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Informed Consent Template for Research

This document provides a template for obtaining informed consent from research participants. It outlines key elements that should be included such as the study title, investigators, background/rationale, purpose, procedures, participants, risks/discomforts, benefits, alternatives, costs, compensation, reimbursement, contact information, confidentiality, voluntary participation, and signatures. Obtaining proper informed consent is important to protect participants and conduct ethical research involving human subjects.

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Pitua Ivaan
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81 views3 pages

Informed Consent Template for Research

This document provides a template for obtaining informed consent from research participants. It outlines key elements that should be included such as the study title, investigators, background/rationale, purpose, procedures, participants, risks/discomforts, benefits, alternatives, costs, compensation, reimbursement, contact information, confidentiality, voluntary participation, and signatures. Obtaining proper informed consent is important to protect participants and conduct ethical research involving human subjects.

Uploaded by

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

MAKERERE UNIVERSITY COLLEGE OF HEALTH SCIENCES

SCHOOL OF HEALTH SCIENCES RESEARCH & ETHICS


COMMITTEE (SHS-REC)

INFORMED CONSENT TEMPLATE FOR INTENDING RESEARCHERS

Title of the proposed study:

Investigators:
Give the names, institutions and contacts of the investigators.

Background and rationale for the study:


Give a brief background and rationale for the proposed research.

Purpose:
Brief description of the purpose of the study and why the participant is being asked to
participate.
A statement that the study involves experimentation and what part of the study is experimental.

Procedures:
Description of the procedures of the study explaining how a participant will be involved and
what is required of the participant.

Who will participate in the study?


Brief description of the intended participants, the expected total number and how long each will
be required to be active in the study.

Risks/Discomforts:
Description of the possible risks and discomforts a participant might experience while in the
study.

Benefits:
Anticipated benefits of conducting the study including possible benefits to the participant,
community and the entire scientific world.
Alternatives:
Participants should be informed that participation in the study is not mandatory and what
possible alternatives are available other than participating in the study.

Cost:
The possible costs to be met during the conduct of the study as far as the particular participant is
concerned. Explain the possible costs and who will meet the bill of paying for the costs.

Compensation for participation in the study:


Explain if participant will be compensated for participating in the study and how they will be
compensated.
Also explain what happens if a participant is injured during their course of participation and how
they will be treated. State how participants who suffer permanent damage will be compensated.

Reimbursement:
State how participant costs in terms of travel and opportunity cost while they come to the study
site will be met.

Questions:
State how participants who have study related questions can reach investigators to answer such
questions.

Questions about participants rights:


Explain how participants who have questions about their rights as research participants can have
their queries addressed.

Statement of voluntariness:
State that participation in the proposed study is voluntary and participants may join on their own
free will. Participants also have a right to withdraw from the study at any time without penalty.

Confidentiality:
The results of this study will be kept strictly confidential, and used only for research purposes.
My identity will be concealed in as far as the law allows. My name will not appear anywhere on
the coded forms with the information. Paper and computer records will be kept under lock and
key and with password protection respectively.
The interviewer has discussed this information with me and offered to answer my questions. For
any further questions, I may contact ……………………….. Tel :( +256)……………. Or the
Chairperson, School of Health Sciences Institutional Review Board (MakSHS-IRB) or Uganda
National Council of Sciences and Technology. Tel: (+256) 772-404970 or (+256)-41-250431

STATEMENT OF CONSENT/ASSENT
........................................................................... has described to me what is going to be done, the
risks, the benefits involved and my rights regarding this study. I understand that my decision to
participate in this study will not alter my usual medical care. In the use of this information, my
identity will be concealed. I am aware that I may withdraw at anytime. I understand that by
signing this form, I do not waive any of my legal rights but merely indicate that I have been
informed about the research study in which I am voluntarily agreeing to participate. A copy of
this form will be provided to me.

Name:………………………….Signature of participant ……………………..Age..……………


Date ……………………………

Name…………………………Signature of parent or guardian for minors ……………………


Date …………………………

Name……………………………………..Signature of Interviewer ………………………….


Date………………………...

Common questions

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The study anticipates benefits not only to the participants but also to the community and the scientific community at large, by contributing valuable knowledge and potential advancements in health sciences .

Participants must be informed about the study's purpose, its experimental nature, possible risks and benefits, alternatives to participation, costs, and compensation. The confidentiality of their information must be assured, and their participation must be voluntary, allowing them to withdraw without penalty .

The template highlights voluntariness by stating that participation is entirely voluntary, participants can join of their own free will, and they have the right to withdraw from the study at any time without penalty .

Participants are assured that their identity will be protected, as their names will not appear on any forms, and all data will be stored securely to prevent unauthorized access .

The document acknowledges possible risks and discomforts by providing a detailed description of them, allowing participants to understand what they might encounter as part of the study .

The document describes possible costs participants might incur and explains that the study may cover these expenses. It also discusses compensation for participation and outlines the procedures for addressing injury or permanent damage suffered during the study .

Participants are informed that participation in the study is not obligatory and are advised about possible alternatives available to them if they choose not to participate .

The document ensures confidentiality by stating that participants' identities will be concealed, their names will not appear on any coded forms and all paper and computer records will be kept secure, either locked or password protected .

Participants can contact the investigators directly or reach out to the Chairperson of the School of Health Sciences Institutional Review Board (MakSHS-IRB) or the Uganda National Council of Sciences and Technology for questions about their rights .

The document clarifies that signing the informed consent form does not mean participants waive any of their legal rights; it merely acknowledges their informed decision to voluntarily participate in the study .

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