Ethics/Risk Assessment Forms

Application for Ethical Clearance for a Research Project Involving Human Participants

ITT Dublin RE_2 Form

To be completed by staff proposing to submit an application to conduct research involving human participants and human biological samples. The signed original and an electronic copy of the completed form should be returned to the Secretary of the Research Ethics Board.

Research must not commence until written approval has been received from the Research Ethics Committee.

Guidelines to applicants submitting applications for ethical clearance are given in the SOP entitled “Procedures for Submitting an Application for Ethics Clearance for Research Projects”.

Please check that all supplementary information is attached to your application (in both hard and soft copy).

ATTACHED NOT APPLICABLE Information on existing protocols/best practice to be followed in the proposed research Ethical Approval from Other Committees Form Bibliography/Reference Section Participant recruitment advertisement Informed Consent form(s) Case report forms/diary cards/questionnaires to be draft final used Interview Schedule draft final Hazard Assessment Form Use of Drug/Medical Device Additional Information Form Use of Ionising Radiation Additional Information Form Use of GMO Form Curriculum Vitae of principal researchers(s) and collaborators indicating expertise in the research area proposed ______

1 SECTION 1: APPLICANT DETAILS

1.1 General Information

PROJECT TITLE

THIS PROJECT IS: Staff Research Project Staff Research Project leading to academic award in another HEI (tick as many as Contract Research Project Clinical Trial apply) Funded Research Consultancy Project Student Research Project Masters Taught postgraduate

PhD Undergraduate Other - Please Describe: Project Start Project End Date: Date:

1.2 Investigator Contact Details

PRINCIPAL INVESTIGATOR(S): TITLE SURNAME FIRST NAME POSITION & PHONE FAX EMAIL ROLE IN RESEARCH

OTHER INVESTIGATORS: Including Collaborators and Off-Campus Supervisors TITLE SURNAME FIRST NAME POSITION & PHONE FAX EMAIL ROLE IN RESEARCH

DEPARTMENT SCHOOL RESEARCH CENTRE

WILL THE RESEARCH BE UNDERTAKEN ON-SITE AT THE INSTITUTE OF TECHNOLOGY TALLAGHT? YES NO (If NO, give details of off-campus location.)

IS THIS PROTOCOL BEING SUBMITTED TO ANOTHER ETHICS COMMITTEE, OR HAS IT BEEN PREVIOUSLY SUBMITTED TO AN ETHICS COMMITTEE?) YES NO (If YES, please complete the Ethical Approval from Other Committees Form and provide letter of approval, detail on decision received etc.)

2 SECTION 2: DETAILS OF RESEARCH STUDY

In this section you are required to provide a brief outline of the project, aims, methods, duration, funding, profile of participants and proposed interaction with them. This description must be in everyday language that is free from jargon. Additional pages may be added where necessary.

2.1 PROJECT OUTLINE - LAY DESCRIPTION Provide a brief outline of the project, including what participants will be required to do. This description must be in everyday language which is free from jargon. Please explain any technical terms or discipline-specific phrases. (No more than 300 words).

2.2 AIMS OF AND JUSTIFICATION FOR THE RESEARCH State the aims and significance of the project (approx. 400 words). Where relevant, state the specific hypothesis to be tested. Also please provide a brief description of current research, a justification as to why this research should proceed and an explanation of any expected benefits to the community. NB – all references cited should be listed in an attached bibliography/reference section.

2.3 PROPOSED METHOD Provide an outline of the proposed method, including details of data collection techniques, tasks participants will be asked to do, the estimated time commitment involved, and how data will be analysed. If the project includes any procedure which is beyond already established and accepted techniques please include a description of it. (No more than 400 words.)

2.4 PARTICIPANT/SAMPLE PROFILE Provide number, age range and source of participants. Please provide a justification of your proposed sample size. Please provide a justification for selecting a specific gender. Please state how, how you are going to comply with the relevant statutory and/or regulatory guidelines.

2.5 PLEASE EXPLAIN WHEN, HOW, WHERE, AND TO WHOM RESULTS WILL BE DISSEMINATED, INCLUDING WHETHER PARTICIPANTS WILL BE PROVIDED WITH ANY INFORMATION AS TO THE FINDINGS OR OUTCOMES OF THE PROJECT?

3 2.6 OTHER APPROVALS REQUIRED Has permission to gain access to another location, organisation etc. been obtained?

YES NO NOT APPLICABLE

(If YES, please specify from whom and attach a copy of approval letter. If NO, please explain when this will be obtained.)

2.7 HAS A SIMILAR PROPOSAL BEEN PREVIOUSLY APPROVED BY THE RESEARCH ETHICS BOARD? YES NO (If YES, please state both the REC Application Number and Project Title)

SECTION 3: PARTICIPANT SELECTION

What are the primary location(s) for data collection? (e.g. classroom, participant’s home, Hospital/clinic, laboratory, place of convenience for participant):

Please specify the types of subjects involved in this study and indicate the number of each type: Type of Subject: Numbe Type of Samples: Number r . healthy subjects – specify: . in-patients a) . clinic attendees b) . minors c) PROCEED NOW TO SECTION 3.2 IF NOT USING HUMAN SAMPLES 3.1 TO BE COMPLETED WHERE THE RESEARCH INVOLVES HUMAN SAMPLES/IMAGES Sample description:

Rationale for using this sample type:

Are there potential risks with using this sample type, for the investigators, samples, the research environment? Delete YES/NO as appropriate.

If YES, you must complete Section 6 of this form Specify the number of samples of this type to be used in this project:

Please provide information on the proposed methods/protocols to be followed and what

4 experiments are to be conducted using these samples: [can use extra sheet]

Provide information on what is to happen to the samples following their use and how they will be treated/stored:

PROCEED NOW TO SECTION 6 IF NOT USING HUMAN SUBJECTS 3.2 TO BE COMPLETED WHERE THE RESEARCH INVOLVES HUMAN SUBJECTS With regard to subjects to be involved in the research: . How will subjects be recruited for the study? (use an additional sheet if needed)

. Is written consent to be obtained? If YES, you must also complete Section Yes No 4

. Are subjects under the age of 18 to be included? If YES, you must also Yes No complete Section 5

. Will any payments be made to subjects? If YES give details: Yes No

. Is any proportion of this payment being paid by a commercially sponsored Yes No organisation and if so by whom?

. Are there potential risks within the project, if any, for the investigator, Yes No subjects, samples, the environment and/or participants? If YES, you must complete Section 6 . If controls are to be included please state how they are to be selected: NB. Names of Student Subjects receiving payment in commercially sponsored research must be notified to the Research Ethics Committee (attach list)

Specify the number of subjects to be used in this project, the selection criteria and the exclusion criteria to be used:

Number:

5 List your exclusion/inclusion criteria for participant selection:

Inclusion criteria:

Exclusion criteria:

Specify whether any of the following procedures are involved: (Delete yes or no as necessary) a) Any invasive procedures Yes No b) Physical contact Yes No c) Any procedure that may cause mental distress Yes No Is a product such as pharmaceutical or devices to be administered to the participant?

DELETE YES/NO as appropriate

Where you have answered YES – Please provide a summary of all toxicological and pharmacological data available on the product and clinical experience with the product to date: [can use an extra sheet]

Information on the sampling procedures involved in your study: . Are samples to be taken? If YES, indicate: Yes No a) Types of sample to be taken: b) Frequency of samples: c) Amount of sample: d) Is this part of the person’s normal treatment? Yes No If Radiological Investigations indicate the number and frequency of exposures and total

6 calculated dosage: . Number of exposures: . Frequency: . Total dosage:

Identify the procedures which may cause physical or mental discomfort or distress and the degree of discomfort or distress likely to be endured by the subjects: a) b) c)

SECTION 4: PARTICIPANT CONSENT I

Informed consent is required for all human subject participants in the proposed research.

4.1 Will informed consent be obtained from the research participants?

YES NO

If yes, please give details of who will take consent and how it will be done. (Please attach a copy of letter, consent form (if required) and information leaflet. See guidelines on how to prepare these documents in the Appendix 2 associated with the Institute Ethics Procedures and adapt examples accordingly to suit your study and participants)

4.2 What is the time interval between giving information and seeking consent? (It is recommended that a period of seven days be provided for reflection. If it is proposed to be less than this, please justify).

4.3 Will the participants be from any of the following groups? (Put an x in the appropriate box)

7 YES NO Children under 18 years of age Adults with learning disabilities, if YES, please specify

Adults with communication difficulties Adults who are unconscious or very ill Adults who have a terminal illness Adults with mental illness Adults suffering from dementia Prisoners Young Offenders in custodial care Those who could have been considered to have a particularly dependent relationship with the investigator, e.g. those in care homes, students People engaged in illegal activities (e.g. drug taking; illegal internet behaviour etc.). If YES please specify group:

Other groups who may be considered vulnerable (Please specify below)

4.4 If participants are to be recruited from any of the potentially vulnerable groups listed above, please give details of:

(a) the extra steps taken to ensure that participants from any of these vulnerable groups are as fully informed as possible about the nature of their involvement:

(b) who will give consent:

(c) how consent will be obtained (e.g. will it be verbal, written or visually indicated?):

(d) When consent will be obtained:

(e) The arrangements that have been made to inform those responsible for the care of the research participants of their own involvement in research:

8 Questions 4.5 and 4.6 to be completed for research involving human participants in biological or clinical trial studies

4.5 Will participants include women of childbearing potential?

If No, please explain Why YES NO Note: This information is required regardless of whether there are potential implications for the well-being of participants or not

4.6 If women of childbearing potential are to be involved, does the study design and the participant information sheet address the 9 essential points listed below?

YES NO N/A

Have you included a copy of the participant information leaflet and consent form to be given to each participant? Does the nature of the study justify involving women of childbearing potential?

Has toxicological and pharmacological testing in animals or humans, performed to date, failed to produce any evidence that the study drug may be teratogenic?

Is there a clear warning in the patient information sheet that the effects of the study drug on a fetus are unknown but that they may be damaging? Is a pregnancy test to be performed immediately before the study begins? Are the forms of contraception allowed (and those forms which are unacceptable) specifically stated in the research protocol? Is there a clear indication in the patient information sheet that effective contraception must be practised during and for a time (corresponding to drug elimination kinetics) after the trial? Does the study exclude any participant whom the investigators feel is unlikely or unable to follow contraceptive advice? Is there a statement that if the patient becomes pregnant, or thinks she may be pregnant, that she should contact the study doctor immediately? If No, please explain why Note: This information is required regardless of whether there are potential implications for the well- being of participants or not

9 SECTION 5: PARTICIPANT CONSENT II (Additional information for “less powerful” subjects or those under the age of 18 years)

1. In what way, if any, does the proposed study benefit the individual subject? [Please type here]

2. Has parent/guardian consent to be obtained? Yes No 3. If YES, what form of consent was/will be obtained? Verbal: Tick as needed Written: Please attach a copy of the relevant forms to be used Witnessed: Other: 4. Will the child's or young person's assent be sought? Yes No 5. Are the risks of the investigation judged to be minimal or nil? Yes No

SECTION 6: POTENTIAL RISKS & RISK MANAGEMENT

6.1 ARE THE RISKS TO SUBJECTS AND/OR RESEARCHERS ASSOCIATED WITH YOUR PROJECT GREATER THAN THOSE ENCOUNTERED IN EVERYDAY LIFE?

YES NO

6.2 DOES THE RESEARCH INVOLVE? use of a questionnaire? (if YES please attach copy) interviews (if YES please attach interview questions) observation of participants without their knowledge participant observation audio- or video-taping interviewees or events access to personal and/or confidential data (including student, patient or client data) without the participant’s specific consent administration of any stimuli, tasks, investigations or procedures which may be experienced by participants as physically or mentally painful, stressful or unpleasant during or after the research process performance of any acts which might diminish the self-esteem of participants or cause them to experience embarrassment, regret or depression investigation of participants or direct contact with anyone involved in illegal activities procedures that involve deception of participants administration of any substance or agent to participant (if YES, please attach a Hazard Assessment Form [ITT Dublin RE_5 Form] and a Use of Drug/Medical Device Form [ITT Dublin RE_6]) the use of a medical device on or in a human participant (if YES, please attach a Use of Drug/Medical Device Additional Information Form [ITT Dublin RE_6]) the use of genetically modified organisms (if YES, please attach a Use of GMO Form [ITT Dublin RE_7]) the use of ionising radiation on a human participant (if YES, please attach a Use of Ionising Radiation Additional Information Form [ITT Dublin RE_8]) use of non-treatment placebo control conditions collection of body tissues or fluid samples collection and/or testing of DNA samples participation in a clinical trial

10 6.3 POTENTIAL RISKS TO PARTICIPANTS AND RISK MANAGEMENT PROCEDURES Identify, as far as possible, all potential risks to participants (physical, psychological, social, legal or economic etc.), associated with the proposed research. Please explain what risk management procedures will be put in place.

6.4 ARE THERE LIKELY TO BE ANY BENEFITS (DIRECT OR INDIRECT) TO PARTICIPANTS FROM THIS RESEARCH?

YES NO (If YES, provide details.)

6.5 ARE THERE ANY SPECIFIC RISKS TO RESEARCHERS? (e.g. risk of infection or where research is undertaken at an off-campus location)

YES NO (If YES, please describe.)

6.6 ADVERSE/UNEXPECTED OUTCOMES Please describe what measures you have, or will put in place, in the event that there are any unexpected outcomes or adverse effects to participants arising from involvement in the project.

6.7 MONITORING Please explain how you propose to monitor the conduct of the project (especially where several people are involved in recruiting or interviewing, and administering procedures) to ensure that it conforms with the procedures set out in this application. In the case of student projects please give details of how the supervisor(s) will monitor the conduct of the project.

11 6.8 SUPPORT FOR PARTICIPANTS Depending on risks to participants you may need to consider having additional support for participants during and/or after the study. Consider whether your project would require additional support, e.g., external counseling available to participants. Please advise what support will be available.

SECTION 7: FUNDING & PAYMENT OF PARTICIPANTS

7.1 OUTLINE SOURCES OF FUNDING FOR THE STUDY IF APPLICABLE AND HOW YOU WILL MANAGE ANY POSSIBLE CONFLICT BETWEEN THOSE FUNDING THE STUDY AND THE AIMS AND RESULTS OF THE STUDY IF APPLICABLE?

7.2 DO YOU PROPOSE TO PROVIDE INCENTIVES AND/OR EXPENSES TO PARTICIPANTS?

YES NO

If you have answered YES, please provide details on proposed incentives

7.3 WILL A PAYMENT BE MADE TO RESEARCH PARTICIPANTS?

YES NONE OTHER THAN MINIMAL NO EXPENSES TO COVER TRAVEL COSTS ETC

7.4 If you answered YES to question 7.3, please specify for what purpose the payment will be made and the amount per participant:

12 SECTION 8: CONFIDENTIALITY/ANONYMITY

8.1 WILL THE IDENTITY OF THE PARTICIPANTS BE PROTECTED?

YES NO (If NO, please explain)

If you have answered YES to question 8.1, then please answer questions 8.2 to 8.8:

8.2 What steps will you take to protect the confidentiality of the following, during and after the study? Participant identities:

Data collected and patient/client records:

Hardcopy records:

8.3 Is there any potential confidentiality issue through identification of the study location?

8.4 If your data is to be held on computer, how will it be protected?

8.5 What other person(s) other than the researcher/team as listed will have access to the data collected and what steps will be done to protect confidentiality?

8.6 The Institute Data Protection Policy recommends secure retention of data for 5 years. If there is any reason to apply for variation from these guidelines, please give details and justify:

13 8.7 If identifiable data or material will be retained after the study is completed, is it stated on an informed consent form that this will be done and that material will not be used in future unrelated studies without further specific permission being obtained?

YES NO IF NO, PLEASE EXPLAIN WHY

8.8 If the study involves audio taping interviews, you must allow the participant access to the transcript, if they so wish. This must be included in an Informed Consent Form and Information Leaflet (if these forms are being used). Will the participant be given access to a transcript of the audio tape interview?

YES NO N/A IF NO, PLEASE EXPLAIN WHY

SECTION 9: DATA/SAMPLE STORAGE, SECURITY & DISPOSAL

For the purpose of this section, “Data” includes that in a raw or processed state (e.g. interview audiotape, transcript or analysis). “Samples” include body fluids or tissue samples.

9.1 HOW WILL THE DATA/SAMPLES BE STORED? (The REC recommends that all data be stored on campus)

Stored at ITT Dubiln

Stored at another site (Please explain where and for what purpose)

9.2 WHO WILL HAVE ACCESS TO DATA/SAMPLES?

Access by named researchers only

Access by people other than named researcher(s) (Please explain who and for what purpose)

Other (Please explain who and for what purpose)

14 9.3 IF DATA/SAMPLES ARE TO BE DISPOSED OF, PLEASE EXPLAIN HOW, WHEN AND BY WHOM THIS WILL BE DONE?

SECTION 10: QUALIFICATIONS, EXPERIENCE & SKILLS OF PROPOSED RESEARCHERS List the academic qualifications and outline the experience and skills relevant to this project that the researchers and any supporting staff have in carrying out the research and in dealing with any emergencies, unexpected outcomes, or contingencies that may arise. No more than 200 words.

15 SECTION 11: DECLARATION BY INVESTIGATORS & APPROVAL SIGNATURES

PRINCIPAL INVESTIGATOR DECLARATION

The information contained herein is, to the best of my knowledge and belief, accurate. I have read and agree to comply with the Institute’s Code of Conduct for Researchers and Process and Procedures for Seeking Ethics Clearance for Research Projects. I have attempted to identify all risks related to the proposed research that may arise in conducting this research and acknowledge my obligations to and the rights of the participants. I am not aware of any other ethical issue not addressed within this form. I and my co-investigators have the appropriate qualifications, experience and facilities to conduct the research set out in the attached application and to deal with any emergencies and contingencies related to the research that may arise. I/We agree to abide by the decision of the Research Ethics Committee.

Name of Principal Investigator(s): ______BLOCK CAPITALS ______

Signature(s): Principal Investigator(s): ______

______

Date: ______

HEAD OF SCHOOL/DEPARTMENT APPROVAL

The Head of School/Department must countersign and date the application below:

I approve this study to be carried out under the auspices of my School/Department:

Name of Head of School/Department: ______BLOCK CAPITALS

Signature: ______

Date: ______

WHERE THE APPLICANT IS REGISTERED FOR AN ACADEMIC AWARD AT ANOTHER HIGHER EDUCATION INSTITUTION THE SIGNATURE OF APPROVAL OF THE OFF-CAMPUS SUPERVISOR SHOULD BE OBTAINED: I approve this study to be carried out:

Supervisor Name: ______BLOCK CAPITALS

Signature: ______

Date: ______