The purpose of this guideline is to ensure that all research/proposals conform to:

(i)     Generally Accepted Scientific Principles

(ii)    The Nigerian National Code for Health Research Ethics (www.nhrec.net)

A. Requirements for Submission:

 To submit a protocol to the Ethics Committee, an Investigator is required to submit the following:

1. Four hard copies of the research protocol/proposal and an electronic version (in MSWord or pdf format),

The protocol/proposal shall have the following sections

a. Cover page that shows:

• Title of research, Full Names and Qualifications of investigators, 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.

The introduction should include:

b. Background of Study   -   Describing current knowledge about the research.

• Rationale for the study

• Objectives of the study

C. Research Methodology:  should include the :

• Study design  -  stating  clearly the nature of the study (descriptive, drug trial, experimental etc)

• Sample size determination

• Sampling strategy/Interview including inclusion/exclusion criteria/frequency of interviews

• Statement on invasive sampling (blood, tissue etc) inclusion/exclusion criteria and frequency of sampling

• Data collection procedure

• Physical examination procedure if indicated

• Follow up details if required

• Laboratory procedure to be used

• Intervention to be used

• Data analysis method to be used

• Copies of Questionnaires, Survey instruments, Case report forms and Samples of Drug or other Devices should be used in the study.

• Ethical considerations which clearly identifies and addresses potential ethical problems that may arise in the research. e.g. if conducting research on prisoners, the issues of vulnerability and diminished autonomy is important and the researcher shall address these concerns in the protocol

1.      Principal Investigator’s CV in NIH Bios ketch format “maximum of 4 pages” (see appendix citing of an appendix), containing enough information to judge the ability of the PI to conduct the research)

2.      Supervisor’s attestation statement .e.g. student’s research.

3.      Co-Investigators attestation statement. (where applicable) or Copy of letter(s) of support from co-investigator(s), laboratories and resources are required where the researcher  will be collaborating with others.

4.      Sponsor’s attestation statement (where applicable)

5.      Materials Transfer Agreement (MTA) - Where samples will be shipped out of Nigeria – (see prototype on the NHREC website for guidelines. insert the link)

6.      Clinical Trial Agreement (CTA) – (Where the research is being conducted on behalf of a sponsor).

7.      Any other agreement that may have been signed and is relevant to the participants in the research.

8.      One page summary of the research in plain language including the title of the study, research objectives, procedures, and outcome variables.

9.      THE INFORMED CONSENT FORM ON INSTITUTIONAL OR DEPARTMENTAL LETTER HEADED PAPER. See IHVN HREC prototype consent form for guide. Insert link.

ATTENTION RESEARCHER:

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

B. Steps for Submission.

1.      Complete an application form.

2.      Compile all prescribed application materials and ensure that they are properly numbered with minimal typographical errors.

3.      Ensure that all relevant institutional officials have signed off on the protocol including a Supervisor in case of student’s research.

4.      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 NHREC http://www.nhrec.net  or West African Bioethics Training Program http://www.westafricanbioethics.net  website for suitable online training programs)

5. Write a covering letter addressed to the Chairperson, Ethics Committee

For more information please download and read a copy of the Nigerian Code for Health Research Ethics at  www.nhrec.net/nhrec/NCHRE_Aug2007.pdf