Ethical Review Application Form
HTS Journal of Legal Issues
Ethical Review Application Form
Section A: Project Proposal
1. Title of Project:
2. Name of Researcher(s):
3. Proposed start date:
4. Proposed end date:
5. Describe the contribution of each researcher to the overarching project (in no more than 100 words):
6. Please provide a summary of the project written in language accessible for a nonexpert audience (approximately 300 words)
HTS Journal of Legal Issues, Ethical Review Application Form (August 2014) 1
HTS Journal of Legal Issues
Section B: Risk Assessment
Will the study involve:
Causing participants physical damage, harm or more than minimal pain
Manual handling of participants, vigorous physical exercise, or physical activity from which there is a likelihood of accidents occurring?
Physiological interventions or procedures outside of standard practice -
These might include the administration of drugs or other substances; taking bodily samples or human tissue (e.g. blood, saliva, biopsy or urine) from participants; use of probes or other equipment to measure or monitor bodily performance
Psychological interventions or procedures outside of standard practice -
These might include techniques such as hypnotherapy, psychometric testing
Exposure of participants to hazardous or toxic materials, such as radioactive materials
Inducing psychological stress, anxiety or humiliation
Questioning of participants regarding sensitive topics, such as beliefs, painful reflections or traumas, experience of violence or abuse, illness, sexual behaviour, illegal or political behaviour, or their gender or ethnic status
Children under 16
Incapacitated adults and/or people with learning disabilities or mental health problems
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
Groups where permission of a gatekeeper is normally required for access to its members, for example specific patient groups, traditional communities or school pupils?
Access to records of personal or confidential information?
Storage and analysis of tissue samples
Have you considered the possibility that your investigations might uncover unexpected and possibly clinically relevant findings?
Yes
Yes
Yes
Yes
No
No
No
No
A heavily researched population e.g. BSMS students Yes No
Any other risk not identified above Yes No
4.1 If you have answered ‘Yes’ to any of the above questions please describe the safeguards and monitoring procedure.
HTS Journal of Legal Issues, Ethical Review Application Form (August 2014) 2
HTS Journal of Legal Issues
Section C: Project Protocol
1. What is the purpose of this study? Please clearly state the aims of the study or hypothesis to be tested.
2. What methodology will be employed in this study?
3. What sort of participants will be involved? (i.e. how many, gender, ages)
4. If vulnerable and disadvantaged groups (i.e. children, incapacitated adults, populations in low income countries) will be involved, please give full details and outline the steps that will be taken to protect them.
5. What are the inclusion/exclusion criteria, if any?
6. Please state the rationale for your participant choice.
7. Please state the rationale for the number of participants to be recruited. (It is generally considered unethical to recruit either more, or less, participants than required to adequately power a study).
8. How will participants be identified and recruited?
9.
What measures will be taken to ensure confidentiality, privacy and data protection?
Data should be secured against unauthorised access. Where possible, the data should be
anonymised, where this is not possible confidentiality should be maintained.
10. What is your procedure for obtaining informed consent from the study participants? If it is not possible to obtain informed consent, full reasons must be given.
HTS Journal of Legal Issues, Ethical Review Application Form (August 2014) 3
HTS Journal of Legal Issues
11. Are there any risks to the participants? If so, how will these be managed?
12. Are there any risks to the researchers? If so, how will these be managed?
13. Will participants be reimbursed for expenses or given any inducements?
If so, please give details.
14. How, where and when will the data be collected?
Please include a copy of any questionnaire that will be used, or sample questions (e.g. a topic
guide), in structured or semi-structured interviews.
15. What facilities will be needed and who will provide them?
16. How will the results be analysed and by whom?
17. What are the expected benefits of the research to participants or researchers?
18. How will any expected benefits be disseminated to participants or researchers?
19. What arrangements will be made for giving the participants access to the results?
20. What results/end points are to be measured/noted?
21. Do any of the researchers have any financial interests in this research or its outcomes or any relevant affiliations?
If ‘Yes’ please give details and include an appropriate comment on the Participant Information
Sheet.
HTS Journal of Legal Issues, Ethical Review Application Form (August 2014) 4
HTS Journal of Legal Issues
HTS Journal of Legal Issues, Ethical Review Application Form (August 2014) 5
