manas hospital ethics committee manas hospital nashik committee sop.pdf · manas hospital ethics...

Manas Hospital Ethics Committee, SOP V1, 01 OCT 2014 of 21

MANAS HOSPITAL ETHICS COMMITTEE Manas Hospital Nashik

Dr. Vasanti Ranjane Dr. Ateesh Borole Chairperson Member Secretary _________________________________________________________________________ STANDARD OPERATING PROCEDURE (SOP) version 1.00 dated 01/Oct/2014 Complete Name of the Ethics Committee : Manas Hospital Ethics Committee, Manas

Hospital, Opposite Tupsakhare Lawns, Mumbai NakaNashik-422002

Complete address of the Ethics Committee : Manas Hospital Ethics Committee, Manas Hospital, Opposite Tupsakhare Lawns, Mumbai NakaNashik-422002

Frequency of Ethics Committee Meeting : Last Sunday of Every Month; Expedited meeting is possible on as and when needed basis; EC meeting can be postponed if there is no new/amended protocol and if there is no specific agenda for the meeting.

Date of Next immediate Ethics Committee meeting

: As decided by the Chairperson/member secretary

Lead time required by the Ethics Committee before which they discuss documents submitted to them

: 15 days

Complete contact number of Ethics Committee member whose details will appear on the informed consent form

: Dr . Ateesh Borole Manas Hospital Ethics Committee, Manas Hospital, Opposite Tupsakhare Lawns, Mumbai NakaNashik-422002 +919869161815

SOP effective date : 01-OCT-2014


Table of Contents Purpose ................................................................................................................................ 3 Scope .................................................................................................................................... 3 Objective............................................................................................................................... 3 Registration .......................................................................................................................... 3 Role ...................................................................................................................................... 4 Composition .......................................................................................................................... 4

A. New Appointment ......................................................................................................... 4 B. Removal Procedure ...................................................................................................... 4 C. Quorum ......................................................................................................................... 5

Confidentiality and Conflict of Interest Agreement Form ...................................................... 5 Training ................................................................................................................................. 6 Correspondence Record ....................................................................................................... 6 Procedure and list of documents required for review ............................................................ 7

A. List of documents .......................................................................................................... 7 B. Meeting Schedule ......................................................................................................... 8 C. Decision Making ............................................................................................................ 8

Policy for studies on vulnerable population ........................................................................ 10 Policy for expedited review ................................................................................................. 11 Application procedure ......................................................................................................... 12

A. Pre meeting Procedure ................................................................................................ 13 B. Committee Meeting Procedure ................................................................................... 14 C. Post Meeting Procedure .............................................................................................. 15

Record Maintenance .......................................................................................................... 16

Appendix Appendix 1- Member Ship List of MANAS HOSPITAL ETHICS COMMITTEE ....................... 17 Appendix 2- Confidentiality Agreement Form for MANAS EC Members .......................... 18 Appendix 3- Conflict of Interest ...................................................................................... 20


1. Purpose The purpose of this standard Operating Procedure (SOP) is to outline the

a) Composition, roles and responsibilities of Member of EC b) Application process for review of submitted clinical trials by EC c) Review guideline for EC members d) Decision-making by the EC and notification to the applicant e) Ongoing review of the conduct, progress, efficacy and safety of a clinical trial. f) Special consideration for vulnerable population

The SOPs provide clear, unambiguous instructions so that the related activities of the committee are conducted in accordance with Indian laws and relevant, National and International Guidelines

2. Scope Each trial, under the GCP principle, should be conducted in compliance with the protocol that has received prior EC approval/favorable opinion. This SOP covers all clinical trials from Phase I to Phase IV. This includes the investigator initiated research as well as organization or pharmaceutical company sponsored trials that are submitted to MANAS HOSPITAL ETHICS COMMITTEE.

3. Objective The objective of this SOP is to contribute to effective functioning of MANAS HOSPITAL ETHICS COMMITTEE (the Institutional Ethics Committee) so that a quality and consistent ethical review mechanism is put in place for all proposals dealt by the committee received. The MANAS HOSPITAL ETHICS COMMITTEE is setup to ensure that the clinical research studies are sound in scientific design, have statistical validity and are conducted according to the parameters of ICH-GCP as well as local regulatory requirements.

Do not compromise the safety, rights and well being of the patients participating in the research study.

are conducted under the supervision of medical persons with the required experience / expertise

Include safely, patients who, through their legally acceptable representative have given informed consent for participation in the research study.

4. Registration


5. Role: The MANAS HOSPITAL ETHICS COMMITTEE will review and approve all types of research proposals involving human participants with a view to safeguard the dignity, right, safety and well being of all actual and potential research participants. The goals of research, however important, would never be permitted to override the health and well being of the research subjects. The MANAS HOSPITAL ETHICS COMMITTEE will take care that all the cardinal principles of research viz. Autonomy, Beneficence, Non-malafide and justice are taken care of in planning, conduct and reporting of the proposed research. For their purpose, the MANAS HOSPITAL ETHICS COMMITTEE will look into the aspects of informed consent process, risk benefit ratio whenever required. The MANAS HOSPITAL ETHICS COMMITTEE will review the proposals before start of the study as well as monitor the research throughout the study until and after completion of the study. The MANAS HOSPITAL ETHICS COMMITTEE will also examine compliance with all regulatory requirement, applicable guidelines and laws.

6. Composition: The MANAS HOSPITAL ETHICS COMMITTEE will comprise of 7-12 members (to allow a quorum of at least 5 members at each review meeting as per ICMR guidelines and schedule ‘Y’ in order to provide collective expertise ensuring a comprehensive review (scientific and ethical) of the projects submitted to it. The chairperson of the MANAS HOSPITAL ETHICS COMMITTEE would be from outside the institution and not head of the same institution to maintain the independence of the committee. The member secretary of the MANAS HOSPITAL ETHICS COMMITTEE would be from same institution and would conduct the business of the committee.

A. New Appointment The members including the member secretary will be nominated & appointed by the Institutional Head in office who would be a mix of medical, non-medical scientific and non-scientific persons including lay public to reflect differed. The term of office of each member is three years. Any change to membership of the Ethics Committee must be approved by the Institutional Head in office viewpoints.

B. Removal procedure

A member may be relieved of his/her membership in case of conduct unbecoming for a member of the Ethics Committee or inability to participate in the meetings on any grounds The members may be replaced at the discretion of the committee members when a majority vote is obtained.


C. Quorum The quorum of at least five members must be present at each meeting. Quorum should at least consist of each one of following:

1. Basic Medical Scientist/ Pharmacologist 2. Clinician 3. Legal Expert 4. Social Scientist /representative of an NGO 5. Lay person from Community

Institutional Ethics Committee membership list would be as per Appendix 1 The requisite quorum of 5 members is required to be present at each review meeting. Decisions will be made only in meetings where quorum is complete. All nominated members including the member secretary have the right to vote.

Ethics Committee Members Conveyance Allowance would be given to the members attending the meeting. The member secretary shall be aware of the amount decided by the Institutional Head.

It is preferable that at least one of the MANAS HOSPITAL ETHICS COMMITTEE members who are not affiliated to the Institute be present during each review meeting as per Schedule-Y. All members should maintain in absolute confidentiality of all discussions during the meeting. They have no rights to participate if they are principal investigator.

7. Confidentiality and Conflict of Interest Agreement Form The appropriate Confidentiality and Conflict of Interest Agreement Form will be provided to the MANAS HOSPITAL ETHICS COMMITTEE member and Independent Consultant

Every member at beginning of the tenure and before he/she commences to review research projects submitted to MANAS EC and before he/she starts to function as an MANAS EC members and before he/she starts attending MANAS EC meeting will read the Confidentiality and Conflict of Interest Agreement Form ‐ Appendix 2 and 3 carefully and thoroughly.

MANAS EC member; Independent Consultant will fill up the details such as name, designation, email id and official address and will be provided it to secretariat of MANAS EC.

The newly appointed MANAS EC member, before the beginning of their tenure, and Independent Consultants will sign and date the document before a member of the Secretariat. They will give the signed form back to the Secretariat

The Secretariat will obtain the signature of the MANAS EC Chairperson on the Confidentiality /Conflict of Interest Agreement Form.


The secretariat will provide MANAS EC member, Independent Consultants a photocopy of the Confidentiality /Conflict of Interest Agreement Form for their records (duly signed and dated by them and MANAS EC Chairperson) and acknowledge the receipt of agreement by their signature.

The Secretariat keeps the original copies of the signed Agreements at the Ethics Committee for Research on Human Subjects office in the file.

The Secretariat will store the file in a secure cabinet with limited key holders.

The member secretary / designee / MANAS HOSPITAL ETHICS COMMITTEE coordinator will record the minutes during each meeting

8. Training of the MANAS EC Members in Research Ethics An individual selected as a new member of the MANAS EC will be required to attend one

meeting as an ‘Observer’ before being inducted as a member of the MANAS EC

• Member‐secretary or an MANAS EC member will provide an introductory training to the new member.

• The MANAS EC Member Secretary, member, Chairperson will be encouraged to receive continued training by participating in a workshop, conference and/ or retraining program related to research ethics, as a delegate, faculty, facilitator, etc. at least once every year.

• The MANAS EC will conduct workshops on ethics in clinical research and good clinical research practices from time to time to impart training to the MANAS EC Members to the Institutional faculty members.

• The MANAS EC may sponsor or reimburse the expenses of an MANAS EC member or prospective members for attending conference, continuing education session workshop and/ or training program etc.

9. Correspondence Record Correspondence between the MANAS HOSPITAL ETHICS COMMITTEE and the principal investigator / study team and other relevant records (response letter, minutes of meetings, membership list composition etc) will be retained for minimum period of 5 years after completion of the trial.

The MANAS HOSPITAL ETHICS COMMITTEE will review all research projects and also the on going research projects at intervals appropriate to the degree of risk to the study subjects. The committee will maintain a list of projects submitted, approved / disapproved and the outcome of each project including subject in formation, relevant correspondence and all study related documents.


10.Procedure and List of Documents required for review

A. List of Documents: The applicant of the proposal generally the principal investigator is required to submit his/her application letter and 10 hardcopies and 1 soft copy of the following documents, 15 days before a scheduled meeting:

o A letter of intent or proposal by the Investigator o Research protocol. o Protocol Amendment, if any. o Investigator’s Brochure. o Case Report Form o Informed consent form, [English] o Informed consent form, [English to Marathi translation]. o Informed consent form, [Marathi to English back translation].

including translation certificate o Informed consent form, [English to Hindi translation]. o Informed consent form, [Hindi to English back translation].

including translation certificate o Patient/ volunteer information Leaflet [English] o Patient/ volunteer information Leaflet [English to Marathi translation]. o Patient/ volunteer information Leaflet [Marathi to English back translation].

including translation certificate o Patient/ volunteer information Leaflet [English to Hindi translation]. o Patient/ volunteer information Leaflet [Hindi to English back translation].

including translation certificate o Any written information to be provided to subjects including patient

emergency card, study related questionnaire o subject recruitment procedures (e.g. advertisements)Safety Reports o DCGI Approval Letter (DCGI Submission letter would be accepted in lieu of

DCGI Approval letter. However, DCGI Approval letter should be notified to EC once available. Even though after receipt of EC approval, trial would not be initiated until DCGI Approval letter is notified to EC)

o Insurance Policy o Import license, where applicable o Investigator’s undertaking o The investigator’s current curriculum vitae o Clinical Trial Agreement o The MANAS HOSPITAL ETHICS COMMITTEE is to be notified of any

payments proposed to be made to study patients towards reimbursement of incidental expenses.

The fees for the consideration of the protocol/clinical study in question will be Rs.35000. The fees for any protocol &/or other amendment/s which required full EC meeting review in the study shall also be Rs. 10000 and should be in the form of a chaque addressed to MANAS HOSPITAL ETHICS COMMITTEE

The Institutional Ethics Committee expects from the principal investigator to be informed about:

a) The initiation of the study/randomization of the first patient (in the status report) , b) The progress of the study at interval of every Six months,


Any Serious Adverse Events occurring in the course of the study within 24 hours of their occurring. In case Member Secretory is not available personally due to weekend or any other condition, it can be notified to EC member secretory by email at [email protected]

c) which will be followed by signature of Member secretory or Chairman within 7 days.

d) Any changes in the protocol and patient information /informed consent documents, prior to their implementation.

e) Amendments/revisions to any study-related document as well as patient safety related information

f) Study completion and discontinuation with reasons g) Justification for approval to restart studies discontinued earlier

The final report of the study shall be submitted to the MANAS HOSPITAL ETHICS COMMITTEE in all cases, even when the study abandoned for any reason (s).

B. Meeting Schedule:

The MANAS HOSPITAL ETHICS COMMITTEE preferably will meet last Sunday of every month. Advance notice before each meeting will be sent out to the members, along with the agenda. Expedited meeting is possible on as and when needed basis; EC meeting can be postponed if there is no new/amended protocol and if there is no specific agenda for the meeting at the discretion of Member Secretory or Chairman.

C. Decision Making: The Member secretary, designated by the Chairperson, will record the Minutes of the meeting and circulate the same to the members within two weeks of the meeting. The Investigator/Co-investigator can 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 ethics committee. A Study Team member including the Principal Investigator will be deemed an interested party with regard to the review. The Study Team Member's non participation in the decision making / voting process will be recorded in the response letter from the EC. Only those EC members who are independent of the investigator and the sponsor of the trial should vote/provide opinion on a trial-related matter. The MANAS HOSPITAL ETHICS COMMITTEE may call upon subject experts as independent consultants who may provide special review of selected research protocols, if need be. These experts may be specialists in ethical or legal aspects, specific diseases or methodologies, or represent specific communities; patient groups or special interest groups e.g. Cancer patients, HIV/AIDS positive person or ethnic minorities. They are required to give their specialized views but do not take part in the decision making process which will be made by the members of the Institutional Ethics Committee The decision of the committee will taken by a majority vote after the quorum requirements are fulfilled to recommend / reject / suggest modifications for a repeat review or advise appropriate steps. If subject experts are invited to offer their views, they will not take part in the voting process.


The MANAS HOSPITAL ETHICS COMMITTEE will give its opinion on the project in one of the following ways: Approval

Disapproval

Modification before Approval

Discontinuation of a previously Approved project

In case MANAS HOSPITAL ETHICS COMMITTEE revokes its approval accorded to a trial protocol, it must record the reasons for doing so and at once communicate such a decision to the Investigator.

In all cases, the study will be unambiguously identified by protocol title and number.

All documents reviewed will be listed in the response letter, which will also state the list of members present and date of the meeting at which the study was reviewed.

The member-secretary will convey the decision of the committee to the Principal Investigator in writing. The response letter will include the signature and date by the MANAS HOSPITAL ETHICS COMMITTEE member-secretary.

The decision letter must contain following information:

Date and time of EC meeting.

Place of the meeting Names and designation of the Chairperson and members who attend the meeting. Title of the Research proposal Name of the Chief investigator

List of documents (with date and version number wherever possible) reviewed by the MANAS HOSPITAL ETHICS COMMITTEE

A clear Statement of the Decision Reached .Any advice (non-binding) by the MANAS HOSPITAL ETHICS COMMITTEE

In the case of Negative decision, reasons for not approving the proposal must be mentioned

In the case of "approval" decision, the responsibilities of the chief investigator must be communicated:

Should an amendment to a study related document be administrative in nature and not involving study design or safety criteria, it may be provisionally approved in writing, by the Chairperson/member-secretary of the MANAS HOSPITAL ETHICS COMMITTEE without calling a full meeting.

The Chairperson/member-secretary will inform other members of the MANAS HOSPITAL ETHICS COMMITTEE of amendment and his / her decision during the subsequent regular meeting of the committee. The decision will be ratified and comminuted.


11.Policy for Studies on Vulnerable Population The purpose of this section is to detail the requirements for Institutional Ethics Committee (EC) approval of research involving vulnerable populations. Vulnerable populations must be given special consideration. Examples of Vulnerable Populations:- A. Handicapped persons: Persons with mental or physical handicaps are considered to be a vulnerable population. B. Elderly persons C. Research on persons below 18 years of Age D. Subordinate Individuals: Subordinate relationships can be unduly influenced by their superior. The following are examples of such relationships: a. Employer/employee b. Military officer/soldier E. Persons with mental health conditions F. Traumatic or emergency situations: Individuals who are in the midst of a traumatic or emergency situation or otherwise under emotional duress can be potentially vulnerable. H. Low Socioeconomic Status: Low socioeconomic status can create a vulnerability of subjects resulting from unique socioeconomic factors. For example, an offer of financial compensation for participation in research may be interpreted as exploitive when directed toward impoverished subjects. I. Incurable disease: The following are examples of such disease: -Cancer Patient with no cure therapy is available -HIV etc J. Research on pregnant women, fetuses and neonates Special Considerations and Procedure to review studies on Vulnerable The inclusion of certain groups of participants who may be vulnerable to undue influence or coercion may require additional protections. When the EC reviews research involving vulnerable populations, the EC applies any additional Indian regulations, Schedule Y requirements, as applicable. The EC evaluates whether additional safeguards have been included in the study to protect the rights and welfare of participants who may be vulnerable to undue influence. The IRB requires at least one or more individuals who are knowledgeable about or have experience in working with these participants are part of the review process. The IRB reviews research involving vulnerable populations according to applicable requirements and guidelines and makes determinations. If the research includes a vulnerable population that does not have additional protections, the EC will evaluate the research proposal to ensure that precautions are taken to protect the participants. The IEC must consider risks to participants when reviewing proposed research. There are risks to vulnerable populations that would not normally need consideration, such as the following:

A. To what risks, unique to their status, will participants be exposed?


B. What protections will be made to mitigate risks?

C. Are subjects capable of providing consent? a. If the IEC determines that a legal representative is appropriate, such as when the

subject is an adult with a cognitive disability, the IRB will work together with its legal advisor to determine who is most appropriate according to Indian Regulations and state law to provide legally effective consent on behalf of the subject.

D. Research involving children a. Where possible, parent/guardian consent should be accompanied by assent

from the child showing them to be a willing participant in the research project. It is recommended that the assent of the child be sought when deemed appropriate by the study team

b. Participant Information Sheets and Consent/Assent forms must be presented in a form and language that is understandable by a child of 10 years of age (that is, to a fifth grade level)

Also based on the requirement of the research area such as HIV, Genetic disorder etc specific population group may also be represented in ethics committee.

12.Policy for Expedited review:

All revised proposals, epidemiological and/or Academic proposal unless specifically required to go to the main committee, will be examined in a meeting of identified members convened by the Chairman to expedite decision-making. Expedited review may also be ordered by the Chairman and/or Member Secretory in cases of proposals requiring urgent review.


14. APPLICATION PROCEDURE

Post Meetin

Inquiry to Ethics Office/ Investigator regarding submission procedures.

Ethics Office to forward to Investigator the EC SOP

Submission must be received by Ethics Office at least 15 days prior to next review meeting.

All details of 1. Letter of Intent 2. Patient consent forms in English, Hindi* and Marathi* 3. Patient Information Leaflets 4. Questionnaires 5. Protocol 6. Investigator Brochure All documents must be bound Processed by Ethics Office.

When all the above requirements are processed, 1. Record receipt of the Proposal in the Log book 2. Include on Agenda for next Research Ethics Committee Meeting.


A. PRE MEETING PROCEDURE

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

Each protocol is allocated to a relevant committee member for detailed review.

Make a Log all amendments, 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 for interview of their appointed time for their proposal presentation.

Notify all committee members of next meeting date.

Ensure that the meeting will be properly constituted – Quorum 5


B. COMMITTEE MEETING PROCEDURE

Previous Minutes and Matters 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 Chairman /Alternate vice chairman may act as Chairman in his/her absence

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

A vote on each submission is taken and recorded in the minutes of the meeting. If any of the members are participating in a trial that is under review by the Committee, he/she may not participate in the discussion on that submission and must absent him/herself from the vote.


C. POST MEETING PROCEDURE

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

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

All correspondence must be signed by either the Chairman or Member Secretary

All Ethically Approved Trials Must Include: Copy of protocol * Copy of Investigator Brochure * Copy of Patient Information Sheet Copy of Patient Consent Form. Copy of Ethics Approval Letter Copy of DCGI approval * Copy of DGFT Export License* * Where Applicable.


15. Record Maintenance All documentation and communication of Ethics committee are to be dated and recorded with Member Secretory which includes the following:

1. Constitution and composition of Ethics Committee 2. CV of the committee member 3. EC SOP and their Subsequent changes 4. Copies of documents submitted for review included but not limited to Protocol, IB 5. Agenda of all EC meetings 6. MoM with signature of Chairman 7. Copies of decision communicated to the applicants 8. Records of all correspondence with EC by applicant including status report, SAE

notification, reason for premature termination of the study. This Ethics committee is constituted and functions as per ICH-GCP guidelines and Good clinical practice guidelines issued by the Central Drug Standards Control Organization, Schedule Y and Ethical guidelines for Biomedical Research on Human subjects, issued by the Indian council of Medical Research.

Dr. Vasanti Ranjane Dr. Atish Borole

Chairman Member secretory


Appendix 1

Member Ship List of MANAS HOSPITAL ETHICS COMMITTEE

Sr. No.

Name of the MANAS EC Member

Qualification Designation Affiliation Affiliation to Institute

1 Smt. Vasanti Ranjane

BSc Med Chairperson Secondary School Teacher at Madhyamik Vidyalaya, Unthwadi Nasik

No

2 Dr. Ateesh Borole M.B.B.S, M.S, D.N.B (Gen. Surg), M.N.A.M.S, M.Ch, D.N.B (Plastic Surgery) Fellow (Cosmetic Surgery)

Member Secretary

Plastic Surgeon in Manas Hospital Nashik

Yes

3 Dr. Bhushan Nemade

M.D. Radiation Oncology PDCR

Member Radiation Oncologist and Institute Head Manas Hospital Nashik

Yes

4 Dr. Sachin Patil M.S. Ortho Member Orthodepic Surgeon Manas Hospital Nashik

Yes

5 Dr. Sagar Mandlik M.D. Chest Medicine

Member Consultant Chest Physician, Vakratund Hospital Nashik

No

6 Dr. Amit Mutha M.D. Pharmacology

Member[ Pharmacologist]

Assistant Professor Pharmacology, Grant Medical College & J. J. group of Hospitals, Mumbai,

No

7 Mr. Raosaheb Ghegde

M.Pharm [Pharmacognosy]

Member Dr. M.S Gosavi College of Pharmaceutical Education and Research Nashik

No

8 Adv. Mayur Jadhav

M.A .L.L.B Layer Nashik District Court

Legal Member


9 Mrs. Sadhana Nikam

M.A Member[ Lay Person]

NO Member

10 Mr. Hemant Patil

M.A. Social Worker No Member

Ethics Committee Assistant

Miss Suvarna Jadhav

B.A. Receptionist Yes Assistant

Appendix 2 Confidentiality Agreement Form for MANAS EC Members In recognition of the fact, that I ______________________________________________ ___________________________________________________________________________ (Member’s name, and his/her affiliation) herein referred to as the “undersigned”, have been appointed as a member of the Manas Hospital Ethics Committee, Manas Hospital, Opposite Tupsakhare Lawns, Mumbai NakaNashik-422002 and have been asked to assess research studies involving human subjects in order to ensure that they are conducted in a humane and ethical manner, adhering to the highest standards of care as per the national, and local regulations and institutional policies and guidelines and international and national guidelines; Whereas, the appointment of the undersigned as a member of the Manas Hospital Ethics Committee, Manas Hospital, Opposite Tupsakhare Lawns, Mumbai NakaNashik-422002 is based on individual merits and not as an advocate or representative of a home province, territory or community nor as a delegate of any organization or private interest; Whereas, the fundamental duty of an MANAS EC member is to independently review both scientific and ethical aspects of research protocols involving human subjects and make a determination and the best possible objective recommendations, based on the merits of the submissions under review;

Whereas, the Manas Hospital Ethics Committee, Manas Hospital, Opposite Tupsakhare Lawns, Mumbai NakaNashik-422002 must meet the highest ethical standards in order to merit the trust and confidence of the communities in the protection of the rights and well‐being of human subjects; The undersigned, as a member of the MANAS EC, is expected to meet the same high standards of ethical behavior to carry out its mandate. This Agreement thus encompasses any information deemed Confidential or Proprietary provided to the Undersigned in conjunction with the duties as a member of the MANAS EC. Any written information provided to the undersigned that is of a Confidential, Proprietary, or Privileged nature shall be identified accordingly. As such, the undersigned agrees to hold all Confidential or Proprietary trade secrets (“information”) in trust or confidence and agrees that it shall be used only for contemplated purposes and shall not be used for any other purpose or disclosed to any third party. Written Confidential information provided for review shall not be copied or retained. All Confidential


information (and any copies and notes thereof) shall remain the sole property of the MANAS EC. The Undersigned agrees not to disclose or utilize, directly or indirectly, any Confidential or Proprietary information belonging to a third party in fulfilling this agreement. Furthermore, the Undersigned confirms that his/her performance of this agreement is consistent with the institute’s policies and any contractual obligations they may have to third parties. Agreement on Confidentiality

Please sign and date this Agreement, if the Undersigned agrees with the terms and conditions set forth above. The original (signed and dated Agreement) will be kept on file in the custody of the MANAS EC. A copy will be given to you for your records. In the course of my activities as a member of the MANAS EC, I may be provided with confidential information and documentation (which we will refer to as the Confidential Information; subject to applicable legislation, including the Access to "Confidential Information"). I agree to take reasonable measures to protect the Information Act, not to disclose the Confidential Information to any person; not to use the Confidential Information for any purpose outside the Committee's mandate, and in particular, in a manner which would result in a benefit to myself or any third party; and to destroy all Confidential Information (including any minutes or notes I have made as part of my duties) to the Chairperson upon termination of my functions as a Committee member. I, ________________________________________________ (name of the member) have read and accept the aforementioned terms and conditions as explained in this Agreement. Signature Date ________________________ __ __________________ Chairperson’s Signature Date I acknowledge that I have received a copy of this Agreement signed by the MANAS EC Chairperson and member Secretary. __________________________ _________________ Signature Date


Appendix 3: Conflict of Interest: Definition: A situation in which a person, such as a public official, an employee, or a professional, has a private or personal interest sufficient to appear to influence the objective exercise of his or her official duties. There are three key elements in this definition: financial interest, official duties, and professional interest. A conflict of interest occurs when: • An individual’s private interest differs from his or her professional obligations to the institute. • Professional actions or decisions occur that an independent observer might reasonably question. • A conflict depends upon situation and not on the character or actions of the individual. • Potential conflicts of interest must be disclosed and managed as per policy. Conflict of Interest Agreement Form for MANAS EC Members It is recognized that the potential for conflict of interest will always exist but has faith in the MANAS EC and its Chairperson to manage the conflict issues so that the ultimate outcome is the protection of human subjects. It is the policy of the MANAS EC that no member may participate in the review, comment or approval of any activity in which he/she has a conflict of interest except to provide information as requested by the MANAS EC. The Undersigned will immediately disclose to the Chairperson of the MANAS EC any actual or potential conflict of interest that he/she may have in relation to any particular proposal submitted for review by the Committee, and to abstain from any participation in discussions or recommendations or decision making in respect of such proposals. If an applicant submitting a protocol believes that an MANAS EC member has a potential conflict, the investigator may request that the member be excluded from the review of the protocol.


The request must be in writing and addressed to the Chairperson. The request must contain evidence that substantiates the claim that a conflict exists with the EC member(s) in question. The Committee may elect to investigate the applicant’s claim of the potential conflict.

When a member has a conflict of interest, the member should notify the Chairperson and may not participate in the MANAS EC review or approval except to provide information requested by the Committee.

Examples of conflict of interest cases may be any of the following:

• A member is involved in a potentially competing research program.

• Access to funding or intellectual information may provide an unfair competitive advantage.

• A member’s personal biases may interfere with his or her impartial judgment.

Agreement on Conflict of Interest

Please sign and date this Agreement, if the Undersigned agrees with the terms and conditions set forth above. The original (signed and dated Agreement) will be kept on file in the custody of the MANAS EC. A copy will be given to you for your records.

Whenever I have a conflict of interest, I shall immediately inform the Chairperson not to count me for discussion or decision making in respect of such proposal.

I, ________________________________________________ (name) have read and accept the aforementioned terms and conditions as explained in this Agreement.

__________________________ __________________ Signature Date ________________________ __ __________________ Chairperson’s Signature Date I acknowledge that I have received a copy of this Agreement signed by the MANAS EC Chairperson and member Secretary. __________________________ _________________ Signature Date