BUHREC

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BABCOCK UNIVERSITY HEALTH RESEARCH ETHICS COMMITTEE (BUHREC), REQUIREMENTS FOR ETHICAL CLEARANCE

Procedure

Categories of researches: BSc. /MSc. /M.Phil. /PhD. /Pg. Diploma/Independent researches.


A well written proposal, which contains all the information listed below, (as may be relevant to each discipline), should be submitted when requesting for Ethical clearance. This should contain sections (or chapters) on Introduction, Literature review, detailed Methodology, List of references, Informed consent form, (see check list overleaf) and the Instrument (questionnaire), for data collection. The items numbered 1-13 below, should be clearly addressed, (as may be applicable to each discipline).

1: Application Letter

: A letter of application for ethical clearance to the BUHREC Chairman, through the supervisor, signed by the supervisor and stamped at the departmental office is required when proposal is being submitted.

2: Title

This should be a concise information about the study, which briefly gives information about what the study is all about. Please note that the title should be made up of only eighteen (18) words: however twenty two (22) words may be acceptable but it should not exceed twenty four (24) words.

3: Introduction

In chapter one, the following should be well addressed.  Background Information, description of the study, device, book, animal, Laboratory Studies or other human studies, etc.

4: Objectives

Primary and/or secondary, tertiary objectives, research questions, hypotheses, etc, should be well and clearly stated.

5: Literature Reviews

This is a summary of researches that have been previously published about a particular subject, on   the current situation, in terms of researches that have been conducted. The format may vary from discipline to discipline. Sometimes it may include suggestions about what needs to be done to increase the knowledge and understanding of a particular problem. The articles referenced should be from professional journals or books, which means they can be trusted, because the authors are trained professionals, hence others have examined the publications.

6: Methodology

    This describes the study design of:
  • How and where the study will be conducted;
    •     
  • How research participants will be recruited, number of study participants; and
    •     
  • Duration of the study etc.

7: Study Population

Defines who would be recruited (where applicable) to:
a. Inclusion criteria
b. Exclusion criteria.
Guidelines based on such factors as:
i)  Age
ii) Type of disease
iii) Medical history
iv)  Current medical condition etc.

8: Study Product/device (Where applicable)

a. Regimen
b. mode of administration
c. product formulation
d. how product will be supplied and how the use and dispense of the product will be accounted for
e. what other products/procedures can or cannot be used with study products/device

9: Study Procedure (Where applicable)

a. Enrollment procedure: (consent of participants)
b. how will clinical and follow-up visits be conducted
c. how does participant exit research
d. clinical and laboratory evaluations
e. specimen collection
f. specimen handling,
g. specimen disposal

10: Assessment of Safety (Where applicable)

a. Safety monitoring
b. Clinical date review
c. Follow up.

11: Clinical Management (Where applicable)

a. Definition of adverse events
b. When and how to modify oral dose (drug)
c. When to discontinue study product or discontinue a trial participant on a product/device, how to manage adverse events,

12: Statistics, data handling and record keeping

a. Data analysis procedure, to include formula/e, (as may be applicable).
b. Data analysis
c. Data safety
d. Confidentiality issues related to data (where applicable)

13:

List of references, Informed consent form, Instrument for data collection, (questionnaire) and appendix   (where applicable), should all be included.

Informed Consent Checklist

Items to be included in the informed consent form (where applicable) should be as follows:
Please see sample form(should be highlighted)

  • Title of the research
  • Purpose(s) of research
  • Very brief information on the procedure(s) of the research
  • Compensation (available or not available)
  • Consequences of participants’ decision to withdraw from research also procedure for orderly termination of participation
  • Modality of providing treatments and action(s) to be taken in case of injury or adverse event(s) (where applicable)
  • What happens to research participants and communities when the research is completed (where applicable)
  • Post research benefits to participants (where applicable)
  • Any apparent or potential conflict of interest by the researcher
  • Detailed contact information including contact address, telephone, fax, e-mail and any other contact information of researchers(s)
  • Name and signature of researcher and date

Further Information

 Four temporarily bound copies of the proposal should be submitted, along with the teller, with TURN-IT-IN (plagiarism check)REPORT (undergraduate- not more than 20%, masters- not more than 15%, PHD- not more than 10%) to BUHREC office, on Mondays to Wednesdays, between 2 pm and 4:30 pm only. A soft copy should also be sent by email to: buhrec@gmail.com

  1. Name, signature of participant and date
  2. Name, signature of witness and date

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