To be on headed paper

CONSENT FORM

Study title: The Story of Us
Researcher name: Ashton Kingdon

ERGO number: 40702
Please initial the box(es) if you agree with the statement(s):

I have read and understood the information sheet and have had the opportunity to ask questions about the study.
I agree to take part in this research project and agree for my data to be used for the purpose of this study.
I understand my participation is voluntary and I may withdraw at any point throughout the interview for any reason without my rights being affected.

Name of participant (print name)……………………………………………………………………………

Signature of participant……………………………………………………………………………………….

Date……………………………………………………………………………………….. ………………….

Name of researcher (print name)……………………………………………………………………………

Signature of researcher ……………………………………………………………………………………….

Date………………………………………………………………………………………………………………..

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Optional - please only initial the box(es) you wish to agree to:

This should be used for any statements that are not mandatory for the participant to take part in the research.
Add as required

Appendix - Possible additional statements

(Please delete this section before submitting your documents for review).

This is a list of consent statements that you may also wish to use depending on your study type. This list is not intended to be exhaustive; therefore, please ensure you add any statements necessary for your research.

Please copy and paste into the template as appropriate.

General
I understand that my interview will be audio/video (delete as appropriate) recorded.
I understand my responses will be anonymised in reports of the research.
I understand that I may be quoted directly in reports of the research but that my name will not be used.
I understand that I will be quoted directly in reports of the research and that my name will be used.
I understand that the information collected about me may be used/ may be anonymised and used (delete as appropriate) in future ethically approved research studies.
I agree to be contacted regarding future unspecified ethically approved research projects. I therefore consent to the University retaining my personal details, kept separately from the research data detailed above. I understand that I can request my details be deleted at any time.
Data Protection

I understand that information collected about me during my participation in this study will be stored on a password protected computer and that this information will only be used for the purpose of ethically approved research studies.

Clinical Research
I understand my participation is voluntary and I may withdraw at any time for any reason without my medical care or rights being affected.
I understand that relevant sections of my medical notes and data collected during the study may be looked at by individuals from University of Southampton, from regulatory authorities, from the research sponsor or from the NHS Trust, where it is relevant to my taking part in this research. I give permission for these individuals to have access to my records.
I agree to my General Practitioner being informed of my participation in the study.
I understand that the information held and maintained by the Health and Social Care Information Centre (or amend as appropriate) and other central UK NHS bodies may be used to help contact me or provide information about my health status.
I understand that the samples of my tissue collected may be used/ may be anonymised and use (delete as appropriate) in future ethically approved research studies.

Tips for Designing a Consent Form

(Please delete this section before submitting your documents for review)

The main features of a good consent form are:
Date and Version number

It is important that the consent form is version numbered and dated so it is possible to track changes if and when they occur.

Use of Ethics reference

This is evidence of ethical approval and will reassure participants – enter the Submission ID generated when you create a submission in ERGO.

Use of itemised statements to allow each component of the research to be agreed to

Information will be commensurate with the study. For example, in an interview study you may want consent to (i) interview and (ii) tape the interview.

Use of Initial boxes

Better than tick boxes to minimise fraud or falsification.

Use of participant in other research

If you wish to keep the contact details of the participant for potential use in further studies you should include a separate statement for them to initial to give consent, and be clear that they can be removed from this contact list at any time. If you are including a statement to this effect it should be listed separately from the mandatory statements and made clear that it is optional and their participation in the research is not dependent on them agreeing to this.

Confirmation of the right to withdraw

You may wish to include a separate statement on confidentiality/anonymity but this is often best explained in the participant information sheet.

Please note that ‘withdraw at any time’ will only apply to certain types of research. Consider up to what point a participant can withdraw themselves or their data. This should also be detailed in the corresponding information sheet.
Space for printed names, signatures and dates

A space for the name and signature of the person taking consent is also desirable if different from the named researcher.

For studies involving the NHS and social care

For NHS research, extensive guidance notes and exemplars are available on the Health Research Authority (HRA) website:

http://www.hra-decisiontools.org.uk/consent/
For studies involving minors

For studies involving minors the consent process should be appropriate to the age and capacity of the participant group. If the minor is unable to consent for himself/herself (due to age or other consideration) then you should seek consent from the most appropriate proxy, usually a parent/guardian/carer. In this situation it is desirable to request that the participant provides assent, either through an assent form or verbally. An assent form should be age appropriate and therefore may not require the same detail or initialled boxes as would be expected on a consent form.

There are situations where it may be appropriate to use ‘opt-out’ consent, for example when researching with children in schools. In this situation you would inform parents/guardians/carers of the study and indicate that consent will be assumed if they do not respond to inform the researcher otherwise.
For further advice on the most appropriate method of consent required you can contact your Faculty Ethics Committee or the Research Governance Office.

The Health Research Authority (HRA) provide helpful guidance on writing assent forms for children at: http://www.hra-decisiontools.org.uk/consent/style.html. Although this is primarily for clinical research many of the points apply to all research involving children.

For studies involving human biological material

Additional consent statements will be required if your project involves collecting human biological material/human tissue. For advice regarding this you can contact the RIG team at [e-mail], the Tissue Bank Manager or the Designated Individual for the university.

For studies involving adults who lack capacity

A proxy consent form or consultee declaration form should be provided to the most appropriate person to provide proxy consent. This should include a statement to the effect that they believe the participant would have no objection to taking part.

Where possible, the participant should also be given the opportunity to assent or decline to take part in the research. Assent is where the participant directly involved in the research gives confirmation that they are happy to take part, when they are not in position to give informed consent. This must only occur in addition to informed consent. The method and appropriateness of determining this will depend on the participant cohort and research design. You should ensure you comply with the Mental Capacity Act 2005 where appropriate. You can seek further advice from your local Ethics Committee or the Research Governance Office.

The Health Research Authority provide guidance on consent forms for adults lacking capacity in England and Wales at: http://www.hra-decisiontools.org.uk/consent/examples.html.

For studies conducted via the internet

For studies taking place on the internet (eg electronic anonymous questionnaires), this consent form may not be the most appropriate method to obtain informed consent. Please follow local guidance on internet based research or contact your Faculty Ethics Committee or the Research Governance Office.

Use of a tick box (for online surveys only)

Most online survey software programmes have an option to allow participants to continue with the survey only if they tick a box giving their consent. This feature should be used at all times. For example, the University of Southampton’s online software, iSurvey, uses the following text and tick box:

Please tick (check) this box to indicate that you consent to taking part in this survey.

[Date] [Version Number] [Ethics/IRAS reference (if applicable)]