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IRB Research approval number: ####

This approval will elapse on: dd/mm/yyyy

Title of the research: FORMTEXT

(For example: Phase III randomized clinical trial of New toothpaste for treatment of fetor oris)

Name(s) and affiliation(s) of researcher(s) of applicant(s): FORMTEXT

(For example: This study is being conducted by Dr. Alex Washington of the University of Alexander Washington, DC and Prof. Ayodele Ajagun of Federal Ministry of Science & Technology, Abuja Nigeria)

Sponsor(s) of research: FORMTEXT

(For example: This study is sponsored by Urals Pharmaceutical, Abeokuta, Nigeria

Purpose(s) of research: FORMTEXT

(For example: The purpose of this research is to find out whether New toothpaste is better than the current best mouth washing practice in reducing mouth odour)

Procedure of the research, what shall be required of each participant and approximate total number of participants that would be involved in the research: FORMTEXT

(For example: We will use lottery to divide participants in this study into 2 groups. Each participant will receive a year’s supply of toothpaste and 12 toothbrushes. Neither you nor your doctors will know whether you have received the New toothpaste or the Old toothpaste. You will be required to brush your teeth for 2 minutes every morning with the toothpaste that you have been given. You should not use any other mouth cleaning product during the course of this trial. Once a month, you will be required to come to the research centre where the doctors will examine your teeth and take measurements of your mouth odour using an odourmeter. In total we expect to recruit 100 participants into this study throughout the country.)

Expected duration of research and of participant(s)’ involvement: FORMTEXT

(For example: In total, we expect you to be involved in this research for 1 year. You should not spend more than 1 hour at each clinic visit)

Risk(s): FORMTEXT

(For example: The New toothpaste used in this study may cause some gum swelling, itching, discoloration and toothache. Some of your teeth may fall out reducing your ability to chew certain foods. You may develop burning sensation in the mouth, loss of appetite and stomach discomfort. We do not know how this toothpaste will affect the unborn child so it is advisable that you do not become pregnant during the course of your participation in this trial. In the event that you become pregnant, you should tell your doctor so that you can withdraw from this study.)

Costs to the participants, if any, of joining the research: FORMTEXT

(For example: Your participation in this research will not cost you anything.)

Benefit(s): FORMTEXT

(For example: The goal of this research is to find ways of reducing mouth odour. We hope that the New toothpaste will reduce mouth odour and make teeth whiter and brighter but we are not certain about this.)

Confidentiality: FORMTEXT

(For example: All information collected in this study will be given code numbers and no name will be recorded. This cannot be linked to you in anyway and your name or any identifier will not be used in any publication or reports from this study. As part of our responsibility to conduct this research properly, officials from NAFDAC, NHREC and ethics and food and drugs regulators from the United States may have access to these records.)

Voluntariness: FORMTEXT

(For example: Your participation in this research is entirely voluntary.)

Alternatives to participation: FORMTEXT

(For example: If you choose not to participate, this will not affect your treatment in this hospital in any way.)

Due inducement(s): FORMTEXT

(For example: You will be compensated for lost wages; cost of transport to and from the research site but you will not be paid any fees for participating in this research.)

Consequences of participants’ decision to withdraw from research and procedure for orderly termination of participation: FORMTEXT

(For example: You can also choose to withdraw from the research at anytime. Please note that some of the information that has been obtained about you before you chose to withdraw may have been modified or used in reports and publications. These cannot be removed anymore. However the researchers promise to make good faith effort to comply with your wishes as much as is practicable.)

Modality of providing treatments and action(s) to be taken in case of injury or adverse event(s): FORMTEXT

(For example: If you suffer any injury as a result of your participation in this research, you will be treated at the University of Ibadan Teaching Hospital and the research will bear the cost of this treatment.)

What happens to research participants and communities when the research is over: FORMTEXT

(For example: The researchers will inform you of the outcome of the research through a news bulletin. During the course of this research, you will be informed about any information that may affect your continued participation or your health.)

Statement about sharing of benefits among researchers and whether this includes or exclude research participants: FORMTEXT

(For example: If this research leads to commercial products, the University of Ibadan and Cleveland University shall jointly own it. There is no plan to contact any participant now or in future about such commercial benefits.)

Any apparent or potential conflict of interest: FORMTEXT

(For example: None of the researchers own shares in Urals Pharmaceuticals or its associated companies. We are not aware of any other information that may cause the researchers not to do their work with fear or favour.)

Statement of person obtaining informed consent:

I have fully explained this research to ____________________________________ and have given sufficient information, including about risks and benefits, to make an informed decision.

DATE: _____________________ SIGNATURE: _______________________________

NAME: ______________________________________________

Statement of person giving consent:

I have read the description of the research or have had it translated into language I understand. I have also talked it over with the doctor to my satisfaction. I understand that my participation is voluntary. I know enough about the purpose, methods, risks and benefits of the research study to judge that I want to take part in it. I understand that I may freely stop being part of this study at any time. I have received a copy of this consent form and additional information sheet to keep for myself.

DATE: ___________________ SIGNATURE: _________________________________

NAME: _____________________________________________

WITNESS’ SIGNATURE (if applicable): ___________________________

WITNESS’ NAME (if applicable): ______________________________________

Detailed contact information including contact address, telephone, fax, e-mail and any other contact information of researcher(s), institutional HREC and head of the institution: FORMTEXT

This research has been approved by the Institute of Human Virology, Nigeria (IHVN) Health Research Ethics Committee of the Institute of Human Virology, Nigeria. If you have any questions regarding your rights as a research participants or have concern that your rights have been violated in the course of your participation in this study, please contact the IHVN HREC using the following:

IHVN Health Research Ethics Committee

Pent House Maina Court,

Central Business District, Abuja

Tel:

Fax

e-mail:

In addition, if you have any question about your participation in this research, you can contact the principal investigator, (Investigator, please provide your full contact details here)

PLEASE KEEP A COPY OF THE SIGNED INFORMED CONSENT.

ATTENTION RESEARCHER: Note that you should include the Ethics Committee assigned approval number and the date/duration of the ethics committee approval on each copy of the consent form that is given to patients.

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