Scribd
Upload
801 views

EDITABLE OLFU IERC Study Protocol Self Assessment Checklist

This document is a self-assessment checklist for a study protocol. It contains questions to evaluate different aspects of a research study protocol, including the proposal, research handling, ethical issues, and informed consent form. The principal investigator is to indicate whether each assessment point is addressed in the study protocol and provide the relevant page and paragraph. Areas covered include the objectives, research question, literature review, research design, sampling methods, data analysis, inclusion/exclusion criteria, specimen storage, duration of participation, risks/benefits to participants, recruitment, consent, and use of a standardized informed consent form template.

Uploaded by

ROSMEL ANGELL UNGOS
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
801 views

EDITABLE OLFU IERC Study Protocol Self Assessment Checklist

This document is a self-assessment checklist for a study protocol. It contains questions to evaluate different aspects of a research study protocol, including the proposal, research handling, ethical issues, and informed consent form. The principal investigator is to indicate whether each assessment point is addressed in the study protocol and provide the relevant page and paragraph. Areas covered include the objectives, research question, literature review, research design, sampling methods, data analysis, inclusion/exclusion criteria, specimen storage, duration of participation, risks/benefits to participants, recruitment, consent, and use of a standardized informed consent form template.

Uploaded by

ROSMEL ANGELL UNGOS
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 2

Study

Protocol Self Assessment Checklist

Principal Investigator:
College/Affiliation:
Date Received: 02-Oct-2020
Research Title:

To be filled out by the Principal Investigator


ASSESSMENT POINTS Indicate if the specified Page and the
assessment point is paragraph where
stated on the study the said point is
protocol discussed
A. Proposal (Scientific and Technical Issues) YES N/A
A.1. Are the objectives/aims of the study protocol clearly and
concisely defined?
A.2. Is the question/issue or general problem of the study
protocol clearly stated?
A.3. Is the research question related to the objective/purpose
of the research study?
A.4. Does the literature review section of the research
protocol provide foundation knowledge of the topic?
A.5. Are the review results in the literature review section
relevant to the proposed study protocol?
A.6. Does the chosen research design effectively address
the research problem in a logical way?
A.7. Are the specific sampling methods and procedure in the
study protocol fully described?
A.8. Is the research approach or type of analysis clearly
described?
A.9. Are the types of sources used clearly discussed?
(primary or secondary texts, interviews, surveys, diaries,
journals, etc.)
A.10. Is the sample size appropriate and well justified?
A.11. Is the statistical method used appropriate?
A.12. Are the statistical and non-statistical methods
relevant to the data analysis and data summary?
A.13. Are the inclusion and exclusion criteria complete and
appropriate?
B. Research Handling
B.1. Do provisions exist in the specimen storage, access,
disposal, and terms of use? (If applicable)


B.2. Are the copies of the CV of the research investigator
included?
B.3. Is the duration/length of the respondents involvement in
the study clearly discussed?
C. Ethical Issues
C.1. Is a vulnerable population being studied?
C.2. Is the justification for studying this vulnerable population
adequate?
C.3. Do adequate provisions exist to ensure that the
vulnerable population is not being exploited?
C.4 Are the risks and benefits for the research participants
been discussed in the research protocol?
C.5 Does the protocol describe how the communities from
which the participants are to be drawn likely benefit from
the research?
C.6 Is the design free of undue inducements to participate in
the research?
C.7. Does the recruitment procedure include adequate
protection for the privacy and psychosocial needs of the
individuals?
C.8. Do provisions exist in the protocol for counseling
research participants during and after the research?
C.9. Are the research participants free not to participate or
to leave the research at any time, without penalty?
C.10. Do provisions exist in the proposal to recruit participants
incapable of giving personal consent, (e.g. because of
cultural factors, children or adolescents less than the legal
D. Informed Consent Form
D.1 Is the attached informed consent form written in English or
in a language that the respondents can understand?
D.2 Is the information sheet free of technical terms, written in
lay-persons’ language, easily understandable, complete &
adequate?
D.3 Is the Informed Consent Form patterned after the WHO
template?
D.4 Are all the sections in the ICF completely and clearly
explained?

Submitted by: __________________ Received by: ____________________

You might also like