GUIDELINES FOR ETHICAL REVIEW OF PROTOCOL

 

The purpose of this summary is to ensure that all protocols conform to:

• Generally Accepted Scientific Principles
• The Nigerian National Code for Health Research Ethics (nhrec.net)

Very Important Information

Applicants are advised to submit protocols three months before the commencement of their research in order to provide adequate room for all the administrative procedures for the review of their submissions.

In order to submit a protocol to the Ethics Committee, you will find the information in this guide useful. For ethical review of protocol, the Committee needs the following materials:

Four paper copies of research protocol and an electronic version (in MSWord or pdf format).

• Cover page that shows the following:
  • Title of research, Full Names, e-mail Address, phone number, Qualifications of investigator(s), Supervisor’s name (where applicable) Sponsors (where applicable), Other Collaborating Institutions and Investigators.
  • Corresponding Investigator, who must be the Project Principal Investigator (PI) or Local PI of the research and bears legal responsibility for the research.
• Supervisor’s attestation statement. (Where applicable – for example, in student’s research).
• One page plain language summary of the research including the title of the study, background, methods, data analysis plan and expected outcome.

• Co-Investigators attestation statement. (Where applicable) or Copy of letter(s) of support from co-investigator(s), laboratories and sources of required resources (where the researcher indicates that (s) he will be collaborating with others.
• Sponsor’s attestation statement e. letter of sponsorship. (Where applicable)
• Materials Transfer Agreement (MTA - Where samples will be shipped out of Nigeria – see prototype on the NHREC website for guidance)
• Clinical Trial Agreement (CTA – Where the research is being conducted on behalf of a sponsor) and any other agreement that may have been signed and is relevant to the participants in the research.

The research proposal should contain enough information to allow the committee judge the ethical aspects of the research.

The protocol should contain the following sections:

• Background of Study - Describing current knowledge about the research.
• Rationale for the study (indicating the justification for the study)
• Objective of the study (general objective and specific objectives)

Research Methodology

• Study design - stating clearly the nature of the study (e.g. descriptive, retrospective, prospective, cross-sectional, case-control, clinical trial, e.t.c)
• Study site – stating clearly the location of the research.
• Study population – stating clearly the population of the study.
• Sample size determination – showing clearly how sample size was determined
• Sampling technique – stating clearly the sampling technique to be used for selecting research participants.
• inclusion criteria and exclusion criteria
• frequency of interviews
• Statement on invasive sampling (blood, tissue etc) frequency of sampling
• Data collection procedure
• Physical examination procedure if indicated
• Follow up details if required
• Laboratory procedure or Intervention to be used
• Data analysis method to be used
• The protocol should contain an ethical considerations section as a separate entity. In this section, researcher is to clearly identify the potential ethical problems that may arise in the research and address these. For example, if conducting research on prisoner, the issue of vulnerability and diminished autonomy is important and the researcher should address this concern in the protocol. For the avoidance of doubt, the following subheadings should be itemized and explained in the protocol:
  • Confidentiality of data
  • Translation of protocol to the local language
  • Beneficence to participants
  • Non–maleficence to participants
  • Voluntariness

• THE INFORMED CONSENT FORM ON INSTITUTIONAL OR DEPARTMENTAL LETTER HEAD PAPER. A prototype to guide you in designing your own consent form is included below.

Note that you can remove sections of the consent form that is not applicable to your research. If you find that you need to provide research participants with more information than can be accommodated within the recommended length of the consent documents, these can be provided as a separate Patient Information Document. The purpose of this is to reduce the length of the core informed consent document so that the research participant can focus on understanding the key ethical issues related to the research.

INFORMED CONSENT FORM

IRB Research approval number: ####                                     

This approval will elapse on: dd/mm/yyyy

Title of the research:      

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

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

(For example: This study is being conducted by Professor IkeOluwapo O. Ajayi of the University of Ibadan and Dr. A. M. Adeoye of University College Hospital, Ibadan

Sponsor(s) of research:      

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

Purpose(s) of research:      

(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:      

(For example: A total of 100 participants will be recruited into the study. We will use lottery to divide participants in this study into 2 groups. You 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.

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

(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):      

(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:      

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

Benefit(s):      

(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:      

(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:      

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

Alternatives to participation:      

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

Due inducement(s):      

(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:      

(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 effort in good faith 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):      

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

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

(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:      

(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:      

(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 and have had it translated into language I understand. I have also discussed 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:      

This research has been approved by the Ethics Committee of the University of Ibadan and the Chairman of this Committee can be contacted at Biode Building, Room 210, 2^nd Floor, Institute for Advanced Medical Research and Training, College of Medicine, University of Ibadan, E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.. In addition, if you have any question about your participation in this research, you can contact the principal investigator, Name…….……....................................................................................................................... Department……….............................................Phone……………............................................

Email………………................................................................................................................

PLEASE KEEP A COPY OF THE SIGNED INFORMED CONSENT.

NB:

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.

 

IN A STUDY THAT INVOLVED CHILDREN, THERE IS NEED TO INCLUDE AN ASSENT FORM

ASSENT FORM

I have had the description of this research explained to me thoroughly by the researcher. The purpose, methods, risk and benefits have also been explained in such manner that I understand and I am satisfied with the explanation.

I have been made to understand that my participation is voluntary and I may choose to withdraw from the research at any time. I have been made to understand that, if at any time during the course of the research I need further explanation or clarification, I can freely enquire from the researcher.

During the research, my Parent/Teacher/Headmaster/Principal may also make enquiries or seek clarification on my behalf.

Name: ………………………………………………………Assent: Hence, I willingly give assent to participate in the research. 

Signature or Thumb Print: …………………………………

Date: ……………………………………………………….

Statement of Person Bearing witness

I bear witness that ……………………………………………………… fully understand the description of the research as explained by the researcher.

Witness Name: ……………………………………………………

Witness Signature: ………………………………………………

Statement of Person Obtaining Consent

I have fully explained the description of the research as explained by the researcher.

Researcher’s Name: …………………………………………………

Researcher’s Signature: ……………………………………………

Research Instrument e.g. Copy of Questionnaire, Data collection form, Survey instruments, Case report forms (CRF) and Samples of Drug or other Devices to be used in the study must be included in the protocol.

List of references

ATTENTION !!!

When all prescribed application materials have been assembled, here are the steps to follow:

• Write an application letter to the Chairperson, UI/UCH Ethics Committee
• Complete an application form. Click here to download APPLICATION FORM
• Compile all prescribed application materials and ensure that they are properly numbered and do not have many typographical errors.
• Ensure that all relevant institutional officials have signed off on the protocol including a Supervisor in case of student’s research.
• Attach a copy of proof that you have recently undertaken satisfactory research ethics training within the last 2 years. Examples of such training include training programs conducted by your institution’s ethics committee, online training programs such as CITI (see citiprogram.org or www.elearning.trree.org)
• For Clinical Trail studies, the PI should provide three (3) evidences of research ethics training certificates as follows:
• Group 1(Biomedical Investigator)
• Good Clinical Practice (GCP)
• National Code for Health Research Ethics

For more information please download and read a copy of the Nigerian Code for Health Research Ethics at www.nhrec.net/nhrec/NCHRE_Aug%2007.pdf