581Mayur Vihar Phase II, Delhi-91

5. Prof. K.M. PrabhuDept. of Biochemistry, UCMSMember

6. Mrs. Sona Khan,Lawyer, Supreme CourtMember

A/2 Oberoi ApartmentsShamnath Marg, Delhi-54

7. Prof. Usha GuptaFormer, Head Dept. of Pharmacology, MAMC, Member

1525, Park View Apartments,Sector 29, NOIDA-201303

8. Prof. Kusum SaigalMember

D-125, Sector 40NOIDA – 201301

9. Prof. Nimesh G. DesaiMember

HOD (Psychiatry), IHBAS

10. Dr. T.B. SinghMember

HOD (Clinical Psychology),IHBAS

11. Dr. Sangeeta SharmaMember Secretary

HOD (Neuropsychopharmacology), IHBAS

12. Office Assistant


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Check list for submission of the project to the Ethics

Committee

1. Application form

2. Summary of the proposal & Justification for study, drug

developmental history in case of drug trials

3. Permission of the HOD & Head of the Institute

4. Protocol

5. Questionnaires

6. Informed consent form (Hindi and English)

7. Patient Information Leaflets (Hindi and English)

8. Investigator’s Brochure

9. Approval of DCGI

10. Agreement/ Undertaking by the Principal Investigator

11. Signed Indemnity bond

12. Insurance

13. Financial disclosure: Details of Funding agency/sponsors and

fund allocation for the proposed work.

14. Curriculum vitae of all the investigators

15. Any other voluntary disclosure


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