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

RESEARCH ETHICS COMMITTEE

STANDARD OPERATING PROCEDURES

SOP Title: National University of Ireland Research Ethics Committee Standard Operating Procedures

Version No: 9.0Effective Supersedes: 8.0

Approval 1: Signed _____________________________ Chairperson

Approval 2: Signed _____________________________ Secretary

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TABLE OF CONTENTS

1 OBJECTIVES 42 PROCEDURE FOR CONSTITUTING THE COMMITTEE 53 PROCEDURE FOR SUBMITTING AN APPLICATION 53.1 Applicant 53.2 Application Procedure 53.3 Application Requirements 6

3.3.1 Required Documentation 63.4 Registration of Applications 74 REVIEW PROCEDURE 94.1 Meeting Procedure 9

4.1.1 Quorum Requirements 104.2 Elements of the Review 11

4.2.1 Scientific Design and Conduct of the Study 114.2.2 Recruitment of Research Participants/Volunteers 124.2.3 Care and Protection of Research Participants/Volunteers 124.2.4 Protection of Research Participant/Volunteer Confidentiality 124.2.5 Informed Consent Process 13

4.3 Post-Meeting Procedure 135 DECISION-MAKING PROCEDURE 135.1 Possible Ethics Committee Decisions 14

5.1.1 Approval 145.1.2 Provisional Approval 145.1.3 Deferral 145.1.4 Approval declined 15

6 PROCEDURE FOR COMMUNICATING A DECISION 157 PROCEDURES FOR MONITORING ONGOING RESEARCH 157.1 Reporting requirements 16

7.1.1 Status Report from Principal Investigator 167.2 Follow-up Review 16

7.2.1 Instances Requiring a Follow-up Review 167.2.2 Amendments 167.2.3 Adverse Events 17

7.3 Study Termination 178 DOCUMENTATION AND ARCHIVING PROCEDURE 179 RESEARCH ETHICS COMMITTEE ANNUAL REPORT 1810 MULTI-CENTRE STUDIES 19APPENDIX 1: GLOSSARY 20APPENDIX 2: CONSTITUTION OF THE RESEARCH ETHICS COMMITTEE 2210.1 Terms of Reference of the Research Ethics Committee 2310.2 Conditions of Appointment 23

10.2.1 Term of Appointment 2310.2.2 Conditions of Appointment 2310.2.3 Declarations of interest 24

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10.2.4 Chairperson 24

APPENDIX 3: INFORMATION SOURCES 25

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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.

1 OBJECTIVESThe 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.

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Complete appropriate application form and

checklistSubmission to REC Secretary at least 3 weeks before next

REC meeting

All details of:Application FormInformed consent proceduresParticipant information leafletsQuestionnairesProtocolOther details as appropriateprocessed by REC Secretary

Application for ethical approval distributed to REC members at least 2 weeks before next REC Meeting


2 PROCEDURE 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).

3 PROCEDURE FOR SUBMITTING AN APPLICATION

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

3.2 Application ProcedureThe 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 (www.nuigalway.ie/research/vp_research/ethics.htm).

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http://www.nuigalway.ie/research/vp_research/ethics.htm


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:NameOffice of the Vice-President for ResearchScience and Engineering Technology BuildingNUI GalwayGalway City

Application form(s) and other accompanying/supporting materials:o 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: [email protected]. All accompanying documentation, should be submitted electronically as well as in hard copy with their application.

o 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.

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mailto:[email protected]


3.3 Application Requirements

3.3.1 Required DocumentationDesign and Conduct of the Studyo Signed and dated application form.o A summary (as far as possible in non-technical language), synopsis, or

diagrammatic representation (‘flowchart’) of the protocolo Protocol of the proposed research (clearly identified and dated) together

with supporting documents and annexeso A description of the ethical considerations involved in the researcho Case report forms, diary cards or questionnaires intended for research

participants, where applicableo Where 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)

o Signature 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)

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

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

Recruitment of Research Participantso Material to be used (including advertisements) for the recruitment of

potential research participantso Written and other forms of information for potential research

participants (e.g. patient information sheet)o A description of the process used to obtain and document consento Informed consent form (clearly identified and dated)o A statement describing compensation, if any, for study participation

(including expenses) to be given to research participants and the rationale for this

o A description of the arrangement for indemnity, if applicableo A description of the arrangements for insurance coverage for research

participants, if applicable

Ethical Considerations/Decisionso A statement of agreement to comply with ethical principles set out in the

relevant professional guidelines (with copy of guidelines attached if relevant)

o All 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

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made on that account. The reasons for any previous negative decisions should be provided

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

o Dating of all incoming materialo Filing of all incoming material and assigning a reference number for all

future correspondence o Checking for the formal completeness of an application (checklist)o Where 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

o Informing the applicant in writing of the expected date of review of a complete application

o Informing all Research Ethics Committee members of the review date of an application

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

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4 REVIEW PROCEDUREETHICS COMMITTEE MEETING PROCEDURE

4.1 Meeting ProcedureThe 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.

Scheduleo Meetings should be planned in accordance with the needs of the workloado Ethics Committee members should be given enough time in advance of

the meeting to review the relevant documentation (at least 2 weeks)Agendao Meetings 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

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Secretary’s duties Confirm agenda and

attendance with all members. Ensure that a quorum of at

least 7 members will be present.

Ensure that any outside experts required have full documentation.

If required to attend, inform

Previous Minutes and Matters arising are discussed.

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

A vote on each submission is taken and recorded in the minutes.

If there is a conflict of interest by any member with a submission, he/she must not participate in the discussion on that submission and must


- 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 meetingo The 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.

Minuteso The 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 itemso Where 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.

o Where 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.

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

4.1.1 Quorum Requirementso A 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.

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o There 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

o The 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

o The 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

o Where 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.

o Where 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.

4.2 Elements of the ReviewThe 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:

4.2.1 Scientific Design and Conduct of the Study o The thoroughness and completeness of the information submitted and its

ability to respond to ethical questions arising within the context of the study

o 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

o The justification of predictable risks and inconveniences weighed against the anticipated benefits for the participants/volunteers and the concerned communities

o Criteria for prematurely withdrawing participants/volunteers from the research.

o Criteria for suspending or terminating the research project as a wholeo The adequacy of provisions made for monitoring and auditing the conduct

of the research, including data safety

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o The adequacy of the site, including the supporting staff, available facilities and emergency procedures, where applicable

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

4.2.2 Recruitment of Research Participants/Volunteerso 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

o The method by which initial contact and recruitment of participants/volunteers is to be conducted and its appropriateness to the study

o 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

o Inclusion and exclusion criteria for participants/volunteers

4.2.3 Care and Protection of Research Participants/Volunteerso The safety of any intervention to be used in the proposed researcho The suitability of the investigator for the proposed study in relation to

his/her qualifications and experienceo The provisions made for receiving and responding to queries and

complaints of participants/volunteers throughout the course of the studyo If applicable, any plans to withdraw or withhold standard therapies for

the purpose of the research, and the justification for such actiono If applicable, the adequacy of health and social supervision and

psychological support for participants/volunteers during and after the course of the research

o Steps to be followed if participants/volunteers voluntarily withdraw during the course of the research

o If appropriate, the arrangements for informing the participant’s/volunteer’s GP, including procedure for seeking consent to do so

o 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)

o 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)

o A description of any financial costs to participants/volunteerso The rewards and compensations, if any, for participants/volunteers

(including money, services and/or gifts) and a justification for theseo The provisions for compensation/treatment in the case of

injury/disability/death of a participant/volunteer attributable to participation in the research

o The insurance and indemnity arrangements covering the liability of the investigator

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o 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

4.2.4 Protection of Research Participant/Volunteer Confidentialityo A description of the persons who will have access to personal data of the

participants/volunteers, including medical records and biological sampleso The measures taken to ensure the confidentiality and security of personal

information concerning research participantso The extent to which the information with be anonymisedo How samples/data will be obtained and the purposes for which they will

be usedo 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.

4.2.5 Informed Consent Processo A full description of the process for obtaining informed consent, including

the identification of those responsible for obtaining consent and the time frame in which it will occur

o The adequacy, completeness, and understandability of written and oral information to be given to the participants/volunteers and, when appropriate, their legally acceptable representative(s) (See Appendix 3)

o The content and the wording of the Participant/Volunteer information sheet

o The content and the wording of the informed consent form and, where applicable, the provisions made for participants incapable of giving consent personally

o Clear justification for the intention to include in the research individuals who cannot consent, and a full account of the arrangements for obtaining consent or authorisation for the participation of such individuals

o Assurances that Participants/Volunteers will receive information that becomes available during the course of the research relevant to their participation (including their rights, safety and well-being)

4.3 Post-Meeting Procedure

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All PIs/sponsors are informed in writing of the EC decision on their submission and any recommendations, with deadlines for

Recorded minutes kept on file

PIs/sponsors who submitted amendments on foot of EC recommendations are notified in writing of EC decision on their submission and any


5 DECISION-MAKING PROCEDUREIn making decisions on submissions for the ethical review of research 2 Committee members will be appointed (by the Chairperson or Vice Chair as appropriate) in advance of the meeting to lead the discussion for each application according to the Elements of Review in Section 4.2. An Ethics Committee should take the following into consideration:

o Decisions should be arrived at through consensus where possible; under this model the proposal will be approved when all members present are willing to allow the proposal to proceed.

o In cases where consensus appears unlikely, the chairperson (or vice chair as appropiate) may call for a vote with a two-thirds majority required for decision.

o A decision may only be taken when sufficient time has been made for review and discussion of an application in the absence of third parties (e.g. PIs, members declaring conflicts of interest, outside experts).

o Dissenting members should have an opportunity to append an opinion to the Research Ethics Committee decision.

o Members who have conflicts of interest should declare these to the chairperson (or vice chair as appropriate) prior to the review of the application and these should be recorded in the minutes.

o Decisions should only be made at meetings where a quorum is present.o The Ethics Committee should follow a pre-defined method for arriving at a

decision as stipulated in the SOP. o The documents required for a full review of the application should be

complete and the relevant elements mentioned above should be considered before a decision is made.

o Only members who participate in the review can participate in the decision.

o Advice that is non-binding may be appended to the decision.o In cases of provisional approval, clear suggestions for revision and the

procedure for having the submission re-evaluated should be specified.o A negative decision on an application should be supported by clearly

stated reasons.

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All correspondence signed by Chairperson or nominee


5.1 Possible Ethics Committee Decisions

5.1.1 ApprovalThe applicant may begin the research as outlined in the research proposal submitted to the Research Ethics Committee

5.1.2 Provisional ApprovalProvisional approval of a research proposal may be granted, subject to recommended revisions to the proposal or answers to questions posed to the applicant. In this case the PI should submit a cover letter along with a modified submission and supplemental information if requested, highlighting any changes in line with Research Ethics Committee recommendations/queries. No research may be started until all conditions have been met and final approval has been granted. When provisional approval is granted the Chairperson (or vice chair as appropriate) may review modified submissions and grant approval subject to the affirmation of the Committee at its following meeting.

5.1.3 DeferralA deferred research proposal must be reviewed and re-submitted to the Ethics Committee as a new proposal.

5.1.4 Approval declinedProposals may be rejected by the Committee. This may occur if the protocol has been deferred several times and/or the Committee feels that the proposed research is not justified and/or poses severe or unnecessary risk to the subjects. A rejection should be supported by clearly defined reasons. The Committee may or may not, as it fees appropriate, invite resubmission of a substantially altered proposal for reconsideration.

6 PROCEDURE FOR COMMUNICATING A DECISION

The Committee decision should be communicated to the applicant in writing within two weeks of the meeting at which the decision was taken and no later than 90 days after acknowledgement of receipt of the application. The chairperson (or in their absence the vice-chairperson) should sign and date all communications.

The decision is to include, but is not limited to:o Project reference number (assigned on receipt) and version of the

proposal upon which the decision is basedo Exact title of the proposal reviewedo Name and title of applicanto Name of the Research Ethics Committee taking the decisiono Date and place of the decisiono Name of Chairperson (or vice chair as appropriate) and list of members

present when the decision was takeno A clear statement of the decision taken

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o Any advise, opinions, requirements or conditions adjoined to the decision by the Ethics Committee, including the procedure for having the application re-reviewed

o Clearly defined reasons for the requirementso In the case of a positive decision, a statement of the responsibilities of the

applicant (e.g. confirmation of the acceptance of any requirements imposed by the Research Ethics Committee, the need to notify the committee in the case of amendments to the protocol likely to affect its decision, or of serious or unexpected adverse effects, of unforeseen circumstances, of the termination of the study, of the outcome of the study, of any significant decisions by other Ethics Committees)

o The schedule/plan for ongoing review by the Research Ethics Committeeo Clearly stated reasons for a negative decisiono Signature (dated) of the Chairperson (or other authorised person) of the

Ethics Committee

7 PROCEDURES FOR MONITORING ONGOING RESEARCH

Research Ethics Committees are responsible for following the progress of all studies (for which a positive decision has been reached) from the time the research commences through to its termination.

7.1 Reporting requirementsOn-going research should be subject to continuing monitoring. The Committee should indicate the quorum requirements, the reporting procedure and the communication procedure for on-going monitoring, which may vary from the requirements and procedures for the initial decision on the application. The frequency of such monitoring should reflect the degree of risk to participants/volunteers in the research project. As a minimum, the Research Ethics Committee will require an annual statement of compliance, see sample template in Appendix 4, from the Principal Investigator, but the Committee can agree more frequent reporting at the time of approval of the application. The Principal Investigator is also required to submit a final statement of compliance, see sample template in Appendix 5.

7.2 Follow-up ReviewThe Research Ethics Committee is responsible for responding to all notifications of instances or events affecting the progress of an approved study. A decision of a follow-up review is to be issued and communicated to the applicant, indicating a modification, suspension or reversal of the Research Ethics Committees’ original decision or confirmation that the decision is still valid.

7.2.1 Instances Requiring a Follow-up ReviewThe following instances or events require the follow-up review of a study:

o Any amendments to the protocol likely to affect the rights, safety and/or well-being of the participants/volunteers or the conduct of the study

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o Serious and unexpected adverse events related to the conduct of the study or study product (in the case of clinical trials) and the response taken by regulatory agencies, investigators and sponsors

o Any event or new information that may affect the benefits/risks ratio of the study

7.2.2 AmendmentsAny significant alterations to a previously approved proposal must receive prior approval from the Research Ethics Committee before implementation. Significant alterations include changes to:

o Personnel (including where work has been subcontracted to another investigator); any changes to named researchers responsible for the conduct of the research; any change to the personnel involved in obtaining informed consent or having access to personal information about research participants/volunteers

o Methodo Design of the studyo Duration of the studyo Informed consent procedureso Participant/volunteer information leafletso Method of recruitment

7.2.3 Adverse EventsAs a condition of approval of the research proposal the Research Ethics Committee will require investigators to immediately report any serious or unexpected adverse events on participants/volunteers or unforeseen events that might affect the benefits/risks ratio of the proposal.

A serious adverse event is defined as any occurrence that:o Results in deatho Is life threateningo Requires in-patient hospitalisation or prolongation of existing

hospitalisation (in the case of a clinical trial)o Results in persistent or significant disability/incapacity.

An unexpected event is an adverse reaction, the nature and severity of which is not consistent with relevant information available at the time of original approval.Investigators may take urgent safety measures to eliminate immediate jeopardy to the research participants/volunteers prior to approval by the Research Ethics Committee. However, investigators should provide the Committee with a written report of any action taken at the earliest opportunity. The Committee will review the new material and decide whether there are sufficient grounds for changing its initial decision to grant approval to the proposal.

7.3 Study TerminationIn the case of the premature suspension/termination of a study, the applicant should notify the Research Ethics Committee of the reasons for the

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suspension/termination. This should be accompanied by a summary of results obtained in a study up to the point of suspended/terminated.

In all cases, the Research Ethics Committee will require a final study report, summarising the main findings.

8 DOCUMENTATION AND ARCHIVING PROCEDURE

All documentation and communications of an Ethics Committee are to be dated, filed and archived according to written procedures. A statement is required defining the access and retrieval procedure (including authorised persons) for the various documents, files and archives. Documents to be filed and archived include, but are not limited to:

o The constitution, historical documents, and SOPs of the Research Ethics Committee

o The curriculum vitae of all Research Ethics Committee Memberso A record of all incomes and expenses of the Research Ethics Committee,

including allowances and reimbursements made to Committee memberso The published guidelines for submission established by the Research

Ethics Committee.o All material submitted by an applicanto All correspondences by Research Ethics Committee members with

applicants or concerned parties regarding applications, decision and follow-up

o Copies of decision and any advice and/or requirements issued to applicants

o The notification of the completion or premature termination of a study and a summary of the reasons

o The agenda of all Research Ethics Committee meetingso The minutes of all Research Ethics Committee meetings which should

include members present, third parties present, time, date and place of meeting

o Annual reports of the Research Ethics Committeeo Annual Investigator Statement of Complianceso Final Statement of Compliance

Documents should be kept for a minimum of five years following notification of completion or premature suspension/termination of a study.

9 RESEARCH ETHICS COMMITTEE ANNUAL REPORT

The Research Ethics Committee should produce an annual report containing information relevant to its procedures including, but not limited to:

o Membership and membership changeso Number and dates of meetings held

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o Attendance of members; confirmation of participation by required categories of members Substantive changes to the standard operating procedures (SOP)

o List of training undertaken by memberso A list of proposals considered and the decision reached on eacho Time taken from acceptance of application to final decision on each

proposalo List of projects completed or terminated during the year

Annual reports are public documents and should be available on request.

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10MULTI-CENTRE STUDIESMulti-centre studies may include research conducted at more than one institution or organisation, in one or more countries, either by the same or different investigators or research conducted jointly by investigators working with different institutions or organisations. The Research Ethics Committee shall require investigators to indicate on their application form if a study is being or has been reviewed by another Research Ethics Committee and if so, the identity and decision of that Committee.

In order to facilitate prompt and efficient review of multi-centre studieso An investigator may wish to distinguish between core elements of the

research that cannot be altered without invalidating the pooling of research data and those elements that can be altered to comply with local requirements.

o The Committee may wish to communicate with, give or receive advice from other Research Ethics Committees reviewing the proposal

o The Committee may wish to accept a scientific assessment of the proposal from another Research Ethics Committee.1

o The Committee may agree to accept the conclusions of a single review committee.2

Notes:1 A common scientific assessment could be produced by qualified members of a number of Research Ethics Committees involved or by one Research Ethics Committee that has accepted the role.2 A single committee could review the scientific and ethical aspects of a proposal. Individual committees could verify the practicability of the proposal in the institution/organisation and that the proposal conforms to the ethos of the institution/organisation in which the research is to be carried out.

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APPENDIX 1: GlossaryThe definitions provided within this glossary apply to terms as they are used in these SOPs/Guidelines. The terms may have different meanings in other contexts:

adverse effect: Any untoward or unfavourable occurrence experienced by a subject participating in a clinical trial.

adviceNon-constraining suggestions or considerations adjoined to a decision intended to provide ethical assistance to those involved in the research.

amendmentA written description of changes to a protocol or document.

applicantA qualified researcher undertaking the scientific and ethical responsibility for a study, either on his/her own behalf or on behalf of a research team or organisation, seeking a decision from an ethics committee through formal application.

clinical trialA systematic study of an investigational product or substance (usually medicinal) on human subjects (including patients and volunteers) intended to identify characteristics or efficacy and/or safety. In this document, reference to research study or proposal includes clinical trials.

communityA community is a group of people understood as having a certain identity due to the sharing of common interests or to a shared proximity.

conflict of interestA conflict of interest arises when a member (or members) of an Ethics Committee holds interests with respect to specific applications for review that may jeopardise his/her ability to provide a free and independent evaluation of the research focused on the protection of the research participants. Conflicts of interest may arise when an EC member has financial, material, institutional or social ties to the research.

decisionThe response, either positive or negative, by an Ethics Committee to an applicant following the review of the application in which the Ethics Committees position on the ethical validity of the proposed research is stated.

ethics committee (EC)An independent body constituted of medical professionals and non-medical members, whose responsibility it is to safeguard the welfare and the rights of subjects participating in research studies, taking into account the scientific procedures and the concerns of the local community.

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principal investigatorA qualified researcher who undertakes scientific and ethical responsibility, either on his/her own behalf or on behalf of an organisation, for the scientific and ethical integrity of a research study at a specific site or group of sites. In some instances a coordinating investigator may be appointed as the responsible leader of a team of sub-investigators.

opinionEthical considerations adjoined to a decision that represents the views of an individual member or a group of members of the Ethics Committee. In most cases an opinion is used to express dissent from the whole or part of a decision not unanimously reached by the Ethics Committee. Opinions are non-constraining elements of a decision intended to express specific ethical concerns that those involved in the research should consider.

protocolA document that provides the background, rationale and objective(s) of a research study and describes its design, methodology and organisation, including statistical considerations

requirementsIn the context of decisions, requirements are constraining elements that express ethical considerations that the ethics committee requires or views as obligatory in pursuing the research.

sponsorAn individual or organisation that takes on the scientific and ethical responsibility for the initiation, management, and/or financing of a clinical trial.

subjectAn individual who participates in a research study. The individual may be a healthy person who volunteers to participate in the research study, or a person with a condition unrelated to the research carried out who volunteers to participate, or a person whose condition is relevant to the study and who agrees to participate.

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APPENDIX 2: Constitution of the Research Ethics Committee

The NUI Galway Research Committee, taking advice as appropriate, shall be responsible for selecting and appointing suitable members to the Ethics Committee from the applications put before it through both internal and external solicitation for members1. Selection of members shall be by consensus.

It is the responsibility of the Research Committee to ensure that the composition of the Ethics Committee shall include:

A chairperson and vice-chairperson, who shall be from or additional to the other categories of members listed below.

One-two persons with law qualifications. These can be from the university Law Faculty or from outside the university but must not be from any firm that represents university interests.

Two members with knowledge of, and current experience in, the areas of research that are regularly considered by the Ethics Committee (e.g. scientists).

Two members with knowledge of, and current experience in, the area of social science.

Three members with knowledge of, and current experience in, the professional care and treatment of people (e.g. practising clinicians, nurses), one of whom shall be a specialist in mental health (e.g. clinical psychologist, psychiatrist, qualified councellor).

One-two members with training in ethics (e.g ethicist, philosopher, moral theologian).

Two-four lay members2. Committee secretary.

Where a chairperson or members of the Ethics Committee believe there is insufficient expertise on the committee to assess an application or an issue, the committee may seek additional expert advice.

All members of the committee should receive training prior to taking up their position and should receive clear documentation outlining their responsibilities, the Standard Operating Procedures of the Ethics Committee and the schedule of meetings for each year.

The Research Committee may appoint a person to act as a alternate to each member of the committee, where the alternate satisfies the same membership criteria as the member. The SOP of the Research Ethics Committee should identify the primary member for whom each alternate member may substitute. When alternates substitute for a primary member, the alternate member should have received and reviewed the same material that the primary member received or would have received. An alternate can only vote if the member for whom he/she acts as an alternate is absent. The use of an alternate member does not relieve the primary member from their commitment to attend the minimum number of scheduled meetings outlined in the conditions of appointment (Section 10.2.2).

As far as possible the Research Committee should strive to achieve gender balance in the membership of the Ethics Committee.

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Notes:(1) When selecting candidates, the Research Committee should take into

account whether or not by virtue of employment, profession or relationship, the candidate could be construed to have a potential conflict of interest with respect to a majority of proposals reviewed.

(2) The qualifications for lay members are independence from the institution and their non-involvement in scientific, clinical practice and legal work. Those who have no experience in professions associated with research on human beings are more likely to have a truly lay perspective.

10.1 Terms of Reference of the Research Ethics Committee

1.Advocate and encourage ethical standards of practice in research; protect subjects of research from unnecessary harm; preserve the subjects’ rights and through its functions, provide reassurance to the public that best practice is being applied.

2.Review proposals for research to be carried out in or by the University, its staff and members.

3.Have authority to approve (with or without modification) or reject proposals for research, on the basis of ethical considerations only.

4.Not undertake functions that might conflict with the above in any way. 5.Make an annual report to the NUI Galway Research Committee.

10.2 Conditions of Appointment

10.2.1 Term of Appointment o The term of appointment will be 3 years.o A member should not serve more than two consecutive terms1.o Renewal of membership for a second consecutive term will be the

decision of the Research Committee, on the recommendation of the Ethics Committee chairperson.

o Disqualification of a member from the Ethics Committee is at the discretion of the chairperson, with the approval by the Research Committee. Grounds for disqualification include, but are not confined to, failure to attend the required number of scheduled meetings, disruptive behaviour at meetings, undeclared conflicts of interest, breach of the code of confidentiality and canvassing of other committee members. Members will be informed of their disqualification in writing by the chairperson.

o Should a member wish to resign from the committee, they should inform the chairperson in writing of their intention, allowing at least 1 month from the date of receipt of their letter of resignation in which to find a replacement.

o The procedure for replacement of members at the end of the term of appointment will be the same as for initial appointment of members.

o Where replacement is required mid term the Chairperson in consultation with the Research Committee will make an interim appointment to the end of term for that committee.

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Notes:(1)The benefit of maintaining some continuity of membership by overlapping

terms of office should be considered.

10.2.2 Conditions of Appointment o Members must be willing to have their name, profession and affiliation

published on the Ethics Committee page of the university website.o A member is expected to attend AT LEAST two-thirds of all scheduled

Research Ethics Committee meetings in each year. Should a member fail to do so, the chairperson should address this with the member concerned.

o Members are expected to treat as confidential all applications, meeting deliberations, information on research participants/volunteers and related matters.

o A member must agree to take part in education and ongoing training appropriate to their role on the Ethics Committee.

o Members will receive reasonable reimbursement of expenses for travel and training, but will not receive an honorarium for participating in the Ethics Committee.

10.2.3 Declarations of interesto When a committee member or deputy member believes they have an

interest in relation to an application for ethical review or any other matter for consideration at the meeting that may compromise their ability to make an impartial decision, they should declare that interest to the Committee. Such a declaration may be made orally at the meeting, prior to the matter being considered, or in writing to the Chairperson (or vice chair as appropriate) prior to the meeting.

o Where the member concerned is the Principal Investigator or another key investigator/collaborator named on the application form, the Committee has the following options:- The member should leave the meeting room and take no part in the

discussion or the vote on the application.- The member may remain in the meeting room in order to provide any

relevant information requested by other members, but may not vote.o In the case of any other declared interest, the Committee should

collectively consider whether or not it is appropriate for the member concerned to take any part in the review of the application. Account should be taken of the closeness of the member’s interest in the application and the potential for a conflict of interest. In some cases, the declaration of the interest may in itself be sufficient to ensure that the decision of the Committee is not unduly influenced. The Committee has the following options:- The member should leave the meeting room and take no part in the

discussion or the vote on the application.- The member may remain in the meeting room in order to provide any

relevant information requested by other members, but may not vote.- The member may remain in the meeting room and take full part in

the review.

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o Failure to declare a known interest in an application for ethical review will result in disqualification of a member from the Committee.

10.2.4 Chairpersono The Chairperson is appointed by the Chairperson of the Research

Committeeo The duties of the Chairperson are;

o Liaise with the Office of the Vice President for Researcho Chair meetings of the RECo Ensure that the Standard Operating Procedures are followedo Ensure an annual report is issued

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APPENDIX 3: Information Sources

SOP/Guidelines compiles from:

1) Operational Procedures for Research Ethics Committees: Guidance 2004. The Irish Council for Bioethics (www.bioethics.ie). ISBN 1-904890-06-7.

2) Operational Guidelines for Ethics Committees that Review Biomedical Research (2000), World Health Organisation, Geneva (TDR/PRD/ETHICS/2000.1).

3) Guidelines and Recommendations for European Ethics committees (1997). European Forum for Good Clinical Practice.

4) Irish College of General Practitioners Research Ethics Committee Standard Operating Procedures (www.icgp.ie ).

5) Guidelines for Research Ethics at Dublin Institute of Technology (www.dit.ie/admin/graduate/ethics/index.html).

6) Research Ethics Committee Guidelines, Royal College of Surgeons of Ireland (2001).

7) UK Central Office for Research Ethics Committees (COREC); Standard Operating Procedures for Research Ethics Committees in the United Kingdom (www.corec.org.uk)

8) Research Ethics Committee Guidelines, University of Limerick.

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http://www.corec.org.uk/

http://www.dit.ie/admin/graduate/ethics/index.html

http://www.icgp.ie/

http://www.bioethics.ie/


APPENDIX 4: Annual Statement of Compliance

Name: _________________________________

Project Title:_____________________________

Research Ethic Reference:____________________

I confirm that the above referenced project (including any amendments hereto) has been carried out in accordance with the approval of the Research Ethics Committee (REC) at the National University of Ireland, Galway

PI signature ______________________________

Date____________________________________

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APPENDIX 5: Final Statement of Compliance

Name: _________________________________

Project Title:_____________________________

Research Ethic Reference:____________________

I confirm that the above referenced project (including any amendments hereto) has been carried out in accordance with the approval of the Research Ethics Committee (REC) at the National University of Ireland, Galway

PI signature ______________________________

Date____________________________________

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