The Ethics Committee are not interested in the content of any study (e.g. survey questions or task descriptions) - these are something that you need to discuss with your supervisor to make sure they are balanced, appropriate etc.
This should be submitted to the relevant departmental contact well in advance of any planned study. Requests are normally processed within one workin week, but may take longer than this for more complex studies.
Extract from the University's Code of Practice on Investigations on Human Beings
Annex 2: Guidance on Compiling Information sheets and Consent Forms
A template for both the information sheet and consent form can be found on the website www.strath.ac.uk/ethics. All investigators are asked to take account of the following checklist. This checklist also provides guidance on the expected content of the information sheet for volunteers.
1. INFORMED CONSENT
Check list for points that should be mentioned on all consent forms, which participants need to sign.
1. Their participation is voluntary.
2. Their signature on the consent form indicates:
(a) that they are aware of what their participation involves, and of any potential risks;
(b) that all their questions concerning the investigation have been satisfactorily answered.
3. They can terminate their participation at any time without giving a reason and without any of their rights being affected (this is particularly important for students who might be concerned that it could be counted towards their success in their course).
4. They can also ask to have their data withdrawn from the investigation.
5. They are under no obligation to respond to all aspects of the investigation: for example, they can refrain from answering any survey question(s) about which they feel uncomfortable.
6. They understand that all information they give will be treated with the utmost confidentiality and their anonymity will be respected at all times.
7. Where relevant, they give their consent to the investigators to access specified records, e.g. medical notes.
8. Where relevant, they give permission for the investigator to maintain records of the investigation should a follow-up to the investigation be conducted in the future, or a further investigation be undertaken.
9. For investigations where it has been decided that ‘no fault compensation’ cover will be provided the following wording should be included in the consent form:
‘In agreeing to participate in this investigation you should be aware that you may be entitled to compensation for accidental bodily injury, including death or disease, arising out of the investigation without the need to prove fault. However, such compensation is subject to acceptance of the Conditions of Compensation, a copy of which is available on request.’ 10. Where human biological samples are taken (e.g. blood samples or biopsy samples) then the following statement should be included in the consent form – ‘All human biological samples will be the property of the University of Strathclyde’.
Where it is proposed to carry out DNA analysis of material in any samples then the following statement should be included in the consent form – ‘I consent to DNA in the samples being analysed’.
2. INFORMATION FOR PARTICIPANTS
The guiding principle is that all participants should be told as much as they might reasonably be expected to know in terms they will understand, about the purpose and procedures involved in the investigation, in order to be able to make an informed choice about whether or not they wish to participate.
List of items which should be addressed on the Information Sheet for participants.
1. Background and purpose of the investigation with possible benefits.
2. Investigator(s)' name, affiliation and contact details.
3. Status/role of investigator(s) (e.g. staff, undergraduate/postgraduate student).
4. Funding body for the investigation (if applicable).
5. Nature of the participants sample: any screening procedures necessary; any inclusion/exclusion criteria; any special skills/attributes involved.
6. Confidentiality and anonymity of participant details. While confidentiality and anonymity must be guaranteed by the researchers, there are certain circumstances where information provided by the participant may have to be disclosed to others e.g. where someone is at risk of harm or has been harmed. This will be discussed with the participant at the time so that they are aware of this and can be involved (or not) in how best to pass this information on. The participant’s identity and any personal identifier information should not be disclosed.
7. The nature of the investigation and what is involved for participants.
8. Duration and location of the investigation and participant timetable.
9. Any potential risks or discomfort for participants, any burdens imposed, any specific preparatory requirements (e.g. special diet, exercise).
10. Any payment/reimbursement to be made.
11. Person to whom questions/concerns should be directed before, during or after the investigation. Plus the name of an independent person to whom any questions may be directed or further information may be sought from – this is normally the secretary to the Ethics Committee.
12. Adequate debriefing/feedback after participation.
13. Where participants are minors or otherwise unable to give their full consent, a named individual responsible for their care will be asked to provide assent or to consent on their behalf.
14. Ethical approval has been obtained/is being sought.
15. Refusal to participate or withdrawal from an investigation should not affect any other aspects of the way a person is treated (e.g. best medical care)
16. How the data from the investigation will be stored, how long it will be retained and, where appropriate, if it will be used in any other future investigation.
OPTIONS FOR INFORMATION SHEET
1. Offer to send information about the results of the investigation to participants (if requested).
2. Researcher(s) will monitor well-being of participants at all times.
3. Arrangements for responding to adverse outcomes in the event of personal injury/damages.