Human Subjects Ethical Review Application Form

UCD Human Research Ethics Application Form

Human Subjects Ethical Review Application Form

Please use the Companion Guide to Completing the HREC Application Form and note that in order to complete this form correctly, you will need to read the HREC Guideline documents – specifically HREC Docs 4, 5 and 6 and the UCD Data Protection Policy and UCD IT Security Policies. Please see www.ucd.ie/researchethics for all guidelines and policies. . Please do not submit this form in PDF or docx format. Please put answers into the boxes provided and do not alter the format of this form.

Part A: Research Investigator(s)

1. Has this proposal been submitted to any other research ethics committee? (please tick appropriate box by double clicking and then checking)

Yes No

If yes, which committee and what was the outcome?

2. Is this a pilot study?

Yes No

3. Have you attended a one-to-one session with the Research Ethics Application Advisory Service?

Yes No

4. Short Title of Proposed Research for which approval is being sought

Title (no more than 10 words)
Start date: (dd/mm/yy) / Completion date: (dd/mm/yy)

5. Principal Investigator /Applicant

a. Name (please include title if applicable)

b.  Position in UCD (please tick appropriate response)

Staff Postgraduate Undergraduate

c. Details of Academic / Professional Qualifications

d. UCD Address of School for correspondence (home addresses are not acceptable)

e. UCD Telephone: UCD E-mail:

6. Recent relevant publications of principal investigator, if applicable

7. Co-Investigator(s), (if applicable)

a.  Names (please include title if applicable)

b.  Position in UCD (please tick appropriate response)

Staff Postgraduate Undergraduate

c.  Details of Academic / Professional Qualifications

8. Supervisor(s), (if applicable) supervisors must be members of UCD Staff

a.  Supervisor Name(s) (please include title if applicable)

b.  UCD School & email address

c.  Details of Academic / Professional Qualifications

9. Is this research being presented for an academic qualification? (please tick)

Yes No

If yes, please specify. a letter of endorsement from the supervisor for this study must accompany this form

10. Research funding (if applicable)

a. Details of funding agency and programme

b. If funded commercially, are there any restrictions on

the freedom of the researcher to publish the results? (please tick)

Yes No

If yes, please explain why.

11. Insurance/Indemnity arrangements –please read the Guidelines on Insurance/Indemnity (you will need to contact the UCD Safety Officer to ascertain whether your study will be/is covered)

Please note: if insurance is required you will need to include details as a supporting document to this application form. You may wish to submit your request for insurance after you have submitted this form and received your research ethics reference number – if so please ensure you quote the reference to the Safety Office.

12. Have you read following?:

a.  the current Guidelines and Policies for Ethical Approval of Research Involving Human Subjects issued by the Human Research Ethics Committee? Please see the research ethics website: http://www.ucd.ie/researchethics/hrec_policies_and_guidelines.html

(please tick) Yes No

b.  Have your read the UCD Data Protection Policy www.ucd.ie/dataprotection/policy

(please tick) Yes No

c.  the Data Protection Guidelines on Research in the Health Sector

http://www.dataprotection.ie/documents/guidance/Health_research.pdf

(please tick) Yes No not applicable

Please note: It is not sufficient to read a paper copy which may be out of date. The latest versions of the guidelines and policies are posted on the UCD website. Your application may not be considered if you have not read the latest version.

Part B: Research Proposal

13. Full Title of the proposed research

14. Has this topic been studied before? (please tick appropriate response)

Yes No

If yes, why is an additional study needed?

15. Provide a brief description of research (not more than 200 words in each of the boxes below). The description must be presented in everyday or lay language and detail:

a)  the aims and objectives of the study

b)  the scientific/theoretical background of study

c)  the research design

d)  the methods of data collection

e)  the size and composition of sample

f)  how the size of the sample was determined

g)  whether there will be a pilot study run initially

.

h)  the methods of analysis to be used

i)  whether formal statistical procedures will be used

j)  the expertise available to the researcher/s for analysis of the data

k)  the proposed starting date of research/study

l)  the proposed duration of research/study

m) the proposed duration of the data collection

16. Please identify any ethical dilemma which may arise in the course of the study.

Part C: Research Participants: Risk, Harm, Selection and Consent

17. Please indicate (tick) the level of risk for research participants:

Extreme risk High risk Some risk Minimal risk

Please indicate the steps that will be taken to control this risk or to address any harm associated with participation (e.g. debriefing procedures, etc.).

18. Provide details on the participants of the study:

a. Subjects. Who will participate in the study?

.

b. Selection and Recruitment: How will the research participants in this study be selected, approached and recruited?

i. Please state clearly who will approach potential participants?

c. Screening criteria for recruitment/selection of participants

i. Inclusion criteria. What inclusion criteria operate?

ii. Exclusion criteria. What exclusion criteria operate?

d.  Vulnerable participants: If the participants (or controls) belong to any of the following vulnerable groups please give details.

i.  Children under 18 years of age.

ii. University Students (see policies – accessing students and recommendations on using students in research)

iii. People who have language difficulty

iv. People who have a recognised or diagnosed intellectual or mental impairment

v. Older people

vi. People confined to institutions (prisoners, residents in 24 hour nursing facilities)

vii. Persons in unequal relationships with the researcher (teacher/student; therapist/client; employer/employee)

viii. Others (please specify)

19. If the study participants (or controls) belong to any of the vulnerable groups

please state what special arrangements will be made to deal with issues of consent/assent.

20. Please confirm (right click to tick) that the following issues have been

addressed in your Information leaflet for participants

Tick

1. Introductory statement

·  Researcher’s name and descriptor (Professor, Ms., Mr.)

·  Name of researcher’s School

·  The topic and title of the research.

2. What is this research about?

3. Why are you doing this research?

4. How will the data be used?

5. What will happen if they decide to take part in this research study?

6. How will you protect their privacy?

7. What are the benefits of taking part in this research study?

8. What are the risks of taking part in this research study?

9. Can they change my mind at any stage and withdraw from the study?

10. How will they find out what happens with this project?

11. Contact details for further information

If not included in the information leaflet fully explain and justify why?

21. Describe the procedures by which consent will be obtained.

a. Is written consent to be obtained? (please tick)

Yes No

i. If yes, describe the procedures by which written consent will be obtained.

ii.  If no, describe procedures regarding how consent will be obtained

Please send one electronic copy of the information sheet and the consent form for this submission together in one attachment.

22. Will payment of any kind, including expenses, be made to participants?

Yes No

If yes, please provide details and justification.

Part D: Confidentiality and Data Protection

23. What arrangements are in place to ensure that the identity of each

participant remains confidential?

24. Do you intend to use any of the following recording devices as a means of collecting information for this research study? (please tick)

a.  Audio/Sound recorder (tape/cds) Yes No
b.  Photography(incl. digital cameras/phones) Yes No
c.  Film/Video/DVD recorder Yes No
d.  Computer Yes No
e.  Other Yes No

If yes is indicated for any of these devices, please indicate the specific permission that will be obtained as part of the informed consent document.

25. Please tick the form in which the data will be collected.

Identified Potentially Identifiable De-Identified

26. Please tick the form in which the data will be stored and/or accessed.

Identified Potentially Identifiable De-Identified

27. Describe the measures that will be taken to protect the confidentiality of the data which will be collected.

a.  Who will have control of the data generated by the research?

b.  Please confirm where the data will be stored and that it complies with the guidelines.

c.  In what format will the data be stored?

d.  For how long will the data be stored?

28. Responsibility for data collected in the study

a.  Who will be responsible, until it has been destroyed or archived, for the secure storage of and for control of access to the data generated by the research?

b.  Who will be responsible for destroying the data at the end of the period indicated in answer to Q 27d?

c.  Will the data be destroyed at or before the end of the study?

Yes No

If yes, please confirm below that destruction has occurred in the Human Research Ethics Committee End of Study Report Form (HREC Doc 12).

If no, please indicate below how the person responsible for destroying the data will confirm to the Human Research Ethics Committee that this has occurred.

d.  Will the data be archived before the end of the study?

Yes No

29. Will any subsequent publication(s) entail the use of audio, video and/or

photographic records? (please tick)

Yes No

If yes, include how participants will be informed of this and confirm that this is included in the information leaflet and consent form.

Part E: Signed Declaration

30. SIGNATURES ARE REQUIRED ONLY POST-REVIEW AND FOLLOWING SATISFACTORY RESPONSES TO ANY CLARIFICATIONS. YOU WILL BE INSTRUCTED BY EMAIL TO PROVIDE A SIGNED HARD COPY OF THIS FORM. Before the final Approval Letter is issued by the HREC (Sciences), this section must be completed and submitted with original signatures.

Reference number:
Title of research project:
We the undersigned researchers acknowledge or agree with the University:
(a) It is our sole responsibility and obligation to comply with all domestic Irish and European legislation and to obtain such statutory consents as may be necessary.
(b) Not to commence any research until any such consents have been obtained.
(c) To furnish to the proper officer of UCD a true copy of any consent obtained.
(d) That neither the University, the Committee, nor individual members of the Committee accept any legal obligation (to us or to any third party) in relation to the processing of this application or to any advice offered in respect of it nor for the subsequent supervision of the research.
(e)  That the research will be conducted in accordance with any approval granted by the Committee and in conformity with the documentation submitted with this application and with licence granted under any legislation.
(f)  That the undersigned researcher(s) have read the most recent UCD Research Ethics Committee Guidelines and Policy for Ethical Approval of Research involving Humans – which are available on the UCD website (www.ucd.ie/researchethics) and agree to abide by them in conducting this research.
(g)  Confirm that the information provided on this form is correct and accurate.
(h)  In conducting research a researcher has both ethical duties and legal obligations. Compliance with one set of responsibilities does not guarantee compliance with the other - what is legally permissible may not be ethical and vice versa. It is for the researcher to inform himself and herself as to what ethical duties and legal obligations apply to his or her research and to comply with these duties and obligations.
(i)  It is not acceptable for an applicant to treat the grant of ethical approval as absolving them from the responsibility of informing themselves of their legal responsibilities in relation to data protection and of complying with these;
(j)  It must be understood that any ethical approval granted is premised on the assumption that the research will be carried out within the limits of the law;
(k)  Ethical approval does not constitute any sort of advice or representation to the applicant that compliance with the requirements, as laid down by the UCD Human Research Ethics Committee, will be sufficient to comply with the applicable law in the area.
Signature of Applicant: Date:
Signature of Principal Investigator (if Applicant is not the P.I.): Date:
Signature of Head of School (or designate): Date:

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