GREAT LAKES UNIVERSITY OF KISUMU



GREAT LAKES UNIVERSITY OF KISUMU (GLUK)

GLUK RESEARCH ETHICS COMMITTEE

(GREC)

Application for Ethical / Scientific Review

[REF: SOPs VERSION 2 -2018]

Date: ______/_________/_______

Project Title:

Name of all person(s) submitting research proposal:

| |Name |Position i.e. PI, Co-PI, |Organization/Institute/Centre |

| | |Supervisors e.t.c | |

|1. | | | |

|2. | | | |

|3. | | | |

|4. | | | |

Address for correspondence relating to this submission:

|Email | |

|Telephone number(s) | |

|Postal Address(es) | |

Date in which the project will begin & end:

|Begin Date; _______/_______/________ |End Date; ________/_________/________ |

|Study Site; |

|Type of Review i.e. BSc, MSc, PhD, Expedited e.t.c | |

1. Describe the purposes of the research proposed:

2. Give a summary of the design and methodology of the project. Include in this section also, details of the proposed sample size, giving indications of the calculations used to determine the required sample size, including any assumptions you may have made. [if in doubt, seek statistical advise]:

3. Describe the research procedures as they affect the research subject(s) and any other parties involved:

4. What in your opinion are the ethical considerations involved in the proposal? (You may wish, for example to comment on issues to do with consent, confidentiality, risk to the subject(s) etc).

5. Outline the reasons which led you to be satisfied that the possible benefits to be gained from the project justify any risks or discomforts involved.

6. Who are the investigators (including assistants) who will conduct the research and what are their qualifications and experience?

7. Are arrangements for the provision of clinical facilities to handle emergencies necessary? If so, briefly describe the arrangements made.

8. In cases where subjects will be identified from information held by another party (for example, a doctor or a hospital) describe the arrangements you intend to make to gain access to this information including, where appropriate, which Multi Centre Research Ethics Committee or Local Research Ethics Committee will be applied to.

9. Specify whether subject(s) will include students or others in a dependent relationship.

10. Specify whether the research will include children or people with mental illness, disability or handicap. If so, please explain the necessity of involving these individuals as research subjects.

11. Will payments or any other incentive, such as a gift or free services, be made to any research subject? If so, please specify and state the level of payment to be made and /or the source of the funds/gifts/free service to be used. Please explain the justification for offering payment or other incentive.

12. Please give details of how consent is to be obtained. A copy of the proposed consent form, along with separate information sheet, written in simple, non-technical language MUST ACCOMPANY THIS PROPOSAL.

13. Comment On any cultural, social or gender-based characteristics of the subject which have affected the design of the project or which may affect its conduct.

14. State who will have access to the data and what measures will be adopted to maintain the confidentiality of the research subject and to comply with data protection requirements e.g., will the data be anonymized?

15. Will the intended group of research subjects, to your knowledge, be involved in other research? If so, please justify.

16. State briefly any precautions being taken to protect the health and safety of researchers and others associated with the project (as distinct from the research subjects) e.g. where blood samples are being taken.

I attest that the information provided above is TRUE;

Name; ………………………………… Signature; ………………….. Date; ……..........

(Proposer of Research)

NB: Where the proposal is from a student, the Supervisors are asked to certify the accuracy of the above account.

Name…………………………………….Signature; …………………..Date……………..

(First Supervisor)

Name…………………………………….Signature; …………………..Date……………..

(Second Supervisor)

COMMENT FROM THE HEAD OF DEPARTMENT/GROUP/INSTITUTE/CENTRE

Name…………………………………….Signature;………………..Date…………….…..

(HoD/ Group/Institute/Centre)

NOTICE: ADDITIONAL CONDITIONS FOR PROTOCOL REVIEW

(This page may be retained by the applicant)

1. Committee meetings are on the first Wednesday of every other month. That is, the first Wednesday of February, April, June, August, October and December

2. Applications MUST reach the Secretary, three weeks before the date of sitting.

3. The application must be duly signed as indicated with the original in inked signature.

4. The Research protocol must be presented to the Secretary in TWO bound hard copies.

5. Should there be any impediment to such ordinary meetings; the Committee will find a convenient [alternative] date within the month but not more that two weeks into the month.

6. Expedited review meetings can be called within convenient interim dates that favor a minimum quorum. All applications for expedited review must have undergone scientific review and been granted approval.

7. The review exercise affects the ENTIRE proposal – that is, research design, methodology and ethical issues. The notion behind this procedure is that “bad science is in itself unethical.”

8. The analysis /review results will be carried under the following notices / recommendations:

a. Unconditional Approval

b. Conditional Approval

c. Defer until more information is obtained

d. Disapprove

9. Review results will be communicated to the PIs and Supervisor(s) within (5) working days of the meeting at which the decision was made and further requirements clearly stated.

10. Regulations require continuing review must be at least every 12 months. The review period will reflect an interval appropriate to the degree of risk. Continuing review has a separate application form that can be obtained on request.

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Further enquiries for clarification may be directed to:

Rose Evalyne Aseyo

Secretary, GREC

0708 648 068

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