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NWU-HREC Stamp

INFORMED CONSENT DOCUMENTATION FOR……………………

TITLE OF THE RESEARCH STUDY:

ETHICS REFERENCE NUMBERS:

PRINCIPAL INVESTIGATOR:

POST GRADUATE STUDENT:

ADDRESS:

CONTACT NUMBER:

You are being invited to take part in a research study that forms part of my/our........ Please take some time to read the information presented here, which will explain the details of this study. Please ask the researcher or person explaining the research to you any questions about any part of this study 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 might be involved. Also, your participation is entirely voluntary and you are free to say no 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 now.

This study has been approved by the NWU-Health Research Ethics Committee of the Faculty of Health Sciences of the North-West University (NWU.............) and will be conducted according to the ethical guidelines and principles of Ethics in Health Research: Principles, Processes and Structures (DoH, 2015) and other international ethical guidelines applicable to this study. It might be necessary for the research ethics committee members or other relevant people to inspect the research records.

What is this research study all about?

We plan to …….:

This study will be conducted ...................and will be done by experienced health researchers trained in ............ X participants will be included in this study.

Why have you been invited to participate?

You have been invited to be part of this research because you are ………..

You will unfortunately not be able to take part in this research if …….

What will be expected of you?

You will be expected to

Will you gain anything from taking part in this research?

The gains for you if you take part in this study will be…………………../There will be no direct gains for you in the study.

The other gains of the study is for ……………….

Are there risks involved in you taking part in this research and what will be done to prevent them?

The risks to you in this study are……. but will be limited by………..

There are more gains for you in joining this study than there are risks.

How will we protect your confidentiality and who will see your findings?

Anonymity of your findings will be protected by............. Your privacy will be respected by …………. Your results will be kept confidential by ……….. Only the researchers and..........will be able to look at your findings. Findings will be kept safe by locking hard copies in locked cupboards in the researcher’s office and for electronic data it will be password protected. (As soon as data has been transcribed it will be deleted from the recorders.) Data will be stored for ..... years.

What will happen with the findings or samples?

The findings of this study will only be used for this study/will be used in future……..

How will you know about the results of this research?

We will give you the results of this research when ……… by……..

You will be informed of any new relevant findings by………………

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

This study is funded by……………………….

Yes, you will be paid an amount of …. when you…. /No you will not be paid to take part in the study because …..

Travel expenses will be paid for those participants who have to travel to the site......../You had no travel expenses and do not to be refunded for traveling.

Refreshments/a meal will be served when............

There will thus be no costs involved for you, if you do take part in this study.

Is there anything else that you should know or do?

You can contact ............ at ............. if you have any further questions or have any problems.

You can also contact the NWU-Health Research Ethics Committee via Mrs Carolien van Zyl at 018 299 1206 or carolien.vanzyl@nwu.ac.za if you have any concerns that were not answered about the research or if you have complaints about the research.

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

Declaration by participant

By signing below, I …………………………………..…………. agree to take part in the research study titled:………………………………….

I declare that:

I have read this information/it was explained to me by a trusted person in a language with which I am fluent and comfortable.

The research was clearly explained to me.

I have had a chance to ask questions to both the person getting the consent from me, as well as the researcher and all my questions have been answered.

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

I may choose to leave the study at any time and will not be handled in a negative way if I do so.

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

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

Signature of participant	Signature of witness

Declaration by person obtaining consent

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

I clearly and in detail explained the information in this document to

………………………………………………….

I did/did not use an interpreter.

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 gave him/her time to discuss it with others if he/she wished to do so.

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

Signature of person obtaining consent

Declaration by researcher

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

I explained the information in this document to ……………………………….. or I had it explained by …………………………………… who I trained for this purpose.

I did/did not use an interpreter

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

or I was available should he/she want to ask any further questions.

The informed consent was obtained by an independent person.

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

I am satisfied that he/she had time to discuss it with others if he/she wished to do so.

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

Signature of researcher

Current details: (23239522) G:\My Drive\9. Research and Postgraduate Education\9.1.5.6 Forms\HREC\9.1.5.6_NWU-HREC_ICF_Template_Feb2019.docm
7 February 2019

File reference: 9.1.5.6