Standard Operating Procedure Version 9.0/ January 2013 NUI Galway Research Ethics Committee
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Standard Operating Procedure Version 9.0/ January 2013 NUI Galway Research Ethics Committee
1 OBJECTIVES
2 PROCEDURE FOR CONSTITUTING THE COMMITTEE
3 PROCEDURE FOR SUBMITTING AN APPLICATION
3.1
Applicant
3.2
Application Procedure
3.3
Application Requirements
3.3.1
Required Documentation
3.4
Registration of Applications
4 REVIEW PROCEDURE
4.1
Meeting Procedure
4.1.1
Quorum Requirements
4.2
Elements of the Review
4.2.1
Scientific Design and Conduct of the Study
4.2.2
Recruitment of Research Participants/Volunteers
4.2.3
Care and Protection of Research Participants/Volunteers
4.2.4
Protection of Research Participant/Volunteer Confidentiality
4.2.5
Informed Consent Process
4.3
Post-Meeting Procedure
5 DECISION-MAKING PROCEDURE
5.1
Possible Ethics Committee Decisions
5.1.1
Approval
5.1.2
Provisional Approval
5.1.3
Deferral
5.1.4
Approval declined
6 PROCEDURE FOR COMMUNICATING A DECISION
7 PROCEDURES FOR MONITORING ONGOING RESEARCH
7.1
Reporting requirements
7.1.1
Status Report from Principal Investigator
7.2
Follow-up Review
7.2.1
Instances Requiring a Follow-up Review
7.2.2
Amendments
7.2.3
Adverse Events
7.3
Study Termination
13
14
14
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14
14
15
15
8 DOCUMENTATION AND ARCHIVING PROCEDURE
9 RESEARCH ETHICS COMMITTEE ANNUAL REPORT
10 MULTI-CENTRE STUDIES
APPENDIX 1: G
LOSSARY
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17
18
APPENDIX 2: C
ONSTITUTION OF THE
R
ESEARCH
E
THICS
C
OMMITTEE
10.1
Terms of Reference of the Research Ethics Committee
10.2
Conditions of Appointment
10.2.1
Term of Appointment
10.2.2
Conditions of Appointment
10.2.3
Declarations of interest
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21
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22
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5
5
5
5
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10
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Standard Operating Procedure Version 9.0/ January 2013
10.2.4
Chairperson
APPENDIX 3: I
NFORMATION
S
OURCES
NUI Galway Research Ethics Committee
22
23
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Standard Operating Procedure Version 9.0/ January 2013 NUI Galway Research Ethics Committee
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.
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.
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Standard Operating Procedure Version 9.0/ January 2013 NUI Galway Research Ethics 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).
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.
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 ( www.nuigalway.ie/research/vp_research/ethics.htm
).
Complete appropriate application form and checklist
Submission to REC Secretary at least 3 weeks before next REC meeting
All details of:
 Application Form
 Informed consent procedures
 Participant information leaflets
 Questionnaires
 Protocol
 Other details as appropriate processed by REC Secretary
Application for ethical approval distributed to REC members at least 2 weeks before next REC Meeting
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.
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Standard Operating Procedure Version 9.0/ January 2013 NUI Galway Research Ethics Committee
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 Engineering Technology Building
NUI Galway
Galway 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: ethics@nuigalway.ie
. 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.
Design and Conduct of the Study o Signed and dated application form. o A summary (as far as possible in non-technical language), synopsis, or diagrammatic representation (‘flowchart’) of the protocol o Protocol of the proposed research (clearly identified and dated) together with supporting documents and annexes o A description of the ethical considerations involved in the research o Case report forms, diary cards or questionnaires intended for research participants, where applicable o 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)
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Standard Operating Procedure Version 9.0/ January 2013 NUI Galway Research Ethics Committee 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 Participants o Material to be used (including advertisements) for the recruitment of potential research participants o 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 consent o 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 applicable o A description of the arrangements for insurance coverage for research participants, if applicable
Ethical Considerations/Decisions o 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 made on that account. The reasons for any previous negative decisions should be provided
The 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 material o 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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Standard Operating Procedure Version 9.0/ January 2013 NUI Galway Research Ethics Committee
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 Principal investigator/sponsor.
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 absent him/herself from the vote.
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 o Meetings should be planned in accordance with the needs of the workload o Ethics Committee members should be given enough time in advance of the meeting to review the relevant documentation (at least 2 weeks)
Agenda o 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
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
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Standard Operating Procedure Version 9.0/ January 2013 NUI Galway Research Ethics Committee o 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.
Minutes o 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 coopted 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 o 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.
o 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. 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
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Standard Operating Procedure Version 9.0/ January 2013 NUI Galway Research Ethics Committee
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.
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:
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 whole o The adequacy of provisions made for monitoring and auditing the conduct of the research, including data safety 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
o 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
o The safety of any intervention to be used in the proposed research o The suitability of the investigator for the proposed study in relation to his/her qualifications and experience
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Standard Operating Procedure Version 9.0/ January 2013 NUI Galway Research Ethics Committee o The provisions made for receiving and responding to queries and complaints of participants/volunteers throughout the course of the study o If applicable, any plans to withdraw or withhold standard therapies for the purpose of the research, and the justification for such action o 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/volunteers o The rewards and compensations, if any, for participants/volunteers (including money, services and/or gifts) and a justification for these o 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 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
o A description of the persons who will have access to personal data of the participants/volunteers, including medical records and biological samples o The measures taken to ensure the confidentiality and security of personal information concerning research participants o The extent to which the information with be anonymised o How samples/data will be obtained and the purposes for which they will be used o 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.
o 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 wellbeing)
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Standard Operating Procedure Version 9.0/ January 2013 NUI Galway Research Ethics Committee
All PIs/sponsors are informed in writing of the EC decision on their submission and any recommendations, with deadlines for resubmission
Recorded minutes kept on file
All correspondence signed by
Chairperson or nominee
PIs/sponsors who submitted amendments on foot of EC recommendations are notified in writing of EC decision on their submission and any further recommendations
In 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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Standard Operating Procedure Version 9.0/ January 2013
NUI Galway Research Ethics Committee
The applicant may begin the research as outlined in the research proposal submitted to the Research
Ethics Committee
Provisional 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.
A deferred research proposal must be reviewed and re-submitted to the Ethics Committee as a new proposal.
Proposals 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.
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 based o Exact title of the proposal reviewed o Name and title of applicant o Name of the Research Ethics Committee taking the decision o Date and place of the decision o Name of Chairperson (or vice chair as appropriate) and list of members present when the decision was taken o A clear statement of the decision taken 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 requirements o 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
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Standard Operating Procedure Version 9.0/ January 2013 NUI Galway Research Ethics Committee 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 Committee o Clearly stated reasons for a negative decision o Signature (dated) of the Chairperson (or other authorised person) of the Ethics Committee
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.
On-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.
The 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.
The 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 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
Any 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 Method o Design of the study o Duration of the study o Informed consent procedures
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Standard Operating Procedure Version 9.0/ January 2013 NUI Galway Research Ethics Committee o Participant/volunteer information leaflets o Method of recruitment
As 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 death o Is life threatening o 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.
In the case of the premature suspension/termination of a study, the applicant should notify the Research
Ethics Committee of the reasons for the 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.
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 Members o A record of all incomes and expenses of the Research Ethics Committee, including allowances and reimbursements made to Committee members o The published guidelines for submission established by the Research Ethics Committee. o All material submitted by an applicant o 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 meetings
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Standard Operating Procedure Version 9.0/ January 2013 NUI Galway Research Ethics Committee o 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 Committee o Annual Investigator Statement of Compliances o 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.
The Research Ethics Committee should produce an annual report containing information relevant to its procedures including, but not limited to: o Membership and membership changes o Number and dates of meetings held 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 members o A list of proposals considered and the decision reached on each o Time taken from acceptance of application to final decision on each proposal o List of projects completed or terminated during the year
Annual reports are public documents and should be available on request.
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Standard Operating Procedure Version 9.0/ January 2013 NUI Galway Research Ethics Committee
Multi-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 studies o 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
1
Notes:
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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Standard Operating Procedure Version 9.0/ January 2013 NUI Galway Research Ethics Committee
The 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. advice
Non-constraining suggestions or considerations adjoined to a decision intended to provide ethical assistance to those involved in the research. amendment
A written description of changes to a protocol or document. applicant
A 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 trial
A 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. community
A 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 interest
A 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. decision
The 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. principal investigator
A 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. opinion
Ethical 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
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Standard Operating Procedure Version 9.0/ January 2013 NUI Galway Research Ethics Committee protocol
A document that provides the background, rationale and objective(s) of a research study and describes its design, methodology and organisation, including statistical considerations requirements
In 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. sponsor 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.
An individual or organisation that takes on the scientific and ethical responsibility for the initiation, management, and/or financing of a clinical trial. subject
An 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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Standard Operating Procedure Version 9.0/ January 2013 NUI Galway 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 members 1 . 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 members 2 .
 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.
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 noninvolvement 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.
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Standard Operating Procedure Version 9.0/ January 2013 NUI Galway 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.
o The term of appointment will be 3 years. o A member should not serve more than two consecutive terms 1 . 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.
Notes:
(1) The benefit of maintaining some continuity of membership by overlapping terms of office should be considered.
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.
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Standard Operating Procedure Version 9.0/ January 2013 NUI Galway Research Ethics Committee
o 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. o Failure to declare a known interest in an application for ethical review will result in disqualification of a member from the Committee.
o The Chairperson is appointed by the Chairperson of the Research Committee o The duties of the Chairperson are; o Liaise with the Office of the Vice President for Research o Chair meetings of the REC o Ensure that the Standard Operating Procedures are followed o Ensure an annual report is issued
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Standard Operating Procedure Version 9.0/ January 2013 NUI Galway Research Ethics Committee
8)
1)
2)
3)
4)
5)
6)
7)
Operational Procedures for Research Ethics Committees: Guidance 2004. The Irish Council for
Bioethics ( www.bioethics.ie
). ISBN 1-904890-06-7.
Operational Guidelines for Ethics Committees that Review Biomedical Research (2000), World
Health Organisation, Geneva (TDR/PRD/ETHICS/2000.1).
Guidelines and Recommendations for European Ethics committees (1997). European Forum for
Good Clinical Practice.
Irish College of General Practitioners Research Ethics Committee Standard Operating
Procedures ( www.icgp.ie
).
Guidelines for Research Ethics at Dublin Institute of Technology
( www.dit.ie/admin/graduate/ethics/index.html
).
Research Ethics Committee Guidelines, Royal College of Surgeons of Ireland (2001).
UK Central Office for Research Ethics Committees (COREC); Standard Operating Procedures for Research Ethics Committees in the United Kingdom ( www.corec.org.uk
)
Research Ethics Committee Guidelines, University of Limerick.
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Standard Operating Procedure Version 9.0/ January 2013 NUI Galway Research Ethics Committee
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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Standard Operating Procedure Version 9.0/ January 2013 NUI Galway Research Ethics Committee
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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