79C3C34C52B45572883A05D425EB0F82
Operational Procedures for Research Ethics Committees: Guidance 2004
https://www.itsligo.ie/files/2019/03/Operational_Procedures1-for-reserach-ethics-committees-The-Irish-council-for-Bioethics-2004.pdf
http://leaux.net/URLS/ConvertAPI Text Files/987AB6C8CB9FAAF975D4D8082767181B.en.txt
Examining the file media/Synopses/987AB6C8CB9FAAF975D4D8082767181B.html:
This file was generated: 2020-12-01 05:59:24
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / vulnerable
Searching for indicator vulnerable:
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p.000007: that the design of the research is scientifically sound, that the investigators and other research personnel are
p.000007: qualified and capable and that the methods to be used should be appropriate to the objectives of the research and the
p.000007: field of study.
p.000007:
p.000007: 1.4 Risks
p.000007: As research involves advancing the frontiers of knowledge, its undertaking usually involves a degree of uncertainty
p.000007: about the precise magnitude of and kind of benefits and harms that attend proposed research. The principle of
p.000007: beneficence requires that researchers maximise the potential benefits to the participants and minimise the potential
p.000007: risks of harm. If there are any risks resulting from participation in the research, then there must be benefits, either
p.000007: to the subject, or to humanity or society in general. The principle of non-maleficence requires that researchers ensure
p.000007: that predictable injury, either through acts of commission or omission, will be prevented.
p.000007:
p.000007: 1.5 Justice
p.000007: Justice imposes duties to neither neglect nor discriminate against individuals or groups who may benefit from advances
p.000007: in research, to avoid imposing on a particular group an unfair burden of participation in research and to design
p.000007: research so that the selection and recruitment of research participants/volunteers is fair. Justice requires also that
p.000007: the research be responsive to the health conditions or needs of vulnerable participants. In such cases there must be
p.000007: clear and unambiguous justification for the research and for its application to such participants, and normally there
p.000007: should be potential for direct health-related benefit to the subject, or the absence of any significant risk or
p.000007: discomfort.
p.000007:
p.000008: 8
p.000008: Section 2 : Research Requiring Ethics Review
p.000008: All Research involving or impacting upon human participants requires ethics review by a research ethics committee,
p.000008: before the research is started, except as stipulated below.
p.000008: For the purposes of this guidance, Research is defined as a systematic investigation to establish facts, principles or
p.000008: knowledge and a study of some matter with the objective of obtaining or confirming knowledge.
p.000008:
p.000008: 2.1 Specific activities that may require REC review
p.000008: Specific activities that may require REC review include, but are not necessarily limited to the following:
p.000008: (a) Clinical trials involving human participants
p.000008: (b) New treatment or interventions
p.000008: (c) Research involving human remains, cadavers, tissues, discarded tissue (e.g. placenta), biological fluids
p.000008: (d) Physiological studies
p.000008: (e) Comparing an established procedure, whether therapeutic, non-therapeutic or diagnostic, with other procedures
p.000008: which are not recognised as established by virtue of their recent development, discovery or use in a new or unfamiliar
p.000008: way
...
Health / Cadavers
Searching for indicator cadavers:
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p.000007: research so that the selection and recruitment of research participants/volunteers is fair. Justice requires also that
p.000007: the research be responsive to the health conditions or needs of vulnerable participants. In such cases there must be
p.000007: clear and unambiguous justification for the research and for its application to such participants, and normally there
p.000007: should be potential for direct health-related benefit to the subject, or the absence of any significant risk or
p.000007: discomfort.
p.000007:
p.000008: 8
p.000008: Section 2 : Research Requiring Ethics Review
p.000008: All Research involving or impacting upon human participants requires ethics review by a research ethics committee,
p.000008: before the research is started, except as stipulated below.
p.000008: For the purposes of this guidance, Research is defined as a systematic investigation to establish facts, principles or
p.000008: knowledge and a study of some matter with the objective of obtaining or confirming knowledge.
p.000008:
p.000008: 2.1 Specific activities that may require REC review
p.000008: Specific activities that may require REC review include, but are not necessarily limited to the following:
p.000008: (a) Clinical trials involving human participants
p.000008: (b) New treatment or interventions
p.000008: (c) Research involving human remains, cadavers, tissues, discarded tissue (e.g. placenta), biological fluids
p.000008: (d) Physiological studies
p.000008: (e) Comparing an established procedure, whether therapeutic, non-therapeutic or diagnostic, with other procedures
p.000008: which are not recognised as established by virtue of their recent development, discovery or use in a new or unfamiliar
p.000008: way
p.000008: (f) Innovative practices in health and disability services
p.000008: (g) Research conducted by students, which includes all activities that meet the definition of research with human
p.000008: participants
p.000008: (h) Observational clinical research
p.000008: (i) Access to personal information by means of questionnaires, interviews or other techniques of information
p.000008: gathering
p.000008: (j) Research involving the secondary use of data (use of data not collected for that research purpose), if any form
p.000008: of identifier is involved and/or if health information pertaining to individuals is involved
p.000008: (k) Case studies, when a series of subject observations allow possible extrapolation of generalisation of the results
p.000008: from the reported cases and when there is an intent to publish or disseminate the data
p.000008: Note to item 2.1(g) above: As supervised student research is conducted primarily for the purpose of educating students
p.000008: on research techniques and methodologies, REC should review research protocols with a view to contributing to the
p.000008: students’ education concerning scientific and ethical principles governing research.
p.000008:
p.000009: 9
p.000009:
p.000009: 2.2 Activities that may not require REC review
...
Health / Healthy People
Searching for indicator volunteers:
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p.000005: research and research workers from harm or exploitation, to preserve the subject's rights, including the right to
p.000005: privacy and to provide reassurance to the public that all of this is being done. In promoting these goals Research
p.000005: Ethics Committees should be mindful that appropriately regulated, ethically acceptable, rigorous research benefits
p.000005: society as a whole. The primary task of Research Ethics Committees is the protection of the welfare and the rights of
p.000005: participants in research. Another important role is to facilitate and support the progress that the research community
p.000005: seeks to achieve.
p.000005: The Council is hopeful that the guidance contained in this document will facilitate Research Ethics Committees in
p.000005: conducting independent, comprehensive, ethical review of research proposals, which will serve investigators and the
p.000005: public alike.
p.000005:
p.000006: 6
p.000006:
p.000006: Section 1 : Principles of Ethical Review
p.000006: Research involving human participants should be based on a fundamental moral commitment to the individuals concerned
p.000006: and to advancing human welfare, knowledge and understanding. A number of guiding moral principles govern the ethical
p.000006: review of research proposals, which aim to protect the well-being and rights of research participants/volunteers.
p.000006: Research involving human participants should be based on a fundamental moral commitment to the individuals concerned
p.000006: and to advancing human welfare, knowledge and understanding. A number of guiding moral principles govern the ethical
p.000006: review of research proposals. These principles aim to protect the well-being and rights of research
p.000006: participants/volunteers.
p.000006:
p.000006: 1.1 Respect for Persons
p.000006: Respect for persons is expressed as regard for the welfare, rights, beliefs, perceptions, and customs, both individual
p.000006: and collective, of individuals involved in research. Respect for persons is most commonly manifested through the
p.000006: exercise of informed consent, which requires that people’s beliefs and opinions be respected, and that they be allowed
p.000006: to choose for themselves whether or not they wish to participate in research. In order to choose they must be informed
p.000006: of their options, including the possible risks and benefits of those options. They must be assured of the necessity of
p.000006: the research, including the fact that all possible risks have been minimised, and, where significant risk is
p.000006: involved, that no other method of research is possible. They must be asked to make their choice in circumstances, which
p.000006: are free of coercion or undue pressure, and they must be free to withdraw from the research process at any time. This
p.000006: decision must not affect their health care in any way. Ethical review should focus on the entire process
p.000006: of obtaining consent, not just on the written consent documents, but on how participants are informed of the study, who
p.000006: discusses it with them, and in what circumstances. The requirement for free and informed consent presumes that adequate
...
p.000007: The scientific merit of a study is itself an ethical issue. The essential features of ethically justified research
p.000007: involving human participants are that the research offers a means of developing information, not otherwise obtainable,
p.000007: that the design of the research is scientifically sound, that the investigators and other research personnel are
p.000007: qualified and capable and that the methods to be used should be appropriate to the objectives of the research and the
p.000007: field of study.
p.000007:
p.000007: 1.4 Risks
p.000007: As research involves advancing the frontiers of knowledge, its undertaking usually involves a degree of uncertainty
p.000007: about the precise magnitude of and kind of benefits and harms that attend proposed research. The principle of
p.000007: beneficence requires that researchers maximise the potential benefits to the participants and minimise the potential
p.000007: risks of harm. If there are any risks resulting from participation in the research, then there must be benefits, either
p.000007: to the subject, or to humanity or society in general. The principle of non-maleficence requires that researchers ensure
p.000007: that predictable injury, either through acts of commission or omission, will be prevented.
p.000007:
p.000007: 1.5 Justice
p.000007: Justice imposes duties to neither neglect nor discriminate against individuals or groups who may benefit from advances
p.000007: in research, to avoid imposing on a particular group an unfair burden of participation in research and to design
p.000007: research so that the selection and recruitment of research participants/volunteers is fair. Justice requires also that
p.000007: the research be responsive to the health conditions or needs of vulnerable participants. In such cases there must be
p.000007: clear and unambiguous justification for the research and for its application to such participants, and normally there
p.000007: should be potential for direct health-related benefit to the subject, or the absence of any significant risk or
p.000007: discomfort.
p.000007:
p.000008: 8
p.000008: Section 2 : Research Requiring Ethics Review
p.000008: All Research involving or impacting upon human participants requires ethics review by a research ethics committee,
p.000008: before the research is started, except as stipulated below.
p.000008: For the purposes of this guidance, Research is defined as a systematic investigation to establish facts, principles or
p.000008: knowledge and a study of some matter with the objective of obtaining or confirming knowledge.
p.000008:
p.000008: 2.1 Specific activities that may require REC review
p.000008: Specific activities that may require REC review include, but are not necessarily limited to the following:
p.000008: (a) Clinical trials involving human participants
p.000008: (b) New treatment or interventions
p.000008: (c) Research involving human remains, cadavers, tissues, discarded tissue (e.g. placenta), biological fluids
p.000008: (d) Physiological studies
p.000008: (e) Comparing an established procedure, whether therapeutic, non-therapeutic or diagnostic, with other procedures
...
p.000011: (d) duration of an appointment
p.000011: (e) policy for renewal of an appointment
p.000011: (f) procedure for replacing members
p.000011: (g) procedure for resignation of a member
p.000011: (h) procedure for the disqualification of a member
p.000011: (i) training of members
p.000011:
p.000012: 12
p.000012:
p.000012: Note to item 3.3(a) above: When selecting candidates, the committee should take into account whether or not by virtue
p.000012: of employment, profession or relationship, the candidate could be construed to have a potential conflict of interest
p.000012: with respect to a majority of proposals reviewed.
p.000012: Note to item 3.3(b) above: appointing members should be by an open process. Vacancies should be advertised publicly in
p.000012: the press and/or via local professional networks.
p.000012: Note to item 3.3(d) above: Members should be appointed for a fixed term, which may be renewed, but should not normally
p.000012: exceed two consecutive terms on the same REC. The benefit of maintaining some continuity of membership by overlapping
p.000012: terms of office should be considered.
p.000012:
p.000012: 3.4 Duties and responsibilities of a Research Ethics Committee Member
p.000012: (a) Committee members have a commitment to protect and safeguard the rights and interests of human participants
p.000012: participating in research, while promoting and facilitating research excellence.
p.000012: (b) A member should be prepared to have his/her name, profession and affiliation published.
p.000012: (c) Members are expected to treat as confidential all applications, meeting deliberations, information on research
p.000012: participants/volunteers and related matters.
p.000012: (d) When a committee member believes they have a conflict of interest on a subject which will compromise their
p.000012: ability to make an impartial decision, they should declare that conflict of interest and withdraw themselves from the
p.000012: discussion and/or activity.
p.000012: (e) A member is expected to attend at least two-thirds of all scheduled REC meetings in each year. Should a member
p.000012: fail to do so, the chairperson should address this with the member concerned.
p.000012: (f) A member must agree to take part in education and ongoing training appropriate to his or her role as a REC
p.000012: member.
p.000012:
p.000013: 13
p.000013: Section 4 : Submitting an application
p.000013: RECs have the responsibility of establishing well-defined submission procedures for research proposals, which are
p.000013: readily available to prospective applicants.
p.000013:
p.000013: 4.1 Application Procedure
p.000013: An application for ethics committee review in respect of proposed research must be made in writing and signed by a
p.000013: qualified researcher responsible for the conduct of the study. This will usually be the chief investigator. Material to
p.000013: be submitted as part of an application may include but is not restricted to:
p.000013: (a) the name(s) and address(es) of the REC members to whom the application is to be submitted.
p.000013: (b) the application forms
p.000013: (c) the documentation required
p.000013: (d) the format for submission
p.000013: (e) the number of copies to be submitted
p.000013: (f) the deadline for submission of the application
p.000013: (g) the means by which applications will be acknowledged, including the communication of an incomplete application
p.000013: (h) the expected time for notification of the decision following review
p.000013: (i) the fee structure, if any, for reviewing an application
p.000013: (j) the application procedure for amendments to the proposal, the recruitment material, the potential research
p.000013: participation information, or the informed consent form
p.000013: (k) the information given to research participants/volunteers and the appropriate safeguards for the protection of
p.000013: personal data
p.000013: 4.2 Documentation
p.000013: The applicant should submit all documentation required for a thorough and complete ethical review of the proposed
p.000013: research. The applicant should be aware of the elements of the review process (see 5.2) and submit the necessary
p.000013: documentation to conduct this review. The REC should advise all applicants on documentation required for review.
p.000013:
p.000014: 14
p.000014:
p.000014: This may include but is not restricted to:
p.000014: (a) a signed and dated application form
p.000014: (b) the protocol of the proposed research (clearly identified and dated), together with supporting documents and
p.000014: appendices
p.000014: (c) a summary, synopsis or diagram (‘flowchart’) in non-technical language
p.000014: (d) a description of the ethical considerations involved in the research
p.000014: (e) case report forms, diary cards, and other questionnaires intended for research participants/volunteers
p.000014: (f) when the research involves the study of a product (such as a pharmaceutical or device under investigation) an
p.000014: adequate summary of all pharmacological and toxicological data available on the product, together with a summary of
p.000014: clinical experience with the product to date (e.g. recent investigator’s brochure, a summary of the product’s
p.000014: characteristics) should be included
p.000014: (g) current curriculum vitae of the applicant(s) (updated, signed and dated)
p.000014: (h) material used (including advertisements) for participant/volunteer recruitment
p.000014: (i) patient/volunteer information
p.000014: (j) a full description of the process to obtain and document consent
p.000014: (k) suitable arrangements for indemnifying participants/volunteers and investigators
p.000014: (l) all significant previous decisions (e.g. those leading to a negative decision or modified proposal) by other RECs
p.000014: or regulatory authorities for the proposed research (whether in the same location or elsewhere) and an indication of
p.000014: the modification(s) to the protocol made on that account. The reasons for previous negative decisions should be
p.000014: provided.
p.000014:
p.000015: 15
p.000015: Section 5 : Review procedure
p.000015: All properly submitted and valid applications shall be reviewed in a timely fashion and according to an established
p.000015: review procedure described in the REC’s standard operating procedures. A valid application is one which has been
p.000015: submitted by an appropriate investigator, is complete, with all the necessary documents attached, and is signed and
p.000015: dated.
p.000015: Under the Clinical Trials on Medicinal Products for Human Use Regulations 2004 RECs are required to give an opinion on
p.000015: research protocols involving standard products, no more than 60 days after acknowledgement of receipt of a “valid”
p.000015: application has been received. Where research involves gene therapy, somatic cell therapy or genetically modified
p.000015: organisms RECs are required to make a decision no more than 90 days after acknowledging that a “valid” application has
p.000015: been received. Where external consultation is deemed necessary RECs are permitted a total of 180 days to make a
p.000015: decision following acknowledgement of receipt of a “valid” application. There are no time limits imposed on RECs making
p.000015: a decision on research involving xenogenic cell therapy.
p.000015:
p.000015: 5.1 Meeting Requirements
p.000015: RECs should meet in accordance with regularly scheduled dates. Meeting requirements should include the following:
p.000015: (a) meetings should follow a previously scheduled agenda
p.000015: (b) members should be given sufficient time to review relevant documentation
p.000015: (c) meetings should be minuted. There should be an approval procedure for the minutes
p.000015: (d) when appropriate, the sponsor and/or investigator may be invited to present the proposal to the members and
p.000015: answer any questions a committee may have
p.000015: (e) when appropriate, independent experts (e.g. researchers with specific competence, ethicists, statisticians) may
p.000015: be invited to attend
p.000015:
p.000016: 16
p.000016:
p.000016: 5.2 Elements of Review
p.000016: When reviewing research proposals a REC should consider the following:
p.000016: Scientific design and conduct of the study
p.000016: (a) the appropriateness of the study design in relation to the objectives of the study, the statistical methodology
p.000016: (including sample size calculation) and the potential for reaching reliable conclusions with the smallest number of
p.000016: research participants/volunteers
p.000016: (b) the justification of predictable risks and inconveniences weighed against the anticipated benefits for the
p.000016: research participants/volunteers and the concerned communities
p.000016: (c) the justification for use of control arms in trials (whether placebo or active comparator), and the randomisation
p.000016: programme to be used
p.000016: (d) criteria for withdrawing participants/volunteers prematurely
p.000016: (e) criteria for suspending or terminating research
p.000016: (f) the adequacy of conditions made for the monitoring and auditing the conduct of the research
p.000016: (g) the adequacy of the site including the supporting staff, facilities and emergency procedures
p.000016: (h) the form in which the results will be reported and published
p.000016:
p.000016: Recruitment of research participants/volunteers
p.000016: (a) the characteristics of the population from which the participants/volunteers will be drawn (including gender,
p.000016: age, ethnicity) and the justification for any decisions made in this regard
p.000016: (b) the method by which initial contact and recruitment are to be conducted
p.000016: (c) the method by which information is to be conveyed to participants/volunteers or their representatives and by
p.000016: which means consent is to be obtained
p.000016: (d) inclusion and exclusion criteria for research participants/volunteers
p.000016:
p.000016: Care and protection of research participants/volunteers
p.000016: (a) the safety of any intervention to be used in the proposed research
p.000016: (b) the suitability of the investigator for the proposed research in relation to his/her qualifications and
p.000016: experience
p.000016: (c) any plans to withdraw or withhold standard therapies or clinical management protocols for the purpose of the
p.000016: research, and the justification for such action
p.000016:
p.000017: 17
p.000017:
p.000017: (d) the adequacy of health and social supervision and psychological support for the research participants/volunteers
p.000017: (e) the adequacy of medical supervision and follow-up concerning the participants/volunteers
p.000017: (f) steps to be followed if participants/volunteers decide to withdraw during the course of the research
p.000017: (g) the arrangements, if appropriate, for informing the participant’s/volunteer’s GP, including procedure for seeking
p.000017: consent to do so
p.000017: (h) a description of any scheme to make the study product available to the participants/volunteers following the
p.000017: research
p.000017: (i) a report of the expenses (if any) payable to participants/volunteers
p.000017: (j) the provisions for compensation/treatment in the case of the injury/disability/death of a participant/volunteer
p.000017: connected to participation in the study
p.000017: (k) the provisions made for receiving and responding to queries and complaints of participants/volunteers throughout
p.000017: the course of the study
p.000017: (i) the insurance and indemnity agreements covering the liability of the investigator by the sponsor
p.000017: (l) a description of any grants, payments or other reward to be made to any researchers or research hosts
p.000017: (m) a description of possible conflicts of interest which might affect the independent judgement of the researcher(s)
p.000017:
p.000017: Protection of confidentiality of participants/volunteers
p.000017: (a) a description of the persons who will have access to personal data of the participant/volunteer including medical
p.000017: records and biological samples
p.000017: (b) a description of provisions to ensure the confidentiality and security of personal information concerning
p.000017: participants/volunteers
p.000017: (c) the extent to which the information will be anonymised
p.000017: (d) how samples/data will be obtained, and the purposes for which they will be used
p.000017: (e) how long samples/data will be kept
p.000017: (f) to which countries (if any) the samples/data will be sent
p.000017:
p.000017: Both REC members and investigators should be aware of the provisions of the Data Protection Acts 1988 and 2003 and
p.000017: their obligations as set out in those Acts.
p.000017:
p.000018: 18
p.000018:
p.000018: Informed consent process
p.000018: (a) description of the procedures for obtaining informed consent, including the identification of those responsible
p.000018: for obtaining consent and the time frame in which it will occur
p.000018: (b) the adequacy, comprehensiveness and understandability of written and oral information given to the participants/
p.000018: volunteers, their relatives/guardians and, if necessary, their legal guardians
p.000018: (c) the content and wording of the informed consent form and, when applicable, the provisions made for participants
p.000018: incapable of giving consent personally
p.000018: (d) clear justification for the intention to include participants/volunteers who cannot consent and a full account of
p.000018: the arrangements for obtaining consent or authorisation for the participation of such individuals
p.000018: (e) description of the procedures for disclosure, if appropriate, of relevant information to participants/volunteers
p.000018: which may become available during the study
p.000018: Community considerations
p.000018: (a) the impact and relevance of the research on the local community and on the concerned communities from which the
p.000018: participants/volunteers are drawn
p.000018: (b) a description of procedures to consult with the concerned communities during the course of designing the research
p.000018: (c) the extent to which the research contributes to e.g. the enhancement of local healthcare, research and the
p.000018: ability to respond to public health needs
p.000018: (d) a description of the availability and affordability of any successful study product to the concerned communities
p.000018: following the research
p.000018: (e) the manner in which the results of the research will be made available to participants/volunteers and the
p.000018: concerned communities
p.000018: 5.3 Expedited Review
p.000018: Where a REC wishes to incorporate expedited review into its standard operating procedures the following specifications
p.000018: should be taken into account:
p.000018: (a) the research should present minimal risk to participants/volunteers e.g. risks related to invasion of privacy
p.000018: and/or breach of confidentiality
p.000018:
p.000019: 19
p.000019:
p.000019: (b) expedited review should be undertaken by the chairperson of the REC or by one or more experienced reviewers
p.000019: i.e. REC members designated by the chairperson
p.000019: (c) reviewers may not disapprove research using expedited review. Research may only be disapproved in accordance with
p.000019: non-expedited operational procedures
p.000019: (d) each REC which uses expedited review must adopt a method for keeping all members informed of research proposals
p.000019: which have been approved under this procedure
p.000019:
p.000020: 20
p.000020:
p.000020: 5.4 Decision-making
p.000020: A REC should ensure that all supporting documentation for an application is complete before coming to a decision on a
p.000020: research proposal. A REC should comply with a pre-defined method for arriving at a decision. It is recommended that REC
p.000020: use the consensus model where the process of discussion and debate will lead to a decision, rather than a formal
p.000020: vote-casting process. Under the consensus model, the proposal will be approved when all members present are willing to
p.000020: allow the proposal to proceed. In cases in which consensus seems unlikely, the chairperson may call for a vote with a
p.000020: two-thirds majority required for approval. Dissenting members should be afforded the opportunity to append an opinion
p.000020: to the REC decision.
p.000020: The REC should accommodate reasonable requests from investigators to participate in discussions about their proposal,
p.000020: but may not be present when the REC is making its decision.
p.000020: It is desirable to adopt a consistent approach to granting or declining approval of a proposal. It is recommended that
...
p.000021: (j) whether approval was by expedited review
p.000021:
p.000022: 22
p.000022: Section 6 : Procedures for monitoring ongoing research
p.000022: REC should establish a review procedure for following the progress of all studies for which approval has been granted.
p.000022: The review procedure should be specified in the standard operating procedure and should be clearly communicated to
p.000022: investigators.
p.000022:
p.000022: 6.1 Status report from investigators
p.000022: On-going research should be subject to continuing ethics review. The frequency of such review should reflect the degree
p.000022: of risk to participants in the research project. As a minimum the REC should require an annual report from
p.000022: investigators on matters including:
p.000022: (a) progress to date or outcome in the case of a completed project
p.000022: (b) a statement of compliance with the approved proposal and/or amendments to the proposal
p.000022: (c) a description of measures taken to maintain and secure personal information/records pertaining to the research
p.000022:
p.000022: 6.2 Amendments
p.000022: Any significant alteration to a previously approved proposal must receive prior approval from the REC before
p.000022: implementation. Significant alterations include changes to:
p.000022: (a) personnel (including where work has been subcontracted to another investigator) any changes to named researchers
p.000022: responsible for the conduct of the research; any change to the personnel involved in obtaining informed consent or
p.000022: having access to personal information about research participants/volunteers
p.000022: (b) method
p.000022: (c) design of the study
p.000022: (d) duration of the study
p.000022: (e) informed consent procedures
p.000022: (f) patient information leaflets
p.000022: (g) method of recruitment
p.000022:
p.000022: Under the Clinical Trials on Medicinal Products for Human Use Regulations 2004, the REC must, within a period of 35
p.000022: days from the day of receipt of a valid notice of an amendment, furnish the applicant with an opinion.
p.000022:
p.000023: 23
p.000023:
p.000023: 6.3 Adverse Event
p.000023: As a condition of approval of the research proposal the REC should require investigators to immediately report any
p.000023: serious or unexpected adverse events on participants or unforeseen events that might affect the benefits/risks ratio of
p.000023: the proposal.
p.000023: A serious adverse event is defined as any untoward medical occurrence that:
p.000023: (a) results in death
p.000023: (b) is life threatening
p.000023: (c) requires in-patient hospitalisation or prolongation of existing hospitalisation
p.000023: (d) results in persistent or significant disability/incapacity
p.000023: (e) results in a congenital anomaly/birth defect
p.000023:
p.000023: An unexpected event is an adverse reaction, the nature and severity of which is not consistent with the applicable
p.000023: product information.
p.000023: Investigators may take urgent safety measures to eliminate immediate jeopardy to the research participants/volunteers
p.000023: prior to approval by the REC. However, investigators should provide the REC with a written report of any action taken
p.000023: at the earliest possible opportunity. The REC should review any new material and decide whether there are sufficient
p.000023: grounds for changing its initial decision to grant approval to the proposal.
p.000023: Under the Clinical Trials on Medicinal Products for Human Use Regulations 2004, a written report of any urgent safety
p.000023: measures taken should be submitted to the REC no later than three days from the date the measures were taken.
p.000023:
p.000023: 6.4 Suspension or Termination of a Project
p.000023: In the case of a premature suspension/termination of a study, the REC should require the investigator to inform the REC
p.000023: of the reasons for premature suspension/termination. This should be accompanied by a summary of the results obtained in
p.000023: the study up to the point of suspension/termination. The REC should require investigators to notify the committee once
p.000023: a study has been completed. The REC should receive a final study report, summarising the main findings.
p.000023:
p.000024: 24
p.000024:
p.000024: Under the Clinical Trials on Medicinal Products for Human Use Regulations 2004, the REC must be provided with a
p.000024: detailed written explanation of the reasons for suspension or premature termination of a clinical trial within 15 days
p.000024: of the trial being halted. The REC must be provided with a written declaration of the end of the trial within 90 days.
p.000024: End of the trial is defined as the date of the last visit of the last patient undergoing the trial. Suspension,
p.000024: termination or end of trial notification to the REC should be done using the Annex 3 form of the Community “Detailed
p.000024: guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent
...
Health / Mentally Disabled
Searching for indicator disability:
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p.000006: the research, including the fact that all possible risks have been minimised, and, where significant risk is
p.000006: involved, that no other method of research is possible. They must be asked to make their choice in circumstances, which
p.000006: are free of coercion or undue pressure, and they must be free to withdraw from the research process at any time. This
p.000006: decision must not affect their health care in any way. Ethical review should focus on the entire process
p.000006: of obtaining consent, not just on the written consent documents, but on how participants are informed of the study, who
p.000006: discusses it with them, and in what circumstances. The requirement for free and informed consent presumes that adequate
p.000006: information is provided to obtain an informed judgement, that information provided is in a form and delivered in a
p.000006: manner that will enable it to be understood and that the consent is voluntary in nature.
p.000006: In the research context, respect for persons requires that limitations to an individual’s autonomy are recognised and
p.000006: that appropriate mechanisms are in place to protect against abuse, exploitation or discrimination. Of particular
p.000006: concern here are children, individuals with an intellectual disability or with short or long-term unconsciousness.
p.000006: Parental or guardian’s consent must be sought, but such consent can only be accepted where the research in question is
p.000006: clearly in the best interests of the subject concerned, or where the research concerned carries minimal risk or impact
p.000006: on the subject concerned.
p.000006:
p.000007: 7
p.000007:
p.000007: 1.2 Privacy and Confidentiality
p.000007: Privacy and confidentiality are an integral part of the protection and promotion of human dignity and help to protect
p.000007: and maintain a person’s mental or psychological well-being. The need for research should be weighed against
p.000007: infringements of privacy and steps must be taken to ensure that individuals are protected from any harm that might be
p.000007: caused as the result of access to their personal information.
p.000007:
p.000007: 1.3 Validity of Research Proposals
p.000007: The scientific merit of a study is itself an ethical issue. The essential features of ethically justified research
p.000007: involving human participants are that the research offers a means of developing information, not otherwise obtainable,
p.000007: that the design of the research is scientifically sound, that the investigators and other research personnel are
p.000007: qualified and capable and that the methods to be used should be appropriate to the objectives of the research and the
p.000007: field of study.
p.000007:
p.000007: 1.4 Risks
...
p.000007: clear and unambiguous justification for the research and for its application to such participants, and normally there
p.000007: should be potential for direct health-related benefit to the subject, or the absence of any significant risk or
p.000007: discomfort.
p.000007:
p.000008: 8
p.000008: Section 2 : Research Requiring Ethics Review
p.000008: All Research involving or impacting upon human participants requires ethics review by a research ethics committee,
p.000008: before the research is started, except as stipulated below.
p.000008: For the purposes of this guidance, Research is defined as a systematic investigation to establish facts, principles or
p.000008: knowledge and a study of some matter with the objective of obtaining or confirming knowledge.
p.000008:
p.000008: 2.1 Specific activities that may require REC review
p.000008: Specific activities that may require REC review include, but are not necessarily limited to the following:
p.000008: (a) Clinical trials involving human participants
p.000008: (b) New treatment or interventions
p.000008: (c) Research involving human remains, cadavers, tissues, discarded tissue (e.g. placenta), biological fluids
p.000008: (d) Physiological studies
p.000008: (e) Comparing an established procedure, whether therapeutic, non-therapeutic or diagnostic, with other procedures
p.000008: which are not recognised as established by virtue of their recent development, discovery or use in a new or unfamiliar
p.000008: way
p.000008: (f) Innovative practices in health and disability services
p.000008: (g) Research conducted by students, which includes all activities that meet the definition of research with human
p.000008: participants
p.000008: (h) Observational clinical research
p.000008: (i) Access to personal information by means of questionnaires, interviews or other techniques of information
p.000008: gathering
p.000008: (j) Research involving the secondary use of data (use of data not collected for that research purpose), if any form
p.000008: of identifier is involved and/or if health information pertaining to individuals is involved
p.000008: (k) Case studies, when a series of subject observations allow possible extrapolation of generalisation of the results
p.000008: from the reported cases and when there is an intent to publish or disseminate the data
p.000008: Note to item 2.1(g) above: As supervised student research is conducted primarily for the purpose of educating students
p.000008: on research techniques and methodologies, REC should review research protocols with a view to contributing to the
p.000008: students’ education concerning scientific and ethical principles governing research.
p.000008:
p.000009: 9
p.000009:
p.000009: 2.2 Activities that may not require REC review
p.000009: Review by REC may not be required for:
p.000009: (a) Research utilising existing publicly available documents or data
p.000009: (b) Observational studies in public places in which the identity of the participants remains anonymous
p.000009: (c) Case study of one patient with the proviso that written informed consent has been obtained from the relevant
p.000009: subject
p.000009: (d) Quality assurance studies
p.000009: (e) Audits
p.000009:
...
p.000016:
p.000016: Care and protection of research participants/volunteers
p.000016: (a) the safety of any intervention to be used in the proposed research
p.000016: (b) the suitability of the investigator for the proposed research in relation to his/her qualifications and
p.000016: experience
p.000016: (c) any plans to withdraw or withhold standard therapies or clinical management protocols for the purpose of the
p.000016: research, and the justification for such action
p.000016:
p.000017: 17
p.000017:
p.000017: (d) the adequacy of health and social supervision and psychological support for the research participants/volunteers
p.000017: (e) the adequacy of medical supervision and follow-up concerning the participants/volunteers
p.000017: (f) steps to be followed if participants/volunteers decide to withdraw during the course of the research
p.000017: (g) the arrangements, if appropriate, for informing the participant’s/volunteer’s GP, including procedure for seeking
p.000017: consent to do so
p.000017: (h) a description of any scheme to make the study product available to the participants/volunteers following the
p.000017: research
p.000017: (i) a report of the expenses (if any) payable to participants/volunteers
p.000017: (j) the provisions for compensation/treatment in the case of the injury/disability/death of a participant/volunteer
p.000017: connected to participation in the study
p.000017: (k) the provisions made for receiving and responding to queries and complaints of participants/volunteers throughout
p.000017: the course of the study
p.000017: (i) the insurance and indemnity agreements covering the liability of the investigator by the sponsor
p.000017: (l) a description of any grants, payments or other reward to be made to any researchers or research hosts
p.000017: (m) a description of possible conflicts of interest which might affect the independent judgement of the researcher(s)
p.000017:
p.000017: Protection of confidentiality of participants/volunteers
p.000017: (a) a description of the persons who will have access to personal data of the participant/volunteer including medical
p.000017: records and biological samples
p.000017: (b) a description of provisions to ensure the confidentiality and security of personal information concerning
p.000017: participants/volunteers
p.000017: (c) the extent to which the information will be anonymised
p.000017: (d) how samples/data will be obtained, and the purposes for which they will be used
p.000017: (e) how long samples/data will be kept
p.000017: (f) to which countries (if any) the samples/data will be sent
p.000017:
p.000017: Both REC members and investigators should be aware of the provisions of the Data Protection Acts 1988 and 2003 and
p.000017: their obligations as set out in those Acts.
...
p.000022: implementation. Significant alterations include changes to:
p.000022: (a) personnel (including where work has been subcontracted to another investigator) any changes to named researchers
p.000022: responsible for the conduct of the research; any change to the personnel involved in obtaining informed consent or
p.000022: having access to personal information about research participants/volunteers
p.000022: (b) method
p.000022: (c) design of the study
p.000022: (d) duration of the study
p.000022: (e) informed consent procedures
p.000022: (f) patient information leaflets
p.000022: (g) method of recruitment
p.000022:
p.000022: Under the Clinical Trials on Medicinal Products for Human Use Regulations 2004, the REC must, within a period of 35
p.000022: days from the day of receipt of a valid notice of an amendment, furnish the applicant with an opinion.
p.000022:
p.000023: 23
p.000023:
p.000023: 6.3 Adverse Event
p.000023: As a condition of approval of the research proposal the REC should require investigators to immediately report any
p.000023: serious or unexpected adverse events on participants or unforeseen events that might affect the benefits/risks ratio of
p.000023: the proposal.
p.000023: A serious adverse event is defined as any untoward medical occurrence that:
p.000023: (a) results in death
p.000023: (b) is life threatening
p.000023: (c) requires in-patient hospitalisation or prolongation of existing hospitalisation
p.000023: (d) results in persistent or significant disability/incapacity
p.000023: (e) results in a congenital anomaly/birth defect
p.000023:
p.000023: An unexpected event is an adverse reaction, the nature and severity of which is not consistent with the applicable
p.000023: product information.
p.000023: Investigators may take urgent safety measures to eliminate immediate jeopardy to the research participants/volunteers
p.000023: prior to approval by the REC. However, investigators should provide the REC with a written report of any action taken
p.000023: at the earliest possible opportunity. The REC should review any new material and decide whether there are sufficient
p.000023: grounds for changing its initial decision to grant approval to the proposal.
p.000023: Under the Clinical Trials on Medicinal Products for Human Use Regulations 2004, a written report of any urgent safety
p.000023: measures taken should be submitted to the REC no later than three days from the date the measures were taken.
p.000023:
p.000023: 6.4 Suspension or Termination of a Project
p.000023: In the case of a premature suspension/termination of a study, the REC should require the investigator to inform the REC
p.000023: of the reasons for premature suspension/termination. This should be accompanied by a summary of the results obtained in
p.000023: the study up to the point of suspension/termination. The REC should require investigators to notify the committee once
p.000023: a study has been completed. The REC should receive a final study report, summarising the main findings.
p.000023:
p.000024: 24
p.000024:
p.000024: Under the Clinical Trials on Medicinal Products for Human Use Regulations 2004, the REC must be provided with a
p.000024: detailed written explanation of the reasons for suspension or premature termination of a clinical trial within 15 days
...
Health / Mentally Incapacitated
Searching for indicator incapable:
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p.000017: records and biological samples
p.000017: (b) a description of provisions to ensure the confidentiality and security of personal information concerning
p.000017: participants/volunteers
p.000017: (c) the extent to which the information will be anonymised
p.000017: (d) how samples/data will be obtained, and the purposes for which they will be used
p.000017: (e) how long samples/data will be kept
p.000017: (f) to which countries (if any) the samples/data will be sent
p.000017:
p.000017: Both REC members and investigators should be aware of the provisions of the Data Protection Acts 1988 and 2003 and
p.000017: their obligations as set out in those Acts.
p.000017:
p.000018: 18
p.000018:
p.000018: Informed consent process
p.000018: (a) description of the procedures for obtaining informed consent, including the identification of those responsible
p.000018: for obtaining consent and the time frame in which it will occur
p.000018: (b) the adequacy, comprehensiveness and understandability of written and oral information given to the participants/
p.000018: volunteers, their relatives/guardians and, if necessary, their legal guardians
p.000018: (c) the content and wording of the informed consent form and, when applicable, the provisions made for participants
p.000018: incapable of giving consent personally
p.000018: (d) clear justification for the intention to include participants/volunteers who cannot consent and a full account of
p.000018: the arrangements for obtaining consent or authorisation for the participation of such individuals
p.000018: (e) description of the procedures for disclosure, if appropriate, of relevant information to participants/volunteers
p.000018: which may become available during the study
p.000018: Community considerations
p.000018: (a) the impact and relevance of the research on the local community and on the concerned communities from which the
p.000018: participants/volunteers are drawn
p.000018: (b) a description of procedures to consult with the concerned communities during the course of designing the research
p.000018: (c) the extent to which the research contributes to e.g. the enhancement of local healthcare, research and the
p.000018: ability to respond to public health needs
p.000018: (d) a description of the availability and affordability of any successful study product to the concerned communities
p.000018: following the research
p.000018: (e) the manner in which the results of the research will be made available to participants/volunteers and the
p.000018: concerned communities
p.000018: 5.3 Expedited Review
p.000018: Where a REC wishes to incorporate expedited review into its standard operating procedures the following specifications
p.000018: should be taken into account:
...
Social / Access to Social Goods
Searching for indicator access:
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p.000006: In the research context, respect for persons requires that limitations to an individual’s autonomy are recognised and
p.000006: that appropriate mechanisms are in place to protect against abuse, exploitation or discrimination. Of particular
p.000006: concern here are children, individuals with an intellectual disability or with short or long-term unconsciousness.
p.000006: Parental or guardian’s consent must be sought, but such consent can only be accepted where the research in question is
p.000006: clearly in the best interests of the subject concerned, or where the research concerned carries minimal risk or impact
p.000006: on the subject concerned.
p.000006:
p.000007: 7
p.000007:
p.000007: 1.2 Privacy and Confidentiality
p.000007: Privacy and confidentiality are an integral part of the protection and promotion of human dignity and help to protect
p.000007: and maintain a person’s mental or psychological well-being. The need for research should be weighed against
p.000007: infringements of privacy and steps must be taken to ensure that individuals are protected from any harm that might be
p.000007: caused as the result of access to their personal information.
p.000007:
p.000007: 1.3 Validity of Research Proposals
p.000007: The scientific merit of a study is itself an ethical issue. The essential features of ethically justified research
p.000007: involving human participants are that the research offers a means of developing information, not otherwise obtainable,
p.000007: that the design of the research is scientifically sound, that the investigators and other research personnel are
p.000007: qualified and capable and that the methods to be used should be appropriate to the objectives of the research and the
p.000007: field of study.
p.000007:
p.000007: 1.4 Risks
p.000007: As research involves advancing the frontiers of knowledge, its undertaking usually involves a degree of uncertainty
p.000007: about the precise magnitude of and kind of benefits and harms that attend proposed research. The principle of
p.000007: beneficence requires that researchers maximise the potential benefits to the participants and minimise the potential
p.000007: risks of harm. If there are any risks resulting from participation in the research, then there must be benefits, either
p.000007: to the subject, or to humanity or society in general. The principle of non-maleficence requires that researchers ensure
p.000007: that predictable injury, either through acts of commission or omission, will be prevented.
p.000007:
p.000007: 1.5 Justice
p.000007: Justice imposes duties to neither neglect nor discriminate against individuals or groups who may benefit from advances
p.000007: in research, to avoid imposing on a particular group an unfair burden of participation in research and to design
...
p.000007: discomfort.
p.000007:
p.000008: 8
p.000008: Section 2 : Research Requiring Ethics Review
p.000008: All Research involving or impacting upon human participants requires ethics review by a research ethics committee,
p.000008: before the research is started, except as stipulated below.
p.000008: For the purposes of this guidance, Research is defined as a systematic investigation to establish facts, principles or
p.000008: knowledge and a study of some matter with the objective of obtaining or confirming knowledge.
p.000008:
p.000008: 2.1 Specific activities that may require REC review
p.000008: Specific activities that may require REC review include, but are not necessarily limited to the following:
p.000008: (a) Clinical trials involving human participants
p.000008: (b) New treatment or interventions
p.000008: (c) Research involving human remains, cadavers, tissues, discarded tissue (e.g. placenta), biological fluids
p.000008: (d) Physiological studies
p.000008: (e) Comparing an established procedure, whether therapeutic, non-therapeutic or diagnostic, with other procedures
p.000008: which are not recognised as established by virtue of their recent development, discovery or use in a new or unfamiliar
p.000008: way
p.000008: (f) Innovative practices in health and disability services
p.000008: (g) Research conducted by students, which includes all activities that meet the definition of research with human
p.000008: participants
p.000008: (h) Observational clinical research
p.000008: (i) Access to personal information by means of questionnaires, interviews or other techniques of information
p.000008: gathering
p.000008: (j) Research involving the secondary use of data (use of data not collected for that research purpose), if any form
p.000008: of identifier is involved and/or if health information pertaining to individuals is involved
p.000008: (k) Case studies, when a series of subject observations allow possible extrapolation of generalisation of the results
p.000008: from the reported cases and when there is an intent to publish or disseminate the data
p.000008: Note to item 2.1(g) above: As supervised student research is conducted primarily for the purpose of educating students
p.000008: on research techniques and methodologies, REC should review research protocols with a view to contributing to the
p.000008: students’ education concerning scientific and ethical principles governing research.
p.000008:
p.000009: 9
p.000009:
p.000009: 2.2 Activities that may not require REC review
p.000009: Review by REC may not be required for:
p.000009: (a) Research utilising existing publicly available documents or data
p.000009: (b) Observational studies in public places in which the identity of the participants remains anonymous
p.000009: (c) Case study of one patient with the proviso that written informed consent has been obtained from the relevant
p.000009: subject
p.000009: (d) Quality assurance studies
p.000009: (e) Audits
p.000009:
p.000009: The opinion of the REC should be sought whenever there is any doubt about the applicability of this guidance to a
p.000009: particular research project.
p.000009:
p.000010: 10
p.000010:
...
p.000017: (g) the arrangements, if appropriate, for informing the participant’s/volunteer’s GP, including procedure for seeking
p.000017: consent to do so
p.000017: (h) a description of any scheme to make the study product available to the participants/volunteers following the
p.000017: research
p.000017: (i) a report of the expenses (if any) payable to participants/volunteers
p.000017: (j) the provisions for compensation/treatment in the case of the injury/disability/death of a participant/volunteer
p.000017: connected to participation in the study
p.000017: (k) the provisions made for receiving and responding to queries and complaints of participants/volunteers throughout
p.000017: the course of the study
p.000017: (i) the insurance and indemnity agreements covering the liability of the investigator by the sponsor
p.000017: (l) a description of any grants, payments or other reward to be made to any researchers or research hosts
p.000017: (m) a description of possible conflicts of interest which might affect the independent judgement of the researcher(s)
p.000017:
p.000017: Protection of confidentiality of participants/volunteers
p.000017: (a) a description of the persons who will have access to personal data of the participant/volunteer including medical
p.000017: records and biological samples
p.000017: (b) a description of provisions to ensure the confidentiality and security of personal information concerning
p.000017: participants/volunteers
p.000017: (c) the extent to which the information will be anonymised
p.000017: (d) how samples/data will be obtained, and the purposes for which they will be used
p.000017: (e) how long samples/data will be kept
p.000017: (f) to which countries (if any) the samples/data will be sent
p.000017:
p.000017: Both REC members and investigators should be aware of the provisions of the Data Protection Acts 1988 and 2003 and
p.000017: their obligations as set out in those Acts.
p.000017:
p.000018: 18
p.000018:
p.000018: Informed consent process
p.000018: (a) description of the procedures for obtaining informed consent, including the identification of those responsible
p.000018: for obtaining consent and the time frame in which it will occur
p.000018: (b) the adequacy, comprehensiveness and understandability of written and oral information given to the participants/
p.000018: volunteers, their relatives/guardians and, if necessary, their legal guardians
p.000018: (c) the content and wording of the informed consent form and, when applicable, the provisions made for participants
...
p.000021: (i) clearly stated reasons if approval has been declined
p.000021: (j) whether approval was by expedited review
p.000021:
p.000022: 22
p.000022: Section 6 : Procedures for monitoring ongoing research
p.000022: REC should establish a review procedure for following the progress of all studies for which approval has been granted.
p.000022: The review procedure should be specified in the standard operating procedure and should be clearly communicated to
p.000022: investigators.
p.000022:
p.000022: 6.1 Status report from investigators
p.000022: On-going research should be subject to continuing ethics review. The frequency of such review should reflect the degree
p.000022: of risk to participants in the research project. As a minimum the REC should require an annual report from
p.000022: investigators on matters including:
p.000022: (a) progress to date or outcome in the case of a completed project
p.000022: (b) a statement of compliance with the approved proposal and/or amendments to the proposal
p.000022: (c) a description of measures taken to maintain and secure personal information/records pertaining to the research
p.000022:
p.000022: 6.2 Amendments
p.000022: Any significant alteration to a previously approved proposal must receive prior approval from the REC before
p.000022: implementation. Significant alterations include changes to:
p.000022: (a) personnel (including where work has been subcontracted to another investigator) any changes to named researchers
p.000022: responsible for the conduct of the research; any change to the personnel involved in obtaining informed consent or
p.000022: having access to personal information about research participants/volunteers
p.000022: (b) method
p.000022: (c) design of the study
p.000022: (d) duration of the study
p.000022: (e) informed consent procedures
p.000022: (f) patient information leaflets
p.000022: (g) method of recruitment
p.000022:
p.000022: Under the Clinical Trials on Medicinal Products for Human Use Regulations 2004, the REC must, within a period of 35
p.000022: days from the day of receipt of a valid notice of an amendment, furnish the applicant with an opinion.
p.000022:
p.000023: 23
p.000023:
p.000023: 6.3 Adverse Event
p.000023: As a condition of approval of the research proposal the REC should require investigators to immediately report any
p.000023: serious or unexpected adverse events on participants or unforeseen events that might affect the benefits/risks ratio of
p.000023: the proposal.
p.000023: A serious adverse event is defined as any untoward medical occurrence that:
p.000023: (a) results in death
p.000023: (b) is life threatening
p.000023: (c) requires in-patient hospitalisation or prolongation of existing hospitalisation
p.000023: (d) results in persistent or significant disability/incapacity
p.000023: (e) results in a congenital anomaly/birth defect
p.000023:
p.000023: An unexpected event is an adverse reaction, the nature and severity of which is not consistent with the applicable
p.000023: product information.
p.000023: Investigators may take urgent safety measures to eliminate immediate jeopardy to the research participants/volunteers
...
p.000023: a study has been completed. The REC should receive a final study report, summarising the main findings.
p.000023:
p.000024: 24
p.000024:
p.000024: Under the Clinical Trials on Medicinal Products for Human Use Regulations 2004, the REC must be provided with a
p.000024: detailed written explanation of the reasons for suspension or premature termination of a clinical trial within 15 days
p.000024: of the trial being halted. The REC must be provided with a written declaration of the end of the trial within 90 days.
p.000024: End of the trial is defined as the date of the last visit of the last patient undergoing the trial. Suspension,
p.000024: termination or end of trial notification to the REC should be done using the Annex 3 form of the Community “Detailed
p.000024: guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent
p.000024: authorities, notification of substantial amendments and declaration of the end of the trial” (ENTR/CT 1). The REC must
p.000024: receive within one year of the end of the trial a summary of the clinical trial report. The format of this summary
p.000024: should comply as closely as possible with Annex 1 of the Community guideline on the Structure and Content of Clinical
p.000024: Study Reports (CPMP/ICH/137/95).
p.000024:
p.000025: 25
p.000025: Section 7 : Documentation & archiving
p.000025: All documentation and communications of a REC should be dated, filed and archived according to provisions set out in
p.000025: the standard operating procedures. Documents must be stored in a secure place where there is adequate protection
p.000025: against fire. A statement is required in the standard operating procedures defining the access and retrieval procedures
p.000025: for documents, including details of who is authorised to access and/or retrieve REC documents.
p.000025: Documents that should be filed and archived include, but are not limited to:
p.000025: (a) written standard operating procedure
p.000025: (b) annual reports
p.000025: (c) curriculum vitae of each REC member
p.000025: (d) record of all income and expenses of the REC, including expenses paid to REC members and co-optees
p.000025: (e) guidelines on application procedures
p.000025: (f) agendas of REC meetings
p.000025: (g) minutes of REC meetings
p.000025: (h) copies of all materials submitted by applicants
p.000025: (i) correspondence by the REC concerning applicants, decisions and follow-up
p.000025: (j) copies of decisions and any advice and/or requirements issued to applicants
p.000025: (k) all written documentation received during follow-up
p.000025: (l) notification of completion or premature suspension/termination of studies
p.000025: (m) final study reports
p.000025:
p.000025: Documents should be kept for a minimum of three years following notification of completion or premature
p.000025: suspension/termination of a study.
p.000025:
p.000026: 26
p.000026: Section 8 : Research ethics committee annual report
p.000026: The REC should produce an annual report containing information relevant to its procedures including, but not limited
p.000026: to:
p.000026: (a) membership/membership changes
p.000026: (b) number and dates of meetings held
p.000026: (c) attendance of members; confirmation of participation by required categories of members
p.000026: (d) substantive changes to the standard operating procedures
p.000026: (e) list of training undertaken by members
p.000026: (f) a list of proposals considered, the decision reached on each
p.000026: (g) time taken from acceptance of application to final decision on each proposal
...
Social / Age
Searching for indicator age:
(return to top)
p.000009:
p.000009: The opinion of the REC should be sought whenever there is any doubt about the applicability of this guidance to a
p.000009: particular research project.
p.000009:
p.000010: 10
p.000010:
p.000010: Section 3 : Research Ethics Committees
p.000010:
p.000010: 3.1 Constituting a Research Ethics Committee
p.000010: A REC should be constituted to ensure competent ethical review of research proposals submitted to the committee and an
p.000010: independent and just review of any such proposals. The REC must define its mandate and authority and must make clear
p.000010: the jurisdiction of the REC and its relationship to other relevant bodies or institutions. Institutions/ organisations
p.000010: under whose authority RECs are established must ensure that RECs have appropriate financial (including indemnity
p.000010: arrangements for members of the committee) and administrative support to fulfil their function. A publicly available
p.000010: standard operating procedure should be produced and RECs should act in accordance with their operating procedures.
p.000010:
p.000010: 3.2 Composition of a Research Ethics Committee
p.000010: The guiding principle for appointing members to a REC is to ensure that the committee has the appropriate expertise,
p.000010: skills, knowledge and perspectives to ensure an adequate and thorough ethics review. RECs should be multidisciplinary
p.000010: and multi-sectoral in composition. Attention should be paid to age and gender balance. One third
p.000010: of the total membership should be lay members. The qualifications for lay members are independence from the
p.000010: institution/organisation under whose authority the REC is established and their non-involvement in scientific, clinical
p.000010: practice and legal work. Those who have no experience in professions associated with research on human beings are more
p.000010: likely to bring a truly lay perspective. Committee members should elect a chairperson and a vice-chairperson.
p.000010: In general it would be advisable for a committee’s membership to include but not be restricted to the following:
p.000010: (a) member(s) with knowledge of and current experience in the areas of research which are regularly considered by the
p.000010: REC (e.g. scientist).
p.000010: (b) member(s) with knowledge of and current experience in the professional care, counselling or treatment of people
p.000010: (e.g. nurse, medical practitioner, clinical psychologist, as appropriate)
p.000010: (c) member(s) with training in ethics (e.g. ethicist, philosopher, theologian)
p.000010: (d) member(s) with a qualification in law
p.000010: (e) member(s) with training in statistics
p.000010: (f) lay member(s)
p.000010:
p.000011: 11
p.000011:
p.000011: A minimum of seven members of the REC is required to be present at a meeting held to determine an opinion in relation
p.000011: to an application to the REC. There should be a reasonable representation of members, which must include the
p.000011: chairperson, or in his/her absence the vice-chairperson; a member with relevant clinical and/or methodological
...
p.000016: When reviewing research proposals a REC should consider the following:
p.000016: Scientific design and conduct of the study
p.000016: (a) the appropriateness of the study design in relation to the objectives of the study, the statistical methodology
p.000016: (including sample size calculation) and the potential for reaching reliable conclusions with the smallest number of
p.000016: research participants/volunteers
p.000016: (b) the justification of predictable risks and inconveniences weighed against the anticipated benefits for the
p.000016: research participants/volunteers and the concerned communities
p.000016: (c) the justification for use of control arms in trials (whether placebo or active comparator), and the randomisation
p.000016: programme to be used
p.000016: (d) criteria for withdrawing participants/volunteers prematurely
p.000016: (e) criteria for suspending or terminating research
p.000016: (f) the adequacy of conditions made for the monitoring and auditing the conduct of the research
p.000016: (g) the adequacy of the site including the supporting staff, facilities and emergency procedures
p.000016: (h) the form in which the results will be reported and published
p.000016:
p.000016: Recruitment of research participants/volunteers
p.000016: (a) the characteristics of the population from which the participants/volunteers will be drawn (including gender,
p.000016: age, ethnicity) and the justification for any decisions made in this regard
p.000016: (b) the method by which initial contact and recruitment are to be conducted
p.000016: (c) the method by which information is to be conveyed to participants/volunteers or their representatives and by
p.000016: which means consent is to be obtained
p.000016: (d) inclusion and exclusion criteria for research participants/volunteers
p.000016:
p.000016: Care and protection of research participants/volunteers
p.000016: (a) the safety of any intervention to be used in the proposed research
p.000016: (b) the suitability of the investigator for the proposed research in relation to his/her qualifications and
p.000016: experience
p.000016: (c) any plans to withdraw or withhold standard therapies or clinical management protocols for the purpose of the
p.000016: research, and the justification for such action
p.000016:
p.000017: 17
p.000017:
p.000017: (d) the adequacy of health and social supervision and psychological support for the research participants/volunteers
p.000017: (e) the adequacy of medical supervision and follow-up concerning the participants/volunteers
p.000017: (f) steps to be followed if participants/volunteers decide to withdraw during the course of the research
...
Social / Child
Searching for indicator children:
(return to top)
p.000004: Helsinki, most recently revised in 2000, requiring that proposed experimentation on humans be approved by a committee
p.000004: independent from the investigators conducting the research. The Belmont report was published in the United States in
p.000004: 1979 and forms the basis of all US human research regulation. The report sets forth the basic ethical principles
p.000004: underlying the acceptable conduct of research involving human participants.
p.000004: Those principles, respect for persons, beneficence, and justice, are now accepted as three essential requirements for
p.000004: the ethical conduct of research involving human participants. Most recently, the Council for International
p.000004: Organisations of Medical Sciences (CIOMS), working with the World Health Organisation, issued a third edition of
p.000004: biomedical research ethical guidelines in 2002 which feature recommendations on ethical review committees and the issue
p.000004: of safeguarding confidentiality. These documents demonstrate a trend towards making more explicit the ethical standards
p.000004: that must be met if research on human beings is to be ethically acceptable.
p.000004: The regulations and recommendations contained within these international codes need to be adapted into institutional
p.000004: operational guidance to be used at the local level to guide the planning, review, approval and conduct of human
p.000004: research. In Ireland, the recent Regulations made by the Minister for Health and Children (Clinical Trials on Medicinal
p.000004: Products for Human Use, S.I. No. 190 of 2004), the report of the Irish College of General Practitioners entitled
p.000004: “Ethical questions to be considered by a research ethics committee when approving clinical trials which involve genetic
p.000004: testing” (2003) and the Health Research Board’s report “Genetic Research and Human Biological Samples: The Legal and
p.000004: Ethical Considerations” (2002) provide useful guidance in relation to ethical review of clinical trials. However,
p.000004: Ireland currently lacks comprehensive guidance with respect to ethical review of research involving human participants
p.000004: outside the remit of clinical trials.
p.000004:
p.000005: 5
p.000005:
p.000005: This document is the result of systematic evaluation and analysis of international best practice (see list of
p.000005: Supporting Documents) and comprehensive discussion undertaken by a working group of the Irish Council for Bioethics. It
p.000005: is based on requirements for ethical review established in international guidelines and provides guidance on general
p.000005: standards and principles that should be considered by Research Ethics Committees when reviewing research proposals.
p.000005: This guidance is intended to facilitate and support efficient and effective ethical review of proposals. This document
p.000005: should be viewed as a basis upon which Research Ethics Committees can establish and develop their standard operating
p.000005: procedures.
p.000005: Impartial ethical review is designed to maintain ethical standards of practice in research, to protect participants in
...
p.000006: of their options, including the possible risks and benefits of those options. They must be assured of the necessity of
p.000006: the research, including the fact that all possible risks have been minimised, and, where significant risk is
p.000006: involved, that no other method of research is possible. They must be asked to make their choice in circumstances, which
p.000006: are free of coercion or undue pressure, and they must be free to withdraw from the research process at any time. This
p.000006: decision must not affect their health care in any way. Ethical review should focus on the entire process
p.000006: of obtaining consent, not just on the written consent documents, but on how participants are informed of the study, who
p.000006: discusses it with them, and in what circumstances. The requirement for free and informed consent presumes that adequate
p.000006: information is provided to obtain an informed judgement, that information provided is in a form and delivered in a
p.000006: manner that will enable it to be understood and that the consent is voluntary in nature.
p.000006: In the research context, respect for persons requires that limitations to an individual’s autonomy are recognised and
p.000006: that appropriate mechanisms are in place to protect against abuse, exploitation or discrimination. Of particular
p.000006: concern here are children, individuals with an intellectual disability or with short or long-term unconsciousness.
p.000006: Parental or guardian’s consent must be sought, but such consent can only be accepted where the research in question is
p.000006: clearly in the best interests of the subject concerned, or where the research concerned carries minimal risk or impact
p.000006: on the subject concerned.
p.000006:
p.000007: 7
p.000007:
p.000007: 1.2 Privacy and Confidentiality
p.000007: Privacy and confidentiality are an integral part of the protection and promotion of human dignity and help to protect
p.000007: and maintain a person’s mental or psychological well-being. The need for research should be weighed against
p.000007: infringements of privacy and steps must be taken to ensure that individuals are protected from any harm that might be
p.000007: caused as the result of access to their personal information.
p.000007:
p.000007: 1.3 Validity of Research Proposals
p.000007: The scientific merit of a study is itself an ethical issue. The essential features of ethically justified research
p.000007: involving human participants are that the research offers a means of developing information, not otherwise obtainable,
p.000007: that the design of the research is scientifically sound, that the investigators and other research personnel are
...
p.000027: committees could verify the practicability of the proposal in the institution/ organisation and that the proposal
p.000027: conforms to the ethos of the institution/organisation in which the research will be carried out.
p.000027: Under the Clinical Trials on Medicinal Products for Human Use Regulations 2004 in the case of multi-centre clinical
p.000027: trials, either limited to sites in Ireland, or to sites located in more than one EU member state, a single ethics
p.000027: committee opinion must be given by a recognised ethics committee and this opinion must prevail at all centres where the
p.000027: trial is to be conducted.
p.000027:
p.000028: 28
p.000028:
p.000028: Supporting Documents
p.000028: CIOMS (Council for International Organisations of Medical Sciences). International Ethical Guidelines for Biomedical
p.000028: Research Involving Human Subjects (1993;2002).
p.000028: CIOMS (Council for International Organisations of Medical Sciences). International Guidelines for Ethical Review of
p.000028: Epidemiological Studies (1991).
p.000028: Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the
p.000028: Application of Biology and Medicine: Convention on Human Rights and Biomedicine (1997).
p.000028: Department of Health & Children. Clinical Trials on Medicinal Products for Human Use Regulations (2004).
p.000028: European Forum for Good Clinical Practice. Guidelines and Recommendations for European Ethics Committees
p.000028: (1995; 1997)
p.000028: Health Research Board. Genetic Research and Human Biological Samples: The Legal and Ethical Considerations
p.000028: (2002)
p.000028: International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human
p.000028: Use (ICH). Note for Guidance on Good Clinical Practice (1996).
p.000028: Irish College of General Practitioners. Ethical questions to be considered by a research ethics committee when
p.000028: approving clinical trials which involve genetic testing (2003).
p.000028: Medical Research Council of Canada. Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans
p.000028: (1998).
p.000028: Ministry of Health, New Zealand. Operational Standard for Ethics Committees (2001).
p.000028: National Health & Medical Research Council. Commentary on the National Statement on Ethical Conduct in Research
p.000028: involving Humans (2001).
p.000028: Nuremberg Code. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol.
p.000028: 2, pp. 181-182. (1947).
p.000028:
p.000029: 29
p.000029:
p.000029: Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
...
Social / Ethnicity
Searching for indicator ethnicity:
(return to top)
p.000016: Scientific design and conduct of the study
p.000016: (a) the appropriateness of the study design in relation to the objectives of the study, the statistical methodology
p.000016: (including sample size calculation) and the potential for reaching reliable conclusions with the smallest number of
p.000016: research participants/volunteers
p.000016: (b) the justification of predictable risks and inconveniences weighed against the anticipated benefits for the
p.000016: research participants/volunteers and the concerned communities
p.000016: (c) the justification for use of control arms in trials (whether placebo or active comparator), and the randomisation
p.000016: programme to be used
p.000016: (d) criteria for withdrawing participants/volunteers prematurely
p.000016: (e) criteria for suspending or terminating research
p.000016: (f) the adequacy of conditions made for the monitoring and auditing the conduct of the research
p.000016: (g) the adequacy of the site including the supporting staff, facilities and emergency procedures
p.000016: (h) the form in which the results will be reported and published
p.000016:
p.000016: Recruitment of research participants/volunteers
p.000016: (a) the characteristics of the population from which the participants/volunteers will be drawn (including gender,
p.000016: age, ethnicity) and the justification for any decisions made in this regard
p.000016: (b) the method by which initial contact and recruitment are to be conducted
p.000016: (c) the method by which information is to be conveyed to participants/volunteers or their representatives and by
p.000016: which means consent is to be obtained
p.000016: (d) inclusion and exclusion criteria for research participants/volunteers
p.000016:
p.000016: Care and protection of research participants/volunteers
p.000016: (a) the safety of any intervention to be used in the proposed research
p.000016: (b) the suitability of the investigator for the proposed research in relation to his/her qualifications and
p.000016: experience
p.000016: (c) any plans to withdraw or withhold standard therapies or clinical management protocols for the purpose of the
p.000016: research, and the justification for such action
p.000016:
p.000017: 17
p.000017:
p.000017: (d) the adequacy of health and social supervision and psychological support for the research participants/volunteers
p.000017: (e) the adequacy of medical supervision and follow-up concerning the participants/volunteers
p.000017: (f) steps to be followed if participants/volunteers decide to withdraw during the course of the research
p.000017: (g) the arrangements, if appropriate, for informing the participant’s/volunteer’s GP, including procedure for seeking
...
Social / Incarcerated
Searching for indicator restricted:
(return to top)
p.000010: the jurisdiction of the REC and its relationship to other relevant bodies or institutions. Institutions/ organisations
p.000010: under whose authority RECs are established must ensure that RECs have appropriate financial (including indemnity
p.000010: arrangements for members of the committee) and administrative support to fulfil their function. A publicly available
p.000010: standard operating procedure should be produced and RECs should act in accordance with their operating procedures.
p.000010:
p.000010: 3.2 Composition of a Research Ethics Committee
p.000010: The guiding principle for appointing members to a REC is to ensure that the committee has the appropriate expertise,
p.000010: skills, knowledge and perspectives to ensure an adequate and thorough ethics review. RECs should be multidisciplinary
p.000010: and multi-sectoral in composition. Attention should be paid to age and gender balance. One third
p.000010: of the total membership should be lay members. The qualifications for lay members are independence from the
p.000010: institution/organisation under whose authority the REC is established and their non-involvement in scientific, clinical
p.000010: practice and legal work. Those who have no experience in professions associated with research on human beings are more
p.000010: likely to bring a truly lay perspective. Committee members should elect a chairperson and a vice-chairperson.
p.000010: In general it would be advisable for a committee’s membership to include but not be restricted to the following:
p.000010: (a) member(s) with knowledge of and current experience in the areas of research which are regularly considered by the
p.000010: REC (e.g. scientist).
p.000010: (b) member(s) with knowledge of and current experience in the professional care, counselling or treatment of people
p.000010: (e.g. nurse, medical practitioner, clinical psychologist, as appropriate)
p.000010: (c) member(s) with training in ethics (e.g. ethicist, philosopher, theologian)
p.000010: (d) member(s) with a qualification in law
p.000010: (e) member(s) with training in statistics
p.000010: (f) lay member(s)
p.000010:
p.000011: 11
p.000011:
p.000011: A minimum of seven members of the REC is required to be present at a meeting held to determine an opinion in relation
p.000011: to an application to the REC. There should be a reasonable representation of members, which must include the
p.000011: chairperson, or in his/her absence the vice-chairperson; a member with relevant clinical and/or methodological
p.000011: expertise; a lay member and a member who is independent of the institution/organisation under whose authority the REC
p.000011: is established.
p.000011: A REC should have sufficient members to secure the minimum number of members required to determine an opinion on an
p.000011: application.
p.000011: A REC may appoint a person to act as an alternate for each member of the committee, where the alternate satisfies the
p.000011: same membership criteria as the member. The standard operating procedure of the REC should identify the primary member
p.000011: for whom each alternate member may substitute. When alternates substitute for a primary member, the alternate member
...
p.000012: participating in research, while promoting and facilitating research excellence.
p.000012: (b) A member should be prepared to have his/her name, profession and affiliation published.
p.000012: (c) Members are expected to treat as confidential all applications, meeting deliberations, information on research
p.000012: participants/volunteers and related matters.
p.000012: (d) When a committee member believes they have a conflict of interest on a subject which will compromise their
p.000012: ability to make an impartial decision, they should declare that conflict of interest and withdraw themselves from the
p.000012: discussion and/or activity.
p.000012: (e) A member is expected to attend at least two-thirds of all scheduled REC meetings in each year. Should a member
p.000012: fail to do so, the chairperson should address this with the member concerned.
p.000012: (f) A member must agree to take part in education and ongoing training appropriate to his or her role as a REC
p.000012: member.
p.000012:
p.000013: 13
p.000013: Section 4 : Submitting an application
p.000013: RECs have the responsibility of establishing well-defined submission procedures for research proposals, which are
p.000013: readily available to prospective applicants.
p.000013:
p.000013: 4.1 Application Procedure
p.000013: An application for ethics committee review in respect of proposed research must be made in writing and signed by a
p.000013: qualified researcher responsible for the conduct of the study. This will usually be the chief investigator. Material to
p.000013: be submitted as part of an application may include but is not restricted to:
p.000013: (a) the name(s) and address(es) of the REC members to whom the application is to be submitted.
p.000013: (b) the application forms
p.000013: (c) the documentation required
p.000013: (d) the format for submission
p.000013: (e) the number of copies to be submitted
p.000013: (f) the deadline for submission of the application
p.000013: (g) the means by which applications will be acknowledged, including the communication of an incomplete application
p.000013: (h) the expected time for notification of the decision following review
p.000013: (i) the fee structure, if any, for reviewing an application
p.000013: (j) the application procedure for amendments to the proposal, the recruitment material, the potential research
p.000013: participation information, or the informed consent form
p.000013: (k) the information given to research participants/volunteers and the appropriate safeguards for the protection of
p.000013: personal data
p.000013: 4.2 Documentation
p.000013: The applicant should submit all documentation required for a thorough and complete ethical review of the proposed
p.000013: research. The applicant should be aware of the elements of the review process (see 5.2) and submit the necessary
p.000013: documentation to conduct this review. The REC should advise all applicants on documentation required for review.
p.000013:
p.000014: 14
p.000014:
p.000014: This may include but is not restricted to:
p.000014: (a) a signed and dated application form
p.000014: (b) the protocol of the proposed research (clearly identified and dated), together with supporting documents and
p.000014: appendices
p.000014: (c) a summary, synopsis or diagram (‘flowchart’) in non-technical language
p.000014: (d) a description of the ethical considerations involved in the research
p.000014: (e) case report forms, diary cards, and other questionnaires intended for research participants/volunteers
p.000014: (f) when the research involves the study of a product (such as a pharmaceutical or device under investigation) an
p.000014: adequate summary of all pharmacological and toxicological data available on the product, together with a summary of
p.000014: clinical experience with the product to date (e.g. recent investigator’s brochure, a summary of the product’s
p.000014: characteristics) should be included
p.000014: (g) current curriculum vitae of the applicant(s) (updated, signed and dated)
p.000014: (h) material used (including advertisements) for participant/volunteer recruitment
p.000014: (i) patient/volunteer information
p.000014: (j) a full description of the process to obtain and document consent
p.000014: (k) suitable arrangements for indemnifying participants/volunteers and investigators
p.000014: (l) all significant previous decisions (e.g. those leading to a negative decision or modified proposal) by other RECs
p.000014: or regulatory authorities for the proposed research (whether in the same location or elsewhere) and an indication of
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000013: (b) the application forms
p.000013: (c) the documentation required
p.000013: (d) the format for submission
p.000013: (e) the number of copies to be submitted
p.000013: (f) the deadline for submission of the application
p.000013: (g) the means by which applications will be acknowledged, including the communication of an incomplete application
p.000013: (h) the expected time for notification of the decision following review
p.000013: (i) the fee structure, if any, for reviewing an application
p.000013: (j) the application procedure for amendments to the proposal, the recruitment material, the potential research
p.000013: participation information, or the informed consent form
p.000013: (k) the information given to research participants/volunteers and the appropriate safeguards for the protection of
p.000013: personal data
p.000013: 4.2 Documentation
p.000013: The applicant should submit all documentation required for a thorough and complete ethical review of the proposed
p.000013: research. The applicant should be aware of the elements of the review process (see 5.2) and submit the necessary
p.000013: documentation to conduct this review. The REC should advise all applicants on documentation required for review.
p.000013:
p.000014: 14
p.000014:
p.000014: This may include but is not restricted to:
p.000014: (a) a signed and dated application form
p.000014: (b) the protocol of the proposed research (clearly identified and dated), together with supporting documents and
p.000014: appendices
p.000014: (c) a summary, synopsis or diagram (‘flowchart’) in non-technical language
p.000014: (d) a description of the ethical considerations involved in the research
p.000014: (e) case report forms, diary cards, and other questionnaires intended for research participants/volunteers
p.000014: (f) when the research involves the study of a product (such as a pharmaceutical or device under investigation) an
p.000014: adequate summary of all pharmacological and toxicological data available on the product, together with a summary of
p.000014: clinical experience with the product to date (e.g. recent investigator’s brochure, a summary of the product’s
p.000014: characteristics) should be included
p.000014: (g) current curriculum vitae of the applicant(s) (updated, signed and dated)
p.000014: (h) material used (including advertisements) for participant/volunteer recruitment
p.000014: (i) patient/volunteer information
p.000014: (j) a full description of the process to obtain and document consent
p.000014: (k) suitable arrangements for indemnifying participants/volunteers and investigators
p.000014: (l) all significant previous decisions (e.g. those leading to a negative decision or modified proposal) by other RECs
p.000014: or regulatory authorities for the proposed research (whether in the same location or elsewhere) and an indication of
p.000014: the modification(s) to the protocol made on that account. The reasons for previous negative decisions should be
p.000014: provided.
p.000014:
p.000015: 15
p.000015: Section 5 : Review procedure
p.000015: All properly submitted and valid applications shall be reviewed in a timely fashion and according to an established
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000026: to:
p.000026: (a) membership/membership changes
p.000026: (b) number and dates of meetings held
p.000026: (c) attendance of members; confirmation of participation by required categories of members
p.000026: (d) substantive changes to the standard operating procedures
p.000026: (e) list of training undertaken by members
p.000026: (f) a list of proposals considered, the decision reached on each
p.000026: (g) time taken from acceptance of application to final decision on each proposal
p.000026: (h) list of projects completed or terminated during the year
p.000026:
p.000026: Annual reports are public documents and should be available upon request.
p.000026:
p.000027: 27
p.000027: Section 9 : Multi-centre studies
p.000027: Multi-centre studies may include research conducted at more than one institution or organisation, in one more
p.000027: countries, either by the same or different investigators or research conducted jointly by investigators working with
p.000027: different institutions or organisations. RECs should require investigators to indicate on application forms if a study
p.000027: is being or has been reviewed by another REC and if so, the identity and decision of the REC.
p.000027: In order to facilitate prompt and efficient review of multi-centre studies:
p.000027: (a) An investigator may wish to distinguish between core elements of the research that cannot be altered without
p.000027: invalidating the pooling of research data and those elements which can be altered to comply with local requirements
p.000027: (b) RECs may wish to communicate with, give or receive advice from other RECs reviewing the proposal
p.000027: (c) RECs may wish to accept a scientific assessment of the proposal from another REC
p.000027: (d) RECs may agree to accept the conclusions of a single review committee
p.000027:
p.000027: Note to item 9(c) above: A common scientific assessment could be produced by qualified members of a number of RECs
p.000027: involved or by one REC which has accepted the role.
p.000027: Note to item 9(d) above: A single committee could review the scientific and ethical aspects of a proposal. Individual
p.000027: committees could verify the practicability of the proposal in the institution/ organisation and that the proposal
p.000027: conforms to the ethos of the institution/organisation in which the research will be carried out.
p.000027: Under the Clinical Trials on Medicinal Products for Human Use Regulations 2004 in the case of multi-centre clinical
p.000027: trials, either limited to sites in Ireland, or to sites located in more than one EU member state, a single ethics
p.000027: committee opinion must be given by a recognised ethics committee and this opinion must prevail at all centres where the
p.000027: trial is to be conducted.
p.000027:
p.000028: 28
p.000028:
p.000028: Supporting Documents
p.000028: CIOMS (Council for International Organisations of Medical Sciences). International Ethical Guidelines for Biomedical
p.000028: Research Involving Human Subjects (1993;2002).
p.000028: CIOMS (Council for International Organisations of Medical Sciences). International Guidelines for Ethical Review of
p.000028: Epidemiological Studies (1991).
p.000028: Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the
p.000028: Application of Biology and Medicine: Convention on Human Rights and Biomedicine (1997).
p.000028: Department of Health & Children. Clinical Trials on Medicinal Products for Human Use Regulations (2004).
p.000028: European Forum for Good Clinical Practice. Guidelines and Recommendations for European Ethics Committees
p.000028: (1995; 1997)
p.000028: Health Research Board. Genetic Research and Human Biological Samples: The Legal and Ethical Considerations
p.000028: (2002)
p.000028: International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human
p.000028: Use (ICH). Note for Guidance on Good Clinical Practice (1996).
...
Social / Soldier
Searching for indicator military:
(return to top)
p.000028: Epidemiological Studies (1991).
p.000028: Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the
p.000028: Application of Biology and Medicine: Convention on Human Rights and Biomedicine (1997).
p.000028: Department of Health & Children. Clinical Trials on Medicinal Products for Human Use Regulations (2004).
p.000028: European Forum for Good Clinical Practice. Guidelines and Recommendations for European Ethics Committees
p.000028: (1995; 1997)
p.000028: Health Research Board. Genetic Research and Human Biological Samples: The Legal and Ethical Considerations
p.000028: (2002)
p.000028: International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human
p.000028: Use (ICH). Note for Guidance on Good Clinical Practice (1996).
p.000028: Irish College of General Practitioners. Ethical questions to be considered by a research ethics committee when
p.000028: approving clinical trials which involve genetic testing (2003).
p.000028: Medical Research Council of Canada. Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans
p.000028: (1998).
p.000028: Ministry of Health, New Zealand. Operational Standard for Ethics Committees (2001).
p.000028: National Health & Medical Research Council. Commentary on the National Statement on Ethical Conduct in Research
p.000028: involving Humans (2001).
p.000028: Nuremberg Code. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol.
p.000028: 2, pp. 181-182. (1947).
p.000028:
p.000029: 29
p.000029:
p.000029: Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
p.000029: Belmont report: ethical principles and guidelines for the protection of human subjects of research (1979)
p.000029: UNESCO (United Nations Educational, Scientific, Cultural Organization. Universal Declaration on the Human Genome and
p.000029: Human Rights (1997).
p.000029: World Health Organisation. Draft Operational Guidelines for Ethics Committees Reviewing Biomedical Research
p.000029: (2000).
p.000029: World Medical Association. Declaration of Helsinki: Recommendations Guiding Physicians in Biomedical Research Involving
p.000029: Subjects (1964; 1975; 1983; 1989; 1996, 2000)
p.000029:
p.000030: 30
p.000030:
p.000030: Working Group on Research Ethics Committees
p.000030: Professor Cecily Kelleher Chairperson
p.000030: Dept. of Public Health Medicine and Epidemiology, University College Dublin
p.000030: Dr. Margaret Fitzgerald Vice-Chairperson
p.000030: Dept. of Public Health, Eastern Regional Health Authority
p.000030: Mr. Dermot Gleeson
p.000030: Senior Counsel
p.000030: Mr. Kenneth Kearon
p.000030: Irish School of Ecumenics
p.000030: Mr. Dan Lynch
...
Social / Student
Searching for indicator student:
(return to top)
p.000008:
p.000008: 2.1 Specific activities that may require REC review
p.000008: Specific activities that may require REC review include, but are not necessarily limited to the following:
p.000008: (a) Clinical trials involving human participants
p.000008: (b) New treatment or interventions
p.000008: (c) Research involving human remains, cadavers, tissues, discarded tissue (e.g. placenta), biological fluids
p.000008: (d) Physiological studies
p.000008: (e) Comparing an established procedure, whether therapeutic, non-therapeutic or diagnostic, with other procedures
p.000008: which are not recognised as established by virtue of their recent development, discovery or use in a new or unfamiliar
p.000008: way
p.000008: (f) Innovative practices in health and disability services
p.000008: (g) Research conducted by students, which includes all activities that meet the definition of research with human
p.000008: participants
p.000008: (h) Observational clinical research
p.000008: (i) Access to personal information by means of questionnaires, interviews or other techniques of information
p.000008: gathering
p.000008: (j) Research involving the secondary use of data (use of data not collected for that research purpose), if any form
p.000008: of identifier is involved and/or if health information pertaining to individuals is involved
p.000008: (k) Case studies, when a series of subject observations allow possible extrapolation of generalisation of the results
p.000008: from the reported cases and when there is an intent to publish or disseminate the data
p.000008: Note to item 2.1(g) above: As supervised student research is conducted primarily for the purpose of educating students
p.000008: on research techniques and methodologies, REC should review research protocols with a view to contributing to the
p.000008: students’ education concerning scientific and ethical principles governing research.
p.000008:
p.000009: 9
p.000009:
p.000009: 2.2 Activities that may not require REC review
p.000009: Review by REC may not be required for:
p.000009: (a) Research utilising existing publicly available documents or data
p.000009: (b) Observational studies in public places in which the identity of the participants remains anonymous
p.000009: (c) Case study of one patient with the proviso that written informed consent has been obtained from the relevant
p.000009: subject
p.000009: (d) Quality assurance studies
p.000009: (e) Audits
p.000009:
p.000009: The opinion of the REC should be sought whenever there is any doubt about the applicability of this guidance to a
p.000009: particular research project.
p.000009:
p.000010: 10
p.000010:
p.000010: Section 3 : Research Ethics Committees
p.000010:
p.000010: 3.1 Constituting a Research Ethics Committee
p.000010: A REC should be constituted to ensure competent ethical review of research proposals submitted to the committee and an
p.000010: independent and just review of any such proposals. The REC must define its mandate and authority and must make clear
p.000010: the jurisdiction of the REC and its relationship to other relevant bodies or institutions. Institutions/ organisations
...
Social / Victim of Abuse
Searching for indicator abuse:
(return to top)
p.000006: to choose for themselves whether or not they wish to participate in research. In order to choose they must be informed
p.000006: of their options, including the possible risks and benefits of those options. They must be assured of the necessity of
p.000006: the research, including the fact that all possible risks have been minimised, and, where significant risk is
p.000006: involved, that no other method of research is possible. They must be asked to make their choice in circumstances, which
p.000006: are free of coercion or undue pressure, and they must be free to withdraw from the research process at any time. This
p.000006: decision must not affect their health care in any way. Ethical review should focus on the entire process
p.000006: of obtaining consent, not just on the written consent documents, but on how participants are informed of the study, who
p.000006: discusses it with them, and in what circumstances. The requirement for free and informed consent presumes that adequate
p.000006: information is provided to obtain an informed judgement, that information provided is in a form and delivered in a
p.000006: manner that will enable it to be understood and that the consent is voluntary in nature.
p.000006: In the research context, respect for persons requires that limitations to an individual’s autonomy are recognised and
p.000006: that appropriate mechanisms are in place to protect against abuse, exploitation or discrimination. Of particular
p.000006: concern here are children, individuals with an intellectual disability or with short or long-term unconsciousness.
p.000006: Parental or guardian’s consent must be sought, but such consent can only be accepted where the research in question is
p.000006: clearly in the best interests of the subject concerned, or where the research concerned carries minimal risk or impact
p.000006: on the subject concerned.
p.000006:
p.000007: 7
p.000007:
p.000007: 1.2 Privacy and Confidentiality
p.000007: Privacy and confidentiality are an integral part of the protection and promotion of human dignity and help to protect
p.000007: and maintain a person’s mental or psychological well-being. The need for research should be weighed against
p.000007: infringements of privacy and steps must be taken to ensure that individuals are protected from any harm that might be
p.000007: caused as the result of access to their personal information.
p.000007:
p.000007: 1.3 Validity of Research Proposals
p.000007: The scientific merit of a study is itself an ethical issue. The essential features of ethically justified research
p.000007: involving human participants are that the research offers a means of developing information, not otherwise obtainable,
...
Social / education
Searching for indicator education:
(return to top)
p.000008: (b) New treatment or interventions
p.000008: (c) Research involving human remains, cadavers, tissues, discarded tissue (e.g. placenta), biological fluids
p.000008: (d) Physiological studies
p.000008: (e) Comparing an established procedure, whether therapeutic, non-therapeutic or diagnostic, with other procedures
p.000008: which are not recognised as established by virtue of their recent development, discovery or use in a new or unfamiliar
p.000008: way
p.000008: (f) Innovative practices in health and disability services
p.000008: (g) Research conducted by students, which includes all activities that meet the definition of research with human
p.000008: participants
p.000008: (h) Observational clinical research
p.000008: (i) Access to personal information by means of questionnaires, interviews or other techniques of information
p.000008: gathering
p.000008: (j) Research involving the secondary use of data (use of data not collected for that research purpose), if any form
p.000008: of identifier is involved and/or if health information pertaining to individuals is involved
p.000008: (k) Case studies, when a series of subject observations allow possible extrapolation of generalisation of the results
p.000008: from the reported cases and when there is an intent to publish or disseminate the data
p.000008: Note to item 2.1(g) above: As supervised student research is conducted primarily for the purpose of educating students
p.000008: on research techniques and methodologies, REC should review research protocols with a view to contributing to the
p.000008: students’ education concerning scientific and ethical principles governing research.
p.000008:
p.000009: 9
p.000009:
p.000009: 2.2 Activities that may not require REC review
p.000009: Review by REC may not be required for:
p.000009: (a) Research utilising existing publicly available documents or data
p.000009: (b) Observational studies in public places in which the identity of the participants remains anonymous
p.000009: (c) Case study of one patient with the proviso that written informed consent has been obtained from the relevant
p.000009: subject
p.000009: (d) Quality assurance studies
p.000009: (e) Audits
p.000009:
p.000009: The opinion of the REC should be sought whenever there is any doubt about the applicability of this guidance to a
p.000009: particular research project.
p.000009:
p.000010: 10
p.000010:
p.000010: Section 3 : Research Ethics Committees
p.000010:
p.000010: 3.1 Constituting a Research Ethics Committee
p.000010: A REC should be constituted to ensure competent ethical review of research proposals submitted to the committee and an
p.000010: independent and just review of any such proposals. The REC must define its mandate and authority and must make clear
p.000010: the jurisdiction of the REC and its relationship to other relevant bodies or institutions. Institutions/ organisations
p.000010: under whose authority RECs are established must ensure that RECs have appropriate financial (including indemnity
p.000010: arrangements for members of the committee) and administrative support to fulfil their function. A publicly available
...
p.000012: with respect to a majority of proposals reviewed.
p.000012: Note to item 3.3(b) above: appointing members should be by an open process. Vacancies should be advertised publicly in
p.000012: the press and/or via local professional networks.
p.000012: Note to item 3.3(d) above: Members should be appointed for a fixed term, which may be renewed, but should not normally
p.000012: exceed two consecutive terms on the same REC. The benefit of maintaining some continuity of membership by overlapping
p.000012: terms of office should be considered.
p.000012:
p.000012: 3.4 Duties and responsibilities of a Research Ethics Committee Member
p.000012: (a) Committee members have a commitment to protect and safeguard the rights and interests of human participants
p.000012: participating in research, while promoting and facilitating research excellence.
p.000012: (b) A member should be prepared to have his/her name, profession and affiliation published.
p.000012: (c) Members are expected to treat as confidential all applications, meeting deliberations, information on research
p.000012: participants/volunteers and related matters.
p.000012: (d) When a committee member believes they have a conflict of interest on a subject which will compromise their
p.000012: ability to make an impartial decision, they should declare that conflict of interest and withdraw themselves from the
p.000012: discussion and/or activity.
p.000012: (e) A member is expected to attend at least two-thirds of all scheduled REC meetings in each year. Should a member
p.000012: fail to do so, the chairperson should address this with the member concerned.
p.000012: (f) A member must agree to take part in education and ongoing training appropriate to his or her role as a REC
p.000012: member.
p.000012:
p.000013: 13
p.000013: Section 4 : Submitting an application
p.000013: RECs have the responsibility of establishing well-defined submission procedures for research proposals, which are
p.000013: readily available to prospective applicants.
p.000013:
p.000013: 4.1 Application Procedure
p.000013: An application for ethics committee review in respect of proposed research must be made in writing and signed by a
p.000013: qualified researcher responsible for the conduct of the study. This will usually be the chief investigator. Material to
p.000013: be submitted as part of an application may include but is not restricted to:
p.000013: (a) the name(s) and address(es) of the REC members to whom the application is to be submitted.
p.000013: (b) the application forms
p.000013: (c) the documentation required
p.000013: (d) the format for submission
p.000013: (e) the number of copies to be submitted
p.000013: (f) the deadline for submission of the application
p.000013: (g) the means by which applications will be acknowledged, including the communication of an incomplete application
p.000013: (h) the expected time for notification of the decision following review
p.000013: (i) the fee structure, if any, for reviewing an application
p.000013: (j) the application procedure for amendments to the proposal, the recruitment material, the potential research
p.000013: participation information, or the informed consent form
...
p.000031: Dr Patrick Flanagan, formerly of Environmental Protection Agency
p.000031: Professor Patrick Hannon, St Patrick's College, National University of Ireland, Maynooth
p.000031: Mr. Kenneth Kearon, Irish School of Ecumenics
p.000031: Professor Cecily Kelleher, Department of Public Health, Medicine and Epidemiology, University College Dublin
p.000031: Professor Mark Lawler, Cancer Molecular Diagnostics Laboratory, St James' Hospital
p.000031: Professor Tony McGleenan, School of Law, University of Ulster
p.000031: Dr Peter McKenna, Department of Obstetrics and Gynaecology, Rotunda Hospital
p.000031: Ms Mary Mulvihill, Science Journalist
p.000031: Dr Nora O’Brien, Department of Food Science, Food Technology and Nutrition, National University of Ireland, Cork
p.000031: Professor Fergal O’Gara, Department of Microbiology, National University of Ireland, Cork
p.000031: Professor Ronan O’Regan, MRIA, Department of Human Anatomy and Physiology, University College Dublin
p.000031: Professor Anne Scott, School of Nursing, Dublin City University
p.000031: Mr Asim Sheikh, BL, Division of Legal Medicine, University College Dublin
p.000031: Professor Seán Strain, School of Biomedical Sciences, University of Ulster
p.000031: Secretariat
p.000031: Dr Siobhán O’Sullivan, Scientific Director Mr Pauric Dempsey
p.000031: Ms Emily de Grae
p.000031:
p.000031: Terms of Reference
p.000031: 1. To identify and interpret the ethical questions raised by biological and medical research in order to respond to
p.000031: and anticipate questions of substantive concern.
p.000031: 2. To investigate and report on such questions in the interests of promoting public understanding informed
p.000031: discussion and education.
p.000031: 3. In the light of the outcome of its work, to stimulate discussion through conferences, workshops, lectures,
...
Searching for indicator educational:
(return to top)
p.000028: (1995; 1997)
p.000028: Health Research Board. Genetic Research and Human Biological Samples: The Legal and Ethical Considerations
p.000028: (2002)
p.000028: International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human
p.000028: Use (ICH). Note for Guidance on Good Clinical Practice (1996).
p.000028: Irish College of General Practitioners. Ethical questions to be considered by a research ethics committee when
p.000028: approving clinical trials which involve genetic testing (2003).
p.000028: Medical Research Council of Canada. Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans
p.000028: (1998).
p.000028: Ministry of Health, New Zealand. Operational Standard for Ethics Committees (2001).
p.000028: National Health & Medical Research Council. Commentary on the National Statement on Ethical Conduct in Research
p.000028: involving Humans (2001).
p.000028: Nuremberg Code. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol.
p.000028: 2, pp. 181-182. (1947).
p.000028:
p.000029: 29
p.000029:
p.000029: Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
p.000029: Belmont report: ethical principles and guidelines for the protection of human subjects of research (1979)
p.000029: UNESCO (United Nations Educational, Scientific, Cultural Organization. Universal Declaration on the Human Genome and
p.000029: Human Rights (1997).
p.000029: World Health Organisation. Draft Operational Guidelines for Ethics Committees Reviewing Biomedical Research
p.000029: (2000).
p.000029: World Medical Association. Declaration of Helsinki: Recommendations Guiding Physicians in Biomedical Research Involving
p.000029: Subjects (1964; 1975; 1983; 1989; 1996, 2000)
p.000029:
p.000030: 30
p.000030:
p.000030: Working Group on Research Ethics Committees
p.000030: Professor Cecily Kelleher Chairperson
p.000030: Dept. of Public Health Medicine and Epidemiology, University College Dublin
p.000030: Dr. Margaret Fitzgerald Vice-Chairperson
p.000030: Dept. of Public Health, Eastern Regional Health Authority
p.000030: Mr. Dermot Gleeson
p.000030: Senior Counsel
p.000030: Mr. Kenneth Kearon
p.000030: Irish School of Ecumenics
p.000030: Mr. Dan Lynch
p.000030: Secretary to the Research Ethics Committee of St. James's Hospital and the Federated Dublin Voluntary Hospitals
p.000030: Professor Anne Scott
p.000030: School of Nursing, Dublin City University
p.000030: Dr. Siobhán O’Sullivan
p.000030: Irish Council for Bioethics
p.000030:
p.000030: Terms of reference
p.000030: 1. To review in depth, the existing practices of Ethics Committees in the Republic of Ireland, with particular
p.000030: reference to Research Ethics Committees.
...
Social / gender
Searching for indicator gender:
(return to top)
p.000009: particular research project.
p.000009:
p.000010: 10
p.000010:
p.000010: Section 3 : Research Ethics Committees
p.000010:
p.000010: 3.1 Constituting a Research Ethics Committee
p.000010: A REC should be constituted to ensure competent ethical review of research proposals submitted to the committee and an
p.000010: independent and just review of any such proposals. The REC must define its mandate and authority and must make clear
p.000010: the jurisdiction of the REC and its relationship to other relevant bodies or institutions. Institutions/ organisations
p.000010: under whose authority RECs are established must ensure that RECs have appropriate financial (including indemnity
p.000010: arrangements for members of the committee) and administrative support to fulfil their function. A publicly available
p.000010: standard operating procedure should be produced and RECs should act in accordance with their operating procedures.
p.000010:
p.000010: 3.2 Composition of a Research Ethics Committee
p.000010: The guiding principle for appointing members to a REC is to ensure that the committee has the appropriate expertise,
p.000010: skills, knowledge and perspectives to ensure an adequate and thorough ethics review. RECs should be multidisciplinary
p.000010: and multi-sectoral in composition. Attention should be paid to age and gender balance. One third
p.000010: of the total membership should be lay members. The qualifications for lay members are independence from the
p.000010: institution/organisation under whose authority the REC is established and their non-involvement in scientific, clinical
p.000010: practice and legal work. Those who have no experience in professions associated with research on human beings are more
p.000010: likely to bring a truly lay perspective. Committee members should elect a chairperson and a vice-chairperson.
p.000010: In general it would be advisable for a committee’s membership to include but not be restricted to the following:
p.000010: (a) member(s) with knowledge of and current experience in the areas of research which are regularly considered by the
p.000010: REC (e.g. scientist).
p.000010: (b) member(s) with knowledge of and current experience in the professional care, counselling or treatment of people
p.000010: (e.g. nurse, medical practitioner, clinical psychologist, as appropriate)
p.000010: (c) member(s) with training in ethics (e.g. ethicist, philosopher, theologian)
p.000010: (d) member(s) with a qualification in law
p.000010: (e) member(s) with training in statistics
p.000010: (f) lay member(s)
p.000010:
p.000011: 11
p.000011:
p.000011: A minimum of seven members of the REC is required to be present at a meeting held to determine an opinion in relation
p.000011: to an application to the REC. There should be a reasonable representation of members, which must include the
p.000011: chairperson, or in his/her absence the vice-chairperson; a member with relevant clinical and/or methodological
...
p.000015:
p.000016: 16
p.000016:
p.000016: 5.2 Elements of Review
p.000016: When reviewing research proposals a REC should consider the following:
p.000016: Scientific design and conduct of the study
p.000016: (a) the appropriateness of the study design in relation to the objectives of the study, the statistical methodology
p.000016: (including sample size calculation) and the potential for reaching reliable conclusions with the smallest number of
p.000016: research participants/volunteers
p.000016: (b) the justification of predictable risks and inconveniences weighed against the anticipated benefits for the
p.000016: research participants/volunteers and the concerned communities
p.000016: (c) the justification for use of control arms in trials (whether placebo or active comparator), and the randomisation
p.000016: programme to be used
p.000016: (d) criteria for withdrawing participants/volunteers prematurely
p.000016: (e) criteria for suspending or terminating research
p.000016: (f) the adequacy of conditions made for the monitoring and auditing the conduct of the research
p.000016: (g) the adequacy of the site including the supporting staff, facilities and emergency procedures
p.000016: (h) the form in which the results will be reported and published
p.000016:
p.000016: Recruitment of research participants/volunteers
p.000016: (a) the characteristics of the population from which the participants/volunteers will be drawn (including gender,
p.000016: age, ethnicity) and the justification for any decisions made in this regard
p.000016: (b) the method by which initial contact and recruitment are to be conducted
p.000016: (c) the method by which information is to be conveyed to participants/volunteers or their representatives and by
p.000016: which means consent is to be obtained
p.000016: (d) inclusion and exclusion criteria for research participants/volunteers
p.000016:
p.000016: Care and protection of research participants/volunteers
p.000016: (a) the safety of any intervention to be used in the proposed research
p.000016: (b) the suitability of the investigator for the proposed research in relation to his/her qualifications and
p.000016: experience
p.000016: (c) any plans to withdraw or withhold standard therapies or clinical management protocols for the purpose of the
p.000016: research, and the justification for such action
p.000016:
p.000017: 17
p.000017:
p.000017: (d) the adequacy of health and social supervision and psychological support for the research participants/volunteers
p.000017: (e) the adequacy of medical supervision and follow-up concerning the participants/volunteers
p.000017: (f) steps to be followed if participants/volunteers decide to withdraw during the course of the research
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000008: participants
p.000008: (h) Observational clinical research
p.000008: (i) Access to personal information by means of questionnaires, interviews or other techniques of information
p.000008: gathering
p.000008: (j) Research involving the secondary use of data (use of data not collected for that research purpose), if any form
p.000008: of identifier is involved and/or if health information pertaining to individuals is involved
p.000008: (k) Case studies, when a series of subject observations allow possible extrapolation of generalisation of the results
p.000008: from the reported cases and when there is an intent to publish or disseminate the data
p.000008: Note to item 2.1(g) above: As supervised student research is conducted primarily for the purpose of educating students
p.000008: on research techniques and methodologies, REC should review research protocols with a view to contributing to the
p.000008: students’ education concerning scientific and ethical principles governing research.
p.000008:
p.000009: 9
p.000009:
p.000009: 2.2 Activities that may not require REC review
p.000009: Review by REC may not be required for:
p.000009: (a) Research utilising existing publicly available documents or data
p.000009: (b) Observational studies in public places in which the identity of the participants remains anonymous
p.000009: (c) Case study of one patient with the proviso that written informed consent has been obtained from the relevant
p.000009: subject
p.000009: (d) Quality assurance studies
p.000009: (e) Audits
p.000009:
p.000009: The opinion of the REC should be sought whenever there is any doubt about the applicability of this guidance to a
p.000009: particular research project.
p.000009:
p.000010: 10
p.000010:
p.000010: Section 3 : Research Ethics Committees
p.000010:
p.000010: 3.1 Constituting a Research Ethics Committee
p.000010: A REC should be constituted to ensure competent ethical review of research proposals submitted to the committee and an
p.000010: independent and just review of any such proposals. The REC must define its mandate and authority and must make clear
p.000010: the jurisdiction of the REC and its relationship to other relevant bodies or institutions. Institutions/ organisations
p.000010: under whose authority RECs are established must ensure that RECs have appropriate financial (including indemnity
p.000010: arrangements for members of the committee) and administrative support to fulfil their function. A publicly available
p.000010: standard operating procedure should be produced and RECs should act in accordance with their operating procedures.
p.000010:
p.000010: 3.2 Composition of a Research Ethics Committee
p.000010: The guiding principle for appointing members to a REC is to ensure that the committee has the appropriate expertise,
p.000010: skills, knowledge and perspectives to ensure an adequate and thorough ethics review. RECs should be multidisciplinary
p.000010: and multi-sectoral in composition. Attention should be paid to age and gender balance. One third
p.000010: of the total membership should be lay members. The qualifications for lay members are independence from the
p.000010: institution/organisation under whose authority the REC is established and their non-involvement in scientific, clinical
p.000010: practice and legal work. Those who have no experience in professions associated with research on human beings are more
p.000010: likely to bring a truly lay perspective. Committee members should elect a chairperson and a vice-chairperson.
p.000010: In general it would be advisable for a committee’s membership to include but not be restricted to the following:
p.000010: (a) member(s) with knowledge of and current experience in the areas of research which are regularly considered by the
p.000010: REC (e.g. scientist).
p.000010: (b) member(s) with knowledge of and current experience in the professional care, counselling or treatment of people
p.000010: (e.g. nurse, medical practitioner, clinical psychologist, as appropriate)
p.000010: (c) member(s) with training in ethics (e.g. ethicist, philosopher, theologian)
p.000010: (d) member(s) with a qualification in law
p.000010: (e) member(s) with training in statistics
p.000010: (f) lay member(s)
p.000010:
p.000011: 11
p.000011:
p.000011: A minimum of seven members of the REC is required to be present at a meeting held to determine an opinion in relation
p.000011: to an application to the REC. There should be a reasonable representation of members, which must include the
p.000011: chairperson, or in his/her absence the vice-chairperson; a member with relevant clinical and/or methodological
p.000011: expertise; a lay member and a member who is independent of the institution/organisation under whose authority the REC
p.000011: is established.
p.000011: A REC should have sufficient members to secure the minimum number of members required to determine an opinion on an
p.000011: application.
p.000011: A REC may appoint a person to act as an alternate for each member of the committee, where the alternate satisfies the
p.000011: same membership criteria as the member. The standard operating procedure of the REC should identify the primary member
p.000011: for whom each alternate member may substitute. When alternates substitute for a primary member, the alternate member
p.000011: should have received and reviewed the same material that the primary member received or would have received. An
p.000011: alternate can only vote if the member for whom he/she acts as an alternate is absent.
p.000011: Where a chairperson or members of a REC believe there is insufficient expertise on the committee to assess an
p.000011: application or an issue, the committee should seek additional expert advice. Experts may have specialist knowledge in
p.000011: particular fields of science or medicine or they may be representatives of communities or special interest groups.
p.000011: Co-opted expert members are not entitled to vote.
p.000011:
p.000011: 3.3 Appointment of Members of a Research Ethics Committee
p.000011: Clear procedures should be formulated to identify and appoint members to RECs. These should include:
p.000011: (a) procedures for selecting candidates
p.000011: (b) procedures for appointing members
p.000011: (c) name or description of person or institution responsible for making appointments
p.000011: (d) duration of an appointment
p.000011: (e) policy for renewal of an appointment
p.000011: (f) procedure for replacing members
p.000011: (g) procedure for resignation of a member
p.000011: (h) procedure for the disqualification of a member
p.000011: (i) training of members
p.000011:
p.000012: 12
p.000012:
...
p.000014: clinical experience with the product to date (e.g. recent investigator’s brochure, a summary of the product’s
p.000014: characteristics) should be included
p.000014: (g) current curriculum vitae of the applicant(s) (updated, signed and dated)
p.000014: (h) material used (including advertisements) for participant/volunteer recruitment
p.000014: (i) patient/volunteer information
p.000014: (j) a full description of the process to obtain and document consent
p.000014: (k) suitable arrangements for indemnifying participants/volunteers and investigators
p.000014: (l) all significant previous decisions (e.g. those leading to a negative decision or modified proposal) by other RECs
p.000014: or regulatory authorities for the proposed research (whether in the same location or elsewhere) and an indication of
p.000014: the modification(s) to the protocol made on that account. The reasons for previous negative decisions should be
p.000014: provided.
p.000014:
p.000015: 15
p.000015: Section 5 : Review procedure
p.000015: All properly submitted and valid applications shall be reviewed in a timely fashion and according to an established
p.000015: review procedure described in the REC’s standard operating procedures. A valid application is one which has been
p.000015: submitted by an appropriate investigator, is complete, with all the necessary documents attached, and is signed and
p.000015: dated.
p.000015: Under the Clinical Trials on Medicinal Products for Human Use Regulations 2004 RECs are required to give an opinion on
p.000015: research protocols involving standard products, no more than 60 days after acknowledgement of receipt of a “valid”
p.000015: application has been received. Where research involves gene therapy, somatic cell therapy or genetically modified
p.000015: organisms RECs are required to make a decision no more than 90 days after acknowledging that a “valid” application has
p.000015: been received. Where external consultation is deemed necessary RECs are permitted a total of 180 days to make a
p.000015: decision following acknowledgement of receipt of a “valid” application. There are no time limits imposed on RECs making
p.000015: a decision on research involving xenogenic cell therapy.
p.000015:
p.000015: 5.1 Meeting Requirements
p.000015: RECs should meet in accordance with regularly scheduled dates. Meeting requirements should include the following:
p.000015: (a) meetings should follow a previously scheduled agenda
p.000015: (b) members should be given sufficient time to review relevant documentation
p.000015: (c) meetings should be minuted. There should be an approval procedure for the minutes
p.000015: (d) when appropriate, the sponsor and/or investigator may be invited to present the proposal to the members and
p.000015: answer any questions a committee may have
p.000015: (e) when appropriate, independent experts (e.g. researchers with specific competence, ethicists, statisticians) may
p.000015: be invited to attend
p.000015:
p.000016: 16
p.000016:
p.000016: 5.2 Elements of Review
p.000016: When reviewing research proposals a REC should consider the following:
p.000016: Scientific design and conduct of the study
p.000016: (a) the appropriateness of the study design in relation to the objectives of the study, the statistical methodology
p.000016: (including sample size calculation) and the potential for reaching reliable conclusions with the smallest number of
...
p.000018: 5.3 Expedited Review
p.000018: Where a REC wishes to incorporate expedited review into its standard operating procedures the following specifications
p.000018: should be taken into account:
p.000018: (a) the research should present minimal risk to participants/volunteers e.g. risks related to invasion of privacy
p.000018: and/or breach of confidentiality
p.000018:
p.000019: 19
p.000019:
p.000019: (b) expedited review should be undertaken by the chairperson of the REC or by one or more experienced reviewers
p.000019: i.e. REC members designated by the chairperson
p.000019: (c) reviewers may not disapprove research using expedited review. Research may only be disapproved in accordance with
p.000019: non-expedited operational procedures
p.000019: (d) each REC which uses expedited review must adopt a method for keeping all members informed of research proposals
p.000019: which have been approved under this procedure
p.000019:
p.000020: 20
p.000020:
p.000020: 5.4 Decision-making
p.000020: A REC should ensure that all supporting documentation for an application is complete before coming to a decision on a
p.000020: research proposal. A REC should comply with a pre-defined method for arriving at a decision. It is recommended that REC
p.000020: use the consensus model where the process of discussion and debate will lead to a decision, rather than a formal
p.000020: vote-casting process. Under the consensus model, the proposal will be approved when all members present are willing to
p.000020: allow the proposal to proceed. In cases in which consensus seems unlikely, the chairperson may call for a vote with a
p.000020: two-thirds majority required for approval. Dissenting members should be afforded the opportunity to append an opinion
p.000020: to the REC decision.
p.000020: The REC should accommodate reasonable requests from investigators to participate in discussions about their proposal,
p.000020: but may not be present when the REC is making its decision.
p.000020: It is desirable to adopt a consistent approach to granting or declining approval of a proposal. It is recommended that
p.000020: the following terminology be used in communicating the decision of the REC to an applicant:
p.000020: i. Approved, the applicant may conduct the research as outlined in the research proposal submitted to the REC
p.000020: ii. Provisionally approved, subject to recommended revisions to the proposal or answers to questions posed to the
p.000020: applicant. The revisions and/or answers must be resubmitted to the REC before receiving final approval. No research may
p.000020: be conducted prior to receiving final approval.
p.000020: iii. Approval declined detailed reasons for declining approval should be forwarded to the applicant, with or without
p.000020: an invitation to resubmit a substantially altered proposal for reconsideration.
p.000020: The REC decision should be communicated to the applicant in writing within two weeks of the meeting at which the
p.000020: decision was taken. The chairperson should sign and date all such communications. The decision is to include, but is
p.000020: not limited to the following:
p.000020: (a) project identification number and/or date of the proposal that the decision is based on
p.000020: (b) exact title of proposal reviewed
p.000020: (c) name and title of applicant
p.000020: (d) name of REC taking the decision
p.000020: (e) date and place of the decision
p.000020: (f) chairperson and list of members present when decision was taken
p.000020: (g) clear statement of the decision taken
p.000020:
p.000021: 21
p.000021:
...
p.000022: of risk to participants in the research project. As a minimum the REC should require an annual report from
p.000022: investigators on matters including:
p.000022: (a) progress to date or outcome in the case of a completed project
p.000022: (b) a statement of compliance with the approved proposal and/or amendments to the proposal
p.000022: (c) a description of measures taken to maintain and secure personal information/records pertaining to the research
p.000022:
p.000022: 6.2 Amendments
p.000022: Any significant alteration to a previously approved proposal must receive prior approval from the REC before
p.000022: implementation. Significant alterations include changes to:
p.000022: (a) personnel (including where work has been subcontracted to another investigator) any changes to named researchers
p.000022: responsible for the conduct of the research; any change to the personnel involved in obtaining informed consent or
p.000022: having access to personal information about research participants/volunteers
p.000022: (b) method
p.000022: (c) design of the study
p.000022: (d) duration of the study
p.000022: (e) informed consent procedures
p.000022: (f) patient information leaflets
p.000022: (g) method of recruitment
p.000022:
p.000022: Under the Clinical Trials on Medicinal Products for Human Use Regulations 2004, the REC must, within a period of 35
p.000022: days from the day of receipt of a valid notice of an amendment, furnish the applicant with an opinion.
p.000022:
p.000023: 23
p.000023:
p.000023: 6.3 Adverse Event
p.000023: As a condition of approval of the research proposal the REC should require investigators to immediately report any
p.000023: serious or unexpected adverse events on participants or unforeseen events that might affect the benefits/risks ratio of
p.000023: the proposal.
p.000023: A serious adverse event is defined as any untoward medical occurrence that:
p.000023: (a) results in death
p.000023: (b) is life threatening
p.000023: (c) requires in-patient hospitalisation or prolongation of existing hospitalisation
p.000023: (d) results in persistent or significant disability/incapacity
p.000023: (e) results in a congenital anomaly/birth defect
p.000023:
p.000023: An unexpected event is an adverse reaction, the nature and severity of which is not consistent with the applicable
p.000023: product information.
p.000023: Investigators may take urgent safety measures to eliminate immediate jeopardy to the research participants/volunteers
p.000023: prior to approval by the REC. However, investigators should provide the REC with a written report of any action taken
p.000023: at the earliest possible opportunity. The REC should review any new material and decide whether there are sufficient
p.000023: grounds for changing its initial decision to grant approval to the proposal.
p.000023: Under the Clinical Trials on Medicinal Products for Human Use Regulations 2004, a written report of any urgent safety
p.000023: measures taken should be submitted to the REC no later than three days from the date the measures were taken.
p.000023:
p.000023: 6.4 Suspension or Termination of a Project
...
p.000027: is being or has been reviewed by another REC and if so, the identity and decision of the REC.
p.000027: In order to facilitate prompt and efficient review of multi-centre studies:
p.000027: (a) An investigator may wish to distinguish between core elements of the research that cannot be altered without
p.000027: invalidating the pooling of research data and those elements which can be altered to comply with local requirements
p.000027: (b) RECs may wish to communicate with, give or receive advice from other RECs reviewing the proposal
p.000027: (c) RECs may wish to accept a scientific assessment of the proposal from another REC
p.000027: (d) RECs may agree to accept the conclusions of a single review committee
p.000027:
p.000027: Note to item 9(c) above: A common scientific assessment could be produced by qualified members of a number of RECs
p.000027: involved or by one REC which has accepted the role.
p.000027: Note to item 9(d) above: A single committee could review the scientific and ethical aspects of a proposal. Individual
p.000027: committees could verify the practicability of the proposal in the institution/ organisation and that the proposal
p.000027: conforms to the ethos of the institution/organisation in which the research will be carried out.
p.000027: Under the Clinical Trials on Medicinal Products for Human Use Regulations 2004 in the case of multi-centre clinical
p.000027: trials, either limited to sites in Ireland, or to sites located in more than one EU member state, a single ethics
p.000027: committee opinion must be given by a recognised ethics committee and this opinion must prevail at all centres where the
p.000027: trial is to be conducted.
p.000027:
p.000028: 28
p.000028:
p.000028: Supporting Documents
p.000028: CIOMS (Council for International Organisations of Medical Sciences). International Ethical Guidelines for Biomedical
p.000028: Research Involving Human Subjects (1993;2002).
p.000028: CIOMS (Council for International Organisations of Medical Sciences). International Guidelines for Ethical Review of
p.000028: Epidemiological Studies (1991).
p.000028: Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the
p.000028: Application of Biology and Medicine: Convention on Human Rights and Biomedicine (1997).
p.000028: Department of Health & Children. Clinical Trials on Medicinal Products for Human Use Regulations (2004).
p.000028: European Forum for Good Clinical Practice. Guidelines and Recommendations for European Ethics Committees
p.000028: (1995; 1997)
p.000028: Health Research Board. Genetic Research and Human Biological Samples: The Legal and Ethical Considerations
p.000028: (2002)
p.000028: International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human
p.000028: Use (ICH). Note for Guidance on Good Clinical Practice (1996).
p.000028: Irish College of General Practitioners. Ethical questions to be considered by a research ethics committee when
p.000028: approving clinical trials which involve genetic testing (2003).
...
Searching for indicator philosophy:
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p.000030: Dept. of Public Health Medicine and Epidemiology, University College Dublin
p.000030: Dr. Margaret Fitzgerald Vice-Chairperson
p.000030: Dept. of Public Health, Eastern Regional Health Authority
p.000030: Mr. Dermot Gleeson
p.000030: Senior Counsel
p.000030: Mr. Kenneth Kearon
p.000030: Irish School of Ecumenics
p.000030: Mr. Dan Lynch
p.000030: Secretary to the Research Ethics Committee of St. James's Hospital and the Federated Dublin Voluntary Hospitals
p.000030: Professor Anne Scott
p.000030: School of Nursing, Dublin City University
p.000030: Dr. Siobhán O’Sullivan
p.000030: Irish Council for Bioethics
p.000030:
p.000030: Terms of reference
p.000030: 1. To review in depth, the existing practices of Ethics Committees in the Republic of Ireland, with particular
p.000030: reference to Research Ethics Committees.
p.000030: 2. To identify best practice in the area internationally and across the island of Ireland.
p.000030: 3. To produce guidance on the composition and operation of Ethics Committees and to suggest a national structure for
p.000030: such organisations in the Republic of Ireland.
p.000030: 4. To report to Council on all aspects of the deliberations and conclusions of the working group on Ethics
p.000030: Committees.
p.000030:
p.000031: 31
p.000031:
p.000031: The Irish Council for Bioethics
p.000031: Comhairle Bitheitice na hÉireann
p.000031: Mr Dermot Gleeson SC, MRIA Chairperson
p.000031: Professor Peter Whittaker (Vice Chair) Institute of Environment, Philosophy and Public Policy at Lancaster University
p.000031: Professor Patrick Cunningham, MRIA, Department of Genetics, Trinity College Dublin
p.000031: Mr Matt Dempsey, Irish Farmers' Journal
p.000031: Dr Dolores Dooley, Department of Philosophy, National University of Ireland, Cork
p.000031: Dr Margaret Fitzgerald, Department of Public Health, Eastern Regional Health Authority
p.000031: Dr Patrick Flanagan, formerly of Environmental Protection Agency
p.000031: Professor Patrick Hannon, St Patrick's College, National University of Ireland, Maynooth
p.000031: Mr. Kenneth Kearon, Irish School of Ecumenics
p.000031: Professor Cecily Kelleher, Department of Public Health, Medicine and Epidemiology, University College Dublin
p.000031: Professor Mark Lawler, Cancer Molecular Diagnostics Laboratory, St James' Hospital
p.000031: Professor Tony McGleenan, School of Law, University of Ulster
p.000031: Dr Peter McKenna, Department of Obstetrics and Gynaecology, Rotunda Hospital
p.000031: Ms Mary Mulvihill, Science Journalist
p.000031: Dr Nora O’Brien, Department of Food Science, Food Technology and Nutrition, National University of Ireland, Cork
p.000031: Professor Fergal O’Gara, Department of Microbiology, National University of Ireland, Cork
p.000031: Professor Ronan O’Regan, MRIA, Department of Human Anatomy and Physiology, University College Dublin
p.000031: Professor Anne Scott, School of Nursing, Dublin City University
p.000031: Mr Asim Sheikh, BL, Division of Legal Medicine, University College Dublin
p.000031: Professor Seán Strain, School of Biomedical Sciences, University of Ulster
p.000031: Secretariat
p.000031: Dr Siobhán O’Sullivan, Scientific Director Mr Pauric Dempsey
p.000031: Ms Emily de Grae
p.000031:
p.000031: Terms of Reference
p.000031: 1. To identify and interpret the ethical questions raised by biological and medical research in order to respond to
p.000031: and anticipate questions of substantive concern.
p.000031: 2. To investigate and report on such questions in the interests of promoting public understanding informed
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.000006: exercise of informed consent, which requires that people’s beliefs and opinions be respected, and that they be allowed
p.000006: to choose for themselves whether or not they wish to participate in research. In order to choose they must be informed
p.000006: of their options, including the possible risks and benefits of those options. They must be assured of the necessity of
p.000006: the research, including the fact that all possible risks have been minimised, and, where significant risk is
p.000006: involved, that no other method of research is possible. They must be asked to make their choice in circumstances, which
p.000006: are free of coercion or undue pressure, and they must be free to withdraw from the research process at any time. This
p.000006: decision must not affect their health care in any way. Ethical review should focus on the entire process
p.000006: of obtaining consent, not just on the written consent documents, but on how participants are informed of the study, who
p.000006: discusses it with them, and in what circumstances. The requirement for free and informed consent presumes that adequate
p.000006: information is provided to obtain an informed judgement, that information provided is in a form and delivered in a
p.000006: manner that will enable it to be understood and that the consent is voluntary in nature.
p.000006: In the research context, respect for persons requires that limitations to an individual’s autonomy are recognised and
p.000006: that appropriate mechanisms are in place to protect against abuse, exploitation or discrimination. Of particular
p.000006: concern here are children, individuals with an intellectual disability or with short or long-term unconsciousness.
p.000006: Parental or guardian’s consent must be sought, but such consent can only be accepted where the research in question is
p.000006: clearly in the best interests of the subject concerned, or where the research concerned carries minimal risk or impact
p.000006: on the subject concerned.
p.000006:
p.000007: 7
p.000007:
p.000007: 1.2 Privacy and Confidentiality
p.000007: Privacy and confidentiality are an integral part of the protection and promotion of human dignity and help to protect
p.000007: and maintain a person’s mental or psychological well-being. The need for research should be weighed against
p.000007: infringements of privacy and steps must be taken to ensure that individuals are protected from any harm that might be
p.000007: caused as the result of access to their personal information.
p.000007:
p.000007: 1.3 Validity of Research Proposals
p.000007: The scientific merit of a study is itself an ethical issue. The essential features of ethically justified research
...
General/Other / Incapacitated
Searching for indicator incapacity:
(return to top)
p.000022: implementation. Significant alterations include changes to:
p.000022: (a) personnel (including where work has been subcontracted to another investigator) any changes to named researchers
p.000022: responsible for the conduct of the research; any change to the personnel involved in obtaining informed consent or
p.000022: having access to personal information about research participants/volunteers
p.000022: (b) method
p.000022: (c) design of the study
p.000022: (d) duration of the study
p.000022: (e) informed consent procedures
p.000022: (f) patient information leaflets
p.000022: (g) method of recruitment
p.000022:
p.000022: Under the Clinical Trials on Medicinal Products for Human Use Regulations 2004, the REC must, within a period of 35
p.000022: days from the day of receipt of a valid notice of an amendment, furnish the applicant with an opinion.
p.000022:
p.000023: 23
p.000023:
p.000023: 6.3 Adverse Event
p.000023: As a condition of approval of the research proposal the REC should require investigators to immediately report any
p.000023: serious or unexpected adverse events on participants or unforeseen events that might affect the benefits/risks ratio of
p.000023: the proposal.
p.000023: A serious adverse event is defined as any untoward medical occurrence that:
p.000023: (a) results in death
p.000023: (b) is life threatening
p.000023: (c) requires in-patient hospitalisation or prolongation of existing hospitalisation
p.000023: (d) results in persistent or significant disability/incapacity
p.000023: (e) results in a congenital anomaly/birth defect
p.000023:
p.000023: An unexpected event is an adverse reaction, the nature and severity of which is not consistent with the applicable
p.000023: product information.
p.000023: Investigators may take urgent safety measures to eliminate immediate jeopardy to the research participants/volunteers
p.000023: prior to approval by the REC. However, investigators should provide the REC with a written report of any action taken
p.000023: at the earliest possible opportunity. The REC should review any new material and decide whether there are sufficient
p.000023: grounds for changing its initial decision to grant approval to the proposal.
p.000023: Under the Clinical Trials on Medicinal Products for Human Use Regulations 2004, a written report of any urgent safety
p.000023: measures taken should be submitted to the REC no later than three days from the date the measures were taken.
p.000023:
p.000023: 6.4 Suspension or Termination of a Project
p.000023: In the case of a premature suspension/termination of a study, the REC should require the investigator to inform the REC
p.000023: of the reasons for premature suspension/termination. This should be accompanied by a summary of the results obtained in
p.000023: the study up to the point of suspension/termination. The REC should require investigators to notify the committee once
p.000023: a study has been completed. The REC should receive a final study report, summarising the main findings.
p.000023:
p.000024: 24
p.000024:
p.000024: Under the Clinical Trials on Medicinal Products for Human Use Regulations 2004, the REC must be provided with a
p.000024: detailed written explanation of the reasons for suspension or premature termination of a clinical trial within 15 days
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000015: (c) meetings should be minuted. There should be an approval procedure for the minutes
p.000015: (d) when appropriate, the sponsor and/or investigator may be invited to present the proposal to the members and
p.000015: answer any questions a committee may have
p.000015: (e) when appropriate, independent experts (e.g. researchers with specific competence, ethicists, statisticians) may
p.000015: be invited to attend
p.000015:
p.000016: 16
p.000016:
p.000016: 5.2 Elements of Review
p.000016: When reviewing research proposals a REC should consider the following:
p.000016: Scientific design and conduct of the study
p.000016: (a) the appropriateness of the study design in relation to the objectives of the study, the statistical methodology
p.000016: (including sample size calculation) and the potential for reaching reliable conclusions with the smallest number of
p.000016: research participants/volunteers
p.000016: (b) the justification of predictable risks and inconveniences weighed against the anticipated benefits for the
p.000016: research participants/volunteers and the concerned communities
p.000016: (c) the justification for use of control arms in trials (whether placebo or active comparator), and the randomisation
p.000016: programme to be used
p.000016: (d) criteria for withdrawing participants/volunteers prematurely
p.000016: (e) criteria for suspending or terminating research
p.000016: (f) the adequacy of conditions made for the monitoring and auditing the conduct of the research
p.000016: (g) the adequacy of the site including the supporting staff, facilities and emergency procedures
p.000016: (h) the form in which the results will be reported and published
p.000016:
p.000016: Recruitment of research participants/volunteers
p.000016: (a) the characteristics of the population from which the participants/volunteers will be drawn (including gender,
p.000016: age, ethnicity) and the justification for any decisions made in this regard
p.000016: (b) the method by which initial contact and recruitment are to be conducted
p.000016: (c) the method by which information is to be conveyed to participants/volunteers or their representatives and by
p.000016: which means consent is to be obtained
p.000016: (d) inclusion and exclusion criteria for research participants/volunteers
p.000016:
p.000016: Care and protection of research participants/volunteers
p.000016: (a) the safety of any intervention to be used in the proposed research
p.000016: (b) the suitability of the investigator for the proposed research in relation to his/her qualifications and
p.000016: experience
p.000016: (c) any plans to withdraw or withhold standard therapies or clinical management protocols for the purpose of the
p.000016: research, and the justification for such action
p.000016:
p.000017: 17
p.000017:
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000008: from the reported cases and when there is an intent to publish or disseminate the data
p.000008: Note to item 2.1(g) above: As supervised student research is conducted primarily for the purpose of educating students
p.000008: on research techniques and methodologies, REC should review research protocols with a view to contributing to the
p.000008: students’ education concerning scientific and ethical principles governing research.
p.000008:
p.000009: 9
p.000009:
p.000009: 2.2 Activities that may not require REC review
p.000009: Review by REC may not be required for:
p.000009: (a) Research utilising existing publicly available documents or data
p.000009: (b) Observational studies in public places in which the identity of the participants remains anonymous
p.000009: (c) Case study of one patient with the proviso that written informed consent has been obtained from the relevant
p.000009: subject
p.000009: (d) Quality assurance studies
p.000009: (e) Audits
p.000009:
p.000009: The opinion of the REC should be sought whenever there is any doubt about the applicability of this guidance to a
p.000009: particular research project.
p.000009:
p.000010: 10
p.000010:
p.000010: Section 3 : Research Ethics Committees
p.000010:
p.000010: 3.1 Constituting a Research Ethics Committee
p.000010: A REC should be constituted to ensure competent ethical review of research proposals submitted to the committee and an
p.000010: independent and just review of any such proposals. The REC must define its mandate and authority and must make clear
p.000010: the jurisdiction of the REC and its relationship to other relevant bodies or institutions. Institutions/ organisations
p.000010: under whose authority RECs are established must ensure that RECs have appropriate financial (including indemnity
p.000010: arrangements for members of the committee) and administrative support to fulfil their function. A publicly available
p.000010: standard operating procedure should be produced and RECs should act in accordance with their operating procedures.
p.000010:
p.000010: 3.2 Composition of a Research Ethics Committee
p.000010: The guiding principle for appointing members to a REC is to ensure that the committee has the appropriate expertise,
p.000010: skills, knowledge and perspectives to ensure an adequate and thorough ethics review. RECs should be multidisciplinary
p.000010: and multi-sectoral in composition. Attention should be paid to age and gender balance. One third
p.000010: of the total membership should be lay members. The qualifications for lay members are independence from the
p.000010: institution/organisation under whose authority the REC is established and their non-involvement in scientific, clinical
p.000010: practice and legal work. Those who have no experience in professions associated with research on human beings are more
p.000010: likely to bring a truly lay perspective. Committee members should elect a chairperson and a vice-chairperson.
p.000010: In general it would be advisable for a committee’s membership to include but not be restricted to the following:
p.000010: (a) member(s) with knowledge of and current experience in the areas of research which are regularly considered by the
p.000010: REC (e.g. scientist).
p.000010: (b) member(s) with knowledge of and current experience in the professional care, counselling or treatment of people
p.000010: (e.g. nurse, medical practitioner, clinical psychologist, as appropriate)
p.000010: (c) member(s) with training in ethics (e.g. ethicist, philosopher, theologian)
p.000010: (d) member(s) with a qualification in law
p.000010: (e) member(s) with training in statistics
p.000010: (f) lay member(s)
p.000010:
p.000011: 11
p.000011:
p.000011: A minimum of seven members of the REC is required to be present at a meeting held to determine an opinion in relation
p.000011: to an application to the REC. There should be a reasonable representation of members, which must include the
p.000011: chairperson, or in his/her absence the vice-chairperson; a member with relevant clinical and/or methodological
p.000011: expertise; a lay member and a member who is independent of the institution/organisation under whose authority the REC
p.000011: is established.
p.000011: A REC should have sufficient members to secure the minimum number of members required to determine an opinion on an
p.000011: application.
p.000011: A REC may appoint a person to act as an alternate for each member of the committee, where the alternate satisfies the
p.000011: same membership criteria as the member. The standard operating procedure of the REC should identify the primary member
p.000011: for whom each alternate member may substitute. When alternates substitute for a primary member, the alternate member
p.000011: should have received and reviewed the same material that the primary member received or would have received. An
p.000011: alternate can only vote if the member for whom he/she acts as an alternate is absent.
p.000011: Where a chairperson or members of a REC believe there is insufficient expertise on the committee to assess an
p.000011: application or an issue, the committee should seek additional expert advice. Experts may have specialist knowledge in
p.000011: particular fields of science or medicine or they may be representatives of communities or special interest groups.
p.000011: Co-opted expert members are not entitled to vote.
p.000011:
p.000011: 3.3 Appointment of Members of a Research Ethics Committee
p.000011: Clear procedures should be formulated to identify and appoint members to RECs. These should include:
p.000011: (a) procedures for selecting candidates
p.000011: (b) procedures for appointing members
p.000011: (c) name or description of person or institution responsible for making appointments
p.000011: (d) duration of an appointment
p.000011: (e) policy for renewal of an appointment
p.000011: (f) procedure for replacing members
p.000011: (g) procedure for resignation of a member
...
p.000028: involving Humans (2001).
p.000028: Nuremberg Code. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol.
p.000028: 2, pp. 181-182. (1947).
p.000028:
p.000029: 29
p.000029:
p.000029: Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
p.000029: Belmont report: ethical principles and guidelines for the protection of human subjects of research (1979)
p.000029: UNESCO (United Nations Educational, Scientific, Cultural Organization. Universal Declaration on the Human Genome and
p.000029: Human Rights (1997).
p.000029: World Health Organisation. Draft Operational Guidelines for Ethics Committees Reviewing Biomedical Research
p.000029: (2000).
p.000029: World Medical Association. Declaration of Helsinki: Recommendations Guiding Physicians in Biomedical Research Involving
p.000029: Subjects (1964; 1975; 1983; 1989; 1996, 2000)
p.000029:
p.000030: 30
p.000030:
p.000030: Working Group on Research Ethics Committees
p.000030: Professor Cecily Kelleher Chairperson
p.000030: Dept. of Public Health Medicine and Epidemiology, University College Dublin
p.000030: Dr. Margaret Fitzgerald Vice-Chairperson
p.000030: Dept. of Public Health, Eastern Regional Health Authority
p.000030: Mr. Dermot Gleeson
p.000030: Senior Counsel
p.000030: Mr. Kenneth Kearon
p.000030: Irish School of Ecumenics
p.000030: Mr. Dan Lynch
p.000030: Secretary to the Research Ethics Committee of St. James's Hospital and the Federated Dublin Voluntary Hospitals
p.000030: Professor Anne Scott
p.000030: School of Nursing, Dublin City University
p.000030: Dr. Siobhán O’Sullivan
p.000030: Irish Council for Bioethics
p.000030:
p.000030: Terms of reference
p.000030: 1. To review in depth, the existing practices of Ethics Committees in the Republic of Ireland, with particular
p.000030: reference to Research Ethics Committees.
p.000030: 2. To identify best practice in the area internationally and across the island of Ireland.
p.000030: 3. To produce guidance on the composition and operation of Ethics Committees and to suggest a national structure for
p.000030: such organisations in the Republic of Ireland.
p.000030: 4. To report to Council on all aspects of the deliberations and conclusions of the working group on Ethics
p.000030: Committees.
p.000030:
p.000031: 31
p.000031:
p.000031: The Irish Council for Bioethics
p.000031: Comhairle Bitheitice na hÉireann
p.000031: Mr Dermot Gleeson SC, MRIA Chairperson
p.000031: Professor Peter Whittaker (Vice Chair) Institute of Environment, Philosophy and Public Policy at Lancaster University
p.000031: Professor Patrick Cunningham, MRIA, Department of Genetics, Trinity College Dublin
p.000031: Mr Matt Dempsey, Irish Farmers' Journal
p.000031: Dr Dolores Dooley, Department of Philosophy, National University of Ireland, Cork
p.000031: Dr Margaret Fitzgerald, Department of Public Health, Eastern Regional Health Authority
p.000031: Dr Patrick Flanagan, formerly of Environmental Protection Agency
p.000031: Professor Patrick Hannon, St Patrick's College, National University of Ireland, Maynooth
p.000031: Mr. Kenneth Kearon, Irish School of Ecumenics
p.000031: Professor Cecily Kelleher, Department of Public Health, Medicine and Epidemiology, University College Dublin
p.000031: Professor Mark Lawler, Cancer Molecular Diagnostics Laboratory, St James' Hospital
p.000031: Professor Tony McGleenan, School of Law, University of Ulster
p.000031: Dr Peter McKenna, Department of Obstetrics and Gynaecology, Rotunda Hospital
p.000031: Ms Mary Mulvihill, Science Journalist
p.000031: Dr Nora O’Brien, Department of Food Science, Food Technology and Nutrition, National University of Ireland, Cork
p.000031: Professor Fergal O’Gara, Department of Microbiology, National University of Ireland, Cork
p.000031: Professor Ronan O’Regan, MRIA, Department of Human Anatomy and Physiology, University College Dublin
p.000031: Professor Anne Scott, School of Nursing, Dublin City University
p.000031: Mr Asim Sheikh, BL, Division of Legal Medicine, University College Dublin
p.000031: Professor Seán Strain, School of Biomedical Sciences, University of Ulster
p.000031: Secretariat
p.000031: Dr Siobhán O’Sullivan, Scientific Director Mr Pauric Dempsey
p.000031: Ms Emily de Grae
p.000031:
p.000031: Terms of Reference
p.000031: 1. To identify and interpret the ethical questions raised by biological and medical research in order to respond to
p.000031: and anticipate questions of substantive concern.
p.000031: 2. To investigate and report on such questions in the interests of promoting public understanding informed
p.000031: discussion and education.
...
General/Other / belmont
Searching for indicator belmont:
(return to top)
p.000004: Multi-centre studies 27
p.000004: Supporting Documents 28
p.000004: Working Group on Research Ethics Committees 30
p.000004: The Irish Council for Bioethics Comhairle Bitheitice na hÉireann 31
p.000004:
p.000004: 4
p.000004:
p.000004: Introduction
p.000004: In the last number of years the expansion of scientific knowledge has resulted in the development of new treatments and
p.000004: technologies. As Research Ethics Committees are among those at the forefront of ensuring that the scope and nature of
p.000004: such advances occur in a safe and ethical manner, it is imperative that a formalised, exemplary process of ethical
p.000004: review be in place. The development of codes of ethics related to research involving humans is comparatively recent.
p.000004: The first international code of ethics for research involving human participants, the Nuremberg Code,
p.000004: was issued in 1947 and laid down standards for carrying out human experimentation, emphasising the subjects’ voluntary
p.000004: consent. In 1964 the World Medical Association took an important additional step by adopting the Declaration of
p.000004: Helsinki, most recently revised in 2000, requiring that proposed experimentation on humans be approved by a committee
p.000004: independent from the investigators conducting the research. The Belmont report was published in the United States in
p.000004: 1979 and forms the basis of all US human research regulation. The report sets forth the basic ethical principles
p.000004: underlying the acceptable conduct of research involving human participants.
p.000004: Those principles, respect for persons, beneficence, and justice, are now accepted as three essential requirements for
p.000004: the ethical conduct of research involving human participants. Most recently, the Council for International
p.000004: Organisations of Medical Sciences (CIOMS), working with the World Health Organisation, issued a third edition of
p.000004: biomedical research ethical guidelines in 2002 which feature recommendations on ethical review committees and the issue
p.000004: of safeguarding confidentiality. These documents demonstrate a trend towards making more explicit the ethical standards
p.000004: that must be met if research on human beings is to be ethically acceptable.
p.000004: The regulations and recommendations contained within these international codes need to be adapted into institutional
p.000004: operational guidance to be used at the local level to guide the planning, review, approval and conduct of human
p.000004: research. In Ireland, the recent Regulations made by the Minister for Health and Children (Clinical Trials on Medicinal
p.000004: Products for Human Use, S.I. No. 190 of 2004), the report of the Irish College of General Practitioners entitled
p.000004: “Ethical questions to be considered by a research ethics committee when approving clinical trials which involve genetic
p.000004: testing” (2003) and the Health Research Board’s report “Genetic Research and Human Biological Samples: The Legal and
...
p.000028: European Forum for Good Clinical Practice. Guidelines and Recommendations for European Ethics Committees
p.000028: (1995; 1997)
p.000028: Health Research Board. Genetic Research and Human Biological Samples: The Legal and Ethical Considerations
p.000028: (2002)
p.000028: International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human
p.000028: Use (ICH). Note for Guidance on Good Clinical Practice (1996).
p.000028: Irish College of General Practitioners. Ethical questions to be considered by a research ethics committee when
p.000028: approving clinical trials which involve genetic testing (2003).
p.000028: Medical Research Council of Canada. Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans
p.000028: (1998).
p.000028: Ministry of Health, New Zealand. Operational Standard for Ethics Committees (2001).
p.000028: National Health & Medical Research Council. Commentary on the National Statement on Ethical Conduct in Research
p.000028: involving Humans (2001).
p.000028: Nuremberg Code. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol.
p.000028: 2, pp. 181-182. (1947).
p.000028:
p.000029: 29
p.000029:
p.000029: Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
p.000029: Belmont report: ethical principles and guidelines for the protection of human subjects of research (1979)
p.000029: UNESCO (United Nations Educational, Scientific, Cultural Organization. Universal Declaration on the Human Genome and
p.000029: Human Rights (1997).
p.000029: World Health Organisation. Draft Operational Guidelines for Ethics Committees Reviewing Biomedical Research
p.000029: (2000).
p.000029: World Medical Association. Declaration of Helsinki: Recommendations Guiding Physicians in Biomedical Research Involving
p.000029: Subjects (1964; 1975; 1983; 1989; 1996, 2000)
p.000029:
p.000030: 30
p.000030:
p.000030: Working Group on Research Ethics Committees
p.000030: Professor Cecily Kelleher Chairperson
p.000030: Dept. of Public Health Medicine and Epidemiology, University College Dublin
p.000030: Dr. Margaret Fitzgerald Vice-Chairperson
p.000030: Dept. of Public Health, Eastern Regional Health Authority
p.000030: Mr. Dermot Gleeson
p.000030: Senior Counsel
p.000030: Mr. Kenneth Kearon
p.000030: Irish School of Ecumenics
p.000030: Mr. Dan Lynch
p.000030: Secretary to the Research Ethics Committee of St. James's Hospital and the Federated Dublin Voluntary Hospitals
p.000030: Professor Anne Scott
p.000030: School of Nursing, Dublin City University
p.000030: Dr. Siobhán O’Sullivan
p.000030: Irish Council for Bioethics
p.000030:
p.000030: Terms of reference
...
General/Other / cioms guidelines
Searching for indicator cioms:
(return to top)
p.000004: technologies. As Research Ethics Committees are among those at the forefront of ensuring that the scope and nature of
p.000004: such advances occur in a safe and ethical manner, it is imperative that a formalised, exemplary process of ethical
p.000004: review be in place. The development of codes of ethics related to research involving humans is comparatively recent.
p.000004: The first international code of ethics for research involving human participants, the Nuremberg Code,
p.000004: was issued in 1947 and laid down standards for carrying out human experimentation, emphasising the subjects’ voluntary
p.000004: consent. In 1964 the World Medical Association took an important additional step by adopting the Declaration of
p.000004: Helsinki, most recently revised in 2000, requiring that proposed experimentation on humans be approved by a committee
p.000004: independent from the investigators conducting the research. The Belmont report was published in the United States in
p.000004: 1979 and forms the basis of all US human research regulation. The report sets forth the basic ethical principles
p.000004: underlying the acceptable conduct of research involving human participants.
p.000004: Those principles, respect for persons, beneficence, and justice, are now accepted as three essential requirements for
p.000004: the ethical conduct of research involving human participants. Most recently, the Council for International
p.000004: Organisations of Medical Sciences (CIOMS), working with the World Health Organisation, issued a third edition of
p.000004: biomedical research ethical guidelines in 2002 which feature recommendations on ethical review committees and the issue
p.000004: of safeguarding confidentiality. These documents demonstrate a trend towards making more explicit the ethical standards
p.000004: that must be met if research on human beings is to be ethically acceptable.
p.000004: The regulations and recommendations contained within these international codes need to be adapted into institutional
p.000004: operational guidance to be used at the local level to guide the planning, review, approval and conduct of human
p.000004: research. In Ireland, the recent Regulations made by the Minister for Health and Children (Clinical Trials on Medicinal
p.000004: Products for Human Use, S.I. No. 190 of 2004), the report of the Irish College of General Practitioners entitled
p.000004: “Ethical questions to be considered by a research ethics committee when approving clinical trials which involve genetic
p.000004: testing” (2003) and the Health Research Board’s report “Genetic Research and Human Biological Samples: The Legal and
p.000004: Ethical Considerations” (2002) provide useful guidance in relation to ethical review of clinical trials. However,
p.000004: Ireland currently lacks comprehensive guidance with respect to ethical review of research involving human participants
p.000004: outside the remit of clinical trials.
p.000004:
p.000005: 5
p.000005:
p.000005: This document is the result of systematic evaluation and analysis of international best practice (see list of
p.000005: Supporting Documents) and comprehensive discussion undertaken by a working group of the Irish Council for Bioethics. It
...
p.000027: invalidating the pooling of research data and those elements which can be altered to comply with local requirements
p.000027: (b) RECs may wish to communicate with, give or receive advice from other RECs reviewing the proposal
p.000027: (c) RECs may wish to accept a scientific assessment of the proposal from another REC
p.000027: (d) RECs may agree to accept the conclusions of a single review committee
p.000027:
p.000027: Note to item 9(c) above: A common scientific assessment could be produced by qualified members of a number of RECs
p.000027: involved or by one REC which has accepted the role.
p.000027: Note to item 9(d) above: A single committee could review the scientific and ethical aspects of a proposal. Individual
p.000027: committees could verify the practicability of the proposal in the institution/ organisation and that the proposal
p.000027: conforms to the ethos of the institution/organisation in which the research will be carried out.
p.000027: Under the Clinical Trials on Medicinal Products for Human Use Regulations 2004 in the case of multi-centre clinical
p.000027: trials, either limited to sites in Ireland, or to sites located in more than one EU member state, a single ethics
p.000027: committee opinion must be given by a recognised ethics committee and this opinion must prevail at all centres where the
p.000027: trial is to be conducted.
p.000027:
p.000028: 28
p.000028:
p.000028: Supporting Documents
p.000028: CIOMS (Council for International Organisations of Medical Sciences). International Ethical Guidelines for Biomedical
p.000028: Research Involving Human Subjects (1993;2002).
p.000028: CIOMS (Council for International Organisations of Medical Sciences). International Guidelines for Ethical Review of
p.000028: Epidemiological Studies (1991).
p.000028: Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the
p.000028: Application of Biology and Medicine: Convention on Human Rights and Biomedicine (1997).
p.000028: Department of Health & Children. Clinical Trials on Medicinal Products for Human Use Regulations (2004).
p.000028: European Forum for Good Clinical Practice. Guidelines and Recommendations for European Ethics Committees
p.000028: (1995; 1997)
p.000028: Health Research Board. Genetic Research and Human Biological Samples: The Legal and Ethical Considerations
p.000028: (2002)
p.000028: International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human
p.000028: Use (ICH). Note for Guidance on Good Clinical Practice (1996).
p.000028: Irish College of General Practitioners. Ethical questions to be considered by a research ethics committee when
p.000028: approving clinical trials which involve genetic testing (2003).
p.000028: Medical Research Council of Canada. Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans
p.000028: (1998).
p.000028: Ministry of Health, New Zealand. Operational Standard for Ethics Committees (2001).
p.000028: National Health & Medical Research Council. Commentary on the National Statement on Ethical Conduct in Research
p.000028: involving Humans (2001).
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.000004: Documentation& Archiving 25
p.000004: Research ethics committee annual report 26
p.000004: Multi-centre studies 27
p.000004: Supporting Documents 28
p.000004: Working Group on Research Ethics Committees 30
p.000004: The Irish Council for Bioethics Comhairle Bitheitice na hÉireann 31
p.000004:
p.000004: 4
p.000004:
p.000004: Introduction
p.000004: In the last number of years the expansion of scientific knowledge has resulted in the development of new treatments and
p.000004: technologies. As Research Ethics Committees are among those at the forefront of ensuring that the scope and nature of
p.000004: such advances occur in a safe and ethical manner, it is imperative that a formalised, exemplary process of ethical
p.000004: review be in place. The development of codes of ethics related to research involving humans is comparatively recent.
p.000004: The first international code of ethics for research involving human participants, the Nuremberg Code,
p.000004: was issued in 1947 and laid down standards for carrying out human experimentation, emphasising the subjects’ voluntary
p.000004: consent. In 1964 the World Medical Association took an important additional step by adopting the Declaration of
p.000004: Helsinki, most recently revised in 2000, requiring that proposed experimentation on humans be approved by a committee
p.000004: independent from the investigators conducting the research. The Belmont report was published in the United States in
p.000004: 1979 and forms the basis of all US human research regulation. The report sets forth the basic ethical principles
p.000004: underlying the acceptable conduct of research involving human participants.
p.000004: Those principles, respect for persons, beneficence, and justice, are now accepted as three essential requirements for
p.000004: the ethical conduct of research involving human participants. Most recently, the Council for International
p.000004: Organisations of Medical Sciences (CIOMS), working with the World Health Organisation, issued a third edition of
p.000004: biomedical research ethical guidelines in 2002 which feature recommendations on ethical review committees and the issue
p.000004: of safeguarding confidentiality. These documents demonstrate a trend towards making more explicit the ethical standards
p.000004: that must be met if research on human beings is to be ethically acceptable.
p.000004: The regulations and recommendations contained within these international codes need to be adapted into institutional
p.000004: operational guidance to be used at the local level to guide the planning, review, approval and conduct of human
p.000004: research. In Ireland, the recent Regulations made by the Minister for Health and Children (Clinical Trials on Medicinal
p.000004: Products for Human Use, S.I. No. 190 of 2004), the report of the Irish College of General Practitioners entitled
...
p.000028: approving clinical trials which involve genetic testing (2003).
p.000028: Medical Research Council of Canada. Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans
p.000028: (1998).
p.000028: Ministry of Health, New Zealand. Operational Standard for Ethics Committees (2001).
p.000028: National Health & Medical Research Council. Commentary on the National Statement on Ethical Conduct in Research
p.000028: involving Humans (2001).
p.000028: Nuremberg Code. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol.
p.000028: 2, pp. 181-182. (1947).
p.000028:
p.000029: 29
p.000029:
p.000029: Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
p.000029: Belmont report: ethical principles and guidelines for the protection of human subjects of research (1979)
p.000029: UNESCO (United Nations Educational, Scientific, Cultural Organization. Universal Declaration on the Human Genome and
p.000029: Human Rights (1997).
p.000029: World Health Organisation. Draft Operational Guidelines for Ethics Committees Reviewing Biomedical Research
p.000029: (2000).
p.000029: World Medical Association. Declaration of Helsinki: Recommendations Guiding Physicians in Biomedical Research Involving
p.000029: Subjects (1964; 1975; 1983; 1989; 1996, 2000)
p.000029:
p.000030: 30
p.000030:
p.000030: Working Group on Research Ethics Committees
p.000030: Professor Cecily Kelleher Chairperson
p.000030: Dept. of Public Health Medicine and Epidemiology, University College Dublin
p.000030: Dr. Margaret Fitzgerald Vice-Chairperson
p.000030: Dept. of Public Health, Eastern Regional Health Authority
p.000030: Mr. Dermot Gleeson
p.000030: Senior Counsel
p.000030: Mr. Kenneth Kearon
p.000030: Irish School of Ecumenics
p.000030: Mr. Dan Lynch
p.000030: Secretary to the Research Ethics Committee of St. James's Hospital and the Federated Dublin Voluntary Hospitals
p.000030: Professor Anne Scott
p.000030: School of Nursing, Dublin City University
p.000030: Dr. Siobhán O’Sullivan
p.000030: Irish Council for Bioethics
p.000030:
p.000030: Terms of reference
p.000030: 1. To review in depth, the existing practices of Ethics Committees in the Republic of Ireland, with particular
p.000030: reference to Research Ethics Committees.
p.000030: 2. To identify best practice in the area internationally and across the island of Ireland.
p.000030: 3. To produce guidance on the composition and operation of Ethics Committees and to suggest a national structure for
p.000030: such organisations in the Republic of Ireland.
p.000030: 4. To report to Council on all aspects of the deliberations and conclusions of the working group on Ethics
p.000030: Committees.
...
General/Other / participants in a control group
Searching for indicator placebo:
(return to top)
p.000015: decision following acknowledgement of receipt of a “valid” application. There are no time limits imposed on RECs making
p.000015: a decision on research involving xenogenic cell therapy.
p.000015:
p.000015: 5.1 Meeting Requirements
p.000015: RECs should meet in accordance with regularly scheduled dates. Meeting requirements should include the following:
p.000015: (a) meetings should follow a previously scheduled agenda
p.000015: (b) members should be given sufficient time to review relevant documentation
p.000015: (c) meetings should be minuted. There should be an approval procedure for the minutes
p.000015: (d) when appropriate, the sponsor and/or investigator may be invited to present the proposal to the members and
p.000015: answer any questions a committee may have
p.000015: (e) when appropriate, independent experts (e.g. researchers with specific competence, ethicists, statisticians) may
p.000015: be invited to attend
p.000015:
p.000016: 16
p.000016:
p.000016: 5.2 Elements of Review
p.000016: When reviewing research proposals a REC should consider the following:
p.000016: Scientific design and conduct of the study
p.000016: (a) the appropriateness of the study design in relation to the objectives of the study, the statistical methodology
p.000016: (including sample size calculation) and the potential for reaching reliable conclusions with the smallest number of
p.000016: research participants/volunteers
p.000016: (b) the justification of predictable risks and inconveniences weighed against the anticipated benefits for the
p.000016: research participants/volunteers and the concerned communities
p.000016: (c) the justification for use of control arms in trials (whether placebo or active comparator), and the randomisation
p.000016: programme to be used
p.000016: (d) criteria for withdrawing participants/volunteers prematurely
p.000016: (e) criteria for suspending or terminating research
p.000016: (f) the adequacy of conditions made for the monitoring and auditing the conduct of the research
p.000016: (g) the adequacy of the site including the supporting staff, facilities and emergency procedures
p.000016: (h) the form in which the results will be reported and published
p.000016:
p.000016: Recruitment of research participants/volunteers
p.000016: (a) the characteristics of the population from which the participants/volunteers will be drawn (including gender,
p.000016: age, ethnicity) and the justification for any decisions made in this regard
p.000016: (b) the method by which initial contact and recruitment are to be conducted
p.000016: (c) the method by which information is to be conveyed to participants/volunteers or their representatives and by
p.000016: which means consent is to be obtained
p.000016: (d) inclusion and exclusion criteria for research participants/volunteers
p.000016:
p.000016: Care and protection of research participants/volunteers
...
General/Other / tri-council policy statement
Searching for indicator tri-council:
(return to top)
p.000027: trial is to be conducted.
p.000027:
p.000028: 28
p.000028:
p.000028: Supporting Documents
p.000028: CIOMS (Council for International Organisations of Medical Sciences). International Ethical Guidelines for Biomedical
p.000028: Research Involving Human Subjects (1993;2002).
p.000028: CIOMS (Council for International Organisations of Medical Sciences). International Guidelines for Ethical Review of
p.000028: Epidemiological Studies (1991).
p.000028: Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the
p.000028: Application of Biology and Medicine: Convention on Human Rights and Biomedicine (1997).
p.000028: Department of Health & Children. Clinical Trials on Medicinal Products for Human Use Regulations (2004).
p.000028: European Forum for Good Clinical Practice. Guidelines and Recommendations for European Ethics Committees
p.000028: (1995; 1997)
p.000028: Health Research Board. Genetic Research and Human Biological Samples: The Legal and Ethical Considerations
p.000028: (2002)
p.000028: International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human
p.000028: Use (ICH). Note for Guidance on Good Clinical Practice (1996).
p.000028: Irish College of General Practitioners. Ethical questions to be considered by a research ethics committee when
p.000028: approving clinical trials which involve genetic testing (2003).
p.000028: Medical Research Council of Canada. Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans
p.000028: (1998).
p.000028: Ministry of Health, New Zealand. Operational Standard for Ethics Committees (2001).
p.000028: National Health & Medical Research Council. Commentary on the National Statement on Ethical Conduct in Research
p.000028: involving Humans (2001).
p.000028: Nuremberg Code. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol.
p.000028: 2, pp. 181-182. (1947).
p.000028:
p.000029: 29
p.000029:
p.000029: Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
p.000029: Belmont report: ethical principles and guidelines for the protection of human subjects of research (1979)
p.000029: UNESCO (United Nations Educational, Scientific, Cultural Organization. Universal Declaration on the Human Genome and
p.000029: Human Rights (1997).
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p.000029: (2000).
p.000029: World Medical Association. Declaration of Helsinki: Recommendations Guiding Physicians in Biomedical Research Involving
p.000029: Subjects (1964; 1975; 1983; 1989; 1996, 2000)
p.000029:
p.000030: 30
p.000030:
p.000030: Working Group on Research Ethics Committees
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| belmont | belmont |
| cadavers | Cadavers |
| children | Child |
| cioms | cioms guidelines |
| disability | Mentally Disabled |
| education | education |
| educational | education |
| emergency | Public Emergency |
| ethnicity | Ethnicity |
| gender | gender |
| helsinki | declaration of helsinki |
| incapable | Mentally Incapacitated |
| incapacity | Incapacitated |
| language | Linguistic Proficiency |
| military | Soldier |
| opinion | philosophical differences/differences of opinion |
| philosophy | philosophical differences/differences of opinion |
| placebo | participants in a control group |
| restricted | Incarcerated |
| single | Marital Status |
| student | Student |
| tri-council | tri-council policy statement |
| volunteers | Healthy People |
| vulnerable | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| education | ['educational'] |
| educational | ['education'] |
| opinion | ['philosophy'] |
| philosophy | ['opinion'] |
Trigger Words
coercion
consent
cultural
developing
ethics
harm
justice
protect
protection
risk
volunteer
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input