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IRB Consent Form Templates

A collection of informed consent, assent, and debriefing templates that can be used for your human participant research study.

General Consent Form Templates

Social and Behavioral Research Projects (last updated 03/16/2023)

Biomedical Research Projects (last updated 07/18/2022)

Consent Form Templates for Specific Biomedical Procedures

MRI and fMRI

Blood Collection by Finger Stick

Blood Collection by Venipuncture

Oral Consent Template

Guidance for Protocols Involving Oral Consent

Debriefing Template

Guidance and Template for Debriefing Participants

Studies Involving Children (Assent/Permission Forms)

Parent-Guardian Permission for Studies Involving Children

Sample Parental Notification Form

Sample Child Assent Form

Performance Release for Minors

Performance Releases

Performance Release for Adults

Sample Consent Forms

Consent form templates.

These consent form templates have been posted for your reference.  When completing and IRB submission in IRBIS, please fill in the application and use the consent form builder specific to your project.  For more information, please find instructions here .

Summary of Changes to the Regulations for Informed Consent:  Revised Common Rule Changes to Informed Consent and Waiver Requirements

Summary of Changes to Consent Documents:

• Informed Consent Documents – Version 2.0 Summary of Changes
• Informed Consent Documents – Version 2.1 Summary of Changes
• Informed Consent Documents – 10/26/2020 Summary of Changes
• Informed Consent Documents – 4/10/2023 Summary of Changes

Concise Summary examples can be found here .

Guidance on the use of plain language in consent forms:

• Clinical Research Glossary
• Webinar: The Promise of Plain Language: Launching a Glossary to Support Participant Understanding of Clinical Research – Recording & Slides

There are a few additional forms that are not provided online and may be accessed below.  As needed, these should be completed and uploaded to your IRB application.

Foreign Language Consent Forms

COVID-19 Related Forms:

• Spanish-IRB-COVID Information Sheet
• Spanish COVID Consent Letter v2
• Spanish COVID Informational Sheet Translation Certificate

Informed Consent Short Form (for a single subject who may be illiterate, or otherwise unable to read the consent form — used when full consent form has to be read or translated for subject).

• Informed Consent Short Form Guidance
• Simplified Chinese

HIPAA Templates

• Sample HIPAA Authorization Template
• Sample HIPAA Authorization Template in Spanish ( Certification )

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Informed Consent Guidelines & Templates

U-m hrpp informed consent information.

See the HRPP Operations Manual, Part 3, Section III, 6 e .

The human subjects in your project must participate willingly , having been adequately informed about the research.  

• If the human subjects are part of a vulnerable population (e.g., prisoners, cognitively impaired individuals, or children), special protections are required.
• If the human subjects are children , in most cases you must first obtain the permission of parents in addition to the consent of the children.

Contact the IRB Office for more information .

See the Waiver Guidelines  for information about, and policies regarding, waivers for informed consent or informed consent documentation. 

See the updated  Basic Informed Consent Elements document  for a list of 2018 Common Rule basic and additional elements. 

Informed Consent Process

Informed consent is the process of telling potential research participants about the key elements of a research study and what their participation will involve.  The informed consent process is one of the central components of the ethical conduct of research with human subjects.  The consent process typically includes providing a written consent document containing the required information (i.e., elements of informed consent) and the presentation of that information to prospective participants.  

In most cases, investigators are expected to obtain a signature from the participant on a written informed consent document (i.e., to document the consent to participate) unless the IRB has waived the consent requirement or documentation (signature) requirement .

• Projects which collect biospecimens for genetic analysis must obtain documented (signed) informed consent.
• It is an ethical best practice to include an informed consent process for most exempt research .   IRB-HSBS reviews, as applicable, the IRB application for exempt research, but not the informed consent document itself.  A suggested consent template for exempt research can be found below under the References and Resources section.  A companion protocol template for exempt research may be found in the feature box, Related Information (top right).

Informed consent documents

An  informed consent document  is typically used to provide subjects with the information they need to make a decision to volunteer for a research study.  Federal regulations ( 45 CFR 46.116 ) provide the framework for the type of information (i.e., the "elements") that must be included as part of the consent process.  New with the revised 2018 Common Rule is the requirement that the consent document begin with a "concise and focused" presentation of key information  that will help potential participants understand why they might or might not want to be a part of a research study.  

Key Information Elements

The image below displays the  five elements identified in the preamble to the revised Final Rule  as suggested key information.  

Note: Element number 5 (alternative procedures) applies primarily to clinical research.

General Information & Tips for Preparing a Consent Document

Reading level.

Informed consent documents should be written in plain language at a level appropriate to the subject population, generally at an 8th grade reading level .  A best practice is to have a colleague or friend read  the  informed consent document for comprehension before submission with the IRB application.  Always:

For guidance on using plain language, examples, and more, visit: http://www.plainlanguage.gov/

• Tailor the document to the subject population.
• Avoid technical jargon or overly complex terms.
• Use  straightforward  language that is understandable.

Writing tips

The informed consent document should succinctly describe the research as it has been presented in the IRB application.

• Use the second (you) or third person (he/she) to present the study details.  Avoid use of the first person (I).  
• Include a statement of agreement at the conclusion of the informed consent document. 
• The consent doucment must be consistent with what is described in the IRB application.

Document Formating for Uploading into eResearch

• Remove "track changes" or inserted comments from the consent documentation prior to uploading the document into the IRB application (Section 10-1) for review.
• Use a consistent, clearly identified file naming convention for multiple consent/assent documents.

Informed Consent Templates

IRB-HSBS strongly recommends that investigators use one of the informed consent templates developed to include the required consent elements (per  45 CFR 46.116 ), as well as other required regulatory and institutional language.  The templates listed below include the new consent elements outlined in the 2018 Common Rule.

References and Resources

PDF.  Lists the basic and additional elements required for inclusion or to be included, as appropriate to the research, in the informed consent documentation, along with the citiation number [e.g., _0116(b)(1)] within the revised Common Rule.  New elements associated with the 2018 Common Rule are indicated in bold text.

Strongly recommended for studies that involve the collection of biospecimens and/or genetic or genomic analysis, particularly  federally sponsored clinical trials that are required to post a consent document on a public website.  Last updated:  04/10/2024.

Informed Consent documents are not reviewed by the IRB for Exempt projects.  However, researchers are ethically bound to conduct a consent process with subjects.  This template is suggested for use with Exempt projects. Last updated 4/17/24

(Word) Blank template with 2018 revised Common Rule key information and other required informed consent elements represented as section headers; includes instructions and recommended language.  It is strongly advised that you modify this template to draft a project-specific informed consent document for your study for IRB review and approval.  Last updated: 04/10/2024

(Word) General outline to create and post a flyer seeking participation in a human subjects study.  Includes instructions.

(Word) Two sample letters for site approval cooperation between U-M and other institutions, organizations, etc.  Letters of cooperation must be on U-M letterhead and signed by an appropriate official.  These letters are uploaded into the Performance Site section of the eResearch IRB application.

For use by U-M Dearborn faculty, staff, and students conducting non-exempt human subjects research using subject pools. Last updated 4/10/24

For use by U-M Dearborn faculty, staff, and students conducting exempt human subjects research using subject pools

Researchers who will conduct data collection that is subject to the General Data Protection Regulation (GDPR) must use this template in tandem with a general consent for participation template/document.

• Child assent ages 3-6
• Child assent 7-11
• Parent permission
• Brief protocol for exempt research including data management and security questionnaire
• Child assent 12-14
• Introductory psychology subject pool general consent template
• Introductory psychology subject pool exempt consent template

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Sample consent and permission forms

General consent form to participate in research (DOC)

Two stage project consent form (DOC)

Parent permission form for research with child (DOC)

Child assent form (DOC)

Multiple consent form including audio-recording and quotations (DOC)

Photo and video consent form (DOC)

Video-recording consent form (DOC)

Re-contact agreement form (DOC)

Post-debriefing consent form (DOC)

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Home » Informed Consent in Research – Types, Templates and Examples

Informed Consent in Research – Types, Templates and Examples

Table of Contents

Informed Consent in Research

Informed consent is a process of communication between a researcher and a potential participant in which the researcher provides adequate information about the study, its risks and benefits, and the participant voluntarily agrees to participate. It is a cornerstone of ethical research involving human subjects and is intended to protect the rights and welfare of participants.

Types of Informed Consent in Research

There are different types of informed consent in research , which may vary depending on the nature of the study, the type of participants, and the context. Some of the common types of informed consent in research include:

Written Consent

This is the most common type of informed consent, where participants are provided with a written document that explains the study and its requirements. The document typically includes information about the purpose of the study, procedures involved, risks and benefits, confidentiality, and participant rights. Participants are asked to sign the document as an indication of their willingness to participate.

Oral Consent

In some cases, oral consent may be used when a written document is not practical or feasible. Oral consent involves explaining the study and its requirements to participants verbally and obtaining their consent. This method may be used for studies with illiterate or visually impaired participants or when conducting research remotely.

Implied Consent

Implied consent is used in studies where participants’ actions are taken as an indication of their willingness to participate. For example, a participant may be considered to have given implied consent if they show up for a scheduled appointment for the study.

Opt-out Consent

This method is used when participants are given the opportunity to decline participation in a study. Participants are provided with information about the study and are given the option to opt-out if they do not wish to participate. This method is commonly used in population-based studies or surveys.

Assent is used in studies involving minors or participants who are unable to provide informed consent due to cognitive impairment or disability. Assent involves obtaining the agreement of the participant to participate in the study, along with the consent of a legally authorized representative.

Informed Consent Format in Research

Here’s a basic format for informed consent that can be customized for specific research studies:

• Introduction : Begin by introducing yourself and the purpose of the study. Clearly state that participation is voluntary and that participants can withdraw at any time without penalty.
• Study Overview : Provide a brief overview of the study, including its purpose, methods, and expected outcomes.
• Procedures : Describe the procedures involved in the study in clear, concise language. Include information about the types of data that will be collected, how they will be collected, and how long the study will take.
• Risks and Benefits : Outline the potential risks and benefits of participating in the study. Be honest and upfront about any discomfort, inconvenience, or potential harm that may be involved, as well as any potential benefits.
• Confidentiality and Privacy : Explain how participant data will be collected, stored, and used, and what measures will be taken to ensure confidentiality and privacy.
• Voluntary Participation: Emphasize that participation is voluntary and that participants can withdraw at any time without penalty. Explain how to withdraw from the study and who to contact if participants have questions or concerns.
• Compensation and Incentives: If applicable, explain any compensation or incentives that will be offered to participants for their participation.
• Contact Information: Provide contact information for the researcher or a representative from the research team who can answer questions and address concerns.
• Signature : Ask participants to sign and date the consent form to indicate their voluntary agreement to participate in the study.

Informed Consent Templates in Research

Here is an example of an informed consent template that can be used in research studies:

Introduction

You are being invited to participate in a research study. Before you decide whether or not to participate, it is important for you to understand why the research is being done, what your participation will involve, and what risks and benefits may be associated with your participation.

Purpose of the Study

The purpose of this study is [insert purpose of study].

If you agree to participate, you will be asked to [insert procedures involved in the study].

Risks and Benefits

There are several potential risks and benefits associated with participation in this study. Some of the risks include [insert potential risks of participation]. Some of the benefits include [insert potential benefits of participation].

Confidentiality

Your participation in this study will be kept confidential to the extent allowed by law. All data collected during the study will be stored in a secure location and only accessed by authorized personnel. Your name and other identifying information will not be included in any reports or publications resulting from this study.

Voluntary Participation

Your participation in this study is completely voluntary. You have the right to withdraw from the study at any time without penalty. If you choose not to participate or if you withdraw from the study, there will be no negative consequences.

Contact Information

If you have any questions or concerns about the study, you can contact the investigator(s) at [insert contact information]. If you have questions about your rights as a research participant, you may contact [insert name of institutional review board and contact information].

Statement of Consent

By signing below, you acknowledge that you have read and understood the information provided in this consent form and that you freely and voluntarily consent to participate in this study.

Participant Signature: _____________________________________ Date: _____________

Investigator Signature: ____________________________________ Date: _____________

Examples of Informed Consent in Research

Here’s an example of informed consent in research:

Title : The Effects of Yoga on Stress and anxiety levels in college students

Introduction :

We are conducting a research study to investigate the effects of yoga on stress and anxiety levels in college students. We are inviting you to participate in this study.

If you agree to participate, you will be asked to attend four yoga classes per week for six weeks. Before and after the six-week period, you will be asked to complete surveys about your stress and anxiety levels. Additionally, we will measure your heart rate variability at the beginning and end of the six-week period.

Risks and Benefits:

There are no known risks associated with participating in this study. However, the benefits of practicing yoga may include decreased stress and anxiety levels, increased flexibility and strength, and improved overall well-being.

Confidentiality:

All information collected during this study will be kept strictly confidential. Your name will not be used in any reports or publications resulting from this study.

Voluntary Participation:

Participation in this study is completely voluntary. You are free to withdraw from the study at any time without penalty.

Contact Information:

If you have any questions or concerns about this study, you may contact the principal investigator at (phone number/email address).

By signing this form, I acknowledge that I have read and understood the above information and agree to participate in this study.

Participant Signature: ___________________________

Date: ___________________________

Researcher Signature: ___________________________

Importance of Informed Consent in Research

Here are some reasons why informed consent is important in research:

• Protection of participants’ rights : Informed consent ensures that participants understand the nature and purpose of the research, the risks and benefits of participating, and their rights as participants. It empowers them to make an informed decision about whether to participate or not.
• Ethical responsibility : Researchers have an ethical responsibility to respect the autonomy of participants and to protect them from harm. Informed consent is a crucial way to uphold these principles.
• Legality : Informed consent is a legal requirement in most countries. It is necessary to protect researchers from legal liability and to ensure that research is conducted in accordance with ethical standards.
• Trust : Informed consent helps build trust between researchers and participants. When participants understand the research process and their role in it, they are more likely to trust the researchers and the study.
• Quality of research : Informed consent ensures that participants are fully informed about the research and its purpose, which can lead to more accurate and reliable data. This, in turn, can improve the quality of research outcomes.

Purpose of Informed Consent in Research

Informed consent is a critical component of research ethics, and it serves several important purposes, including:

• Respect for autonomy: Informed consent respects an individual’s right to make decisions about their own health and well-being. It recognizes that individuals have the right to choose whether or not to participate in research, based on their own values, beliefs, and preferences.
• Protection of participants : Informed consent helps protect research participants from potential harm or risks that may arise from their involvement in a study. By providing participants with information about the study, its risks and benefits, and their rights, they are able to make an informed decision about whether to participate.
• Transparency: Informed consent promotes transparency in the research process. It ensures that participants are fully informed about the research, including its purpose, methods, and potential outcomes, which helps to build trust between researchers and participants.
• Legal and ethical requirements: Informed consent is a legal and ethical requirement in most research studies. It ensures that researchers obtain voluntary and informed agreement from participants to participate in the study, which helps to protect the rights and welfare of research participants.

Advantages of Informed Consent in Research

The advantages of informed consent in research are numerous, and some of the most significant benefits include:

• Protecting participants’ autonomy: Informed consent allows participants to exercise their right to self-determination and make decisions about whether to participate in a study or not. It also ensures that participants are fully informed about the risks, benefits, and implications of participating in the study.
• Promoting transparency and trust: Informed consent helps build trust between researchers and participants by providing clear and accurate information about the study’s purpose, procedures, and potential outcomes. This transparency promotes open communication and a positive research experience for all parties involved.
• Reducing the risk of harm: Informed consent ensures that participants are fully aware of any potential risks or side effects associated with the study. This knowledge enables them to make informed decisions about their participation and reduces the likelihood of harm or negative consequences.
• Ensuring ethical standards are met : Informed consent is a fundamental ethical requirement for conducting research involving human participants. By obtaining informed consent, researchers demonstrate their commitment to upholding ethical principles and standards in their research practices.
• Facilitating future research : Informed consent enables researchers to collect high-quality data that can be used for future research purposes. It also allows participants to make an informed decision about whether they are willing to participate in future studies.

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

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Consent Examples

About this page.

To assist UW researchers with designing subject-focused consent, the UW IRB provides example consent forms. Many of these examples are actual UW IRB approved consent forms designed by UW researchers. Some of the examples were created using one of our consent templates . The use of our template is not required and some of the examples deviate significantly from our templates.

We encourages researchers to use the Designing the Consent Process guidance and the examples below to create consent forms and processes that: (1) are written from the perspective of the subject population being enrolled, emphasizing the Key Information that is mostly likely to assist those subjects with deciding whether to enroll; and (2) are designed and presented in a way that facilitates comprehension and understanding.

• Exempt Research Example Consents
• Expedited and Full Board Research Example Consents
• Key Information Examples

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How to obtain informed consent for research

1 University of Messina, “G. Martino” Hospital, Messina, Italy

Amelia Licari

2 University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

Current biomedical research on human subjects requires clinical trial, which is defined as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions [ i.e. drugs, cells or other biological products, surgical procedures, devices] to evaluate the effects on health outcomes” [1]. In our modern ethical conception, all research conducted on humans must be pre-emptively accepted by the subjects themselves through the procedure known as informed consent, which is a process by which “a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate”, as stated in the International Council for Harmonisation Good Clinical Practice guidelines [2]. Informed consent is documented by means of a written, signed and dated informed consent form. This form is required in the following cases: 1) when the research involves patients, children, incompetent/incapacitated persons, healthy volunteers, immigrants or others ( e.g. prisoners); 2) when the research uses/collects human genetic material, biological samples or personal data [3].

Short abstract

The process of obtaining informed consent for clinical trials is tightly regulated; complications arise in circumstances when consent may be waived, or when needed from vulnerable populations http://ow.ly/rEMe30j5MVq

Current biomedical research on human subjects requires clinical trial, which is defined as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions [ i.e. drugs, cells or other biological products, surgical procedures, devices] to evaluate the effects on health outcomes” [ 1 ]. In our modern ethical conception, all research conducted on humans must be pre-emptively accepted by the subjects themselves through the procedure known as informed consent, which is a process by which “a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate”, as stated in the International Council for Harmonisation Good Clinical Practice guidelines [ 2 ]. Informed consent is documented by means of a written, signed and dated informed consent form. This form is required in the following cases: 1) when the research involves patients, children, incompetent/incapacitated persons, healthy volunteers, immigrants or others ( e.g. prisoners); 2) when the research uses/collects human genetic material, biological samples or personal data [ 3 ].

The informed consent form must be written in language easily understood by the subjects, it must minimise the possibility of coercion or undue influence, and the subject must be given sufficient time to consider participation. However, informed consent is not merely a form that is signed, but is a process in which the subject has an understanding of the research and its risks, and it is tightly described in ethical codes and regulations for human subject research [ 2 ].

Educational aims

• To provide a comprehensive overview of issues in obtaining informed consent in clinical research.
• To describe the process of obtaining informed consent in clinical trials.
• To highlight the circumstances under which informed consent can be waived.
• To review the setting of obtaining informed consent from “vulnerable populations”.

The informed consent process

The voluntary expression of the consent by a competent subject and the adequate information disclosure about the research are critical and essential elements of the informed consent process [ 4 ]. Competent subjects able to comprehend the research-related information should personally decide and provide the consent on research participation. Conditions posing practical challenges in obtaining informed consent from the real subject may include situations of medical emergency or obtaining consent from “vulnerable” subjects and/or children [ 5 ].

Research-related information must be presented to enable people to voluntarily decide whether or not to participate as a research subject. For an ethically valid consent, information provided to a research subject should include, but not be limited to: information about the health condition for which the research is proposed; details of the nature and purpose of the research; the expected duration of the subject’s participation; a detailed description of study treatment or intervention and of any experimental procedures (including, in the case of randomised clinical trials (RCTs), also blinding and randomisation); a statement that participation in research is voluntary; probable risks and benefits associated with research participation; details of the nature of the illness and possible outcome if the condition is left untreated; availability, risks and benefits of alternative treatments; information about procedures adopted for ensuring data protection/confidentiality/privacy, including duration of storage of personal data; details about the handling of any incidental findings of the research; description of any planned genetic tests; details of insurance coverage in case of injury; reference contacts for any further answers to pertinent questions about the research and the subject’s rights and in case of any research-related injury to the subject; and any other information that seems necessary for an informed decision to be taken by the subject. Of particular importance, a statement offering the subject the opportunity to withdraw at any time from the research without consequences must be provided during the information disclosure [ 2 ]. Specific information should be provided in case of research projects involving children, incapacitated adults not able to give informed consent, illiterate populations, etc. (as will be described later in this article).

The information about the research should be given by a physician or by other individuals ( i.e.  researchers) with appropriate scientific training and qualifications [ 6 ]. Furthermore, the location where the informed consent is being discussed, and the subject’s physical, emotional and psychological capability, must be taken into consideration when taking consent from a human subject.

Informed consent: when is it not necessary?

After institutional review board (IRB) or independent ethics committee approval is achieved, obtaining informed consent from each human subject prior to his/her participation in clinical trial is mandatory [ 5 ]. However, when specific circumstances occur, the informed consent can be waived, and “research without consent” is possible, which allows enrolment of patients without their consent, under strict regulation [ 7 ]. In order that research without consent is considered justifiable, the following three conditions have to be met: 1) it is impracticable to obtain consent, 2) the research does not infringe the principle of self-determination, and 3) the research provides significant clinical relevance [ 8 ].

The first condition, of “impracticability”, occurs when obtaining informed consent is burdened by high impact in terms of time and economic resources or could compromise the study’s validity [ 8 ]. The second condition means that, although physicians are requested to ensure that the patient has understood the aim of the research and the risks and/or benefits associated with study participation, the researchers are also advised to respect the patient’s decision-making capacity, not interfering with his/her decisions and acting always in the patient’s best interest [ 9 ]. The third condition leads to justification of waiving consent when the clinical relevance and public health importance are potentially high [ 8 ].

The formal literature identifies different types of RCTs and classifies them into three macro-areas: 1) RCTs based on infeasibility of informed consent; 2) RCTs that omit informed consent only for control groups; and 3) RCTs that omit informed consent entirely.

RCTs based on infeasibility of informed consent

Emergency clinical studies, involving critically ill subjects, represent an exception to the requirement of informed consent. The investigated life-saving therapy and the medical intervention may be required immediately, not permitting the researchers to wait and respect all procedures of obtaining informed consent. Within this context, the researchers will be able to proceed with patient recruitment, also without the subject’s consent to treatment, when, prior to the study, the IRB has ascertained the presence of mandatory conditions ( table 1 ) [ 10 ].

Table 1

Conditions to be met in emergency clinical study

Cluster randomised studies include cluster-cluster and individual-cluster research [ 11 ]. In cluster-cluster designs ( e.g. studies on infectious disease prevention), the intervention involves the entire target community, so that single subjects cannot refuse it [ 12 ]. Conversely, in individual-cluster designs ( e.g. studies on primary care), although the intervention involves all the selected community, the right to refuse treatment is allowed. Under this circumstance, the omission of informed consent is justified only when the treatment refusal undermines the validity of the research study and/or procedures [ 13 ].

RCTs that omit informed consent only for control groups

In Zelen’s single-consent model ( e.g. RCTs in infectious or oncological diseases), randomisation occurs prior to any consent, and informed consent is sought only from individuals assigned to experimental treatment [ 14 ]. In the control group, the physicians do not make substantial changes in routine patient care, so informed consent is not required for patient enrolment [ 8 ].

In order to improve study recruitment, Zelen developed the double-consent design. Specifically, informed consent is requested for subjects to be involved in the study but not for the randomisation, preventing psychological distress [ 14 ].

In follow-up studies, the nested consent model ( e.g. for single cohort studies) or cohort multiple RCTs model ( e.g. for multiple cohort studies) is applied. In these variants, patients give their consent for prospective follow-up; however, they remain blinded to any randomised experimental interventions [ 15 ].

In trials using the model of “consent to postponed information”, the informed consent process is carried out after the study is completed [ 16 ].

All these RCT types aim to avoid unnecessary stress in patients who will not receive the new promising experimental treatment. Moreover, these clinical study designs do not affect the standard therapeutic approach or infringe the rights of the patients in the control group; therefore, the clinical trial can proceed without obtaining informed consent [ 8 ].

RCTs that omit informed consent entirely

Based on the fact that patients are assigned to standard care interventions, no informed consent is sought either in low-risk pragmatic RCTs [ 17 ] or in prompted optional randomisation trials [ 18 , 19 ]. However, in a low-risk pragmatic RCT, patients do not have the possibility to choose one of the two standard treatments, whereas in a prompted optional randomisation trial, both the researchers and the enrolled patients can choose one type of treatment over another, despite the randomisation results [ 6 ].

Special needs: vulnerable patients

A “vulnerable population” is defined as a disadvantaged community subgroup unable to make informed choices, protect themselves from inherent or intended risks, or keep their own interests safeguarded [ 20 ]. In the health domain, “vulnerable populations” refers to physical vulnerability ( e.g. pregnant women, fetuses, children, orphans, students, employees, prisoners, the military, and those who are chronically or terminally ill), psychological vulnerability (cognitively and intellectually impaired individuals) and social vulnerability (those who are homeless, from ethnic minorities, are immigrants or refugees) [ 20 ].

Due to a compromised free will and inability to make conscious decisions, several ethical dilemmas (related to communications, privacy and treatment) often arise when research involves these populations. Guaranteeing protection of rights, safety, data privacy and confidentiality of vulnerable subjects are prerogatives of good clinical practice, and law dispositions are regulated and strictly monitored by the applicable authorities [ 21 ].

Physical vulnerability

For a long time, pregnant women were excluded from clinical research because of their “vulnerability”. Although pregnant women are able to make informed and conscious choices, they have been considered “vulnerable” due to the potential risks to the fetus, who is also considered as a “patient” [ 22 ]. More recently, with the consideration of pregnant women as “scientifically complex” rather than “vulnerable” subjects, it has been permitted to involve this category in research trials [ 23 ]. The “scientific complexity” reflects both ethical and physiological complexity. The ethical aspects are secondary to the need to find a balance between interests of the fetus and the mother. The physiological aspects are strictly related to the pregnancy status [ 24 ].

Research studies involving pregnant women and fetuses have to satisfy specific federal regulations ( table 2 ). The following appropriate precautions should be taken in research studies involving pregnant women: no pregnant woman may be involved as a subject in a human clinical research project unless the purpose of the research is to meet the health needs of the mother and the fetus will be placed at risk only to the minimum extent necessary to meet such needs, or the risk to the fetus is minimal [ 25 ].

Table 2

Conditions to be met in research studies involving pregnant women and fetuses

Researchers can enrol pregnant women only when the mother and/or the father are legally competent. In fact, the consent to participate in research may be either self-directed (only the mother’s consent is required) or made with the guidance of the woman’s partner. However, the father’s consent need not be obtained when: 1) the research activity is directed to the health needs of the mother; 2) the father’s identity is doubtful; 3) the father is absent; or 4) a pregnancy from rape has occurred [ 26 ]. The consent signature requirements from the mother and father are summarised in table 3 . Once the informed consent is obtained, the pregnant women will be included into any phase of the study unless the research project will be compromised or the patient’s health (mother and/or fetus) will be in danger.

Table 3

Consent signature requirements for pregnant women and children

# : consent requirements are the same whether the risk is “no more than minimal” or “more than minimal”.

Medical students and employees, who take part in numerous aspects of patient care in primary, secondary and tertiary care settings, are often invited to participate in human studies as volunteers. Frequently, the requesting researcher is their supervisor or instructor, who may push them to participate in the study, which can negatively influence their decision and also violate the consent legitimacy. Therefore, in order to protect these subjects against “coercion” or “undue influence”, when an investigator wishes to recruit medical students or employees, they must first obtain IRB approval for inclusion in the study of these vulnerable subgroups [ 27 ].

Prisoners, defined as any individual involuntarily confined or detained in a penal institution, are considered as “vulnerable” because they may be coerced into study participation, and also, due to both cognitive and psychiatric disorders, they can show an impaired ability to provide voluntary informed consent [ 28 ]. To protect this population, the Office for Human Research Protections has stipulated federal regulations according to which the only studies that may involve prisoners are those with independent and valid reasons for involving them ( table 4 ) [ 25 ].

Table 4

Studies that may involve prisoners

Due to the context of war in which they work, as well as the critical care setting in which they are treated, military subjects often receive medical care and/or participate in biomedical research under an “implied consent” condition. Moreover, the superior–subordinate relationship contributes to favour coercion or undue influence, making this population vulnerable [ 29 ]. To curb this phenomenon and to ensure that participation is truly voluntary, the US Dept of Defense agencies have adopted requirements similar to those that govern medical research that applies to the civilian population. Accordingly, the medical research recruitment session happens in the absence of superiors, and the informed consent is obtained prior to participating in a medical research study. The presence of an ombudsman guarantees and verifies that the participation is voluntary and that the information provided during recruitment is complete, accurate and clear. A payment as an incentive is acceptable but it must not be used to legitimise a coercive interference. Additional protection is provided to students at service academies, especially those aged <18 years. However, when emergency research is conducted or the research study advances the development of a medical product needed by the armed forces, informed consent will not be required [ 29 ].

Psychological vulnerability

Mental disability may compromise the self-determination and decision-making capacities [ 30 ]. Researchers interested in enrolling individuals with cognitive disorders are invited to apply different strategies to promote a better understanding of information-gathering processes. Simplifying the questions and content, adopting supportive technologies, using a more simple language, and spending more time for the information process have been suggested as useful and valid measures. When all these strategies prove to be insufficient, the investigators are required to obtain consent from a legally authorised representative [ 30 ].

Social vulnerability

Similarly to other vulnerable populations, research involving the homeless, ethnic minorities, immigrants and refugees is regulated by laws and specific procedures. Cultural and language differences, “undocumented” migrant status, and the precarious legal positions of these subjects raise several ethical issues, such as whether the participation is truly voluntary, or there are unrealistic expectations, or any benefits for their “status”.

Obtaining informed consent in these groups is extremely complex. A friendly procedure has been identified as the best way to adequately involve these vulnerable groups. A health centre or community building could represent an accessible location. The reimbursement of travel expenses for applicants can be a valid solution to obtain a representative sample for the clinical research. Clear and simple language, emphasising confidentiality, with the help of professional interpreters, can tempt migrants to sign the consent form. Lastly, the possibility of receiving something back in return for their contribution may enable successful enrolment of migrants in research [ 31 ].

Special needs: children

Because of their young age as well as their limited emotional and intellectual abilities, children are considered to be legally incompetent to give valid informed consent; thus, to enrol a child in a research study, the permission by at least one parent or legal representative is mandatory ( table 3 ). For subjects aged <18 years, biological or adoptive parents or legal guardians (persons having both legal capacity and responsibility) can give consent on behalf of their child, exercising free power of choice without any form of coercion. While married mothers and fathers both have parental responsibility, unmarried parents can exert parental responsibility only if they are named individually on the child’s birth certificate. Also, divorced parents maintain parental responsibility, but it is necessary to know to whom the child’s custody has been assigned [ 32 ]. However, on this matter, the European laws and regulations are not harmonised and several discrepancies are present in each country [ 33 ].

Despite potential benefits for the research subjects, the failure of parents to give consent (or their refusal to give consent) is not a rare circumstance [ 34 ]. It can be the case that researchers are dealing with underage parents, so that, although underage parents are responsible for representing their children, as minors themselves they are not considered to be sufficiently mature; therefore, they will be not able to give valid consent. Literacy and socioeconomic levels have been identified as the most common reasons for parental non-response [ 34 ]. Clarity and adequate explanation of research information materials should be part of effective planning to overcome language and social barriers.

In clinical studies in which the adopted methodology constitutes “less than minimal risks” for children, passive parental consent represents a possible way to more easily obtain informed parental consent [ 34 ]. Furthermore, parents can be informed with regard to a possible study involving their children, and, at the time of data collection, only the child’s assent is required. In fact, although the child’s decision-making capacity and understanding of the research project in which he/she will be involved may be limited, the Medical Research Council have shown that, when study details are provided and communicated in a clear and adequate manner, the child can be able to reach a decision and participate consciously in the research [ 35 ]. “Assent” is the term coined to express the child’s willingness to participate in clinical trials despite their young age. The “assent” should include and respect the following key points: 1) helping the child to acquire disease awareness; 2) explaining the potential impact of the experimental treatment; 3) evaluating the child’s ability to understand and adapt to new situations or challenges; and 4) positively influencing the patient’s willingness to participate in clinical trials [ 36 ]. Although the “assent” is not mandatory for research offering a direct benefit for the child, it arises from the need to respect paediatric research subjects [ 37 ]. The evaluation of the capacity to provide the “assent” is based on developmental stage, intellectual abilities and life or disease experience. Usually, the cut-off age of 7 years is used for the beginning of logical thought processes and rational decision making [ 38 ]. However, “assent” for children aged <7 years can be also required once the ability to read and write has been verified [ 32 ]. Figures 1 and ​ and2 2 summarise the parental and assent permission requirements, respectively.

Flow chart of parental permission requirements.

Flow chart of child assent requirements.

When conducting clinical research, the obtaining of informed consent is required. Informed consent is a procedure through which a competent subject, after having received and understood all the research-related information, can voluntarily provide his or her willingness to participate in a clinical trial. However, when it is impracticable to obtain consent, and the research does not infringe the principle of self-determination and also provides significant clinical relevance, the researcher is legally authorised to proceed without informed consent. Furthermore, in order to preserve the self-determination and decision-making rights, specific law dispositions are applied when vulnerable populations are enrolled in clinical trials.

Self-evaluation questions

• a) Diagnosis
• b) Risks and benefits of treatment
• c) Alternatives to treatment
• d) Family’s wishes
• a) When a minor is considered as emancipated
• b) When a patient is found to be incompetent
• c) When immediate treatment is necessary to prevent death or permanent impairment
• d) When the subject is aged >18 years
• a) Minor is married or divorced
• b) Minor on active duty in the US armed forces
• c) Minor is considered self-sufficient by a court
• d) Minor having a son

Suggested answers

• All research conducted on humans must be pre-emptively accepted by the subjects themselves through the procedure known as informed consent.
• Voluntary expression of consent and adequate information disclosure about the research are critical and essential elements of the informed consent process.
• When specific circumstances occur, informed consent can be waived: if it is impracticable to obtain consent, if the research does not infringe the principle of self-determination, and if the research provides significant clinical relevance.
• Participation of vulnerable patients in clinical trials is regulated by specific law dispositions.

Conflict of interest: None declared.

Research Informed Consent Form

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Updated June 23, 2023

A research informed consent form is used for the purpose of freeing students/faculty of any liability while performing a research study with human participants. Not only does the consent form liberate the researchers of accountability, it briefs the participants of how the research will be conducted, presented and reported. The participants must be fully aware of any risks or potential discomfort that may arise during the study. It should also be made known that participation is voluntary and that the participants can withdraw from the study. A step-by-step guide to filling out a general research informed consent form can be found below.

Instructions – Use to fill in the blank template.

How to Write

Step 1 – Download in PDF , Microsoft Word (.docx) , or Open Document Text (.odt) .

Step 2 – The title of the research study being conducted must be included at the top of the consent form.

Step 3 – Enter the following information related to the primary researcher in the fields provided:

• Phone number
• Email address

Step 4 – The purpose of the study, the procedures, the risks, and the benefits should be listed under each appropriate corresponding category with the participant’s initials included at the bottom of the page.

Step 5 – Any compensation that is to be provided to the participant(s) should be included under the “Compensation” section on page 2.

Step 6 – A telephone number and email address should be supplied under the “Contact Information” section in case the participant does not want to contact the primary researcher directly. The participant must initial the bottom of the second page.

Step 7 – Signatures must be produced by the participant and the researcher, with the date on which the form was signed next to each signature.

Writing A Consent Form

Below are some useful tips on writing a consent form for your proposed subject population. The procedures for obtaining consent should be documented on the Consent tab of the protocol application.

Coercion  - The subject must be given the opportunity to consent or not consent without the intervention of any element of force, fraud, trickery, duress, coercion, or undue influence on the subject’s decision. Payments & credits should be pro-rated & not withheld until completion. Any payment or class credit must be appropriate to the tasks involved and the subject population.

Compensation  - Compensation payments must be pro-rated or provided in full even if a subject withdraws from the study early. If the payment includes a  lottery , participants must be at least 18 years of age to participate and be entered into the lottery and payment (e.g. prorating) cannot be withheld until the completion of the study. A participant may withdraw from a study and still be entered into a lottery. Approximate odds of winning need to be included in the consent form.

Class Credit  - Any project where class credit is involved must be open to all members of the class AND there must be a non-research option to obtain the same credit for the same amount of effort. The Psych & Geography pools are currently the only pools at UCSB whose procedures are codified and do not need to be documented in this form. All other use of class credit & non research alternatives must be documented in the ORahs protocol application on the Consent tab.

Elements of Consent  - Consent forms should include all the required elements of informed consent and additional elements (if applicable), unless a waiver of consent is requested, justified, and approved by the IRB.

Identifiable data  - Consent for using identifiable data (e.g., video recordings) must be obtained, unless a waiver is requested, justified, and approved by the HSC. If participants are to be recorded or photographed, they must be informed as to how this media may be used (e.g., used in conferences, presentations, publications, shared with other researchers). The use of check boxes is recommended for varying levels of consenting to participate. If there are informational risks to the participant, additional safeguards may need to be put in place. These should be described in the risk tab and discussed in the participant consent. The disposition of identifiable data should be described in the consent form. Identifiable data may be retained indefinitely or destroyed. The consent form should describe if/when identifiable data will be destroyed and how such data will be protected and how it will be used or shared.

Language  - Consent forms should be written in the 2nd person (i.e., "you are") and in a language that is clear, concise, and understandable to the subject population. This includes both reading level and language (e.g, English, Spanish, French). Field specific jargon should be avoided and all concepts should be explained in lay terms. For studies involving multiple subject populations (e.g., children and adults), multiple consent forms are required and must be tailored to the reading and comprehension level(s) of the subject populations to be enrolled.

Translation  - If the subject population involves individuals who speak a different language, consent forms should be translated into the target language and translated back into English by two different individuals to ensure that the appropriate concepts are being conveyed. Using a translator app, such as Google translate should not be used to translate consent forms.

Other Helpful Hints  -

• Avoid using terms such as "agree to" or "certify understanding".
• Only use the consent form that is approved in the ORahs application.
• Think about how you would explain this project in a conversation with someone who was not familiar with your research or field.
• If social security numbers are required to process payment to human subjects participants, then this should be included in the consent form.
• Any alterations or changes to the approved protocol must be reviewed and approved by the HSC prior to initiation.

Consent forms must be signed by the subject, and/or by the parent or legal guardian UNLESS a waiver of documentation or consent is requested, justified & approved. Signed consent forms must be stored securely in your UCSB Department.

 For information on requesting a waiver of documentation or consent, visit the  Waiver of Consent or Documentation page .

Action Research Tutorials-CCAR

Action research tutorials, tutorial 5: plan for action, consent letters.

When is a consent letter needed? Action research is conducted primarily on the researcher as it is about improving skills through taking action. When actions are a part of doing one's job and do not require anything that a person would not already be doing as a part of their job, then one could argue that informed consent is not required, but it is crucial all people involved are aware of the effort. This means that any immediate supervisor should be aware of the plans and those involved should also know what is being done and why. Often this can be accomplished informally with co-workers. For example one might say to co-workers, I am interested in the way that social networking might improve the way we deal with this specific problem. Are you interested in exploring this with me? In this way, you enlist co-action researchers in your investigations, not subjects. However, if you are dealing with a protected group, such as children, you need to be very careful that your procedures have been approved by your academic advisor, your work supervisor or any other body that either of these people might require. In this case, a consent or information letter to the parents is good practice. If the activity is part of your teaching and you expect all students to participate in all aspects of the activity, then an information notice rather than a consent letter might be sent to the parents. If school-age children are being asked to give feedback on your teaching or complete a voluntary survey, it is likely that you will follow research approval procedures including collecting parental consent. Pay attention to your situation and edit these letters as appropriate for your situation. For example, an educational activity may be something that will be expected of all children in the classroom and therefore is not voluntary. So you would delete the comment about this activity being voluntary.  

Templates for Action Research letters

1) Consent Letter Template for an Action Researcher in a Graduate Program 2) Consent Letter Template for an A ction Researcher in a School 3) Information Letter Template  

1) For a Graduate Student...

Dear Parent/Guardian: I am a graduate student in _[name of program and university]. I am working towards a [type of degree] degree in [type of degree]. As part of my work, I want to increase my skill and understanding of [topic of research]. Specifically, I want to understand more about [details of action research project]. My goal is to improve my skills in [anticipated outcomes of the project]. I expect that this will help your child/the student in my class to be able to.  I would like to invite your child to participate in this activity. I will [a detailed description of what you will be doing, where it will take place and who will be involved, and their role and relationship to the child]. This will involve keeping track of [detailed description of any data collected and what exactly will be done with it. Specify any risks that you see to the student, no matter how minor they might seem. For example, "students might be concerned to let other students see their writing" and then what you are going to do to minimize this risk. ] I will protect your child's identity and privacy by [paragraph of how you will protect the child's privacy specifically concerning analysis and sharing of data with others in discussions or reports] Participation in this activity is voluntary. Your child is free to refuse to be interviewed, surveyed, and observed. Your child may change his/her mind about participating in this activity at any time. Your child’s standing in [activity or class] will not be influenced by agreeing or refusing to participate in any portion of this project. If you have any questions about my plans, please contact me, [name] by e-mail [email] or by phone [number]. You are also welcome to contact my professor, [name] at [contact information] .  If you agree that your child can take part in my project, please return a signed copy of this form to me as soon as possible. You may keep the other copy for future reference. Thank you in advance for your cooperation, and I hope your child enjoys [name the activity]! I am very excited about the potential of [name of project] to improve [anticipated outcome for the child]. I give my permission for my child [name] to participate in the [name of project]. Date:_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Parent/Guardian Signature:_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Please print your name on this line:_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Questions or concerns about your rights in this research project can be directed to [contact information] EXAMPLE of a Consent Letter using his Template  

Template for teachers engaged in Action Research on their own.

Dear Parent/Guardian of _: I am your child's [topic or grade level] teacher, and I want to increase my skill and understanding about [topic of action research]. Specifically, I want to understand more about [more details about the project]. My goal is to improve my ability to help your child (or the students in my class) to be able to. I would like to invite your child to participate in this activity. I will ....[detailed description of what you will be doing]. This will involve keeping track of [detailed description of any data collected and what exactly will be done with it. Specify any risks that you see to the student, no matter how minor they might seem. For example, "students might be concerned to let other students see their writing" and then what you are going to do to minimize this risk. ] I will protect your child's privacy by [paragraph of how you will protect the child's privacy specifically concerning analysis and sharing of data with others in discussions or reports] (if there are risks) The risks that I see to your child is the possibility of concern over [describe any risks you see to the student, for example, concern about sharing their ideas with others.] I will reduce this risk by [what will you do to minimize the risk, for example, work with the students to develop a respectful attitude for sharing work in progress).  Participation in this activity is voluntary. Your child is free to refuse to be interviewed, surveyed, and observed. Your child may change his/her mind about participating in this activity at any time. Your child’s standing in [describe action - technology club, running team or program] will not be influenced by agreeing or refusing to participate in any portion of this project. If you have any questions about my plans, please contact me, [name] by e-mail [email] or by phone [number]. You are also welcome to contact Principal [name] at [contact information] with any questions you might have.  If you agree that your child can take part in my project, please return a signed copy of this form to me as soon as possible. You may keep the other copy for future reference. Thank you in advance for your cooperation, and I hope your child enjoys [name the activity]! I am very excited about the potential of [anticipated outcome for the child and researcher]_ I give my permission for my child [name] to participate in the [name of project]. [name]_ _ _ _ _ _ to participate in the [name of project]. Date:_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Parent/Guardian Signature:_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Please print your name on this line:_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Questions or concerns about your rights in this research project can be directed to [contact information] (If the impact is minimal and you see no risks, your school district might only require passive consent, in which case you might change the last paragraph to something more like: I expect that participation in this experience will benefit your child as well as help me improve my skills in [area you are working on]. If you would do not want to have your child participate, please contact me. [name and contact information] An Information Letter Template Dear Parent/student/Coworker/ This year I am working on developing my skills to ... I am pleased to be working with you/your child and hope you will help me in my quest to learn more about..... I look forward to learning with and from you and hope that you will be willing to share your feedback and be as honest as possible. I will learn more if you are willing to share what you notice or think about these new ideas. You can reach me at (contact information is not already known)

How To Write An Info/Consent Document

What is a consent form.

A consent form is a document which provides prospective research participants with the information necessary to make an informed decision about whether to take part in research or not. It may or may not include a signature section. It will be referred to as the  info/consent document .

What’s the difference between a consent form and an information letter?

• Some researchers like to separate the information (found in an information letter) from the signature section (which they term the consent form) – this is your decision and is NOT required by the Research Ethics Board (REB), but DO NOT REPEAT the same information in both places.
• You MUST provide the participant with a copy of the info/consent letter regardless of how you document consent.

General instructions

• Write in a conversational tone.
• Who is your audience? Speak directly to them. The language should be at grade 8-level.
• Directly address the participant. ‘You’ are invited, not ‘the participant’ is invited. 
• Avoid legalistic language (e.g. you hereby agree, you certify that, etc.)
• Use bullet point lists to increase readability.
• Use a readable font such as Arial, Courier, or Verdana. Use a minimum 12 point font.
• The REB will NOT proof read for spelling and grammar.
• The bodyshould provide a plain-language description of what the participant will experience. If you need to include more than a couple of sentences, add the description of the procedure as an appendix.

What are the biggest review problems I can avoid?

• Inconsistency between the info/consent document, recruitment documents, and the REB application.
• Unnecessary repetition of information between information letters and consent documents.
• Missing required elements.
• Cut and paste errors.
• CONFIDENTIALITY – a person’s identity is kept confidential. The data you collect will be shared when you publish it.
• ANONYMITY – data are anonymous ONLY when a person’s identity has never been associated with it.
• We will use your name in the final report.
• Your name will not be released with any of the data.
• We will not collect any identifiers other than your signature on the consent form.

Readability

Give a draft to someone who is NOT in your academic discipline to proof read. Have them circle every word which is not entirely clear. Remove these words.

There is a feature in Word to test ‘Readability’ . It is best used on individual paragraphs and is NOT fool-proof. But it will give you an idea.

• In Word, go to “File”→”Options” → “Proofing”, then click ”Show Readability Statistics”. After Spell Check has been completed, Word displays readability information.
• The Flesch Reading Ease scale has a maximum value of 100, with higher numbers representing greater reading ease (approximately 60-70 is a good target). 
• The Flesch-Kindcaid Grade Level is an approximation of the grade-level of education necessary for someone to understand the document (e.g., a value of 8 means Grade 8). 
• If you want to determine the readability for an individual paragraph, highlight the paragraph, run Spell Check and then click “No” when the message pops up “Word finished checking the selection. Do you want to continue checking the remainder of the document?”

Informed consent

Information and guidance for researchers, what is informed consent.

Informed consent is one of the founding principles of research ethics. Its intent is that human participants can enter research freely (voluntarily) with full information about what it means for them to take part, and that they give consent before they enter the research.

Consent should be obtained before the participant enters the research (prospectively), and there must be no undue influence on participants to consent. The minimum requirements for consent to be informed are that the participant understands what the research is and what they are consenting to.  

There are two distinct stages to a standard consent process for competent adults:

• Stage 1 (giving information) : the person reflects on the information given; they are under no pressure to respond to the researcher immediately.  
• Stage 2 (obtaining consent): the researcher reiterates the terms of the research, often as separate bullet points or clauses; the person agrees to each term (giving explicit consent) before agreeing to take part in the project as a whole. Consent has been obtained.

Researchers should ensure that they comply with the General Data Protection Regulation (GDPR) during and after the consent process, especially if they will be collecting 'special category' (ie sensitive) data or personal data in the course of their research (also refer to the advice on consent in research involving children ).  See also the guidance on data protection and research and the data protection checklist for use when preparing an application for ethical review.

Where your research includes filming or photography, you should refer to specific guidance in the Photography and GDPR toolkit .

Written or oral consent – which process suits your project?

Which process to use depends on the research project (its context, design and participants), though an oral process is usually only appropriate where a written process is not feasible. Any consent process must be understandable to the participants concerned. Please see the sections below to find out about different processes which may be used depending on the context, as well as informed consent templates for each process.

Written informed consent process

A written process is used where:

• Reading and signing forms is not problematic.
• The research is complex or has multiple stages.
• First access to the research participants is by providing written information.

Though opinions differ about the legal force of signed consent forms, they provide extra proof that the terms of consent have been understood. This can be especially important when seeking consent for copyright over data, or for future uses of data. Also, future funders or regulators may want written proof of the terms of original consent.

For literate participants who are not put off by written information, a written process is often a straightforward way of communicating the 'research contract'.

Between the provision of information and obtaining consent, the participant should be given a reasonable amount of time to consider whether to consent and to ask questions, though the time given depends on the project design, the context of the research and the participants.

The written consent templates below can be adapted to suit your study.

Oral informed consent process

An oral consent process is where researcher and participant have a conversation to give information and obtain consent.  There is no paper form to sign. It is normally used:

• where literacy is a problem
• where there are cultural or political concerns with signing contract-like documents
• where either the researcher and/or the participant could be put at risk by existence of a paper record
• where time for consent is limited, eg a chance interaction between researcher and participant (although you should not use an oral process merely to correct poor planning of research)
• for research conducted via remote video conferencing software

It may also be more appropriate when interviewing elite participants as part of the research.

For all other research, how you arrange the oral process depends on how you will encounter your participants (for example email, phone, an on-the-street-meeting by chance). Between the information-giving and consent stage the participant should be given a reasonable amount of time to consider whether to consent, though this depends on the project design, the type of participants and the context of the research.

When obtaining oral consent, please ensure you are recording the consent process either using a recording device (for example audio recorder if you are conducting an interview that needs to be recorded) or, if participants do not agree to audio recording or if using or keeping audio records is unsafe, by using a researcher record of oral consent template or completing a written consent form on their behalf.

The oral consent templates below can be adapted to suit your study, but careful consideration is required to ensure that these are appropriate for the research and the participants.

Informed consent templates

Written informed consent process (including online surveys).

Template agreements

Cases where 'implied consent' may be acceptable (for example online surveys)

Researchers should always aim to inform people fully and obtain appropriate consent. However, in some cases the research may be straightforward enough that a separate, deliberate process for obtaining consent is not needed. In these cases participants, by their actions, imply consent. This is seen most often in research:

BPG 06 Internet-mediated research

Template information sheet for online research

• where no participant personal details are obtained
• where the topic of research is very low risk and no special category data will be collected
• where participation is confined to one small task, eg completing a survey or simple pencil or computer task

Please note: consent cannot be inferred from inaction (eg failure to move away from a camera).  

When consent works against the aims of research

If your research employs deception, you will not be able to inform participants fully about your project’s true aims. In this case please check if you can fully apply the CUREC approved procedure on research involving the deception of participants . If the deception raises ethical concerns such that the application is not covered by this procedure please complete a CUREC 2 application form.

Some research settings evolve very rapidly (for example in conflict studies). Similarly, some research participants may only be revealed in time-poor or emergency settings (eg heart attack patients). This infringes on the standard information-giving stage of research. The vulnerability of participants in those settings may justify an expedited or fully waived consent process. Again it is important to describe the research setting clearly. You may need to complete a CUREC 2 application to the relevant committee in these cases: please check with your DREC or your IDREC .

Last updated Thursday 2 December 2021

Related links

• Where and how to apply for ethics review
• Committee information
• Research ethics FAQs and glossary
• Research integrity and ethics policy
• Ethics committee contacts

Permission Letter To Conduct Research: How To Draft It Right!

In this article, I’ll share my insights and provide you with a step-by-step guide, including customizable templates , to craft your own effective permission letter for research.

Key Takeaways Understand the purpose and importance of a permission letter for research. Learn the essential components to include in your letter. Get a step-by-step guide to writing a compelling permission letter. Benefit from a customizable template to streamline your writing process. Discover practical tips from my personal experience to enhance your letter.

Understanding the Importance of a Permission Letter for Research

A permission letter for research is a crucial document that formally requests authorization to conduct a study in specific locations or collect data from a particular group.

It serves as a formal agreement between the researcher and the authority or individuals involved, ensuring that the research is conducted ethically and legally.

Step-by-Step Guide to Writing Your Permission Letter

Step 1: start with contact information and date.

Always begin your letter by stating your contact information at the top, followed by the date. This should include your name, address, phone number, and email address.

Step 2: Address the Recipient Properly

Address the recipient by their proper title and name. If you’re unsure, a general “To Whom It May Concern” can suffice, but personalized greetings are always more impactful.

Step 3: Introduce Yourself and Your Affiliation

Trending now: find out why.

Introduce yourself, your position, and your affiliation. This sets the context and establishes your credibility.

Step 4: Clearly State the Purpose of Your Letter

Be clear and concise about your intent to seek permission for research. Mention the research topic and why the specific site or group is essential for your study.

Step 5: Provide Details of Your Research

Explain the scope of your research, the methodology you’ll use, and the expected duration. Transparency is key to gaining trust and approval.

Step 6: Assure Ethical Compliance

Highlight your commitment to ethical standards, including how you’ll ensure participant confidentiality and data protection.

Step 7: Request for Approval

Politely request permission to proceed with your research, expressing your willingness to comply with any required protocols or guidelines.

Step 8: Include Contact Information for Follow-up

Offer your contact information again, encouraging the recipient to reach out with any questions or requests for further details.

Step 9: Close with a Professional Salutation

End your letter with a professional closing, such as “Sincerely,” followed by your name and signature.

Template for a Permission Letter To Conduct Research

[Your Name] [Your Address] [City, State, Zip Code] [Phone Number] [Email Address] [Date]

[Recipient’s Name or Title] [Organization’s Name] [Address] [City, State, Zip Code]

Dear [Recipient’s Name or Title],

I am writing to request permission to conduct research at [location/site/group], as part of my [research project/study] on [topic]. My name is [Your Name], and I am a [Your Position] at [Your Institution or Organization].

The purpose of my research is to [briefly state the objective]. I believe that [location/site/group] is essential for my study because [reason]. The research will involve [describe the methodology], and I anticipate it will take approximately [duration] to complete.

I assure you that all research activities will adhere to the highest ethical standards. Participant confidentiality and data protection will be strictly maintained throughout the research process.

Your approval to conduct this research would be greatly appreciated. I am more than willing to adhere to any specific protocols or requirements you may have. Please feel free to contact me at [Your Phone Number] or [Your Email Address] if you have any questions or need further information.

Thank you for considering my request. I look forward to your positive response.

[Your Name] [Your Signature, if sending a hard copy]

Personal Tips from My Experience

• Personalize Your Letter:  Tailoring the letter to the recipient shows respect and attention to detail.
• Be Concise but Thorough:  Provide enough detail to inform but not so much that it overwhelms the reader.
• Follow-Up:  Don’t hesitate to follow up if you haven’t received a response within a reasonable time frame.
• Show Appreciation:  Always express gratitude for the recipient’s time and consideration.

I hope this guide helps you craft an effective permission letter for your research. I’d love to hear about your experiences or any additional tips you might have. Please share your thoughts and questions in the comments below!

Related Posts

• Free Templates for Research Permission Letters
• 3 Must-Have Templates for Requesting Permission Easily
• Sample Letter To Request To Attend A Conference: Free & Effective

Frequently Asked Questions (FAQs)

Q: What is a permission letter to conduct research?

Answer : A permission letter to conduct research is a formal request to obtain permission from an organization or individual to conduct research on a particular topic. This type of letter is commonly used by students, researchers, and scholars who require permission to carry out their research.

Q: Why is a permission letter to conduct research important?

Answer : A permission letter to conduct research is important because it shows that the researcher has obtained the necessary permissions to conduct their research. It also provides a clear understanding of the scope and nature of the research and how it will be conducted, which can help to prevent misunderstandings or legal issues.

Q: Who should I address my permission letter to?

Answer : You should address your permission letter to the individual or organization that has the authority to grant permission for your research. This could be the head of the organization, a department manager, or an individual who is responsible for the area that you wish to conduct research in.

Q: What should I include in my permission letter to conduct research?

Answer : Your permission letter to conduct research should include an introduction that outlines your research topic and objectives, an explanation of why you need permission, an overview of your research methodology, details on the timeline and logistics of your research, and a formal closing that thanks the recipient for their time and consideration.

Q: How do I ensure that my permission letter to conduct research is effective?

Answer : To ensure that your permission letter to conduct research is effective, make sure that it is clear, concise, and polite. Provide detailed information about your research and the nature of your request, and address any potential concerns or objections that the recipient may have. Finally, proofread your letter carefully to ensure that it is free from errors and typos.

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