Standard Operating ProcedureVersion 9.0/ January 2013NUI Galway Research Ethics Committee

Research Ethics Committee

Standard Operating Procedures

SOP Title:NationalUniversity of Ireland Research Ethics Committee Standard Operating Procedures

Version No: 9.0

Effective Supersedes: 8.0

Approval 1: Signed______Chairperson

Approval 2: Signed______Secretary

TABLE OF CONTENTS

1OBJECTIVES

2PROCEDURE FOR CONSTITUTING THE COMMITTEE

3PROCEDURE FOR SUBMITTING AN APPLICATION

3.1Applicant

3.2Application Procedure

3.3Application Requirements

3.3.1Required Documentation

3.4Registration of Applications

4REVIEW PROCEDURE

4.1Meeting Procedure

4.1.1Quorum Requirements

4.2Elements of the Review

4.2.1Scientific Design and Conduct of the Study

4.2.2Recruitment of Research Participants/Volunteers

4.2.3Care and Protection of Research Participants/Volunteers

4.2.4Protection of Research Participant/Volunteer Confidentiality

4.2.5Informed Consent Process

4.3Post-Meeting Procedure

5DECISION-MAKING PROCEDURE

5.1Possible Ethics Committee Decisions

5.1.1Approval

5.1.2Provisional Approval

5.1.3Deferral

5.1.4Approval declined

6PROCEDURE FOR COMMUNICATING A DECISION

7PROCEDURES FOR MONITORING ONGOING RESEARCH

7.1Reporting requirements

7.1.1Status Report from Principal Investigator

7.2Follow-up Review

7.2.1Instances Requiring a Follow-up Review

7.2.2Amendments

7.2.3Adverse Events

7.3Study Termination

8DOCUMENTATION AND ARCHIVING PROCEDURE

9Research Ethics Committee Annual Report

10Multi-centre studies

APPENDIX 1: Glossary

APPENDIX 2: Constitution of the Research Ethics Committee

10.1Terms of Reference of the Research Ethics Committee

10.2Conditions of Appointment

10.2.1Term of Appointment

10.2.2Conditions of Appointment

10.2.3Declarations of interest

10.2.4Chairperson

APPENDIX 3: Information Sources

PREFACE

These Standard Operating Procedures (SOPs) are focused on assisting in the ethical review of any area of research within NUI Galway that involves humans or their tissues, biological materials or hazardous substances. The SOPs apply to research carried out by NUI Galway research personnel, whether permanent staff members or on fixed-term research contracts of any duration, and either alone or in collaboration with colleagues within the university or in other research institutes (where ethical approval has not been sought in those other institutes).

The aim is to provide complementary support to the Declaration of Helsinki and to international Good Practice guidelines currently in use in Europe, taking into account any EU Directives or National legislation pertaining to the ethical conduct of research.

1OBJECTIVES

The objective of the NUI Galway Research Ethics Committee is to safeguard the health, welfare and rights of human and researchers (in the case of hazardous materials) in research studies and to afford dignity to the handling and treatment of biological materials, taking into account the scientific procedures and concerns of the local community. For any research proposal to gain ethical approval it must be necessary and of a design that minimises predictable risk to both the research participant and the researcher.

The NUI Galway Research Ethics Committee;

  1. aspires to provide timely, comprehensive and independent reviews of the ethics of proposed studies, acting in accordance with the Declaration of Helsinki, statements of appropriate ethical practice produced by relevant professional organisations, following International Good Practice Guidelines, relevant EU Directives, National Guidelines and National legislation pertaining to the ethical conduct of research, and acting in good faith with respect to both applicants and the community.
  2. through its operation, would hope to provide NUI Galway researchers (staff and students) with the resources for understanding and addressing ethically significant problems which might arise in their research and to promote responsible research and practice.
  3. in carrying out these objectives, respects academic freedom and remembers that research is an important activity within the academic community, and that care should be taken not to hinder research without good cause.

2PROCEDURE FOR CONSTITUTING THE COMMITTEE

Membership of the Research Ethics Committee is on a strictly voluntary basis. A statement of the requirements for candidacy, constitution of the membership, Terms of Reference and an outline of the duties and responsibilities of NUI Galway Research Ethics Committee Members is appended to this SOP (Appendix 2).

3PROCEDURE FOR SUBMITTING AN APPLICATION

3.1Applicant

A qualified researcher responsible for the ethical and scientific conduct of the research should submit an application for review of the ethics of proposed research.

3.2Application Procedure

The requirements for the submission of a research project for ethical review are clearly described in the application procedure, available, along with the required application forms and a Checklist, on the Research Ethics Committee Webpage (

An application for Ethics Committee review in respect of proposed research must be made in writing and signed by a qualified researcher responsible for the conduct of the study. All properly submitted and valid applications shall be reviewed in a timely fashion and in accordance with the review procedures described in this SOP. A valid application is one which has been submitted by an appropriated investigator, is complete, with all the necessary documents attached and is signed and dated.

The application should include the following information and materials:

  • Application material should be submitted to the Research Ethics Committee Secretary:

Name

Office of the Vice-President for Research

Science and EngineeringTechnologyBuilding

NUI Galway

GalwayCity

  • Application form(s) and other accompanying/supporting materials:
  • Format of submission:
    The completed application, signed by the Responsible Investigator, should be submitted in hard copy, accompanied by an identical soft copy either on CD ROM, or emailed to the Research Ethics Committee Secretary at: . All accompanying documentation, should be submitted electronically as well as in hard copy with their application.
  • Deadline for submission:
    Signed applications and accompanying documentation must reach the Research Ethics Committee Secretary no later than 21 days before the next scheduled Ethics Committee Review Meeting (see schedule of meeting on website).
  • All applications will be acknowledged in writing within 7 days of receipt, including the communication of the incompleteness of an application where this applies.
  • All applications will receive notification in writing of the decision of the Research Ethics Committee following review no later than 90 days after acknowledgement of receipt of a valid application.
  • The letter of notification will, where applicable, outline the application procedure of amendments to the protocol, the recruitment material, the potential research participant information or the informed consent form.
  • Where the Research Ethics Committee requires supplementary information or changes to documents from the applicant, the timeframe for this will be outlined in the letter of notification.
  • No revisions may be made, prior to the Research Ethics Committee meeting, to an application that has been accepted for review and assigned a reference number. Where an applicant considers it necessary to revise the application form or supporting documents prior to review, the application should be withdrawn.

3.3Application Requirements

3.3.1Required Documentation

Design and Conduct of the Study

oSigned and dated application form.

oA summary (as far as possible in non-technical language), synopsis, or diagrammatic representation (‘flowchart’) of the protocol

oProtocol of the proposed research (clearly identified and dated) together with supporting documents and annexes

oA description of the ethical considerations involved in the research

oCase report forms, diary cards or questionnaires intended for research participants, where applicable

oWhere relevant, an adequate summary of all safety, pharmacological, pharmaceutical and toxicological data available on a study product (where one is being used) together with a summary of clinical experience with the study product to date (e.g. recent investigators’ brochure, published data etc)

oSignature of a Radiation Safety Officer or Medical Physics Expert (research involving the use of radiation) or by the educational supervisor (applications submitted by, or on behalf of, students)

oInvestigator(s) curriculum vitae – maximum of two pages (updated, signed and dated)

oConfirmation, where applicable, that external funding for the project costs has been granted subject to ethical approval (letter of offer or equivalent)

Recruitment of Research Participants

oMaterial to be used (including advertisements) for the recruitment of potential research participants

oWritten and other forms of information for potential research participants (e.g. patient information sheet)

oA description of the process used to obtain and document consent

oInformed consent form (clearly identified and dated)

oA statement describing compensation, if any, for study participation (including expenses) to be given to research participants and the rationale for this

oA description of the arrangement for indemnity, if applicable

oA description of the arrangements for insurance coverage for research participants, if applicable

Ethical Considerations/Decisions

oA statement of agreement to comply with ethical principles set out in the relevant professional guidelines (with copy of guidelines attached if relevant)

oAll significant previous decisions by other Ethics Committees or regulatory authorities for the proposed study (whether it be in the same location or elsewhere) and an indication of modifications to the protocol made on that account. The reasons for any previous negative decisions should be provided

3.4Registration of Applications

The Secretary to the Ethics Committee should follow a registration procedure for all incoming applications. This procedure includes, but is not limited to:

oDating of all incoming material

oFiling of all incoming material and assigning a reference number for all future correspondence

oChecking for the formal completeness of an application (checklist)

oWhere an application is found to be invalid, the applicant will be informed of the reasons in writing within 1 week of receipt. The application is void and should be deleted from the agenda of the next meeting. The Principal Investigator may re-submit the application, in which case it will be treated as a new application and will be allocated a new reference number

oInforming the applicant in writing of the expected date of review of a complete application

oInforming all Research Ethics Committee members of the review date of an application

oMaintaining a record of all communications regarding applications (whether written, verbal or electronic)

4REVIEW PROCEDURE

ETHICS COMMITTEE MEETING PROCEDURE

4.1Meeting Procedure

The Ethics Committee will meet in accordance with published meeting dates scheduled regularly. The established quorum requirements are to be met prior to the review of applications.

Schedule

oMeetings should be planned in accordance with the needs of the workload

oEthics Committee members should be given enough time in advance of the meeting to review the relevant documentation (at least 2 weeks)

Agenda

oMeetings should follow a previously scheduled agenda, amended where appropriate, which should include at least the following:

-The date, time and venue of the meeting

-Declarations of interest relating to items on the agenda

-Minutes of the previous Research Ethics Committee meeting

-Matters arising at the previous meeting(s) that the Committee specifically indicated that it wished to consider again

-Applications for ethical review to be considered at the meeting

oThe agenda may also include for discussion, where appropriate, general ethical issues (e.g. new guidelines), matters relating to the membership of the committee and matters relating to Committee procedures.

Minutes

oThe minutes of the meeting should be prepared by the secretary to the meeting, in consultation with the Chairperson and other members as necessary. The minutes should contain a record of the following:

-The members, deputy members, co-opted experts present for the review and, where applicable, any investigator/ sponsor present for the review.

-Any interests declared and the decision of the Committee on the participation of the member or deputy member concerned.

-The submission of written comments by members or deputy members unable to attend.

-The substance of any advice given by a co-opted expert.

-The decision of the Committee on the application including a summary of the main ethical issues considered.

-In the case of a favourable opinion, any special approval conditions or additional advice to be given to the applicant.

-In the case of an unfavourable opinion, the reasons for the decision.

-In the case of a provisional opinion, the further information requested by the Committee and the arrangements for considering the information and confirming the final opinion of the Committee.

-Where no decision is reached, the issues on which further advice is required from a co-opted expert.

-The outcome of any vote taken.

-Any formal dissent from the decision of the Committee by a named member, with reasons.

Other procedural items

oWhere appropriate, the principal investigator and/or sponsor may be invited to present the proposal or to elaborate on specific issues. The decision to do so will be taken by the Chairperson or, in their absence, the Vice-Chairperson.

oWhere appropriate, outside experts (e.g. researchers with specific competencies, statisticians) will be invited to the meeting or asked to provide written comments, subject to applicable confidentiality agreements.

oWhere appropriate, representatives of special patient or interest groups (e.g. in studies concerning pregnancy or AIDS) will be invited to assist at the meeting.

4.1.1Quorum Requirements

oA minimum of seven members of the Ethics Committee are required to be present at a meeting held to determine an opinion in relation to an application to the Committee.

oThere must be a reasonable representation of member categories in any quorum, including at least the following:

-The chairperson, or in their absence the vice-chairperson.

-One clinician or one scientist,

-One lay person

oThe following may be counted for the purposes of the quorum:

-A deputy member who is attending in place of their ‘lead’ member

-A co-opted member

oThe following should not be counted for the purposes of the quorum:

-The Committee Secretary

-Members who are yet to arrive at the meeting or who have left early

-Members who submit comments but do not attend

-Deputy members attending alongside the lead member

oWhere a quorum is not present, the Committee may not commence, continue or conclude any discussion with the purpose of determining the Committees’ opinion on an application for ethical review.

oWhere a quorum is not present for all or part of a meeting, the Committee may proceed with any other business on the agenda, provided that the Chairperson (or vice-chairperson) is present.

4.2Elements of the Review

The primary task of the Research Ethics Committee is to review research proposals and their supporting documentation, with special attention being given to the informed consent process, documentation and the suitability and feasibility of the protocol. Research Ethics Committees need to take into account prior scientific reviews, if any, and any requirements of applicable laws and regulations. The following should be considered as applicable:

4.2.1Scientific Design and Conduct of the Study

  • The thoroughness and completeness of the information submitted and its ability to respond to ethical questions arising within the context of the study
  • The suitability of the protocol and the data collection forms in relation to the objectives of the study (taking into account rules and regulations), the statistical methodology (including sample size calculation), and the potential for reaching sound conclusions with the smallest possible exposure of subjects and number of research participants/volunteers
  • The justification of predictable risks and inconveniences weighed against the anticipated benefits for the participants/volunteers and the concerned communities
  • Criteria for prematurely withdrawing participants/volunteers from the research.
  • Criteria for suspending or terminating the research project as a whole
  • The adequacy of provisions made for monitoring and auditing the conduct of the research, including data safety
  • The adequacy of the site, including the supporting staff, available facilities and emergency procedures, where applicable
  • The manner in which the results of the research will be reported and published

4.2.2Recruitment of Research Participants/Volunteers

  • The characteristics of the population from which the Participants/Volunteers will be drawn (including gender, age, literacy, culture, economic status and ethnicity) and the justification for any decisions made in this regard
  • The method by which initial contact and recruitment of participants/volunteers is to be conducted and its appropriateness to the study
  • The method by which full information is to be conveyed to potential participants/volunteers or their representatives and by which means consent is to be obtained
  • Inclusion and exclusion criteria for participants/volunteers

4.2.3Care and Protection of Research Participants/Volunteers

  • The safety of any intervention to be used in the proposed research
  • The suitability of the investigator for the proposed study in relation to his/her qualifications and experience
  • The provisions made for receiving and responding to queries and complaints of participants/volunteers throughout the course of the study
  • If applicable, any plans to withdraw or withhold standard therapies for the purpose of the research, and the justification for such action
  • If applicable, the adequacy of health and social supervision and psychological support for participants/volunteers during and after the course of the research
  • Steps to be followed if participants/volunteers voluntarily withdraw during the course of the research
  • If appropriate, the arrangements for informing the participant’s/volunteer’s GP, including procedure for seeking consent to do so
  • The criteria for extended access to, the emergency use of, and/or the compassionate use of study products (in the case of a clinical trial)
  • A description of any plans to make the study product available to the participants/volunteers following the research (in the case of a clinical trial)
  • A description of any financial costs to participants/volunteers
  • The rewards and compensations, if any, for participants/volunteers (including money, services and/or gifts) and a justification for these
  • The provisions for compensation/treatment in the case of injury/disability/death of a participant/volunteer attributable to participation in the research
  • The insurance and indemnity arrangements covering the liability of the investigator
  • A description of any grants, payments or other reward to be made to any researchers or research hosts, related to the conduct of the study

4.2.4Protection of Research Participant/Volunteer Confidentiality

  • A description of the persons who will have access to personal data of the participants/volunteers, including medical records and biological samples
  • The measures taken to ensure the confidentiality and security of personal information concerning research participants
  • The extent to which the information with be anonymised
  • How samples/data will be obtained and the purposes for which they will be used
  • How long samples/data will be kept

Both Research Ethics Committee members and investigators should be aware of the provisions of the Data Protection Acts 1988 and 2003 and their obligations as set out in these acts.