Standard Operating Procedures for the Institute of Community Health Nursing Research Ethics Committee
9th November 2016
Part 1: About the Institute of Community Health Nursing
The Institute of Community Health Nursing (ICHN) is the leading organisation in supporting and promoting the work of nurses working in community. The primary aim of the ICHN is to promote the delivery of optimum nursing care, to support the health and wellbeing of the population and to assist nurses working in community settings. The ICHN, established in 1985, is a professional and educational body for Community Nursing throughout the State and it provides a professional forum for nurses working in community to identify and respond to evolving health care needs. The ICHN is not a trade union. Its work is underpinned by the following values:
- Leadership (being proactive in identifying and addressing unmet needs in community nursing services);
- Quality (through evidence-based and solutions focused supports);
- Integrity (ensuring we are transparent in our communication, decision making and collaboration); and
- Professionalism in all our relationships with members, partners and other agencies.
Organisational and governance structure
The ICHN has a robust organisational and governance structure in place that includes:
- Our Patron (President Michael D. Higgins)
- An elected Council (with membership from management, practice, education)
- An Advisory Board drawn from experts in areas relevant to community nursing including, Care of Older Persons, Paediatrics Public Health Children and Young People Infectious Diseases and Community Nursing Research
- The ICHN is guided by its Constitution which sets out the Memorandum of Association, Articles of Association and Bye-Laws and these provide the organisation with a legal context for its work.
The ICHN works in collaboration with all its partners to ensure it identifies the professional needs of its members and responds accordingly so that it supports community nursing services in Ireland. Considerations around the future development of the ICHN led to the development of a Service Level Agreement (SLA) which was signed in 2015 with the Royal College of Surgeons Ireland (RCSI) and Research Matters Ltd. This SLA provides the ICHN with a sound basis for the conduct and implementation of educational and research projects of importance. This collaboration also ensures that the ICHN can respond in a flexible and timely way to the needs of the HSE and others in areas such as clinical care, primary care and integration, health and wellbeing and child health and welfare.
Part 2: Background to the Research Ethics Committee
A central focus of the ICHN is to support the creation of an evidence base relevant to nurses working in community. Following consideration of a number of options, the ICHN Council identified a need for an ICHN Research Ethics Committee (REC) to ensure appropriate ethical oversight of research projects taking place through the ICHN. While there are some research projects that do not require ethics approval (e.g. secondary data analysis of large data sets, analysis of publically available data, and systematic reviews), research that involves human participants/subjects can raise particular ethical issues and concerns that require careful consideration. Therefore, all research projects that involve human participants/subjects require ethical review and must obtain ethics approval before they can commence.
Eligibility to apply to REC
The REC will only review applications for pilot, feasibility, and full studies from ICHN staff and members. Where an individual REC member is involved in a study under review, the person must declare their interest and remove them self from discussions in respect of it.
2.1 Research integrity
The ICHN is committed to ensuring the highest standards of integrity in all aspects of its research and endorses the eight basic principles of the European Code of Conduct for Research Integrity. These principles are:
- honesty in communication;
- reliability in performing research;
- impartiality and independence;
- openness and accessibility;
- duty of care;
- fairness in providing references and giving credit; and
- responsibility for the scientists and researchers of the future.
These principles are also consistent with the Singapore Statement on Research Integrity, which was developed as part of the 2nd World Conference on Research Integrity, 2010 and the National Policy Statement on Ensuring Research Integrity in Ireland.
2.2 Terms of reference of the ICHN REC
The key role of the ICHN REC is to consider proposals/projects with human participants/subjects for which ethical approval is required. “The central focus of the ICHN REC will be on ensuring research meets the following requirements: respect for the persons taking part; privacy and confidentiality; and purpose of the research.” Key issues to be taken into account include:
- To respect the dignity and autonomy of persons taking part; to obtain their informed, valid and voluntary consent; to protect their privacy and confidentiality.
- Validity of the research and its scientific merit.
- To minimise any risks to the individual participant/subject and to the rest of society.
- To distribute fairly across society the benefits and risks of the research.
In keeping with the HSE guidance in the area, the role of the REC will be to ensure:
- Protection: To contribute to safeguarding the dignity, rights, safety and wellbeing of all actual or potential research participants/subjects, to weigh the risks and benefits for research participants/subjects, to protect the rights of researchers to carry out legitimate investigation and the ICHN’s reputation for research conducted and sponsored by it.
- Advice: Can advise individual researchers on whether a research project requires research ethics review, that is if it is likely to be harmful or offensive to participants/subjects, the broader community or the HSE.
- Research Quality: For research to be ethical, it must be scientifically sound. It is acknowledged, however, that this may sometimes be difficult for a REC to judge.
The REC will provide an annual activity report to the President of the ICHN and Council and highlight issues of importance arising.
2.3 Research activities to be considered by ICHN REC
The HSE note that review by Research Ethics Committees may not be required for the following research:
(a) Research utilising existing publicly available documents or data
(b) Observational studies in public places in which the identity of the participants/subjects remains anonymous
(c) Case study of one patient with the proviso that written informed consent has been obtained from the relevant subject
(d) Quality assurance studies
(f) Service evaluations
It is expected that the ICHN REC will focus primarily on social research that employs methodologies such as surveys, interviews, evaluations and consultations. In this context, social research is defined as follows:
the process of systematically gathering, analysing and interpreting information about the behaviour, knowledge, beliefs, attitudes and values of human populations.
Pilot studies or similar type studies should be treated in the same way as full research projects and should not be undertaken unless and until ethical approval is given.
All clinical trials involving human participants are regulated for under the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004, S.I. 190 of 2004. In Ireland, such trials require consideration by Research Ethics Committees with the competence to review clinical trials of investigational medicinal products (IMPs) who must be recognised by the Ethics Committees Supervisory Body. This Body is currently the responsibility of the Minister for Health. Based on the Guidance published by the Irish Council for Bioethics (2004), the ICHN REC will not consider proposals related to:
(a) Clinical trials involving human participants
(b) New treatment or interventions
(c) Research involving human remains, cadavers, tissues, discarded tissue (e.g. placenta), or biological fluids
(d) Physiological studies
(e) Comparing an established procedure, whether therapeutic, non-therapeutic or diagnostic, with other procedures which are not recognised as established by virtue of their recent development, discovery or use in a new or unfamiliar way.
2.4 Composition of the REC
The ICHN REC will be constituted to ensure competent ethical review of research proposals submitted and to ensure it has the appropriate expertise, skills, knowledge and perspectives to provide an adequate and thorough review. In line with the operational procedures set out by the Irish Council for Bioethics (2004), the REC will include the following areas of expertise:
- Member with knowledge of and current experience in the areas of research which are regularly considered by the REC
- Member with knowledge of and current experience in the professional care, counselling or treatment of people
- Members with training in ethics
- Member with a qualification in law including data protection issues
- Member with training in statistics
- Lay members
Additional experts may be co-opted on to the REC if the need should arise.
The REC will have a Chairperson and Vice-Chairperson who can substitute when required. Both will be appointed by the President of the ICHN.
2.4 Procedures for selecting candidates
Nominees for inclusion on the REC may be proposed by:
- a member of the ICHN elected Council;
- a member of ICHN Advisory Board; or
- a member of the REC.
Vacancies on the REC may be advertised through the ICHN and submissions sought from interested individuals.
In the selection of candidates, consideration will be given to key issues around professional discipline, age and gender, so that the overall membership is well-balanced. Consideration will also be given to whether 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.
Procedure for appointing members
Nominated members will be invited to submit a short Curriculum Vitae (CV) outlining their particular expertise for inclusion on the REC.
The CVs along with any other supporting information will be considered by members of the ICHN elected Council.
Proposed nominations will be presented to the REC for consideration.
The President of the ICHN will make the final decision on the inclusion of a candidate on the REC.
2.5 Name and description of person or institution responsible for making appointments
The appointment of members will be made by the President of the ICHN following the procedure outlined above.
2.6 Duration of an appointment
Membership is for a period of four years with an option of renewing membership for one further term. The membership will rotate with some members stepping down after two years so that all members do not resign at the same time.
2.7 Procedure for resignation of a member
Members must notify the Chair of the Committee and the President of the ICHN in writing (by email or post) that they intend to step down.
Members who resign will be removed from the email circulation list.
2.8 Procedure for the disqualification of a member
Members who do not make a contribution to the work of the Committee or who are deemed to be unsuitable or who, without sending apologies, do not attend three consecutive meetings may, at the discretion of the Committee, be asked to step down and a replacement member may be sought. The following process will be followed:
- The member will be informed in writing by the President of the ICHN of the concerns and given an opportunity to respond within an appropriate timeframe (four weeks).
- The response by the member will be given consideration by the ICHN Council and President of the ICHN and a decision taken on the most appropriate course of action.
- In the event that a response is not received from the member, the President, in agreement with the ICHN Council, will, following an appropriate period of time (six weeks following response date), terminate his/her membership of the REC.
2.9 Duties and responsibilities of REC members
Individual researchers have a responsibility to ensure the project is ethically sound and is carried out in an ethical way. Committee members have a commitment to protect and safeguard the rights and interests of human participants/subjects participating in research, while promoting and facilitating research excellence. Individual committee members shall not be liable for the decisions of the REC. The members of the committee are indemnified.
A member should be prepared to have his/her name, profession and affiliation published. It is important to ensure that lobbying of members of the committee does not take place. In the event lobbying is attempted, the REC member will report this to the REC.
Members are required to treat as confidential all applications, meeting deliberations, information on research participants/subjects and related matters.
When a committee member believes there is a conflict of interest on a subject which will compromise their ability to make an impartial decision, they should declare that conflict of interest and withdraw themselves from the discussion and/or activity.
A member is expected to attend at least two-thirds of all scheduled REC meetings in each year. Should a member fail to do so, the Chairperson should address this with the member concerned.
A member must agree to take part in education and ongoing training appropriate to his or her role as a REC member.
2.10 Operating procedures for meetings
- Members are required to regularly attend the meetings.
- Members are required to send apologies and comments by email to the ICHN REC Support Office if they are unable to attend.
- Members are required to provide comments by email on revisions, application reviews and any other business on which the Chair requires commentary.
- For reasons of security and administration, the work of the Committee will be conducted via a special members’ area of the ICHN IT infrastructure. Each member will be issued with a personal username and password which must be kept confidential.
- The Committee must have a quorum of people in order to proceed with a meeting. To be quorate a Committee meeting must have one-third of its current membership in attendance.
- Within the Committee, members will have a responsibility to declare any conflict of interest which could affect their role as members of the Committee and to absent themselves, as appropriate, from the relevant discussion.
- Provision for voice conference will be made available where possible.
RECs should meet in accordance with regularly scheduled dates.
Meeting requirements should include the following:
(a) Meetings should follow a previously scheduled agenda.
(b) Members should be given sufficient time to review relevant documentation.
(c) Meetings should be minuted. There should be an approval procedure for the minutes.
(d) When appropriate, the sponsor and/or investigator will be invited to present the proposal to the members and answer any questions the committee may have.
(e) When appropriate, independent experts (e.g. researchers with specific competence, ethicists, statisticians) may be invited to attend.
Part 3: Review process
When reviewing research proposals the ICHN REC should consider the following:
- Scientific design and conduct of the study
- Potential benefits and risks of the research
- Recruitment of research participants/subjects and whether or not they will be offer inducement, voluntary involvement in the research and option to withdraw at any time without any adverse consequence
- Care and protection of research participants/subjects
- Protection of confidentiality of participants/subjects
- The extent to which the information will be anonymised
- Informed consent process
- Data protection issues including procedures for retention and destruction of data
- Community considerations, including the impact on the local community and the extent to which the research makes a contribution (for example, in the enhancement of local healthcare, contribution to research, and the ability to enhance health care)
A more extensive list of areas for consideration can be found in Appendix 1.
3.1 Expedited review
The REC may wish to incorporate expedited review into its Standard Operating Procedures. The following should be taken into account:
(a) The research should present minimal risk to participants/subjects, e.g. risks related to invasion of privacy and/or breach of confidentiality. Initially this decision will be made by the applicant.
(b) The expedited review application documentation will be used to make the application.
(c) The review will be undertaken by at least two members of the REC, one of whom should be the Chairperson.
(d) If the reviewers are of the view that the project is not at minimal risk, the application will be passed on to the full Committee for review.
(e) All REC members will be informed of research proposals which have been approved under this procedure within an appropriate timeframe.
The REC should ensure that all supporting documentation for an application is complete before coming to a decision on a research proposal. It is expected that that REC will use the consensus model, where the proposal will be approved when all members present are willing to allow the proposal to proceed. In cases in which consensus seems unlikely, the Chairperson may call for a vote with a two-thirds majority required for approval. Dissenting members should be afforded the opportunity to append an opinion to the REC decision.
The REC should accommodate reasonable requests from investigators to participate in discussions about their proposal, but may not be present when the REC is making its decision.
The following terminology should be used in communicating the decision of the REC to an applicant:
- Approved: The applicant may conduct the research as outlined in the research proposal submitted to the REC.
- Provisionally approved: Subject to recommended revisions to the proposal or answers to questions posed to the applicant. The revisions and/or answers must be resubmitted to the REC before receiving final approval. No research may be conducted prior to receiving final approval.
iii. Approval declined: Detailed reasons for declining approval should be forwarded to the applicant, with or without an invitation to resubmit a substantially altered proposal for reconsideration.
The REC decision should be communicated to the applicant in writing within two weeks of the meeting at which the decision was taken. The ICHN Notification of Decision Form should be used to communicate with the application. The Chairperson should sign and date all such communications.
Any significant alteration to a previously approved proposal must receive prior approval from the REC before implementation. Significant alterations include changes to:
(a) Personnel (including where work has been subcontracted to another investigator), any changes to named researchers responsible for the conduct of the research, and any change to the personnel involved in obtaining informed consent or having access to personal information about research participants/subjects
(c) Design of the study
(d) Duration of the study
(e) Informed consent procedures
(f) Patient information leaflets
(g) Method of recruitment
As a condition of approval of the research proposal the REC should require investigators to immediately report any serious or unexpected adverse events on participants or unforeseen events that might affect the benefits/risks ratio of the proposal.
Part 4: Monitoring ongoing research
The REC will put in place a review procedure for following the progress of all studies for which approval has been granted. The review date will be included on the Notification of Decision Form for approved proposals.
The review should seek a status report using the ICHN REC Status Report Form from the investigator at least on an annual basis.
4.1 Suspension or termination of a project
In the case of a premature suspension/termination of a study, the REC requires the investigator to inform the REC of the reasons for premature suspension/termination. This should be accompanied by a summary of the results obtained in the study up to the point of suspension/termination. The REC requires investigators to notify the Committee once a study has been completed. The REC should receive a final study report summarising the main findings.
Part 5: Standard Operating Procedure for documentation and archiving
All documentation and communications of the REC should be dated, filed and archived at the ICHN headquarters. Documents will be stored in a secure place where there is adequate protection against fire. Requests for access to documents stored will dealt with by the President of the ICHN. Documents that should be filed and archived include, but are not limited to:
(a) Written standard operating procedure
(b) Annual Reports
(c) CV of each REC member
(d) Record of all income and expenses of the REC, including expenses paid to REC members and co-optees
(e) Guidelines on application procedures
(f) Agendas of REC meetings
(g) Minutes of REC meetings
(h) Copies of all materials submitted by applicants
(i) Correspondence by the REC concerning applicants, decisions and follow-up
(j) Copies of decisions and any advice and/or requirements issued to applicants
(k) All written documentation received during follow-up
(l) Notification of completion or premature suspension/termination of studies
(m) Final study reports
Guidance in respect of the length of time documents are to be kept has not been provided in the Data Protection Guidelines on Research in the Health Sector (Data Protection Commissioner, 2007). However, the Irish Council of Bioethics (2004) recommend that documents be kept for a minimum of three years following notification of completion or premature suspension/termination of a study. In this situation, documents will be kept for a minimum of three years.
5.1 REC Annual Report
The REC will produce an Annual Report containing information relevant to its procedures including, but not limited to:
(a) Membership/membership changes
(b) Number and dates of meetings held
(c) Attendance of members and confirmation of participation by required categories of members
(d) Substantive changes to the standard operating procedures
(e) List of training undertaken by members
(f) A list of proposals considered and the decision reached on each
(g) Time taken from acceptance of application to final decision on each proposal
(h) List of projects completed or terminated during the year
The Annual Report will be submitted to the President of the ICHN for consideration by the ICHN elected council.
The Annual Reports are public documents and should be available upon request.
Appendix 1: Review considerations
When reviewing research proposals, a REC should, if relevant, consider the following:
Scientific design and conduct of the study
(a) the appropriateness of the study design in relation to the objectives of the study, the statistical methodology (including sample size calculation) and the potential for reaching reliable conclusions with the smallest number of research participants/subjects;
(b) the justification of predictable risks and inconveniences weighed against the anticipated benefits for the research participants/subjects and the concerned communities;
(d) criteria for withdrawing participants/subjects prematurely
(e) criteria for suspending or terminating research;
(f) the adequacy of conditions made for the monitoring and auditing the conduct of the research;
(g) the adequacy of the site including the supporting staff, facilities and emergency procedures; and
(h) the form in which the results will be reported and published.
Recruitment of research participants/subjects
(a) the characteristics of the population from which the participants/subjects will be drawn (including gender, age and ethnicity) and the justification for any decisions made in this regard;
(b) the method by which initial contact and recruitment are to be conducted;
(c) the method by which information is to be conveyed to participants/subjects or their representatives and by which means consent is to be obtained; and
(d) inclusion and exclusion criteria for research participants/subjects.
Care and protection of research participants/subjects
(a) the safety of any intervention to be used in the proposed research;
(b) the suitability of the investigator for the proposed research in relation to his/her qualifications and experience;
(c) any plans to withdraw or withhold standard therapies or clinical management protocols for the purpose of the research, and the justification for such action;
(d) the adequacy of health and social supervision and psychological support for the research participants/subjects;
(e) the adequacy of medical supervision and follow-up concerning the participants/subjects;
(f) steps to be followed if participants/subjects decide to withdraw during the course of the research;
(g) the arrangements, if appropriate, for informing the participant’s/subject’s GP, including procedure for seeking consent to do so;
(h) a description of any scheme to make the study product available to the participants/subjects following the research;
(i) a report of the expenses (if any) payable to participants/subjects;
(j) the provisions for compensation/treatment in the case of the injury/disability/death of a participant/subject connected to participation in the study;
(k) the provisions made for receiving and responding to queries and complaints of participants/subjects throughout the course of the study;
(l) the insurance and indemnity agreements covering the liability of the investigator by the sponsor;
(m) a description of any grants, payments or other reward to be made to any researchers or research hosts;
(n) a description of possible conflicts of interest which might affect the independent judgement of the researcher(s);
Protection of confidentiality of participants/subjects
(a) a description of the persons who will have access to personal data of the participant/subject including medical records and biological samples;
(b) a description of provisions to ensure the confidentiality and security of personal information concerning participants/subjects;
(c) the extent to which the information will be anonymised;
(d) how samples/data will be obtained and the purposes for which they will be used;
(e) how, and for how long, samples/data will be kept; and
(f) to which countries (if any) the samples/data will be sent.
Both REC members and investigators should be aware of the provisions of the Data Protection Acts 1988 and 2003 and their obligations as set out in those Acts.
Informed consent process
(a) description of the procedures for obtaining informed consent, including the identification of those responsible for obtaining consent and the time frame in which it will occur;
(b) the adequacy, comprehensiveness and ease of understanding of written and oral information given to the participants/subjects, their relatives/guardians and, if necessary, their legal guardians;
(c) the content and wording of the informed consent form and, when applicable, the provisions made for participants incapable of giving consent personally;
(d) clear justification for the intention to include participants/subjects who cannot consent and a full account of the arrangements for obtaining consent or authorisation for the participation of such individuals; and
(e) description of the procedures for disclosure, if appropriate, of relevant information to participants/subjects which may become available during the study.
(a) the impact and relevance of the research on the local community and on the concerned communities from which the participants/subjects are drawn;
(b) a description of procedures to consult with the concerned communities during the course of designing the research;
(c) the extent to which the research contributes to, for example, the enhancement of local healthcare, research and the ability to respond to public health needs;
(d) a description of the availability and affordability of any successful study product to the concerned communities following the research; and
(e) the manner in which the results of the research will be made available to participants/subjects and the concerned communities.