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“Molecular Medicine Ireland is a charitable company established by TCD, UCD, RCSI, UCC and UCG to foster institutional collaboration between their five ...
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"Engagement with [Research] Ethics Committees
I appreciated that my Office was approached during the year to participate in the finalisation of a draft Common Application Form for persons or entities applying for ethical approval to [Research] Ethics Committees in various hospitals and HSE areas. The process which was convened by Molecular Medicine Ireland was intended to assist in streamlining the process for researchers applying for ethical approval to Research Ethics Committees. It provided a key opportunity for my Office to assist
[Research] Ethics Committees to highlight to applicants for ethical approval what the key data protection requirements are for any work with personal data for research purposes. A pilot of the new application form will now be put in place across selected hospitals and I look forward to continuing to work on this important initiative."
Billy Hawkes Data Protection Commissioner March 2010 From the Twenty‐First Annual Report of the Data Protection Commissioner 2011
“Molecular Medicine Ireland is a charitable company established by TCD, UCD, RCSI, UCC and UCG to foster institutional collaboration between their five respective medical schools and academic hospitals in clinical and translational research and post graduate education. This has led to a number of collaborative initiatives including the Wellcome Trust and Health Research Board (HRB) funded
Dublin Centre for Clinical Research (DCCR), the HEA funded Clinician Scientist Fellowship Programme (CSFP) and the HRB/HSE funded Irish Clinical Research Infrastructure Network (ICRIN). Key to the success of these initiatives is the development of a more streamlined approach to clinical research governance and ethical review….For academic and investigator led research studies that do not involve medicinal products covered by SI 190, the conduct of multi‐site clinical research requires that
a separate application is made to the ethics committee of each hospital before a study can commence. With more collaborative and networked clinical research activities taking place in Ireland, applications for approval of the same study to multiple hospital Research Ethics Committees (RECs) are increasing and will continue to grow in number. At present each REC has its own application form,
adding considerable to the complexity of conducting multi‐site clinical studies.”
Dr. Ruth Barrington Chief Executive Molecular Medicine Ireland May 2009
“The St. James’s Hospital & Adelaide & Meath Hospital Dublin, incorporating the National Children’s Hospital Research Ethics Committee is one of the busiest in the country. The Committee reviews many clinical trials and academic and investigator led research studies that do not involve medicinal
products covered by SI 190. The SJH/AMNCH Ethics Committee and Secretariat has been very happy to play a role in creating a collaborative research network across the county. It is hoped that the work to date on streamlining the processes and procedures will continue and so facilitate the review and conduct of research in Ireland.”
Dr. Ray McDermott Consultant Medical Oncologist Chairperson Research Ethics Committee Adelaide and Meath Hospital, Dublin, Incorporating the National Children’s Hospital July 2010
SECTION A GENERAL INFORMATION MANDATORY
SECTION B STUDY DESCRIPTORS MANDATORY
SECTION C STUDY PARTICIPANTS MANDATORY
SECTION D RESEARCH PROCEDURES MANDATORY
SECTION E DATA PROTECTION MANDATORY
SECTION F HUMAN BIOLOGICAL MATERIAL OPTIONAL
SECTION G RADIOCATIVE MATERIAL / DIAGNOSTIC OR
THERAPEUTIC IONISING RADIATION OPTIONAL
SECTION H MEDICAL DEVICES OPTIONAL
SECTION I MEDICINAL PRODUCTS / COSMETICS / FOOD AND FOODSTUFFS OPTIONAL
SECTION J INDEMNITY MANDATORY
SECTION K COST AND RESOURCE IMPLICATIONS AND FUNDING MANDATORY
SECTION I ETHICAL ISSUES MANDATORY
A1 Title of the Research Study:
Please provide a 2 page curriculum vitae of the Principal Investigator for review.) Title: DR / MS / MR / PROF Name: [TYPE ANSWER=TA] Qualifications: [TA]
Position: [TA] Dept: [TA]
Organisation: [TA] Address: [TA]
Tel: [TA]
Action: Please copy and paste the headings in Question A2, should you wish to add a Joint Principal Investigator.
A3 (a) Is this a multi-site study?
Yes / No
lead investigator for each site: (the ‘lead investigator’ at a site takes primary responsibility for the study at that site.) SITE: LEAD INVESTIGATOR: [TYPE ANSWER=TA] [TYPE ANSWER=TA]
Action: Please add rows to the above table should you wish to add a site.
A3 (c) For any of the sites listed above, have you got an outcome from the Research Ethics Committee (where applicable)? (Please ensure that you have provided copies of any approvals which you have referred to in your response.)
A4: Co-Investigators: (Please provide the details of the Main ‘Co-Investigators’) Name of Site : [TYPE ANSWER=TA]
Title: DR / MS / MR / PROF Name: [TA] Qualifications: [TA]
Position: [TA] Organisation: [TA]
Address: [TA] Role in Research: [TA]
Action: Please copy and paste the headings in Question A4 should you wish to add a Co-Investigator
A5. Lead contact person who is to receive correspondence in relation to this application / who is to be contacted if a query arises in relation to this application. (For administrative and correspondence purposes, committees require a person who is familiar with this study who is available to address queries as they arise. This person can be the Principal Investigator, or any person who has been delegated this task by the Principal Investigator.)
Title: DR / MS / MR / PROF Name: [TA] Address: [TA]
Tel (work): [TA] Tel (mobile): [TA] E-mail: [TA]
A6 Please provide a lay description of the study. (The lay summary should be in simple language between 100 and 500 words in length only. There is a word limit in place. )
[TYPE ANSWER]
A7 (a) Is this study being undertaken as part of an academic qualification? (Students are encouraged not to complete this application form without the assistance of an academic supervisor)
Yes / No
Action: If you chose ‘no’ please delete Question A7 (b).
A7 (b) If yes , please complete the following: Student name: [TA] Course: [TA]
Institution: [TA] Academic supervisor: [TA]
B1. Provide information on the study background. (Committees are interested in knowing where the idea for this study has come from, if a literature review has been done and what the rationale for doing this study is. Your answer should be between 100 – 500 words in length to include a maximum of five references. There is a word limit in place. If a study protocol is available, please ensure that the study protocol has been provided for the review of the committee. Please note that study protocols are not distributed to all committee members. However, all committee members will receive a copy of this application form.)
[TYPE ANSWER]
B2. List the study aims and objectives. (Any study proposed which cannot answer the research question posed is unethical)
[TYPE ANSWER]
B3. List the study endpoints (if applicable). (A study ‘endpoint’ is the outcome that this study is designed to evaluate.)
[TYPE ANSWER]
The focus of this question (C1) is different and is on the totals at each site. Committees will have a particular interest in knowing the numbers of participants at the site or sites for which they provide an ethical review.)
NAME OF SITE: Names of Treatment Group (if applicable) Insert name of group (if applicable): [TYPE NAME OF GROUP]
Insert name of group (if applicable): [TYPE NAME OF GROUP]
Insert name of group (if applicable): [TYPE NAME OF GROUP] [TYPE ANSWER] [TYPE NUMBER]
[TYPE NUMBER]
[TYPE NUMBER]
Action: Please add rows to the above table should you wish to add a site. Action: Please add columns to the above table should you wish to add an ‘arm’
C1.2 How will the participants in the study be selected? (Please outline how you will identify the participants for the study e.g. referral list to hospital clinic, random selection of patients from GP Register etc.)
[TYPE ANSWER]
C1.3 How will the participants in the study be recruited? (Please indicate how and who will identify the participants for the study e.g. letter of invitation, verbal approach when attending the clinic, poster advertisement, web advertisement etc. Please ensure that you provide copies of all letters and advertisements referred to in your response for review)
[TYPE ANSWER]
C1.4 What are the main inclusion criteria for research participants? (Please justify) (Please be careful when responding to this question especially if there is more than one grouping of research participants. Please state the inclusion criteria for each group of research participants.)
[TYPE ANSWER]
C1.5 What are the main exclusion criteria for research participants? (Please justify) (Please be careful when responding to this question especially if there is more than one grouping of research participants. Please state the exclusion criteria for each group of research participants.)
[TYPE ANSWER]
C1.6 Will any participants recruited to this research study be simultaneously involved in any other research project? (Researchers should consider the effect of over- burdening participants in terms of the number of research projects they are invited to participate in.)
Yes / No / Not to my knowledge
“In medical research regarding competent human subjects, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researchers, the anticipated benefits and potential risks of the study and the discomfort it may entail, and any other relevant aspects of the study….
After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must seek the potential subject’s freely-given informed consent, preferably in writing…..” World Medical Association Declaration of Helsinki, 2008.
“Participation by competent individuals as subjects in medical research must be voluntary. Although it may be appropriate to consult family members……, no competent individual may be enrolled in a research study unless he or she freely agrees.” World Medical Association Declaration of Helsinki, 2008.
C2.1 (a) Will informed consent be obtained?
Yes / No
Action: If you chose ‘no’ please delete C2.1 (c) (d) (e) (f) (g) and (h)
Action: In addition, if you chose ‘no’ please delete the following questions in Section C4: C4.4, C4.5 C4. and C4.7 (These questions relate to consent of parents/legal guardians of children and assent of children)
Action: If you chose ‘yes’ please delete C2.1 (b)
C2.1 (b) If no, please justify.
[TYPE ANSWER]
C2.1 (c) If yes, how will informed consent be obtained and by whom? (Only appropriately qualified and competent persons should take informed consent. Please ensure you provide copies of any Information Leaflets, Consent Forms and Assent Forms referred to in response to this question.)
[TYPE ANSWER]
C2.1 (d) Will participants be informed of their right to refuse to participate and their right to withdraw from this research study? Yes / No (“A patient’s refusal to participate in research must not influence your care of that patient in any way.” Guide to Professional Conduct and Ethics for Registered Medical Practitioners 2009
“The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal.” World Medical Association Declaration of Helsinki 2008
It is noted that in some studies, e.g. those involving anonymous questionnaires it will be impossible for the research participant to withdraw from the study. However, where withdrawal is a possibility, please confirm that all identifiable data and identifiable human biological tissue samples will be destroyed either when the participant withdraws or when the research participant specifically requests that this occur. All relevant Information Leaflets should also include this information.)
[TYPE ANSWER]
C2.1 (e) If No, please justify.
[TYPE ANSWER]
C2.1 (f) Will there be a time interval between giving information and seeking consent? (Research participants should be given a reasonable period of time in order to make a decision about whether or not they wish to participate in a research study. Ideally, there should be adequate time for the participant to consult with family, friends and general practitioners before making a decision.
C3.1 (c) If no, is this research of such a nature that it can only be carried out on adults without capacity? (If this research study can validly take place using adult participants with capacity, adult participants without capacity should not be included.)
Yes / No
C3.1 (d) What arrangements are in place for research participants who regain their capacity during the study?
[TYPE ANSWER]
C4.1 (a) Will any research participants be under the age of 18 i.e. children? (A “child” is a person under the age of 18 years as per Section 2 of the Child Care Act 1991)
Yes / No
Action: If you chose ‘no’ please delete all remaining questions in C4.
C4. 1 (b) If yes, please specify:
Persons < 16 (Persons under the age of 16IV^ cannot give consent to take part in most research studies, and (if consent is being sought) it should be sought from one parent or one legal guardian. It is recommended however that persons under the age of 16 be assented to participate in a manner appropriate to their age and level of understanding. It is strongly recommended that expert advice be sought where the research study involves persons under 16.)
Yes / No
Persons aged 16 – 18 (Persons between the ages of 16 and 18 form a special category of persons under the age of 18 who can legally give consent for medical, surgical and dental treatment.V^ It can be argued that this entitlement does not extend to participation in medical research.VI^ This has not been tested in the Irish courts however. Therefore the conservative approach would be (if consent is being sought) to approach one parent or one legal guardian to give consent on their behalf and for the persons between 16-18 to read an Information Leaflet appropriate for young persons and to sign an Assent Form. This matter however will need to be dealt with on a case by case basis, as some research studies involve the collection of data only.VII VIII^ It is strongly recommended that expert advice be sought where the research study involves persons between 16 – 18 )
Yes / No
Children in Care (There may be legal difficulties in recruiting a child who is the subject of a care order under Section 18 of the Child Care Act 1991 to a research study. This issue also arises in respect of a child who is in foster care as per the 1995 Children in Foster Care Regulations.IX^ It is strongly recommended that expert advice be sought where the research study involves children in care. ) Yes / No
C4.2 Is this research of such a nature that it can only be carried out on children? (Research which can validly take place using adult participants should proceed without the inclusion of child participants)
Yes / No
C4.3 Please comment on what will occur if the researcher discovers that a child is at risk during the course of this study? (It is recommended that all researchers familiarise themselves with the Children’s First National Guidelines for the Protection and Welfare of Children)
[TYPE ANSWER]
Action: The following questions apply only if consent is being sought as per your response to Question 2. (a). If you responded ‘no’ to Question C2.1 (a), please delete C4.4, C4.5, C4.6 and C4.7.
C4.4 Will each child receive information according to his/her capacity of understanding regarding the risks and benefits of the study? Please elaborate and provide copies. (Age–Appropriate Information Leaflets and Assent Forms are important in this respect e.g. an Information Leaflet should be designed for 12-16 year olds, for 8 to 12 year olds and for children under 8. While children over 8 may read the Information Leaflet themselves, children under 8 should have the Information Leaflet read to them.)
[TYPE ANSWER]
C4.5 Will the explicit wish of the child who is capable of forming an opinion and assessing information to refuse to participate or to be withdrawn from the study be considered by the lead investigators, co-investigators and principal investigator? Please elaborate. (Where the child refuses to participate or wishes to be withdrawn from a study, it is strongly recommended that the wishes of the child be upheld. Children may not always be in a position to form an opinion however, either due to their age or depending on how sick they are.)
[TYPE ANSWER]
C4.6 Please comment on the involvement (if any) of Parents / Legal Guardians of the child in the consent process. (Please note that it is only necessary (where consent is being sought from parents / legal guardians) for one parent or one legal guardian to sign a Consent Form in order for the child to participate in a research study. Please also refer to the Endnotes at the rear of the Guidance Manual – Appendix Nine.)
[TYPE ANSWER]
C4.7 Please explain your approach to reviewing assent where research subjects reach the age of 18 during the course of the study.
[TYPE ANSWER]
“Medical research is subject to ethical standards that promote respect for all human subjects and protect their health and rights. Some research populations are particularly vulnerable and need special protection. These include those who cannot give or refuse consent for themselves and those who may be vulnerable to coercion or undue influence. “ World Medical Association Declaration of Helsinki, 2008
Please confirm if any of the following groups will participate in this study. This is a quick checklist for research ethics committee members and it is recognised that not ALL groups in this listing will automatically be vulnerable or lacking in capacity.
relationship with the Principal Investigator, Lead Investigator or Co-Investigator. This is particularly the case where employees or staff members are in a dependent relationship with the Principal Investigator, Lead Investigator or Co-Investigators.)
Yes / No
C5.9 Prisoners (A number of committees provide an ethical review for studies taking place in prison facilities.)
Yes / No
C5.10 Residents of nursing homes (A number of committees provide an ethical review for research studies taking place in community settings including private and public nursing homes)
Yes / No
C5.11 Pregnant women (Committees are interested to know if pregnant women are being recruited to a study. This applies to studies involving exposure to radiation in particular. Secondly, a number of research ethics committees provide an ethical review specifically on behalf of maternity hospitals.)
Yes / No
C5.12 Women of child bearing potential (Committees are interested to know if women who may be or may become pregnant are being recruited to a study. This applies to studies involving exposure to radiation in particular.)
Yes / No
C5.13 Breastfeeding mothers (Committees are interested to know if breastfeeding mothers are being recruited to a study. This applies to studies involving exposure to radiation in particular.)
Yes / No
C5.14 Persons with an acquired brain injury (Some research participants may lack capacity by virtue of an acquired brain injury. However, capacity should be assessed on a case by case basis.)
Yes / No
C5.15 Intellectually impaired persons (Some research participants may lack capacity by virtue of an intellectual disability. However, capacity should be assessed on a case by case basis. There is no available definition for ‘intellectual impairment’ and hence this term should be taken to refer to both learning disability and intellectual disability. A number of committees provide an ethical review for research occurring in the community, including specifically the ‘intellectual disability’ services.)
Yes / No
C5.16 Persons aged > 65 (Persons over the age of 65 are not necessarily either vulnerable or lacking in capacity)
Yes / No
C5.17 If yes to any of the above, what special arrangements have been made to deal with issues of consent and assent (if any)? (It is recognised that not ALL groups in the above listing will automatically require special arrangements in relation to consent and assent. Secondly, you may have already provided the necessary information in your response to Question C3.1 (b). There can be
a crossover between groups which may be vulnerable, groups which may require special arrangements in relation to consent and assent and persons who lack capacity.)
[TYPE ANSWER]
D1. What research procedures or interventions (over and above those clinically indicated and/or over and above those which are part of routine care) will research participants undergo whilst participating in this study? (This means research procedures or interventions which the participants are undergoing as part of the research study, and not those procedures and interventions which participants are undergoing as part of routine care (or equivalent) i.e. which they would undergo irrespective of involvement in this research study or not. ‘Research Procedures’ is a very broad term which encompasses medical examinations, laboratory tests, x-rays, other imaging, physiotherapy sessions, counselling sessions, psychological assessments, questionnaires, interviews and focus groups i.e. any type of intervention or measure which research participants will engage in. It is further noted that not all research participants will be patients. For a healthy volunteer or staff member taking part in a research study, no procedures or interventions will be ‘clinically indicated’ or ‘part of routine care.’ Nevertheless, please also list interventions or procedures which healthy volunteers or staff members will undergo due to their involvement in this research study only. Secondly, committees are also interested in knowing if there are any extra tests or analyses being done on samples taken which are over and above those tests done as part of routine clinical care. Please also refer to tests / analyses in response to this question where this applies.) [TYPE ANSWER]
D2. If there are any potential harms resulting from any of the above listed procedures, provide details below: (All research on human beings carries the possibility of harm. Whether the risk of harm is acceptable or not depends on the importance of the question being addressed and the likelihood of a meaningful result from the study. Harms can be physical, psychological, psychosocial or other and can include pain, discomfort, inconvenience or change to lifestyle. Even seemingly innocuous questionnaires can upset patients and / or change the way they view or manage their illness. It is also wise to classify the harms listed. Harms can be classified as serious, non-serious, transient etc. It is also useful to committees if you state the risk (probability) of the harms occurring, where this is possible: the risk of harms occurring can in some studies be stated with accuracy. It is recognised however that for many studies the risk (probability) of harm occurring will not be quantifiable. Where relevant, please also state in your answer what measures will be put in place, if any, to ensure the risk of these harms occurring is minimised. Important Note: Please ensure any relevant harms listed in response to this questions are clearly outlined in any Information Leaflets related to this study Important Note: All serious adverse events occurring during the course of this research study must be reported as per each committee’s local guidelines in this matter. Note: The term ‘serious adverse event’ is more typically associated with clinical trials of medicinal products. A generic definition for a ‘serious adverse event’ outside of S.I. 190/2004 is not available. Hence, please report all Serious Adverse Events in line with each committee’s local definitions and guidelines in this matter.)
[TYPE ANSWER]
D3. What is the potential benefit that may occur as a result of this study? (There may be a direct benefit for research participants. There may be a benefit for the researcher in terms of academic qualification or career advancement. There may be a benefit for the healthcare system in
