how to write consent form for research

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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

IRB-Health Sciences and Behavioral Sciences (IRB-HSBS)

Phone: (734) 936-0933 Fax: (734) 936-1852 [email protected]

• Human Subjects Protections

How to write the perfect consent form for research

Consent forms play a vital role in protecting both researchers and participants.

In fact, they’re an essential aspect of any study. They make sure everyone involved understands the purpose of the research, their rights, and what’ll be done with the data you collect. Consent forms also protect participants by flagging any content that might cause offence or distress, ensuring they’re informed and have the option to not take part.

Read on to discover why consent forms for research matter, what to include in one, and some handy tips and tricks for ensuring yours covers every base.

Why research consent forms matter

A thoughtful, thorough research consent form can really add to the participant’s experience – while keeping you compliant, and them safe. Here’s how.

The only way is ethics

Consent forms are a key part of ethical research. They provide a clear and concise understanding of the study's objectives, methods, and potential risks.

Asking for informed consent shows respect to your participants. It ensures they're voluntarily taking part in the study without feeling coerced or misled.

Consent forms are mandatory

All academic institutions have an ethics board (also known as the institutional review board in the US). This group must approve any research being done by researchers who are connected to the university.

Consent forms are an important part of this process. The ethics board requires them to ensure that participants understand what they’re agreeing to and that their rights are being protected.

Compliance is key

Research consent forms also serve as a legal safeguard for both researchers and participants. They outline the rights and responsibilities of each party, which helps you stay on the right side of data protection rules like the General Data Protection Regulation (GDPR).

They can also keep you out of court. They allow you to uphold participants’ rights, and your own rights, if a dispute occurs and avoid potential legal complications.

Trust matters

A well-crafted research consent form establishes trust between you and your participants.

By being transparent about the study's purpose and procedures, people will feel more comfortable engaging in your research.

Creating the perfect consent form for research

Your consent form will no doubt be unique, depending on the nature of your research and the specifics of your study.

But here are eight key components you won’t want to miss out.

1. A study description and purpose

Kick off your consent form by outlining your study's purpose and objectives. Briefly explain why the study’s being conducted.

This section should be clear, concise, and easy to understand, as it sets the stage for the rest of the form.

2. What’s expected

Describe the tasks participants will be asked to complete and any equipment they’ll need, along with an overview of the time commitment required.

With this information, participants can make an informed decision as to whether they want to take part or not.

3. Voluntary participation

Make it clear that taking part in your study is entirely voluntary. Explain that the participants can withdraw from the research at any time without penalty or negative consequences.

This a legal requirement – but it also helps you promote trust and allow participants to feel in control of their involvement.

4. Risks and rewards

Address any potential risks or discomforts that participants may experience during the study. Be open about any physical, psychological, or social risks – even if they’re small.

Don’t forget to shout about the benefits, too! If taking your study means gaining insights, learning new skills, or contributing to scientific knowledge that’ll make the world a better place, highlight it here.

5. The privacy bit

This one’s crucial. Explain what data will be collected during your study – including any sensitive info, like racial or ethnic origin, religious or political beliefs, or health status – and how this data will be used and protected.

You’ll also want to mention how the data will be stored, and for how long, as well as how participants can withdraw their consent and data.

Assure participants that their personal information will be kept confidential, and outline the measures you have in place to protect the anonymity of their responses.

If you plan on making their anonymised data available to other researchers online at some point, be really clear about this, too.

6. Compensation and incentives

Give participants full details of the compensation they’ll receive for their time. Be open about the amount, form of payment, and any conditions required to receive it.

This information helps participants understand the value of their efforts.

7. Your contact info

Offer participants a point of contact for questions, concerns, or feedback related to the study.

8. A consent statement and tick box

End your research consent form with a clear statement of consent. This should explicitly state that the participant has read and understood the information provided and agrees to participate in the study.

Then, add a button or check box participants must click to record that they’ve given their consent. This should be timestamped and, if you’re using the Prolific platform, stored alongside the participant’s Prolific ID. If a participant selects ‘Does Not Consent’, ask them to return their submission on Prolific by clicking ‘Stop Without Completing’. They shouldn’t be penalised for this.

Our top tips for writing consent forms

So, you know why you need a consent form for research and how to write a comprehensive one.

Now, make it even better with these tips and tricks.

Use clear and accessible language

Make sure your consent form is written in clear and accessible language that participants can easily understand. Steer clear of technical jargon and keep acronyms to a minimum.

Keep it simple

Try to keep your form concise and focused. Reams of text and check boxes can be overwhelming and may discourage potential participants. Rather than getting the participant to consent to several different things, try and stick to one check box that confirms whether they do or don’t consent to the study.  

Be transparent

Be open and honest about the study's purpose, methods, and potential risks. If participants feel informed and at ease when taking your study, you're more likely to get better responses from them.  

Test and revise

Before distributing your research consent form, have a couple of people you trust review it for clarity and comprehensibility. Use their feedback to revise it before you put it in front of participants.

Create consent forms with confidence by using our downloadable template

To make getting consent simple as possible, we’ve created a comprehensive consent form template that you can use for your research.

This template includes all the key fields required to ensure you and your participants are protected. Download the template now .

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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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Format and Style of Informed Consent Documents- Key Points

• The IRB strongly encourages Investigators to use the standard UCI IRB consent template, which is available on the Applications and Forms page . The template is written in the 2nd person. IRB requires that the consent and assent documents be written in the 2nd person, i.e., "you" rather than "I." Do not start sentences with "You understand..."
• Consent forms should be written in lay language , at a level understandable to the participants in the study (6th to 8th grade reading level for adult participants). Researchers may use flowcharts and tables to enhance reading comprehension. Also, try to avoid medical/scientific/technical language or include simple definitions/explanations for such terms if they must be used, also see Consenting Subjects Who Do Not Read, Speak or Understand English .
• The use of a 12-point font is recommended. A larger type size may be appropriate for some populations, such as, children, the elderly, or the visually impaired.
• Documents must be typewritten.
• A place for the subject and researcher signature and date must appear on the consent document. A witness signature is required in specific circumstances. See How to Consent for more information on this topic.
• The consent form should identify any external sponsor or funding agency.

Glossary of Lay Terminology

An EQUIP-TIPS Guidance document providing lay language for common medical / scientific terminology (source:

Instructions for Developing an Informed Consent Document

As part of the informed consent process, the consent document is designed to provide information to potential subjects about a research study so they can make an informed decision about their participation. The use of a form to document the consent process is required unless specifically waived by the IRB. One of the most common reasons for delay in IRB approval is an incomplete, inaccurate, and/or unclear consent form document. Informed consent templates (biomedical and social/behavioral versions) are available on the IRB Applications and Forms page. You can download a template and customize it to your research study.

General Information

Describe the purpose(s) of this research study in lay terms. Include a statement that indicates why this is considered a research study (e.g., testing how a non-FDA approved drug works and whether it is safe). Provide definitions for specific research design features (e.g., double-blind, randomization, placebo-controlled).

Purpose of the Study

Include a thorough description of the specific procedures involved in the study, which procedures are considered experimental and why. Include detailed inclusion/exclusion criteria, length of involvement. If the subject will be interviewed or asked to complete a questionnaire, describe the types of questions that he/she will be asked to answer. Provide a procedures table if subjects would benefit from the addition of a table.

This element will ask if the study involves more than minimal risk. If so you will be prompted for a detailed description of the potential risks and discomforts involved (physical, psychological, social, and economic). For some procedures you may choose to use standard text (e.g., blood draw). If applicable, include a statement that the treatment or procedure may involve risks, which are currently unforeseeable, to the subject (or to the embryo or fetus, if the subject is or may become pregnant). You may build a table or cut and paste an existing table into the Word document.

Describe all expected benefits and who will benefit. Note: Compensation for participation is not a benefit; provision for free drugs or procedures is not a benefit.

Compensation, Costs and Reimbursement

If subjects will be compensated for their participation or reimbursed for costs (e.g., parking), describe in detail the type of payment, amount, and terms. Specify any additional costs to the subject that may result from participation in this study that will not be reimbursed.

Withdrawal or Termination from Study

When applicable, subjects should be informed of circumstances under which their participation may be terminated by the investigator without the subject’s consent. Subjects should also be informed of procedures for safe and orderly termination should they decide to withdraw from the study before it is completed.

Confidentiality

Include information about the protection of subject’s privacy, method of protecting research data, and who may have access to study records.

New Findings

Standard text explains that significant new information will be provided to the subject by the investigator.

Alternatives to Participation

Include applicable information on alternative procedures or courses of treatment that may be advantageous to the potential subject if he/she refuses to participate or withdraws from the study. Social/behavioral research - if compensation for participation in the research is extra course credit, explain that the course instructor is to provide a reasonable alternative way to earn extra course credit.

Compensation for Injury

Standard non-alterable text describes the provision for subject injury incurred as a result of this study, if applicable.

Other Considerations

If a research team member has a disclosable financial interest in the outcome of this particular study or research program, a statement to that effect should be inserted. If the study involves collection of specimens, the appropriate standard language should be included.

Contact Information

Includes contact information to answer study questions and standard text that instructs subjects to contact the Research Protections office if they have any comments or questions regarding the conduct of the study and/or their rights as research subjects.

Voluntary Participation

Standard text emphasizes that the decision to participate, or not participate, is solely up to the subject.

Signature Lines

Signature lines should be included for the subject and for the researcher obtaining informed consent. A “Legally-Authorized Representative” signature line should be included if you will obtain surrogate consent or are developing a parental permission form for enrollment of a minor in research. Also, you may obtain the assent of a minor ages 13-17 (as well as parental permission) using this consent form.

A “Witness” signature line must be included for specific types of research. See How to Consent for more information on this topic.

Waiver of Written (Signed) Informed Consent

An IRB may waive the requirement to obtain a signed informed consent document in two situations:

• The only record linking the participant and the research would be the consent document;
• The principal risk would be potential harm resulting from a breach of confidentiality;
• Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant's wishes will govern;
• The research presents no more than minimal risk of harm to participants and
• The research involves no procedures for which written consent is normally required outside of the research context.

In cases where the documentation requirement for informed consent is waived, the IRB often requires the researchers to provide participants with a written statement regarding the research. This written statement requires IRB approval. The template Study Information Sheet can be used as a guide.

Researchers interested in obtaining a waiver of written (signed) informed consent should make sure that their research qualifies for one of the above options, and should address how the research qualifies for each of the option's requirements in the IRB Application.

Waiver or Alteration of Informed Consent

An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent , or waive the requirements to obtain informed consent if:

• The research or clinical investigation involves no more than minimal risk to the participants;
• The waiver or alteration will not adversely affect the rights and welfare of the participants;
• The research could not practicably (i.e., capable of being done) be carried out without the waiver or alteration;
• Whenever appropriate, the participants will be provided with additional pertinent information after participation.

When an IRB waives the requirement to obtain informed consent, it waives the entire requirement for the informed consent process. However, when the IRB grants an alteration of some or all of the elements of the informed consent (e.g., removes a required element of consent from the document), the process of obtaining informed consent is still required. Researchers interested in obtaining a waiver or an alteration of the consent process should address how the research qualifies for each of the above requirements in the IRB Application.

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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.

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)

Select language

Research Data Management Support

How to write an informed consent form .

Informed consent is commonly used as the legal basis to collect personal data in research. Explicitly asking participants whether their personal data can be collected for a particular purpose, gives them an opportunity to be informed, ask questions, and decide whether they wish to participate. By giving participants information and choice, you can fulfil both your legal and ethical requirements - that is, if you adequately formulate your informed consent forms.

Information sheet 

When you collect personal data, it is crucial to inform participants about how you are using their data. You should at the very least describe: 

• Your research and your team. 
• The data you are collecting and how you are using it. Describe explicitly intents to make data available for reuse. 
• Participants’ rights, for example the right to withdraw consent and to contact the university's Data Protection Officer. 
• Additional information in special cases, for example if you are sharing data outside of the European Economic Area, or if you apply automatic decision making in your project. 

In this document , you can find an overview of information that you need to include in your information to participants. Please note that this is a general template and there may be additional requirements imposed by your faculty and/or Ethical Review Board .  

How to present the information 

The information you provide should be easily understandable and accessible for your participants. So try to include concrete and active language, and consider whether text is the most suitable way to deliver the information (other formats such as audio and video are also allowed). The GDPR also permits layering information to improve readability: you can place the most relevant information in the information sheet preceding the consent and provide external links to pages that contain additional information. The additional information may provide participants with a more detailed breakdown of how their data will be processed, or include the way in which the data will be de-identified, or information on the security of the tools and technologies to be used. An external website with additional information can also be used to inform participants of small changes to the processing that may occur after consent. 

Consent 

To ensure consent is valid, you need to ensure that it is “freely given, specific, informed and unambiguous”, signified by a “clear, affirmative action” (Art. 4 GDPR): 

Freely given

Participants must have a real choice whether to participate or not. Although coercion and intimidation are obvious violations, be aware that disproportionate compensation and power imbalances should also be avoided. For example, students must not feel compelled to consent to a research study for the sake of their studies, nor should any participant consent because the compensation is vital to their survival or quality of life.  

Research projects can often involve multiple types of processing. In such cases, the participants should be free to choose which purpose they accept, rather than having to consent to a bundle. For example, if a research project involves behavioral tests, interviews and surveys; the participant should be able to consent to each process separately if they are not all necessary for participation in your project. The concept of specificity also extends to the way in which the collected data is going to be used. Thus, the data should only be used for the purpose for which it was specified in the information sheet. Since this would compromise your ability to share data, the re-use of data for research purposes is allowed under the GDPR. To be able to share your data for reuse purposes for research, you must ensure that participants have been informed about the intent to share and the data should be adequately safeguarded with clear security and privacy measures (i.e., secure storage, access restriction, pseudonymization, aggregation and minimization). 

Providing information is essential to a valid consent. How the information is provided however need not always be through a written information sheet. This means valid information may be presented in other ways, such as oral statements, or audio/video messages. 

Unambiguous, affirmative action

The information provided must be clear and understandable and “the action of giving consent” has to be unquestionable and explicit. To demonstrate a clear affirmative action, the participant must take a deliberate action. For this reason, pre-ticked opt-out boxes are invalid, since they require no action from the participant. Ambiguity can also be avoided by providing participants with the option to tick a “NO” or a “YES” box, instead of only a “YES” box. The deliberate action of consent can be both a written (e.g., ticking a box, writing an email) or a recorded oral statement.  

To sign or not to sign

In research, signing a consent form is rarely needed, as it often leads to the collection of unnecessary personal data, and a consent form is not a binding document anyways (it can be withdrawn at any point). Therefore, a signature only makes sense if the identity of the individuals is meant to be used in the process (e.g., in clinical trials), since that does not lead to additional data collection. If your research does not require the collection of names, or is using pseudonyms, using a signature leads to the collection of unnecessary personal data and is therefore not necessary. A check box (and possibly a statement/signature of the person/researcher who collected the consent) is often sufficient. 

Data sharing 

As we move towards more open science practices, researchers are faced with the dilemma of sharing the personal research data they’ve collected whilst protecting the privacy of their participants. To properly determine whether personal data can be shared, a privacy scan is strongly recommended. This is a crucial step wherein you will assess the potential privacy risks. By contacting [email protected] you will be put in contact with a privacy officer who is able to help you with this task. Once you’ve assessed the risks and have determined that the data is fit for sharing it is important to adequately phrase your informed consent form.

Information sheets and consent forms should address the possibility of sharing data, future data publication (including storage in a repository) or long-term retention of data for verification. In this way informed consent from research participants can be obtained.

• State the conditions under which access to the data may be granted to others. E.g., sensitive data can be safely shared through mediated/controlled access, specific user agreements, de-identification and custom approval by the original research team. In some cases, it may also be appropriate to provide an opportunity for participants to select whom they agree to share their data with (and with whom they don't). 
• Explain that you as a researcher have an obligation to protect your subject's confidentiality and that you will only share the study data with the broad scientific community by retaining this confidentiality. 
• Indicate how data will be de-identified in practice (e.g., by removing all personal information that could directly identify an individual). 
• State when the retention of personally identifiable information expires. 
• Consent should be documented with the collected data so subsequent users of the data are aware of the conditions agreed upon with participants. 

If statements only mention the current study, sharing is not explicitly possible. You should add a sentence to make it clear to participants that the data could be used for further research, de-identified where possible, or identifiable with enough safeguards and security measures. 

Don'ts

Try to avoid putting this in your consent form: 

• Terms such as 'fully anonymous' or 'strictly confidential' as they are often impossible to achieve. 
• Promises to destroy data. 
• The mention of an expiration time period for the consent. 
• Promises that the data will only be seen or accessed by the research team.

Can I share personal data without consent?

Sensitive data can legally be shared without explicit consent if the information given to participants prior to their consent for data collection indicated future use of the data, or if ALL of the following are applicable:

• The opportunity to gain consent no longer exists or is not practical.
• The data have been de-identified. 
• There is no risk that publishing or sharing the data will cause harm or contribute to discrimination towards the research participants or subjects. 
• Information sheets and consent forms from the original data collection did not preclude sharing. 
• “Any personal information that could reasonably identify you will be removed or changed before files are shared with other researchers or results are made public." 
• "If you decide to be in this study, the study researchers will get information that identifies you and your personal health information. This may include information that might directly identify you, such as your name and address. This information will be kept for the length of the study and a fixed period afterwards (x-years). After that time, it will be destroyed or de-identified, meaning we will replace your identifying information with a code that does not directly identify you.” 
• “The principal investigator will keep a link that identifies you to your coded information, but this link will be kept secure and available only to the principal investigator or selected members of the research team. Any information that can identify you will remain confidential.” 
• “The information in this study will only be used in ways that will not reveal who you are. You will not be identified in any publication from this study or in any data files shared with other researchers. Your participation in this study is confidential.” 
• “Other genuine researchers [may] have access to this data only if they agree to preserve the confidentiality of the information as requested in this form.” 
• “Other genuine researchers may request access to de-identified data in the future. Access will only be granted if they agree to preserve the confidentiality of the information as requested in this form. Their access will also require approval from the original research team." 
• “If you withdraw from the study, you do not have to state why. Please do inform the researcher about your decision. All data already collected up until that moment will be used for the current and future research.”

When using tick boxes

Be careful with tick-boxes. There must be an opt-in option. Tick-boxes may never be coloured in advance and they should allow for a “Yes” AND “No” option.

“I agree that research data gathered for the study may be published or made available provided my name or other identifying information is not used.”

“I understand that the research data, without any personal information that could identify me (not linked to me) may be shared with others.”

Sharing data under restricted access 

In many cases, you will be sharing data under restricted access. This means that the data will be placed in a repository where others are able to find it, but users will only be granted access to the data when approved by the dataset owner. 

This enables you to gate who can use the personal data and under which conditions. Upon receiving a request, you will then send the requestors a data transfer agreement determining the purpose of re-use and the privacy measures that the requestors must adopt to use the data. A data transfer agreement template can be found here , although they will often always need adaptation to your particular case. Please contact [email protected] or check the data privacy handbook for more information on this topic. 

Sources and further reading 

Check the Data Privacy Handbook , a knowledge base and overview of tools to learn about data privacy. This guide was set up by RDM Support of Utrecht University (UU) with input from the UU Faculty Ethics Review Board (FERB) of the Faculty of Social and Behavioural Science. 

Utrecht University Heidelberglaan 8 3584 CS Utrecht The Netherlands Tel. +31 (0)30 253 35 50

• Initial Review
• Post-Approval Submission
• Submission Document Format
• How to Write Research Proposal
• How to Write Informed Consent Form
• Clinical Trial vs Non-Clinical Trial
• Protecting Research Subject Information
• Importance of De-identifying Research Data
• Template & Guideline
• External link

iium rESEARCH eTHICS cOMMITTEE

How to write informed consent form.

Writing an informed consent form is crucial for ethical research or medical practices. The form should provide participants with comprehensive information about the study, ensuring they understand the purpose, procedures, potential risks, benefits, and their rights. Here’s a general guide on how to write an informed consent form:

• Start with a clear and concise title such as “Informed Consent Form.”

Introduction:

• Begin with a brief introduction explaining the purpose of the study or procedure.
• Include information about the researcher, institution, and contact details.

Study/Procedure Overview:

• Provide an overview of the study or procedure in simple, non-technical language.
• Include the purpose, duration, and any relevant background information.

Voluntary Participation:

• Clearly state that participation is voluntary.
• Explain that participants are free to withdraw at any time without consequences.

Inclusion/Exclusion Criteria:

• Specify any criteria for participation (e.g., age, health conditions) to help potential participants determine their eligibility.

Study/Procedure Details:

• Provide detailed information about the study or procedure, including methods, tests, and interventions.
• Explain the expected timeline and frequency of participation.

Risks and Discomforts:

• Clearly outline potential risks or discomforts associated with participation.
• Distinguish between common, uncommon, and severe risks.
• Describe any potential benefits to the participant or society.
• Differentiate between direct and indirect benefits.

Confidentiality:

• Explain how participant information will be handled and emphasize the measures taken to maintain confidentiality.

Contact Information:

• Provide contact information for the researcher, including phone numbers and email addresses.
• Include emergency contact information if applicable.

Questions and Clarifications:

• Encourage participants to ask questions.
• Specify who participants can contact for clarifications.

Participant Rights:

• Clearly state the rights of participants, including the right to withdraw, refuse, or skip any part of the study.
• Emphasize that their decision will not affect their current or future medical care.

Consent Statement:

• Include a statement indicating that the participant understands the information provided and consents to participate voluntarily.

Witness and Date:

• Include spaces for the participant’s signature, the researcher’s signature, and a witness’s signature.
• Include the date of signing.

IRB/Ethics Committee Approval:

• Specify that the study has received approval from the Institutional Review Board (IRB) or ethics committee.

Remember to adapt the language to the specific context and target audience. If your study involves specific legal or ethical considerations, seek guidance from relevant authorities or experts. Additionally, it’s crucial to comply with local and international ethical standards and regulations.

*Refer to template below for guidance.

Informed Consent General Template

Informed Consent Form

[Title of the Project/Procedure/Study]

I, [Participant’s Full Name], have been fully informed and understand the nature, purpose, risks, and benefits of participating in [Title of the Project/Procedure/Study]. I have had the opportunity to ask questions and have received satisfactory answers.

The purpose of this [project/procedure/study] is to [briefly explain the main goals and objectives].

Procedures:

I understand that I will be involved in the following procedures: [List and describe each specific procedure in detail].

I am aware that there may be risks and discomforts associated with my participation, including [enumerate potential risks]. The researchers/practitioners have explained these risks to me.

I understand that potential benefits of participating may include [enumerate potential benefits]. However, there may be no direct benefits to me.

I understand that my personal information will be kept confidential to the extent permitted by law. Only authorized personnel will have access to my information.

My participation in this [project/procedure/study] is entirely voluntary. I understand that I can withdraw at any time without penalty or loss of benefits to which I am otherwise entitled.

Compensation:

I have been informed of any compensation or reimbursement for my participation, including [details of compensation].

If I have any questions or concerns about the [project/procedure/study], I can contact [researcher/practitioner’s name and contact information].

Statement of Consent:

I have read and understood the information provided in this form. I have had the opportunity to ask questions, and my questions have been answered to my satisfaction. I voluntarily agree to participate in [Title of the Project/Procedure/Study].

Participant’s Name: ___________________________

Signature: ___________________________ Date: _______________

Researcher/Practitioner Certification:

I confirm that I have provided adequate information to the participant and have answered their questions to the best of my ability.

Researcher/Practitioner’s Name: ___________________________

Remember, this template is a general guide, and you should customize it to fit the specific requirements and regulations of your project or situation. Additionally, seek legal advice to ensure compliance with local laws and ethical standards .

Template can be downloaded at https://research.iium.edu.my/irec/?page_id=500 

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 .