PDCH – Institutional Review Committee

STANDARD OPERATING PROCEDURE FOR THE INSTITUTIONAL REVIEW COMMITTEE (IRC)  OF PEOPLES DENTAL COLLEGE AND HOSPITAL

1. Functions and Duties of the IRC

1.1. To review research proposals according to the National Ethical Guidelines for Health Research in Nepal as per guidelines of  Nepal Health Research Council with a view to approve, amend or reject the proposal.

1.2 To supervise or monitor the implementation of health research projects approved by IRC.

1.3. To conduct training programmers for members and reviewers of  IRC  on the ethical review process.

2. Membership of IRC

2.1 Executive Committee  of  Peoples Dental College and Hospital will appoint the members, member secretary and chairman of the IRC.

2.2. The IRC  member will be appointed for the duration of a three year term.

2.3 any member, if fails to attend 4 consecutive meetings in a year, without prior informed reasonable reasons, can be discontinued from the IRC PDCH membership.

2.4 any member, if discontinues his/her service from PDCH, will automatically discontinued from the IRC PDCH membership.

3. Meetings

3.1  Member Secretary of the IRC will prepare the agenda for the meeting in consultation with the Chairman of the IRC.  The Member Secretary will also keep minutes of the meeting and notify decisions to the researcher. The Member Secretary will be assisted in his or her tasks by an administrative secretary.

3.2  IRC  will have 7  members.

3.3  At least 4  members must be present to compose a quorum. Presence of members of only one gender will not constitute a quorum.

4. Independent Consultant(s) to the IRC

3.1 IRC will prepare a list of independent consultants within the institution who can be called upon by IRC to provide expert opinion on proposed research proposals.

5. Education of the IRC Members

All new IRC members will be provided with orientation training.

6. Submitting the Application

Individuals desirous of conducting health research in Peoples Dental College and Hospital are required to submit their health research proposal to IRC.

6.1 Application Submission

6.1.1 The Principal Investigator (PI) and/or the one responsible for the health research will submit the health research proposal for review.

6.2 Application Requirements Include

6.2.1 Application: Application should be addressing to the Member Secretary of IRC.

6.2.2 Format for Application: Application should be submitted in the format provided by IRC.

6.2.3 Language of Applications: All Applications should be submitted in English.

6.2.4 Application should include one hard copy and an electronic copy of the proposal.

6.2.5 Only those applications fulfilling the requirements will be accepted for review. Deficits in the application shall be informed to the applicants within two weeks of submission. Incomplete applications will have to be resubmitted.

6.2.6 A receipt of the accepted application will be provided to the researcher via email.

6.2.7 Application Fee: IRC will not charge any application fee for the faculty and students of  Peoples Dental College and Hospital.

6.2.8 Additional documents or changes: IRC can request the applicant for supplementary documents/or changes to the proposal during the review which will be communicated to the applicant and the application will be considered in the subsequent meeting after those changes are made by the researcher.

6.2.9 Amendments: If any amendments are made in the proposal already submitted and approved, the researcher must submit in writing the changes made with reasoning. The proposal will be reviewed again in the IRC, taking the amendments into consideration during the re-approval process.

6.2.10 Informed consent: Application should include the Informed Consent Form as a separate copy which is to be used while undertaking the research. In addition, this can include a translation copy, in a local language if that is applicable.

6.3 Documentation Requirements for the Application

All the documents that are required by the IRC for a process of review and approval should be submitted along with the application. If any additional documents are required during the review process, the researcher will be notified by IRC.

6.3.1 The application form should be submitted with the signature and date of submission using the IRC format.

6.3.2 Application must include the most current version of the curriculum vitae of the Principal Investigator and co-investigators with special mention of academic qualification and research experiences.

6.3.3 Application must include the protocol of the proposed research project in the provided format

Along with the supporting documents. (A copy of research tools, questionnaires etc).

6.3.4 A copy of informed consent form should be included in the application. This should include a detail description of the process of giving the information to the research participant and its content, process of obtaining the consent, the person responsible for obtaining the informed consent and documentation of the signature of the researcher/research participant and /witness if applicable.

6.3.5 Any compensation to be given to the research participant should be clearly mentioned. (E.g. any transportation costs, food, free health care or insurance coverage etc that is to be borne by the

researcher).

6.3.6 A signed statement by the researcher stating that he or she will abide by the ethical principles of research.

6.3.7 Information about any previous submission of this application to ERB or any other Institutional Review Committee and the result of such submission in the past will have to be provided along with the application.

6.3.8 A declaration of the conflict of interest , if applicable, should be mentioned in the application.

7. Ethical Review Process

The IRC will review all the submitted health research proposals in a timely manner and in accordance with the set review process.

7.1 Meeting of the IRC

The Member Secretary of IRC with the permission of the Chairman of the IRC will call the meeting. The followings are considered as applicable for an IRC meeting:

7.1.1 The meeting of IRC will be planned in accordance with the workloads and number of proposals received for review. Normally, IRC will meet once a month. The IRC meeting will be held on 1^st of each Nepali month.

7.1.2 IRC members will be informed about the meeting at least 72 hours prior to the scheduled date.

7.1.3 If felt necessary by the IRC, the applicant researcher or sponsor of the research can be invited

to present the proposal or elaborate on specific issues of the proposal. Similarly, if necessary, experts can also be invited to the meeting for expert opinion about the research.

7.1.4 Minutes will be kept of all decisions and procedures of the meeting.

7.1.5 All the members and invitees present in the meeting should sign the minutes to indicate their presence.

7.2 Elements of the Review Process

Technical Review by the Reviewers: Once the application is submitted and screened for completeness of documents, technical review of the proposal is done by the internal reviewers for the scientific and technical contents. The application received after internal review is then subjected for review by the external reviewers.

Ethical Review: Those applications which qualify are then submitted to the Member-Secretary of the IRC and then discussed in full board IRC meeting for ethical review.

7.2.1 Scientific Design of Research Proposal and Conduct of Research

7.2.1.a The appropriateness of the study design in relation to the objectives of the study

7.2.1.b Statistical methods: sampling method, sample size and analysis of data

7.2.1.c Justification of predictable risks and inconveniences against the anticipated benefits for the research participants and community by the proposed study

7.2.1.d Justification of the use of control arm (if relevant for the study)

7.2.1.e Criteria for prematurely withdrawing research participants

7.2.1.f Criteria for suspending or terminating the research

7.2.1.g Provisions for data safety monitoring board(DSMB)

7.2.1.h Plan for dissemination or publication of research results

7.2.1.i Infrastructure and other facilities in the institutions conducting the research

7.2.1.j Suitability of researcher‟s qualification and experiences for The proposed research

7.2.1.k Description of the population from which the research participants will be drawn

7.2.1.l Inclusion criteria for the research participants

7.2.1.m Exclusion criteria for the research participants

7.2.1.n Protection of research participants

7.2.1.o Measures to ensure the confidentiality of the research participants

7.2.1.p Description about who has access to data and biological samples

7.2.1.q The compensation provided to the participants in case of adverse drug reaction and or adverse events

7.2.1.r Description of the process of reporting any adverse drug reaction and/or adverse event

7.2.1.s Description about the provision of availability of the research product for the participants  after completion of the research project

7.2.2 Informed consent process

7.2.2.a A full description of the process for obtaining informed consent including the description about who is responsible for obtaining the informed consent

7.2.2.b Process of communication with the research Participants about the objectives, methods, risks and benefit of the research

7.2.2.c Description about obtaining consent from the vulnerable research participant (e.g. children,

elderly, disabled, prison population, people in uniform services, etc.)

7.2.2.d Description about the provision for the participants to queries and complaints during the course of research

8. Decision Making

The IRC will consider the following while making decision about the research proposal.

8.1 The IRC will make the decision only if the meeting has met required quorum.

8.2 Normally the decision will be taken by consensus, (if consensus is not possible then a vote will be taken).

8.3 The IRC member should withdraw from the decision process when conflict of interests arises; the member should declare the conflict of interest.

8.4 The IRC may approve the proposal conditionally with specific suggestions to the researcher.

8.5 The negative decision on a proposal should be supported by clearly stated reasons.

9. Communicating a Decision

On behalf of the IRC, the Member Secretary will communicate its decision to the applicant in writing within two weeks after the meeting. The communication of the decision will include, but is not limited to the following information:

9.1 The exact title of the research proposal reviewed

9.2 The clear identification of the protocol of the proposed Research or amendment, date and version number (if applicable) on which the decision is based

9.3 The names and (where possible) specific identification numbers (version numbers/dates) of the documents reviewed, including the potential research participant information sheet/material and informed consent form;

9.4 The name and title of the applicant

9.5 The name of the research site(s)

9.6 The date and place of the decision

9.7 A clear statement of the decision reached

9.8 Any advice by the IRC

9.9 In the case of a conditional decision, any requirements by the IRC, including suggestions for revision and the procedure for having the application re-reviewed

9.10 In the case of a positive decision the following is required:

9.10.1 A statement of the responsibilities of the applicant

9.10.2 Confirmation of the acceptance of any requirements imposed by the IRC

9.10.3 Deadlines for the submission of progress report(s)

9.10.4 The need to notify the IRC in cases of protocol amendments (other than amendments involving only logistical or administrative aspects of the study)

9.10.5 The need to not ify the IRC in the case of amendments to the recruitment material, the

potential research participant information, or the informed consent form

9.10.6 The need to report serious and unexpected adverse events related to the conduct of the study

9.10.7 The need to report unforeseen circumstances, the termination of the study, or significant decisions by other Ethical Committees

9.10.9 The information the IRC expects to receive in order to perform ongoing review and deadlines for the submission of final report

9.11 The schedule/plan of ongoing monitoring by the IRC

9.12 In the case of a negative decision, clearly stated reason(s) for the negative decision

9.13 Signature (dated) of the Member Secretary (or other Authorized person) of the IRC

10. Follow up

IRC will establish a follow-up procedure for following the progress of the studies for which a positive decision has been reached, from the time the decision was taken until the termination of the research.

10.1 The following instances or events require the follow-up review of a study

10.1.1  Any protocol amendment

10.1.2 Serious and unexpected adverse events related to the conduct of the study or study product, and the response taken by investigators, sponsors, and regulatory agencies

10.2 In the case of the premature suspension/termination of a study, the applicant should notify the IRC of the reasons for suspension/termination; a summary of results obtained in a study prematurely suspended/terminated should be submitted to the IRC.

10.3 The applicant will inform the IRC at the time of the completion of a study.

10.4 The applicant will submit to the IRC a copy of the final summary or final report of a study.

11. Documentation and Archiving

All documentation and communication of IRC will be dated, filed, and archived according to written procedures. A statement is required defining the access and retrieval procedure (including authorized persons) for the various documents, files, and archives. The documents will be archived

for a period of 5 years following the completion of a study.

Documents that should be filed and archived include

11.1 The Constitution, written standard operating procedures of the IRC, and regular (annual) reports

11.2 The curriculum vitae of all IRC members

11.3 A record of all income and expenses of the IRC, including allowances and reimbursements made to the secretariat and IRC members

11.4 The published guidelines for submission established by the IRC

11.5 The agenda of the IRC meetings

11.6 The minutes of the IRC meetings

11.7 All materials submitted by an applicant

11.8 The correspondence by IRC members with applicants or concerned parties regarding application, decision, and follow up

11.9 A copy of the decision and any advice or requirements sent to an applicant

11.10 All written documentation received during the follow-up

11.11 The notification of the completion, premature suspension, or premature termination of a study

11.12 The final summary or final report of the study