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Informed Consent Form Template

This document provides a template for creating an informed consent form for research participants. The form should include: [1] the title, principal investigator's name and contact details; [2] an assurance that participation is voluntary and questions are welcome; [3] the study's purpose, procedures, duration and risks/benefits in lay terms; [4] how confidentiality will be maintained; [5] contact information for questions; and [6] sections for participant and researcher signatures with an optional witness section. Completing this form ensures participants understand the research and can provide informed consent.

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Kevin Laganao
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308 views4 pages

Informed Consent Form Template

This document provides a template for creating an informed consent form for research participants. The form should include: [1] the title, principal investigator's name and contact details; [2] an assurance that participation is voluntary and questions are welcome; [3] the study's purpose, procedures, duration and risks/benefits in lay terms; [4] how confidentiality will be maintained; [5] contact information for questions; and [6] sections for participant and researcher signatures with an optional witness section. Completing this form ensures participants understand the research and can provide informed consent.

Uploaded by

Kevin Laganao
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
  • Information Section
  • Confidentiality
  • Voluntary Participation
  • Risks
  • Duration
  • Benefits
  • Contact Information
  • Consent Section
  • If the Participant is Illiterate

Creating an Informed Consent Form

(Based on the DLSU document: “Template for Creating an Informed Consent Form”.)

Title of Study
Name of Principal Investigator
Department / Office / Institution
Contact Information
Sponsor / Funding Agency
Research Project

[Inform participants that they may talk to anyone they feel comfortable talking with about the research
and that they can take time to reflect on whether they want to participate or not. Assure the participant
that questions are welcome and will be addressed.]

INFORMATION SECTION

PURPOSE OF THE STUDY

You are being invited to take part in a research study. Before you decide to participate in this study, it is
important that you understand why the research is being done and what your participation will involve.
Please read the following information carefully and feel free to ask the researcher if there is anything that
is not clear or if you need more information.

The purpose of this study is to: [Briefly explain in layman’s terms. Use local and simplified words rather
than scientific terms and professional jargon. In your explanation, consider local beliefs and knowledge
when deciding how best to provide the information. Indicate why you have chosen the individual to
participate in this research.]

STUDY PROCEDURES

[Provide a clear procedure of the participation in the research study. State what participants will be asked
to do if they choose to participate. List all procedures, preferably in chronological order, which will be
employed in the study.

Explain the type of questions that the participants are likely to be asked in the focus group, interview,
questionnaire, or the survey. If the research involves questions or discussion which may be sensitive or
potentially cause embarrassment or discomfort, inform the potential participant of this. If the study
involves experiments, the type of procedures that will be undertaken while they participate in the

1
experiment should be clearly explained. If the individual might experience non-normative bodily
sensations, inform them of this.]

DURATION

[Include a statement about the time commitments for a participant. This includes the length of time of
the interview, survey questionnaire, or experiment. This also includes involvement in a follow-up, if
relevant.]

VOLUNTARY PARTICIPATION

[Indicate clearly that participation is voluntary. Indicate clearly that the individual may withdraw from the
study at any time and without giving a reason. Indicate clearly that the individual will not receive any
penalty or sanction if participation is declined. If the individual inquires, indicate that they are entitled to
review their remarks in individual interviews and to erase a part of the recording.]

RISKS

[Explain and describe any risks that you anticipate or that are possible. The risks depend upon the nature
of your study and their participation and tailored to the specific issue and situation. Provide measures you
are undertaking to minimize the foreseeable risks.]

BENEFITS

[Benefits may be divided into benefits to the individual, benefits to the community in which the individual
resides, and benefits to society as a whole because of finding an answer to the research question. Explain
the kind of benefits the participant will receive, whether it is a token, gift certificate, expense
reimbursement, education, new knowledge, etc. If there is no direct benefit to the participant, state so.]

CONFIDENTIALITY

[Explain how the research team will maintain the confidentiality of data with respect to both information
about the participant and information the participant shares. Measures taken to ensure confidentiality
may include: (1) assigning codes / pseudonyms for participants to be used on all research notes and
documents, (2) keeping notes, interview transcriptions, and any other personal identifiers in a locked
cabinet that only the researchers will have access to. If the research is sensitive and / or involves
participants who are highly vulnerable, explain any extra precautions you will take to ensure safety and
anonymity. For focus groups, provide a particular challenge to confidentiality because once something is
said in a group, it becomes common knowledge. Explain that you will encourage group participants to
respect confidentiality, but that you cannot guarantee it.]

2
CONTACT INFORMATION

[State that the researcher may be contacted if the individual has any questions. Indicate other personnel
or agency (with relevant contact information) that may be contacted should be individual have questions
about their rights as a research participant, or if problems arise for which the individual may feel unease
in discussing with the Principal Investigator.]

CONSENT SECTION

I have read the provided information, or it has been read to me. I have had the opportunity to ask
questions. Any questions I asked have been answered to my satisfaction. I understand that I will be given
a copy of this form. I understand that the researcher will keep another copy on file. I consent voluntarily
to be a participant in this study.

Mandatory
Printed Name of Participant
Signature of Participant
Date

Mandatory
Printed Name of Researcher
Signature of Researcher
Date

Optional
Printed Name of Impartial Witness
Signature of Impartial Witness
Date

IF THE PARTICIPANT IS ILLITERATE

NOTE: If the participant is illiterate, then a literate witness must sign (if possible, this person should be
selected by the participant and should have no connection to the researcher or the research team.

I have witnessed the accurate reading of the consent form to the potential participant. I have witnessed
that the individual has had the opportunity to ask questions. I confirm that the individual has given
consent freely.

3
Mandatory if the Participant is Illiterate
Printed Name of Witness
Signature of Witness
Date

Common questions

Powered by AI

Essential components of an informed consent form include: the study's title, information about the principal investigator and contact details, purpose of the study in layman's terms, study procedures and participant expectations, any risks and benefits, confidentiality protections, voluntary participation, and contact information for questions or concerns . Furthermore, there should be a section for providing consent, including printed names and signatures of both the participant and researcher. If the participant is illiterate, the consent process should involve a literate witness .

Achieving this balance involves clearly communicating potential risks while also outlining strategies to manage them, providing reassurances and emphasizing voluntary participation. It's essential to be transparent but also to contextualize risks, ensuring participants feel informed yet not alarmed, thereby maintaining trust and willingness to participate .

Researchers can use plain language, avoiding jargon and using simplified explanations that align with local knowledge and beliefs. They might employ analogies, visual aids, or illustrative examples to convey complex objectives and ensure cultural relevance and understanding among participants .

Participation is voluntary when participants have the right to choose whether to participate without any coercion or penalty. Researchers should communicate this by clearly stating that participants can withdraw at any time without giving reasons and will face no sanctions. Participants should also be assured they can review and edit their input in interviews .

Researchers should address language barriers by providing an impartial, literate witness who can ensure the accurate reading of the consent form to the participant. This witness should have no connection to the research team and should confirm that the participant understands the content and provides consent voluntarily .

Potential societal benefits of research could include new knowledge, solutions to community issues, or advancements in a field of study. These should be communicated to participants by describing how their contributions could lead to broader findings that benefit society, even if direct individual benefits are not present .

Researchers can minimize risks by clearly identifying potential risks and implementing measures to mitigate them, such as providing detailed procedures and precautions in the informed consent form. They should communicate these measures and risks in plain language, ensuring participants know what to expect and how the risks are managed. This includes explaining any non-normative bodily sensations or sensitive topics that might arise during the study .

Providing contact information is important to facilitate communication and address participants' questions or concerns about their rights or the research itself. The consent form should include contact details of the Principal Investigator and any relevant agencies or additional personnel who can assist with participant inquiries or grievances .

Researchers can ensure confidentiality in studies with sensitive data by assigning codes or pseudonyms to participants, storing personal data securely, and encouraging focus group participants to respect confidentiality agreements. However, confidentiality challenges persist in focus groups because what is shared can become common knowledge. Extra precautions may include locking sensitive information in a secure cabinet . Despite these efforts, complete confidentiality in focus groups cannot be guaranteed .

Researchers should clearly outline any procedures that might cause discomfort or embarrassment, specifying the nature and context of such situations. They must inform participants in advance, providing reassurance and details on how they would handle these situations, such as offering support or allowing participants to skip uncomfortable questions .

1 Creating an Informed Consent Form (Based on the DLSU document: “Template for Creating an Informed Consent Form”.) Ti
2 experiment should be clearly explained. If the individual might experience non-normative bodily sensations, inform them
3 CONTACT INFORMATION [State that the researcher may be contacted if the individual has any questions. Indicate other per
4 Mandatory if the Participant is Illiterate Printed Name of Witness Signature of Witness Date

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