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Research Ethics Policy and Procedures

Research Ethics Policy and Procedures

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LYIT ETHICS POLICY AND PROCEDURES<br />

Good ethical practice requires that all research is conducted on the basis of respect for <strong>and</strong> adherence to<br />

regulatory guidelines <strong>and</strong> internationally accepted ethical norms focusing on the welfare of the study<br />

participants. All research carried out in the Institute or on behalf of the Institute must be governed by the<br />

LYIT ethics policy <strong>and</strong> procedures.<br />

All staff <strong>and</strong> learners must secure ethics approval for any research involving or impacting upon human or<br />

animal participants, Approval must be given before research begins. The Institute’s research ethics policy<br />

covers everyone carrying out research for the Institute, whether their place of research is within or outwith<br />

the Institute premises. The Institute’s research ethics policy seeks to develop best practice in research in<br />

accordance with the Declaration of Helsinki <strong>and</strong> statements of appropriate ethical practice produced by<br />

professional bodies. It follows good practice in International ethical guidelines, relevant EU directives,<br />

National guidelines <strong>and</strong> National legislation. LYIT ethics policy <strong>and</strong> procedures respect academic freedom<br />

<strong>and</strong> do not seek to restrict academic research unnecessarily.<br />

PROCEDURES:<br />

Appeals<br />

The decision of the Institute <strong>Research</strong> <strong>Ethics</strong> Committee may be appealed to the Office of the Registrar.<br />

(Section E of the <strong>Research</strong> <strong>Ethics</strong> Application Form).<br />

INSTITUTE RESEARCH ETHICS COMMITTEE<br />

The Institute <strong>Research</strong> <strong>Ethics</strong> Committee overseas good practice in ethical research <strong>and</strong> develops the<br />

Institute’s ethics policies <strong>and</strong> procedures.<br />

It will be for the Institute <strong>Research</strong> <strong>Ethics</strong> Committee to develop detailed ethics policies <strong>and</strong> to oversee <strong>and</strong><br />

refine procedures. The policies will sit within the internationally accepted norms on ethical research <strong>and</strong> will<br />

promote the welfare of all human <strong>and</strong> animal participants while at the same time respecting academic<br />

freedom.These may include:<br />

1. the confidentiality of information provided by those taking part in the research;<br />

2. the anonymity of the respondents;<br />

3. any consents which may be required;<br />

4. the transparency to both researchers <strong>and</strong> those taking part in the research as to the purpose, methods,<br />

application of the research <strong>and</strong> any risks involved;<br />

5. arrangements for the publication of the results, including issues of co-authorship;<br />

6. legal restrictions governing access to or the use of research resources <strong>and</strong> data.<br />

The IREC may choose to adopt more precise definitions which will clarify the scope of the ethics policy. It is<br />

likely that it will develop detailed guidance on, inter alia, the implications of the policy on research involving<br />

animals. It will also develop procedures for dealing with recurring research at the undergraduate level which<br />

will ensure that ethics approval is granted expeditiously, while at the same time requiring that all researchers<br />

conduct their research in line with best ethical practice.


REGULATIONS/ DIRECTIVES GOVERNING ETHICAL CONDUCT OF RESEARCH<br />

• Declaration of Helsinki<br />

• EU Directive 2001/20EC on Clinical Trials<br />

POLICY AND GUIDANCE DOCUMENTS ON ETHICAL ISSUES RELATED TO RESEARCH<br />

• Consent in <strong>Research</strong> - National Federation of Voluntary Bodies - Providing Services to People with<br />

Intellectual Disability<br />

• The Data Protection Acts 1988 <strong>and</strong> 2003 - Some implications for public health <strong>and</strong> medical research -<br />

Health <strong>Research</strong> Board<br />

• Human Biological Material: Recommendations for Collection, Use <strong>and</strong> Storage in <strong>Research</strong> 2005 -<br />

Irish Council for Bioethics<br />

• The Medical <strong>and</strong> Health Sector - Data Protection Rules in Practice - Data Protection Commissioner<br />

• Personal Information in Medical <strong>Research</strong> - UK's Medical <strong>Research</strong> Council<br />

• Operational <strong>Procedures</strong> for <strong>Research</strong> <strong>Ethics</strong> Committees: Guidance 2004 - Irish Council for Bioethics<br />

Guideline document<br />

• Human <strong>Ethics</strong> H<strong>and</strong>book - Commentary on the Australian National Statement on ethical conduct of<br />

research involving humans<br />

• Genetically modified crops: the ethical <strong>and</strong> social issues - Publication by Nuffield Council on Bioethics<br />

• Organs retained at Autopsy: Ethical <strong>and</strong> practical issues - Advice of the Australian Health <strong>Ethics</strong><br />

Committee<br />

• Embrios, scientific research <strong>and</strong> European legislation -DG <strong>Research</strong> Briefing Note No. 14/2001<br />

• Animal to human transplants; the ethics of Xenotransplantation - Publication by Nuffield Council on<br />

Bioethics<br />

COMPOSITION<br />

The composition of the Institute <strong>Research</strong> <strong>Ethics</strong> Committee will be as follows:<br />

1. Member of Executive Board (Chair);<br />

2. Independent<br />

3. Chair of Academic Council <strong>Research</strong> Committee;<br />

4. President of the Student’ Union<br />

5. Two members of research active members of academic staff.<br />

6. The four LYIT Heads of School<br />

The quorum for the Committee will be six.<br />

The Committee will normally reach decision by consensus. If consensus cannot be obtained then the<br />

majority decision will apply with the Chair having the casting vote.<br />

INDEPENDENT MEMBERSHIP OF IREC<br />

Governing Body will approve independent members who may be called upon to sit on the IREC. The panel<br />

list will be valid for three years.


Dates of meetings<br />

The Committee will hold one meeting each semester. Dates will be published on the website.<br />

All papers must be submitted to the committee at least one week in advance of the meeting dates. Late<br />

submissions will not be considered until the subsequent meeting.<br />

Remit<br />

Having considered all the material submitted the IREC may:<br />

<br />

<br />

<br />

<br />

grant ethical approval <strong>and</strong> authorise the research to proceed without requiring any amendment.<br />

Any such authorisation is granted on the basis of the project as stated on the research submission;<br />

any changes must be notified to (<strong>and</strong> approved by) the Committee.<br />

seek additional information, if necessary through a formal meeting of the Committee with the<br />

researcher (though this will be the exception rather than the rule).<br />

ask for modifications <strong>and</strong> a resubmission of the application.<br />

withhold approval until all conditions set by the Committee have been met <strong>and</strong> all<br />

recommendations set by the Committee have been addressed.<br />

In all instances the Committee will give reasons in writing for its decision.


Application Form for <strong>Ethics</strong> Approval submitted to the School <strong>Ethics</strong> Committee<br />

IREC reviews Application<br />

Seeks<br />

Modifications<br />

<strong>Ethics</strong> Approval<br />

Granted<br />

/clearance not<br />

required<br />

Reject<br />

Appeal to<br />

Office of<br />

Registrar<br />

Proceed with any one of the following:<br />

• Funding application<br />

• Application for admission to<br />

research degree programme<br />

• Begin research project

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