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TRINITY COLLEGE DUBLIN
HEALTH POLICY AND MANAGEMENT / CENTRE FOR GLOBAL HEALTH
RESEARCH ETHICS COMMITTEE
GUIDELINES FOR
THE SUBMISSION OF
ETHICAL APPROVAL APPLICATIONS
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TABLE OF CONTENTS
1. ABOUT THE COMMITTEE ...................................................................................................................... 3
2. PURPOSE OF THE GUIDELINES .............................................................................................................. 3
3. RELEVANT RESEARCH ETHICS AND GOVERNANCE LITERATURE ............................................................ 4
4. THE ETHICAL REVIEW PROCESS ............................................................................................................ 6
4.1 COMMITTEE MEETINGS.............................................................................................................................. 6
4.2 OUTCOME OF ETHICAL REVIEW.................................................................................................................... 7
4.3 ANNUAL REVIEW AND PROGRESS REPORT...................................................................................................... 7
4.4 PROCEDURE FOR PROPOSING AMENDMENTS TO APPROVED PROTOCOLS ............................................................. 8
5. ETHICAL APPROVAL DOCUMENTATION................................................................................................ 9
5.1 SUBMISSION OF FULL PROTOCOLS ................................................................................................................ 9
5.2 THE CONSENT DOCUMENTATION ............................................................................................................... 10
5.3 GUIDELINES FOR STORAGE OF INFORMATION ................................................................................................ 12
5.4 CHECKLIST FOR THE REVIEW OF SUBMITTED PROTOCOLS ................................................................................ 13
5.5 (A) TEMPLATE FOR INFORMED CONSENT FORM ................................................................................ 16
5.5 (B) TEMPLATE FOR PARTICIPANT INFORMATION LEAFLET ................................................................................ 18
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1. About the Committee
The Health Policy & Management / Centre for Global Health Research Ethics Committee
(henceforth HPM/CGH REC) was established to promote high ethical standards in
ensuring the protection of the rights and welfare of potential research participants and
that researchers are guided in conducting ethical research.
To this end the HPM/CGH REC has developed a set of guidelines and standard operating
procedures to ensure that research conducted under the auspices of the two Academic
Units is independently reviewed in a fair and consistent manner.
In addition to the review of submitted research protocols, the HPM/CGH REC will work
to ensure the ethical conduct of research through continuing development of guidelines
for human research participant protection in keeping with established national and
international principles of research ethics and governance, as well as periodically
providing training on research ethics, so as to build capacity for researchers in
conducting ethical research as well as to build capacity of the Committee members in
ensuring appropriate research governance.
It is mandatory that all research – whether undertaken by staff or students – conducted
under the auspices of the two Academic Units be reviewed by the HPM/CGH REC. The
only exception concerns studies that involve clinical and/or therapeutic interventions, in
which case the researchers are strongly encouraged to submit for ethical approval by
the TCD Faculty of Health Sciences Research Ethics Committee.
2. Purpose of the Guidelines
This document provides guidelines for individuals preparing applications to the
HPM/CGH REC for ethical review of research projects.
Students Research Projects
A student must at the planning stage discuss his or her project with their supervisor in
preparing for the submission of an ethical approval application to the REC.
The supervisor is considered to be in charge of overseeing the research project. The
supervisor is responsible for reviewing the student’s application to ensure that it is
complete and accurate before passing it to the REC for review. Once the REC has
completed the review the results will be issued to both the supervisor and the student.
Please contact the HPM/CGH REC Secretary for clarification of these guidelines, the
application process or the application form.
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3. Relevant Research Ethics and Governance Literature
Applicants should be familiar with the various national and international guidelines
concerning the involvement of human subjects in research. Specifically, the HPM/CGH
REC recommends the following literature on research ethics and governance as key
reference documents. These guidelines are available online at the URL addresses
outlined below, and copies of same are also available to students through their course
intranets. Copies could also be made available from the Committee Secretary upon
request.
These recommended guidelines include, but are not limited to, the following:
1. Trinity College Dublin Good Research Practice
http://www.tcd.ie/about/policies/assets/pdf/TCDGoodResearchPractice.pdf
2. Declaration of Helsinki
http://www.wma.net/en/30publications/10policies/b3/index.html.pdf?print-media-type&footerright=[page]/[toPage]
3. The Belmont Report
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
4. Annual Reports and Guidelines from the Office of the Data Protection Commissioner
(Ireland), such as Guidelines to Data Controllers
http://www.dataprotection.ie/documents/forms/NewAGuideForDataControllers.pdf
5. EU Legislation on Biomedical Ethics
http://cordis.europa.eu/search/index.cfm?fuseaction=search.resultlist&#page=1@perPage=10@q=3F2F5
5FBF64446E2A0C57199C9668472@type=hom@showtype=lib@sortBy=RELEVANCE@sortOrder=DESC
6. Guidance Note on Healthcare Management Research and the Role of Gatekeeper
within Such Studies.
For guidelines using human participants in behavioural research see:
 US Department of Health and Human Services: Office for Human Research
Protections: http://www.hhs.gov/ohrp/policy/index.html
 The
American
Anthropological
Association's
code
of
Ethics:
http://www.aaanet.org/committees/ethics/ethcode.htm
 The British Sociological Association: http://www.britsoc.co.uk/equality/
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When research involves children or other potentially vulnerable groups, rigorous adherence
to the appropriate professional codes of ethical practice is required and particular attention
must be paid to issues such as access, informed consent by both participants and carers,
and duty of care. Detailed guidelines for such research are available:
 The (UK) National Children’s Bureau:
http://www.ncb.org.uk/PDF/Guidelines%20for%20research%20Oct%202009.pdf
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4. The Ethical Review Process
4.1 Committee Meetings
The HPM/CGH REC meets for the purpose of evaluating protocol submissions three
times a year. Dates of these meetings will be confirmed at the operational meeting to
be held at the beginning of each academic year.
Full protocols and all attachments (please see Section 5 for more details) must be
received by the application deadline date (usually two weeks before the Committee
meeting).
All ethical approval applications will require HPM/CGH REC review. There are two levels
of review:
Level 1: Full Committee review. Each application will be independently reviewed by
three reviewers before being discussed by all members of the Committee at one of their
monthly meetings. Applications can be awarded full approval or conditional approval by
the Committee, or they could be rejected outright (please see 4.2 for more details).
If an application is conditionally approved, the applicant must re-submit an application
for review by the Chair (see Level 2) within the time-frame specified (usually three
weeks).
If an application is rejected, the applicant may re-submit an application for full
Committee review at a later meeting.
Level 2: Review by the Chair. Supplementary information and/or amendments to
proposals that have been awarded conditional approval following full Committee review
will be considered by the Chair, who has the authority (delegated from the Committee)
to decide whether the amended application receives full approval or a further
conditional approval.
In rare cases whereby the Chair deems an amended application to warrant a rejection in
spite of the initial conditional approval, this would be brought back for a full Committee
review.
Researchers who are unsure about whether their proposed research requires full
Committee review should consult the Chair of the Committee through the Committee
Secretary.
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4.2 Outcome of Ethical Review
Written responses from the HPM/CGH REC will be sent by the Committee Secretary
within 5 working days after the Committee meeting. The different outcomes from the
review process are as follows:
I. Full Approval: Research can begin immediately upon receipt of the ethical
approval letter.
II. Conditional Approval: Research cannot be initiated. The researcher is required
to submit additional information or a revised proposal as outlined in the REC
response letter. The Chair will review this information as soon as it is received.
The Chair will give Full Approval or a further Conditional Approval, or rejection.
III. Rejection: Research cannot be initiated. Full resubmission of protocol is advised.
A formal letter of ethical approval will be issued to principal investigators whose
protocols have received full approval.
4.3 Annual Review and Progress Report
The HPM/CGH REC is committed to a partnership approach regarding research
governance. Such partnership rests on open and honest communication between the
investigator and the Committee as the project unfolds. When unforeseen circumstances
arise, the Committee seeks to provide appropriate guidance in a manner that protects
the research participants, the members of the research team as well as the College.
All applicants with approved protocols are required to submit a one-page progress
report one calendar year after the date of ethical approval. Those who are conducting
longitudinal studies have to submit such reports annually. Those who are conducting
studies that involve an iterative research design (such as action research, or certain
types of sequential mixed methods studies) may need to submit a progress report
earlier than a year as significant changes or departures from the initially approved
protocols arise.
Notices of closure/termination of research, e.g. operational research study evaluation
should reach the Committee six months before the date of termination of research
activities.
Documents to be submitted include:
i)
Progress report (Please use the progress report form available from the
Committee Secretary)
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ii)
iii)
Copies of exemption and/or approval by relevant local research ethics
committees / institutional review boards. Original feedback documents
from such local research governance bodies must also be included.
Any further materials as requested by the Committee.
4.4 Procedure for Proposing Amendments to Approved Protocols
Once protocols have been approved, investigators could propose further amendments if
fieldwork conditions demand adjustments to the initially-approved protocols.
Amendments to approved protocols must be reviewed and formally approved by the
Committee before implementation.
The following should be considered as changes to approved protocols that warrant
further approval by the Committee:
i)
Changes in sample size
ii)
Changes in study sites
iii)
Review of payments to research participants
iv)
Additional study objectives
v)
Changes in the approved informed consent, PIL, invitation to participate in the
research, etc.
Advice should be sought in the first instance from the Committee Chairperson if the
investigator is unsure about the need for further approval of amendments to their
protocols.
Change/Replacement of Principal Investigator
The Committee should be notified of a change of the PI. The likely impact of such a
change on the study should be outlined in writing to the Committee.
Submission of Amendments
i)
Areas of amendments to approved protocols must be clearly stated.
ii)
There should be a point-by-point justification for each point amended.
iii)
Amended applications should include three hard copies and an electronic copy
of all amended protocols (application form and appendices). All amendments
must be highlighted via the use of track changes on the Word document.
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5. Ethical Approval Documentation
5.1 Submission of Full Protocols
Investigators must submit full protocols at the first instance of applying for ethical
approval by the HPM/CGH REC. Full protocols comprises of a completed application
form as well as all relevant appendices:
i)
Completed application form – all sections must be answered (including the
insertion of “not applicable” to those questions irrelevant to the proposed
study); signature(s) from investigator(s) and, in the case of student applications,
the signature of their principal supervisors, must be inserted. The checklist on
the front-page of the application must be completed.
ii)
Appendices – these include the following:
 Informed consent form – please see Section 5.5 for more details.
 Participant information leaflet (PIL) – please see Section 5.5 for more details.
 Copy of research instruments – please indicate if the draft or final
instruments are attached with the application. In the case of the former,
applicants must supply the final instruments to the Research Ethics
Committee as soon as they are ready.
 Letters regarding Gatekeeper Permissions – these could either be draft
letters seeking gatekeeper permissions; or they could be actual letters
received from gatekeepers confirming their permission for investigators to
conduct the proposed study pending receipt of ethical approval.
 Letters confirming Exemptions or Approvals from Local Research Ethics
Committees (if available at the time of application).
Three hard copies of the complete application and all relevant appendices, including
appropriate signatures from the investigator(s) as well as their supervisor(s) where
relevant, plus one electronic copy of the same documentation, must be submitted to
the Committee Secretary by 5pm of the stated application deadline date.
Supporting documents (such as letters confirming gatekeeper’s permission to conduct
the study) should also be provided as part of the documentation if they are available at
the time of submission. Three hard copies of these documents must accompany the
application as an appendix, and an electronic copy should also be provided to the
Committee Secretary as far as practicable (hard copy letters could be scanned and emailed to the Committee Secretary).
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5.2 The Consent Documentation
The consent documentation consists of the Participant Information Leaflet (PIL), and an
Informed Consent Form.
The consent documentation should be written in lay language. The consent document
should be written so that the intended participants are likely to understand the
important information. In situations where the research participants of the target
population do not understand the English Language adequately, the consent document
must be translated to the relevant language of the participants.
The Informed Consent Form is a legal document in which the project must be
comprehensible to a reader without reference to the Participant Information Leaflet. It
must contain Project Title, names of the Principal Investigators and a summary of what
will be involved for a participant. This summary should be written in the first person
since the signatory is agreeing to undertake whatever procedures are involved.
Participants must agree that they understand what is involved in participation in the
project, consent to take part on a voluntary basis and understand that they may
withdraw at any time at their request or be withdrawn by the investigator without any
affect on access to services or legal rights.
If appropriate, the investigator may also wish to obtain agreement to:
o Use of data in other future studies without the need for additional
consent.
o Access to non-anonymised patient records.
o Waiver of intellectual property rights.
o Consent to possible publication of results.
In an interview based study it is good practice to inform participants that copies of the
transcript of their interview will be made available to them and, where appropriate, to
provide them with the opportunity of deleting any wording that they may perceive as
identifying them. Applications should indicate that these procedures will be followed.
If a commercial sponsoring body is involved, the investigator will need to name the
sponsor and obtain consent for a copy of the signed form to be sent to that body.
The form needs to be signed by the actual research participant (or a parent or guardian
in the case of the participant being unable to understand the scope, nature or
significance of the study or in the case of the participant being under 18 years) and
dated.
The above section must be followed by a signed declaration by the researcher that s/he:
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


Has explained the study.
Has answered questions.
Believes that the participant understands and is freely giving consent.
The Informed Consent Form must be signed by each individual research participant and
by the researcher. The researcher should retain the original of the signed form in a
secure file. A copy of the signed consent form should be provided back to the participant
for his/her own reference.
Please follow the template given for the Participant Information Leaflet and the
Informed Consent Form in Section 5.5(a) and 5.5(b).
Photographic Consent
The REC can only consider giving approval for the taking of photographs where this is an
integral part of the research. Where photographs are being taken for other reasons
(including for use in presentations or publications) this falls outside the remit of the
committee. In cases where the REC is asked to approve photographs as part of the
research process it will require a clear and explicit consent process.
Role of the gatekeeper
The role of a gatekeeper is to protect the interests of the participants and to ensure that
they are not under any pressure to participate. They act as a neutral buffer between the
researcher and the participant. For example if a lecturer wanted to give a questionnaire
to their students, the students might feel pressurised to take part. Therefore a third
party (the gatekeeper) should distribute the questionnaires, thus removing the direct
link between the researcher and the participant, thereby eliminating the pressure to
participate.
Informed assent from minors
It is accepted by the Irish courts and international guidelines that minors have
independent rights. All minors regardless of age should therefore be informed as fully
as is practicable about the research and agree to be involved. The child should be asked
if they agree (assent) to be in the study and be asked to sign an assent form. The assent
form should be a simpler version of the consent form that parents/guardians sign. If
they do not wish to do so, then this must take precedence over any consent given by a
responsible adult.
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5.3 Guidelines for storage of information
The investigator must consider carefully the documents that will bear personal
information such as participant’s name, address and telephone number. Often only one
document, i.e. the consent form, will need to bear such information.
An identity code should be generated for each participant, and any personal identifying
information should be removed from raw data, such as interview transcripts. The
identification key should be stored securely and separately from the main data. Only
members of the research team as designated on the approved protocols could have
access to raw data.
Transcriptionists and other data-entry personnel who may have access to raw data must
sign a confidentiality agreement that contain the same terms and conditions for
maintaining data protection and participants’ confidentiality as stated in the approved
protocols. The investigator must formally inform the Committee if s/he decides to
employ the services of transcriptionists/data entry personnel if this is not already stated
in the original approved protocols.
Data should be handled in the following way:
1. Each researcher will store the document bearing personal information in a
locked cabinet with access strictly restricted to personnel working on the study.
2. All computerised data/information must be encrypted and stored on passwordprotected computer terminals with access restricted to only designated
members of the research team. This data is more prone to loss or theft and
normal username/password access may not be sufficient to protect against
unlawful access to the information.
3. Due care and caution must be exercised when transporting data from one
computer terminal to another. The Committee advises against the use of USB
memory sticks and other portable media to transport raw data containing
personally identifiable information of the research participants.
4. Raw data will be stored for the duration of the study, i.e. until the work is fully
reported and disseminated. Anonymised data will then be kept in a locked
cabinet for the period as recommended by the College research best practice
guidelines (typically five to ten years).
Guidelines from the Data Protection Commissioner of Ireland must always be
adhered to over and above the general guidance given above.
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5.4 Checklist for the Review of Submitted Protocols
We advise that all applicants study the checklist below so as to meet the review
requirement of the HPM/CGH REC.
Study Objectives and Rationale


Are the specific study objectives and questions clearly specified?
Is there appropriate justification for the proposed study?
Study Design



Is the study design adequately described and justified?
Is the study design appropriate to address the stated objectives?
Is the study feasible within the stated study time-frame?
Participant Selection




Are inclusion and exclusion criteria clearly specified and appropriate?
If members of vulnerable groups are included, is this justified?
Are the selected participants able to contribute to the stated study objectives?
Is the principle of distributive justice adequately incorporated into the inclusion
and exclusion criteria for the research protocol? Is subject selection equitable?
Participant Recruitment






Are the methods for recruiting potential subjects well defined?
Are the location and timing of the recruitment process acceptable?
Is the individual performing the recruitment appropriate for the process?
Are all recruitment materials submitted and appropriate?
Where relevant, are there acceptable methods for screening participants prior to
recruitment?
Do the stated procedures for participant recruitment minimize risk for potential
research coercion, especially for members of vulnerable populations?
Data Collection Procedures


Are the research procedures clearly described and justified?
Are the sites for research participation appropriate from the perspectives of
maintaining confidentiality and respecting the participants’ integrity and
autonomy?
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
Are there adequate plans to inform participants about specific research results if
necessary?
Data Analysis

Are the plans for data analysis defined and justified, including the use of
stopping rules and endpoints for randomized control trials? (Investigators who
propose the use of RCTs as part of their study design are strongly encouraged to
apply for ethical approval from the Trinity College Faculty of Health Sciences
Research Ethics Committee).
Compensation and Costs for Subjects



Are there adequate provisions to avoid out-of-pocket expenses by the research
subject, or is there sufficient justification to allow subjects to pay?
Is the amount or type of compensation or reimbursement reasonable?
If members of vulnerable groups are involved, who receives the compensation,
and is this appropriate (i.e. does not constitute risk of research inducement)?
Privacy and Confidentiality



Are there adequate provisions to protect the privacy and ensure the
confidentiality of the research participants?
Are there adequate plans to store and code the data?
Is the use of identifiers or links to identifiers necessary, and how is this
information protected?
Potential Risk, Discomforts, and Benefits for Participants





Are the risks and benefits adequately identified, evaluated, and described?
Are the potential risks minimised and likelihood of benefits maximised?
Is the risk/benefit ratio acceptable for proceeding with the research?
Are there appropriate procedures for addressing the potential risks of research
participation for members of vulnerable populations?
Are the principles of voluntary participation and informed consent upheld in all
stages of the proposed research and manifested in all research protocols?
Funding

Are there any funding conflicts? Are there any concerns over the integrity of the
research? Has the investigator addressed these concerns?
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Local Ethical Approval

Has the investigator any plan for applying for local ethical approval? If not, is
there an acceptable justification provided?
Other Issues (Appendices)

Are adequate references provided?
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5.5 (a) TEMPLATE FOR INFORMED CONSENT FORM
Please use the exact wording below for the Participant’s Declaration of Agreement and
the Statement of Investigator’s Responsibility:
PROJECT TITLE:
PRINCIPAL INVESTIGATORS:
BACKGROUND
(Provide short summary of what project involves for participants, including the
procedures to be carried out and the assurance of confidentiality. If relevant it should
be stated that participants have a right to their transcripts.)
DECLARATION:
I have read, or had read to me, the information leaflet for this project and I understand
the contents. I have had the opportunity to ask questions and all my questions have
been answered to my satisfaction. I freely and voluntarily agree to be part of this
research study, though without prejudice to my legal and ethical rights. I understand
that I may withdraw from the study at any time and I have received a copy of this
agreement.
PARTICIPANT'S NAME: …………………………………………………………..
CONTACT DETAILS: ………………………………..……………………………..
PARTICIPANT'S SIGNATURE: ……………..……………………………………..
Date:…………………………..
Where the participant is incapable of comprehending the nature, significance and scope
of the consent required or is under 18 years old, the form must be signed by a person
legally competent to give consent.
NAME OF CONSENTER, PARENT or GUARDIAN:………………………………
SIGNATURE:………………………………………………………………………..
RELATION TO PARTICIPANT:…………………………………………………
Statement of investigator's responsibility: I have explained the nature and purpose of
this research study, the procedures to be undertaken and any risks that may be
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involved. I have offered to answer any questions and fully answered such questions. I
believe that the participant understands my explanation and has freely given informed
consent.
INVESTIGATOR’S SIGNATURE:………………………… Date:…………………..
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5.5 (b) Template for Participant Information Leaflet
Please adapt as required.
Study Title:
Name of Investigator:
Name of Supervisor:
This study is conducted in partial fulfillment of the M.Sc. Health Services Management
degree at Trinity College Dublin.
1. Research purpose and procedures: a statement that gives an explanation of the
research, the expected duration of the participant’s involvement in the study, a
description of the procedures to be followed, and identification of any procedures
which are experimental;
2. Risks and discomforts: a description of any reasonably foreseeable risks or
discomforts to the subject
 Research-related injury: for research involving more than minimal risk, an
explanation as to whether any medical treatments are available if injury occurs
and, if so, what they consist of, or where further information may be obtained;
 Unforeseeable risks: a statement that the particular treatment or procedure
may involve risks to the subject (or to the embryo or foetus, if the subject is or
may become pregnant) which are currently unforeseeable;
3. Potential benefits: a description of any benefits to the subject or to others that may
reasonably be expected from the research;
4. Alternative procedures or treatments: a disclosure of appropriate alternative
procedures or courses of treatments, if any, that might be advantageous to the
participant;
5. Provisions for confidentiality: a statement describing the extent, if any, to which
confidentiality of records identifying the participant will be maintained;
6. Voluntary participation and the right to discontinue participation without penalty:
a statement that participation is voluntary, refusal to participate will involve no
penalty or loss of benefits to which the subject is otherwise entitled, and the
participant may discontinue participation at any time without having to give a
reason, and without any penalty or loss of benefits to which the subject is otherwise
entitled. A statement that explains that any significant new findings developed
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during the course of the research that may relate to the participant’s willingness to
continue participation will be provided to the participant.
7. Contacts for additional information: an explanation of whom to contact for answers
to pertinent questions about the research and research subject’s rights, and whom
to contact in the event of a research-related injury to the subject.
8. Termination of participation by the investigator: anticipated circumstances under
which the participant’s involvement may be terminated by the investigator.
9. Permissions: the investigator has obtained permission to conduct the study from
[organisational gatekeeper]. The study has also obtained ethical approval from the
HPM-CGH Research Ethics Committee at Trinity College Dublin, as well as from the
[local research ethics committee].
10. Access to transcripts: In an interview based study, there should be a statement
informing participants that copies of the transcript of their interview will be made
available to them and, where appropriate, provide them with the opportunity of
deleting any wording that they may perceive as identifying them.
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