NNAMDI AZIKIWE UNIVERSITY
HUMAN RESEARCH ETHICS COMMITTEE
Template for Submitting Applications for Ethical Review of Research Protocols
The foregoing is a summary template whose aim is guide all categories of researchers to ensure that all proposal protocols conform to:
(i) Generally Accepted Scientific Principles
(ii) Nnamdi Azikiwe University Code for Health and Scientific Research
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;
- 15 paper copies of research protocol and an electronic version (in MSWord or pdf format). The protocol should have the following sections;
- Cover page that shows the following
- 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 research proposal should contain enough information to allow the committee judge the ethical aspects of the research.
The protocol may contain the following sections:
iii. Background of Study – Describing current knowledge about the research.
- Rationale for the study
- Objectives of the study
- Research Methodology
- Study design – stating clearly the nature of the study (descriptive, drug trial, experimental
- 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 to be used in the study must be included in the protocol
- 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.
- Principal Investigator’s CV in NIH Biosketch format (maximum 2 pages, containing enough information to judge the ability of the PI to conduct the research).
- Supervisor’s attestation statement. (Where applicable – in student’s research, for example).
- 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 i.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.
- One page plain language summary of the research including the title of the study, research design, methodology, principal exposure and outcome variables.
- THE INFORMED CONSENT FORM ON INSTITUTIONAL OR DEPARTMENTAL LETTER HEADED PAPER. Please see NHREC prototype consent form to guide you in designing your own consent form.
- ATTENTION RESEARCHER:
When all prescribed application materials have been assembled, here are the steps to follow:
- Write an application letter to the Chairman, Ethics Committee
- Complete an 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.
Chairman, Ethics Committee
First Floor Medical Library building,
College of Health Sciences
Nnamdi Azikiwe University Teaching Hospital Nnewi
Secretary, Ethics Committee
Faculty of Law, Nnamdi Azikiwe University Awka