Ethics Committee for Language Matters (ECLM)

Informed consent FORM TEMPLATE

Use as a guideline to be modified as necessary for a specific project

DATE:

ECLM Authorization

PARTICIPANT INFORMATION LEAFLET AND CONSENT FORM

TITLE OF THE RESEARCH PROJECT:

ETHICS NUMBER:

NAME OF PRINCIPAL INVESTIGATOR (student/staff number):

ADDRESS:

CONTACT NUMBER:

SUMMARY: [please provide a short summary of the consent form in plain language, including the following – topic of the study, who participants will be, what participation will entail, and that participation is entirely voluntary; any important points may be added]

DETAILED INFORMATION

You are being invited to take part in a research project that forms part of my........ Please take some time to read the information presented here, which will explain the details of this project. Please ask the researcher any questions about any part of this project that you do not fully understand. It is very important that you are fully satisfied that you clearly understand what this research is about and how you could be involved. Also, your participation is entirely voluntary and you are free to decline to participate. If you say no, this will not affect you negatively in any way whatsoever. You are also free to withdraw from the study at any point, even if you do agree to take part. Prior to publication of the study’s results (or the point that publication is in process), you may also withdraw the data you generate.

This study has been approved by the Ethics Committee for Language Matters (ECLM) of the Faculty of Humanities of the North-West University (NWU.............) and will be conducted according to the ethical guidelines and principles of the international Singapore Statement on Research Integrity (2010) and the ethical guidelines of the National Health Research Ethics Council. It might be necessary for the research ethics committee members or relevant authorities to inspect the research records to make sure that we (the researchers) are conducting research in an ethical manner.

What is this research study all about?

This study will be conducted ...................and will involve............. The researchers have been trained to use the methods mentioned in the previous sentence.

Approximately X participants will be included in this study.

The objectives of this research are: XXX

Why have you been invited to participate?

You have been invited to participate because you are XXX

You have also complied with the following inclusion criteria: XXX

You will be excluded if: XXX

What will your responsibilities be?

You will be expected to XXX

Will you benefit from taking part in this research?

The direct benefits for you as a participant will probably be XXX

The indirect benefit will probably be XXX

Are there risks involved in your taking part in this research and how will these be managed?

The risks in this study, and how these will be managed, are summarised in the table below:

Probable/possible risks/discomforts	Strategies to minimize risk/discomfort
[E.g., Because you will spend about three hours completing the questionnaires, it is possible that you will become tired]	[E.g., The researchers facilitating your completion of the questionnaire, will give you a15-minute break, with some refreshment (a juice and a piece of fruit) about halfway through]
[E.g., Because the researcher will ask you questions about what has been hard for you in your life, you will need to think about difficult times in your life. This could make you feel uncomfortable.]	[E.g., The researcher has a list of local mental health organizations/practitioners (add specific examples/names of organizations/practitioners who know about research and are willing to support participants) whom you can contact for one counselling session of 50 minutes.]
Etc.

However, we do believe that the benefits to you and to science (as noted in the previous section) outweigh the risks we have listed. If you disagree, then please feel free not to participate in this study. We will respect your decision.

Should we learn, in the course of the research, that someone is harming you, or that you are intending to harm someone, then we must tell someone who can help you/warn the person you are intending to harm.

Who will have access to the data?

Anonymity (that is, in no way will your results be linked to your identity) will .............Confidentiality (that is, I/we assure you that we will protect the information we have about you) will be ensured by........... Reporting of findings will be anonymous by.......

Only the researchers and.......... Data will be kept safe and secure by locking hard copies in locked cupboards in the researcher’s office and for electronic data it will be password protected.

Audio-recorded data will be sent to a transcriber who will sign a confidentiality clause (i.e., she will not be allowed to talk to anyone about any aspect of the data). As soon as data has been transcribed it will be deleted from the recorders. The transcripts will be stored on a password-protected computer. All co-coders will sign confidentiality clauses.

Data will be stored for..... years in .....

What will happen to the data?

The data from this study will be reported in the following ways: .... In all of this reporting, you will not be personally identified. This means that the reporting will not include your name or details that will help others to know that you participated (e.g., your address or the name of your school).

This is a once-off study, so the data will not be re-used.

Will you be paid/compensated to take part in this study and are there any costs involved?

No/yes, you will/will not be paid/compensated to take part in the study, but refreshments will be............ If participating in the research means that you have to travel especially for the purpose of participating, then your travel costs will be paid. There will thus be no costs involve

How will you know about the findings?

The general findings of the research will be shared with you by

If you would like feedback on your personal results, then ...

Is there anything else that you should know or do?

You can contact (researcher)............ at ............. if you have any further queries or encounter any problems.

You can contact the chair of the Ethics Committee for Language Matters (Prof Johanita Kirsten) at johanita.kirsten@nwu.ac.za if you have any concerns or complaints that have not been adequately addressed by the researcher.

You will receive a copy of this information and consent form for your own records.

Declaration by participant

By signing below, I …………………………………..…………. agree to take part in a research study entitled:

I declare that:

I have read and understood this information and consent form and it is written in a language with which I am fluent and comfortable.

I have had a chance to ask questions to both the person obtaining consent, as well as the researcher (if this is a different person), and all my questions have been adequately answered.

I understand that taking part in this study is voluntary and I have not been pressurised to take part.

I understand that what I contribute (what I report/say/write/draw/produce visually) could be reproduced publically and/or quoted, but without reference to my personal identity.

I may choose to leave the study at any time and will not be penalised or prejudiced in any way.

I may be asked to leave the study before it has finished, if the researcher feels it is in my best interests, or if I do not follow the study plan, as agreed to.

Signed at (place) ......................…........…………….. on (date) …………....……….. 20....

Signature of participant	Signature of witness

You may contact me again	Yes No

I would like a summary of the findings of this research	Yes No

I would like feedback on my functioning/wellbeing as reflected

in the questionnaires I completed	Yes No

The best way to reach me is:

Name & Surname:	________________________________________________

Postal Address:	________________________________________________

Email:	________________________________________________

Phone Number:	_____________________

Cell Phone Number:	______________________

In case the above details change, please contact the following person who knows me well and who does not live with me and who will help you to contact me:

Name & Surname:

___________________________________________________________________________

Phone/ Cell Phone Number /Email:

___________________________________________________________________________

Declaration by person obtaining consent

I (name) ……………………………………………..……… declare that:

I explained the information in this document to …………………………………..

I encouraged him/her to ask questions and took adequate time to answer them.

I am satisfied that he/she adequately understands all aspects of the research, as discussed above

I did/did not use an interpreter.

Signed at (place) ......................…........…………….. on (date) …………....……….. 20....

Signature of person obtaining consent	Signature of witness

Declaration by researcher

I (name) ……………………………………………..……… declare that:

I explained the information in this document to …………………………………..

I encouraged him/her to ask questions and took adequate time to answer them.

I am satisfied that he/she adequately understands all aspects of the research, as discussed above

I did/did not use an interpreter.

Signed at (place) ......................…........…………….. on (date) …………....……….. 20....

Signature of researcher

Signature of witness