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Copy1-4. Principal Investigators Declaration-1

The document is a declaration for Principal Investigators affirming their responsibilities in conducting research studies. It outlines the obligations to adhere to ethical guidelines, ensure informed consent, maintain accurate records, and report any adverse events. The investigator must also keep co-investigators informed and comply with all relevant regulations and ethics committee requirements.

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2 views

Copy1-4. Principal Investigators Declaration-1

The document is a declaration for Principal Investigators affirming their responsibilities in conducting research studies. It outlines the obligations to adhere to ethical guidelines, ensure informed consent, maintain accurate records, and report any adverse events. The investigator must also keep co-investigators informed and comply with all relevant regulations and ethics committee requirements.

Uploaded by

catville100
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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INVESTIGATORS’ RESPONSIBILTY DECLARATION- (To be signed by Principal Investigator)

By signing below I agree/certify that:

1. I have reviewed this protocol submission in its entirety and that I am fully cognizant of, and in
agreement with, all submitted statements.
2. I will conduct this research study in strict accordance with all submitted statements except where a
change may be necessary to eliminate an apparent immediate hazard to a given research subject.
 I will notify the ethics committee promptly of any change in the research procedures
necessitated in the interest of the safety of a given research subject.
 I will request and obtain the ethics committee approval of any proposed modification to the
research protocol or informed consent document(s) prior to implementing such modifications.

3. I will ensure that all co-investigators and other personnel assisting in the conduct of this research
study have been provided a copy of the entire current version of the research protocol and are fully
informed of the current (a) study procedures (including procedure modifications); (b) informed
consent requirements and process; (c) potential risks associated with the study participation and the
steps to be taken to prevent or minimize these potential risks; (d) adverse event reporting
requirements; (e) data and record-keeping; and (f) the current ethics committee approval status of
the research study.

4. I will respond promptly to all requests for information or materials solicited by the ethics
committee or ethics committee Office.

5. I will submit the research study in a timely manner for ethics committee renewal approval.
6. I will not enroll any individual into this research study until such time that I obtain his/her written
informed consent, or, if applicable, the written informed consent of his /her authorized
representative (i.e., unless the ethics committee has granted a waiver of the requirement to obtain
written informed consent).

7. I will employ and oversee an informed consent process that ensures that potential research subjects
understand fully the purpose of the research study, the nature of the research procedures they are
being asked to undergo, the potential risks of these research procedures, and their rights as a
research study volunteer.

8. I will ensure that research subjects are kept fully informed of any new information that may affect
their willingness to continue to participate in the research study.

9. I will maintain adequate, current, and accurate records of research data, outcomes, and adverse
events to permit an ongoing assessment of the risks/benefit ratio of research study participation.

10. I am cognizant of, and will comply with, current National regulations and ethics committee
requirements governing human subject research including adverse event reporting requirements.
11. I will make a reasonable effort to ensure that subjects who have suffered an adverse event
associated with research participation receive adequate care to correct or alleviate the consequences
of the adverse event to the extent possible.

12. I will ensure that the conduct of this research study adheres to Good
Clinical/Laboratory/Pharmaceutical (Cross-out the inappropriate ones) Practice guidelines.
Etu, Udu Egete
.
Principal Investigator’s Name Principal Investigator signature and Date
Prof. O Awodele

14/08/2024

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