Erebouni Medical Center

ETHICS COMMIITTEE. STANDARD PROCEDURE: RULES OF PROCEDURE OF THE LOCAL ETHICS COMMITTEE OF EMC

I. Requests assessment

1. Ethics Committee assesses written applications submitted by applicants of clinical trials or other research projects. Request for assessment of clinical trial or other research project must include:

  1. protocol title, protocol code number, brief object of the clinical trial, b. clinical trial protocol, including all amendments,
  2. summary of the protocol,
  3. procedures for recruitment of subjects (especially advertising), e. information for the investigator (Investigator´s Brochure),
  4. information for the subject of the clinical trial and the informed consent form on Armenian, Russian and other languages in case of request, eventually information and the informed consent form for an minor participants,
  5. forms for the record of subjects of clinical trials (if they are used in the clinical trial),
  6. information on eventual compensation or regard given to the subjects of the clinical trial, i.  information on amount, eventually method of determining remuneration or compensation for the investigator and the medical facility, eventually calculation of costs associated with the implementation of the clinical trial,
  7. fundamental terms of agreements between sponsor, investigator, or medical facility, k. insurance contracts (or their drafts) procuring insurance of investigator and sponsor,
  8. proof of provision of compensation or insurance in case of death or damage to health due to the clinical trial,
  9. logbooks (if they are used in the clinical trial),
  10. current signed curriculum vitae of the investigator and other documents confirming his qualification,
  11. conditions and means of recruitment of patients in acute cases, p. list of other centres, where the clinical trial shall take place,
  12. information on the multi-centric Ethics Committee, which assesses the project,
  13. a contact person or company that pays out an invoice to cover costs associated with the assessment of the clinical trial.


2. Request for the assessment of the clinical trial from the local Ethics Committee for medical facilities:

 

  1. constitutive document,
  2. decision on registration of the medical facility,
  3. license of Ministry of Health or the Scientific Centre of Drug and Medical Technology Expertise of MH RA,
  4. current, signed CV of the investigator,
  5. statutory declaration of appropriateness of the facility for the implementation of the clinical trial


3. The Chairman, without undue delay, assigns documents of the clinical trial for the examination to one of members of the Committee with medical education. This is usually a member with the most proper expertise for assessment of the study. This member prepares  information on clinical trial evaluation, which takes up with the other members of the Committee at the Committee meeting. A member with legal education takes up with the documents of the clinical trial before the Committee meeting and controls the completeness of the documentation and the formalities of the documentation, particularly the text of the informed consent, insurance certificate, etc. He deals with the protection of the patient´s rights. In case of lack in the documentation he takes part in the correspondence with sponsors or investigators.

4. Other members of the Committee assess especially completeness and clarity of the information for patients and other issues that are not explicitly of medical nature (eg. remuneration and compensation, compensation requirements, etc.)

5. Before and during the Committee meeting other members also take up with the documentation.

6. During the Committee meeting are discussed identified problems and shortcomings, objections and questions of individual members. Members of EC assess, whether the expected therapeutic benefits prevails the risks of the research.

7. EC members are entitled to request a consultation or order an elaboration of expertise by a non-member of EC, or request a consultation with a representative of sponsor or investigator. In case of requesting consultation or expert´s testimony outside the EC, those can be rewarded on the basis of a fixed job contract or an agreement on work performed outside the employment. Before acceptance of the documentation, experts must also sign a commitment to respect confidentiality of all matters related to the clinical trial, which they learn about in connection with consultation and the opinion elaboration. Signed statements are archived in the office of the Committee. Contracts concluded towards the payment of reward are archived at the HR department of EMC.

8. Ethics Committee shall communicate its opinion to the sponsor and the Scientific Centre of Drug and Medical Technology Expertise of MH RA at the latest within 60 days from the request receipt. The deadline may be extended by 30 days for clinical trials of medicinal products for gene therapy or somatic cell therapy or medical products containing genetically modified organisms. In justified cases the deadline may be extended up to 180 days. In case of xenogenic cell therapy the deadline for issuing opinion is not limited.

9. If there are any deficiencies or ambiguities in the submitted documentation, Committee may request a written statement or completion from the sponsor. Running of the deadline for sending the opinion is stopped until the receipt of the response.

II. Ethics Committee Meeting

1. Ethics Committee operates in accordance with the written Rules of Procedure and Standard
Operating Procedures (SOP). The Committee keeps records from all meetings.

2. Rules of Procedure are publicly available on the website of EMC (www.erebouni.am), a copy of which can be also downloaded.

3. Projects are discussed at meetings that are held regularly every month. If necessary, the Chairman convenes the meeting at irregular date so as to comply with the period mandatory for announcement of the Committee´s opinion. Members of the Ethics Committee are invited to every meeting by a written invitation, which distribution will be ensured by administrative staff member of the Committee. Date of following regular meeting of the Committee is stated also in the previous meeting´s proceedings.
 
4. Any invitation of the investigator, sponsor or external expert at the Committee meeting in order to consult will be ensured by an administrative staff member of the Committee.

5. At the meetings other agenda is also being discussed, such as amendments to the ongoing studies, adverse effects reporting, etc.

6. From each meeting a written protocol shall be provided. The protocol includes date of meeting, time and place of meeting, names of attending members and guests (attendance list), titles of clinical trials at issue (or projects) or issues discussed, record of the opinion including the method of its approval, announcement of conflict of interest, record of quickly assessed amendments, signature of the Chairman of the Committee (or his representative) and a date of the following regular meeting of the Committee.

7. Committee meetings are private. The meeting agenda is prepared by the Chairman of the Committee. Committee meeting is under the control of the Chairman or a member of the Committee appointed by him. Committee meetings can be attended by invited guests.

8. After discussion, guests are asked to leave the room and voting follows. The Chairman controls whether the Ethics Committee has a quorum. For opinion adoption unanimous standpoint of all voting members of the Ethics Committee is required.

9. Ethics Committee members at risk of conflict of interest must inform Chairman of that fact and don´t participate in voting on the relevant clinical trial. Chairman shall make a record about that fact in the protocol.

III. Decision-making of the Ethics Committee

1. For opinion adoption unanimous standpoint of all voting members of the Ethics Committee is required.

2. Ethics Committee shall communicate its opinion to the sponsor and the Scientific Centre of Drug and Medical Technology Expertise of MH RA at the latest within 60 days from the date of submission of the application form. The deadline may be extended only in cases specified by law.

3. If there are any deficiencies or ambiguities in the documentation submitted, Committee may request a written statement or completion from the sponsor.

4. In the Ethics Committee´s opinion shall be mentioned in particular the following elements:

 

  1. the exact title of the clinical trial,
  2. identification number (including EudraCT), c) list of assessed documentation,
  3. name of applicant and sponsor,
  4. date of submission of the application form, f) date of opinion issue,
  5. address of the Ethics Committee,
  6. determining way of assessment according to the relevant SOP, i) name and signature of the Chairman (or accredited agent),
  7. names of the members present at the meeting (full list),
  8. clearly and unambiguously expressed Ethics Committee´s opinion (verdict),
  9. statement of reasons for the decision,
  10. opinion on the way of classifying patients in acute condition.


The Chairman or his authorized representative has the power of attorney.
 
5. The opinion is sent to sponsor, relevant multi-centric Ethics Committee, to the Scientific Centre of Drug and Medical Technology Expertise of MH RA, to investigator and director of EMC.

6. Sending of the opinion is provided by an administrative staff member of the Ethics
Committee.

IV. Local Ethics Committee for other medical facility

1. Ethics Committee of EMC may perform expertise also for other medical facilities than
EMC.

2. Local Ethics Committee of EMC assesses expertise of the investigator and suitability (sufficient equipment) of the workplace, where the medical clinical trial shall be performed. Opinion shall be issued within 60 days from the date of submission of the application form.

3. If the Ethics Committee of EMC has crucial remarks on clinical trial, even on tasks it is not in authority to comment, it shall immediately contact relevant body and inform on the discovered deficiencies. Notice shall be taken in written form by mail. If necessary the notice is taken via e-mail or fax, whose copy is kept in the documentation.

4. Local Ethics Committee may oppose the clinical trial, so that the clinical trial in that facility
can´t be opened.

V. Inclusion of clinical trial subjects in acute conditions

In exceptional cases, when it is impossible to obtain signed informed consent of the clinical trial subject (e.g. minor, unconscious people), protocol must precisely describe the procedure of the inclusion of such clinical trial subject and the procedure of obtaining additional consent. Ethics Committee must explicitly approve such procedure.

VI. Monitoring of course of the clinical trial

1. All documents coming to already approved clinical trial (i.e. in particular the protocol amendments, reporting of serious unexpected adverse reactions, new propositions of information for patients, new releases of Investigator´s Brochure, quarterly safety reports, etc.) are entered in book of sent and received mail.

2. Chairman or a member of the Committee appointed by him reads up these documents and compares them with the original documentation.

3. Administrative staff member prepares a written copy of the decision and distributes it to the appropriate recipients. The documents are also archived, along with the clinical trial.

4. Sponsor reports to the Ethics Committee all the information regarding suspected serious unexpected adverse reactions, that are fatal or life-threatening to the subject, within 7 days after the sponsor became aware of such facts. Advanced information is submitted within the next 8 days.

5. Suspected serious unexpected adverse reactions, that don´t result in death or life- threatening, are reported to the Ethics Committee within 15 days.

6. Detailed conditions for reporting of serious unexpected adverse reactions is stated in GCP
guideline.

7. Investigators are required to report at least once a year on the course of the clinical trial. In clinical trials, where subjects are minors, report is required every 6 months. Report on the  course of clinical trial shall be sent no later than 60 days after the end of annual (or six-month)
interval.

8. The sponsor also provides the Ethics Committee at least once a year an interim safety report, which is submitted within 60 days after the conclusion of data collection.

9. In case of higher incidence of serious adverse reactions to assessed drug the investigator
may be invited to the Ethics Committee´s meeting for discussion.

10. If it is suspected that the execution of the clinical trial doesn´t comply with good clinical practice, the Ethics Committee is entitled to send a working group of Ethics Committee´s members for a review on site.

11. In obtaining evidence that would suggest a greater risk to subjects of clinical trial than it was expected when the opinion was issued or in case of failure of good clinical practice, it is possible to withdraw the consent of the Ethics Committee to execute the clinical trial.

12. The investigator is obliged to send the final report to the Ethics Committee within 90 days from the ending of the clinical trial. In case of early termination of the clinical trial, the sponsor sends the final report to the Ethics Committee within 15 days indicating the reasons for early termination of the clinical trial.

VII. Approval of amendments and changes to the protocol

1. Every request to discuss amendment to protocol of the approved clinical trial is recorded by administrative staff member of the Ethics Committee in posting book (book of sent and received mail). Amendment is marked with sequence number and clinical trial number.


Clinical trial number is a number stated in electronic database of clinical trials.

2. The administrative staff member assesses whether it is an administrative amendment or an amendment, which contains substantial changes of conditions of the clinical trial.

3. If the amendment contains substantial changes of conditions of the clinical trial, the Chairman of the Ethics Committee or another member appointed by him reviews proposed changes of the protocol in the area of impact of proposed changes on the investigator and place of clinical trial execution. At the same time he prepares evaluation for the Ethics Committee meeting. Ethics Committee adopts an opinion on the amendment at the meeting. If the Ethics Committee comes to dissenting opinion, it is entitled to withdraw its original opinion on the exertion of the clinical trial. The opinion shall be sent to sponsor, investigator, multi-centric Ethics Committee no later than 35 days after the announcement. A copy shall be put in the documentation of the clinical trial.

4. If the amendment contains only administrative changes (e.g. change in contact information, authorized persons, addresses, etc.), it is assessed quickly, without discussion at the meeting of the Ethics Committee. Assessment is executed by the Chairman of the Ethics Committee or its other member appointed by him. A written record about the quickly discussed amendments is made in the minutes of the meeting.

VIII. Withdrawal of Ethics Committee´s consent

1. Ethics Committee may permanently or temporarily withdraw its consent to the execution of clinical trial or other research project, if new information essential for safety of the subjects of the clinical trial come up or the sponsor or the investigator break their duties, or information that indicates negative effect on the risk/benefit ratio of the clinical trial appears.

2. Ethics Committee announces the withdrawal of the consonant opinion immediately in written form to the investigator and sponsor. Except cases where safety of the subjects of the clinical trial is at risk, the Ethics Committee before taking a decision requests sponsor´s or investigator´s opinion.

3. Withdrawal of the consent of the Ethics Committee contains identification data of the clinical trial (including EudraCT), title of the clinical trial, name of sponsor and places, for which the consent is dismissed, reasons for withdrawal of the consent, measures to the termination of the clinical trial, date of recall of the consent, signature of the Chairman of the Ethics Committee or a member of the Committee, who is authorized based on written procedure to do that in case of absence of the Chairman.

IX. Announcement of termination of the clinical trial

1. The investigator shall send to Ethics Committee a final report within 90 days from the completion of the clinical trial.

2. In case of early termination of clinical trial, the sponsor sends the final report to the Ethics
Committee within 15 days indicating reasons for early termination.

X. Archiving and destruction of the Ethics Committee´s documents

1. Documentation of clinical trials is archived at the Ethics Committee´s office and in a separate room (archive). Clinical trials are arranged chronologically by year and numbers of clinical trial. Into particular volumes supplements and other related documents can be added.

2. After at least 3 years from the date of completion of the clinical trial or other research project, the documentation is destroyed.

3. Correspondence that is not directly related to the clinical trials and other research projects is archived separately and the destruction takes place after at least 5 years.

XI. Change of the Chairman of the Ethics Committee, termination of the Ethics Committee

1. In case of withdrawal or resignation of the Chairman of the Ethics Committee, the outgoing Chairman must hand over all the documentation within 4 weeks to the new Chairman of the Ethics Committee or to a member of the Ethics Committee in charge. The outgoing Chairman and the incoming Chairman provide a written statement of handover of the documentation.

2. Termination of the Ethics Committee shall be announced in written form to the Managing Body of EMC. In case of termination of the Ethics Committee it is necessary to hand over (according to prior agreement) all agenda to a different Ethics Committee, which is capable of replacing the ending Committee. In case of termination of the Ethics Committee without taking over of the agenda by a different Committee, all issued opinions on clinical trials are considered invalid. The Chairman of the related Committee hands over and takes over the agenda and the takeover must be documented by a written protocol.

XII. Validity and effectiveness of the Rules of Procedure of the Ethics Committee

These Rules of Procedure of the local Ethics Committee of EMC take effect on 27.10. 2011.

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