Information for applicants applying to the Institute of Community Health Nursing Research Ethics Committee (ICHN REC)

 

24th January 2017

Part 1: General information

The Institute of Community Health Nursing (ICHN) is the leading organisation in supporting and promoting the work of nurses working in community. A central focus of the ICHN is to support the creation of an evidence base relevant to nurses working in community. Following a 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 by members or staff at 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.

 

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[1]. These principles are:

  • honesty in communication;
  • reliability in performing research;
  • objectivity;
  • 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[2], which was developed as part of the 2nd World Conference on Research Integrity in 2010[3] and the National Policy Statement on Ensuring Research Integrity in Ireland.[4]

1.1 Role of the REC

  • The key role of the REC is to consider research proposals 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.”

In keeping with the HSE guidance[5] 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; to weigh the risks and benefits for research participants; 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, 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.

1.2 Research activities that will be considered by ICHN REC

The HSE[6] 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 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

(e) Audits

(f) Service evaluations

 

1.3 Criteria for applications

Applications that meet the following criteria will be reviewed:

  • The applicant must be a member of the Institute of Community Health Nursing.
  • The research must meet the criteria outlined above and must not be a clinical trial.
  • A fully completed Application Form must be submitted.

 

Part 2: Procedure for application

Two broad approaches can be adopted in the application process and these are:

Expedited Review: The Chair of the REC is responsible for determining whether or not a protocol is eligible for expedited review.

Applicants must make a submission as per normal to the ICHN REC and on review of the documentation, the Chairperson will decide if the application has to come before the full Committee or, in the case of some low risk studies, whether expedited approval can be granted.

The Application Form relating to this is available at Appendix 1.

 

Full Review

The Standard Application Form for the Ethical Review of Health-Related Research Studies, which are not Clinical Trials of Medicinal Products for Human Use as defined in S.I. 190/2004 forms the basis for applications. This Standard Application Form is widely used in the health services, including by those operating in acute and community settings.

A Guidance Manual accompanies the Standard Application Form and its purpose is to guide applicants when completing the form. It is a reference document that provides detailed context for the questions asked and directs applicants to other related sources of information. The Standard Application Form is available in Appendix 2.

An application for REC review in respect of proposed research must be made in writing and signed by a qualified researcher responsible for the conduct of the study. This will usually be the chief investigator. The applicant is expected to submit all documentation required for a thorough and complete ethical review of the proposed research. This may include but is not restricted to:

(a) a signed and dated Standard Application Form

(b) questionnaires/interview guides intended for research participants/subjects

(c) current curriculum vitae of the applicant(s) (updated, signed and dated)

(d) material used (including advertisements) for recruiting participants

(e) Participant information (see example provided)

(f) consent forms (see example provided)

(g) any significant previous decisions (e.g. those leading to a negative decision or modified proposal) by other RECs or regulatory authorities for the proposed research (whether in the same location or elsewhere) and an indication of the modification(s) to the protocol made on that account. The reasons for previous negative decisions should be provided.

The Standard Application Form is available at Appendix 2.

2.1 Making a submission

Completed applications, including all documentation, written in English in typescript in single bound form (double sided) x 3 copies should be sent to:

Ethics Coordinator,

Institute of Community Health Nursing

Milltown Park,

Sandford Road,

Ranelagh,

Dublin 6,

Ireland.

 

On receipt of your submission, the ICHN will notify you by email. If you do not receive this receipt confirmation email, please contact the Ethics Coordinator at the ICHN office on
(0)1 220 0200.

Your proposal will be considered, where relevant, by the REC and proposals will be assessed in respect of the key following areas:

  • scientific design and conduct of the study;
  • recruitment of research participants/subjects;
  • care and protection of research participants/subjects;
  • protection of confidentiality of participants/subjects;
  • anonymity of information
  • informed consent process; and
  • 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 A more extensive list of areas for consideration can be found in Appendix 3.

2.2 REC decision

A response will be issued to you within two weeks following consideration of your proposal by the REC. The decision taken will be provided to you along with terms and conditions, if any, of approval/provisional approval of proposal, with clearly defined reasons for such terms and conditions. Where approval is declined, clear reasons for this decision will be provided to you.

  1. Approved: The applicant may conduct the research as outlined in the research proposal submitted to the REC.
  2. 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.

 

Appendix 3: Review considerations[7]

When reviewing research proposals, a REC should 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

(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

(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/volunteer’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/volunteer 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/volunteer 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 long samples/data will be kept

(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

(e) description of the procedures for disclosure, if appropriate, of relevant information to participants/subjects which may become available during the study

 

Community considerations

(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 make a contribution 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

(e) the manner in which the results of the research will be made available to participants/subjects and the concerned communities

 

 

 

[1] European Science Foundation (2011) The European Code of Conduct for Research Integrity. Strasbourg http://www.esf.org/fileadmin/Public_documents/Publications/Code_Conduct_ResearchIntegrity.pdf

[2] http://www.singaporestatement.org/

[3] Mayer T. & Steneck N (2007) Final Report To ESF And ORI First World Conference On Research Integrity: Fostering Responsible Research (Lisbon, Portugal, 16-19 September 2007). http://www.icsu.org/freedom-responsibility/research-integrity/pdf-images/WCRI_2007_report.pdf

[4] Irish University Association (2014) National Policy Statement on Ensuring Research Integrity in Ireland. Dublin. http://www.iua.ie/wp-content/uploads/2014/06/National-Policy-Statement-on-Ensuring-Research-Integrity-in-Ireland-2014.pdf

[5]Health Service Executive  Research Ethics Committees. http://www.hse.ie/eng/services/list/5/publichealth/publichealthdepts/Research/rec.html. Accessed 26th September 2016

[6] http://www.hse.ie/eng/services/list/5/publichealth/publichealthdepts/Research/rec.html

[7] This section is drawn directly from the Irish Council for Bioethics (2004) Operational Procedures for Research ethics committees: Guidance 2004. Dublin, Irish Council for Bioethics.