INFORMED CONSENT

FOR CLINICAL TRIALS

STUDY TITLE
INFORMED CONSENT FOR:	[Name of Group]
NAME OF RESEARCH INSTITUTION
NAME OF PRINCIPLE INVESTIGATOR
NAME OF SPONSOR
NAME OF PROPOSAL	VERSION

This informed consent has two parts:

INFORMATION SHEET

CONSENT FORM

You will be given a copy of the full Informed Consent form for your records.

Part I: Information Sheet

INTRODUCTION

I am [PI Name] from [the research institute the study is from]. This research is on [X disease/condition]. I will give you information on this study and invite you to be part of this research. You do not have to decide today if you will participate. You may speak with anyone you wish before you decide if you want to participate. As we go through this information sheet, if there are words or terms you do not understand, please stop me and I will explain them to you. If you think of questions later, you can also ask them of me or anyone on the study.

Purpose of the Research

Describe the reasons why the research is being conducted. Use concrete, accessible language that avoids jargon.

Type of Research Intervention

Briefly describe the type of intervention that is planned in this study. This will be expanded on in detail in the procedure section. (For example, a single injection will be administered in your thigh muscle and there will be several clinic visits.)

Participant Selection

Describe why the participant has been chosen for this research.

Voluntary Participation

Clearly describe the fact that participation is voluntary. Describe what the alternate treatment will be for their disease or condition, if applicable. State that any treatment they receive in lieu of the study will not be biased in any way, and that this treatment is voluntary.

PROCEDURE(S)

Description of the Drug being Tested

Describe the drug or drug product being tested, who developed the drug or drug product, and why it is being studied (e.g., for a different indication).

Description of the Process

Describe the step-by-step process of the study for the prospective participant. If this is a clinical study, this portion should not only include the procedures and protocol, but also a description of the physical processes that the participants will go through.

Duration

Describe the time commitments for participation in the research, including both during the research and follow-up. If a chart or table makes sense here, please include it for clarity.

Side Effects

Describe any anticipated or known side effects and what would happen in the event of a side effect or unexpected event.

Risks

Describe any anticipated or possible risk, the care that will be available if harm occurs, and who will pay for the treatment.

Benefits

Describe the activities from the study that will yield actual benefits, not just those they are entitled to regardless of participation. These benefits may be delineated into individual, community, and societal because of the research questions being answered.

Reimbursements

Describe what the study will provide the participants because of their participation.

Confidentiality

Describe how the research team will ensure the confidentiality and privacy of the research data, especially the information provided by the participants.

Results

Describe the plan for sharing the results of the study. Include any details such as timelines and plans.

Right to Refuse or Withdraw

Reconfirm that participation is voluntary and includes the right to withdraw from the study.

Alternative to Participation

If the study involves investigational drugs or new therapies, describe the standard treatment.

Who to Contact?

Provide the name and contact information of someone involved in the study who can be contacted at any time. Also, state that the proposal was approved and how it was approved.

Part II: Certificate of Consent

The certificate of consent should be written in the first person and have a statement of consent (see below). If the prospective participant cannot adequately read and agree, an oral agreement may be given, but a witness must sign below.

Statement of Consent:

I have read the study information, or it has been read to me. The risks of the procedure have been explained to me and are also identified in this documentation. Any questions I have about the intervention, its benefits, and its risks have been explained to my satisfaction. I give my informed consent to voluntarily participate in this research.

Print Name of Participant	Signature of Participant	Date

Statement by Witness:

I have witnessed the reading of the consent form to this possible participant, and they have had the opportunity to ask questions. I confirm that this individual has given their consent freely.

Print Name of Witness	Signature of Witness	Date

Statement by the researcher taking consent:

I have accurately read the information sheet to the potential participant and have ensured, to the best of my ability, that they understand the research study. I confirm that the participant was given adequate opportunity to ask questions about the study and I provided them answers to the best of my ability. I confirm that this individual has not been coerced into providing consent and that their consent has been given willingly and freely.

Print Name of Witness	Signature of Witness	Date

––––––– A copy of this Informed Consent must be provided to the participant. –––––––

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