informed consent form for research study template

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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

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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

Informed Consent Templates

Use These Templates to Properly Inform Prospective Participants on Scope of Research

Informed consent is a cornerstone principal of ethical human subjects research. Researchers must ensure prospective participants receive information about the study, sufficiently detailed to facilitate a truly informed choice, in a manner that facilitates voluntary consideration of whether to participate. This ethical obligation exists for all research—exempt and non-exempt.

Federal regulations outline informed consent requirements for non-exempt research, including a list of information participants must receive (i.e.,  elements of informed consent ).  Using one of the templates below helps ensure that your consent form includes these elements.  The templates are only a guide.  Templates can and should be adapted to fit the study plans and needs of prospective participants. However,  all  of the consent elements must be included in your consent form unless your study is eligible for exempt review.

Consent forms must be carefully drafted to facilitate comprehension.   Detailed guidance  and  a checklist  are available to aid researchers.

An IRB-approval stamp will be applied to approved consent forms.  Please leave a 1 ½ inch margin at the top of the document to accommodate the stamp.  Avoid including unnecessary headings (e.g., Attachment or Appendix) on the consent form.  Researchers are strongly advised to copy/print the stamped consent form for use during the study—doing so assures the current IRB-approved version is used and assures participants that the study has been reviewed by the IRB.

I nformed Consent Form Template –Q & A Format  (UPDATED: 1.24.22)

Informed Consent Form Template –Standard Format  (UPDATED: 1.24.22)

Parental Informed Consent Form Template –Q & A Format  (UPDATED: 1.24.22)

Parental Informed Consent Form Template –Standard Format  (UPDATED: 1.24.22)

Informed Consent Addendum Template –use for re-consenting or to inform participants of new information  (UPDATED: 3.22.22)

For additional guidance about informed consent, see the following:

Consent Process  – guidance on developing a meaningful informed consent process

Assent Process  – guidance on obtaining assent from children

Elements of Informed Consent  – a detailed description of required consent elements and consent form considerations

Waivers or Alterations of Consent  – guidance on when consent requirements can be altered or waived

Retention of Signed Consent Forms  – guidance on retention of consent forms

Informed Consent for Exempt Research

Use of a formal informed consent form containing all the elements of consent is not required for research under exempt review.  However, researchers are ethically obligated to obtain the voluntary agreement of prospective participants before including them in research.  For more information and examples of consent forms appropriate for exempt research see  Informed Consent for Exempt Studies .

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 )

Editable documents containing required information.

Standard Informed Consent Template

New IRBMED studies should most often use the latest Standard Informed Consent template available on this webpage.

Specialty Consent Templates may be appropriate for low-risk studies with simpler study methodologies.

Downloadable Standard Informed Consent Template

The working version template containing blue and orange text boxes is updated with additional instructions and required language. IRBMED recommends using the working version template for creating the consent document. If using the outline version (without the blue-box instructions), always use the working version as a companion document for additional information and as-applicable required language.

Changes to the Standard Consent Template

April 2024: Extensive revisions, including a new section

Changes to note throughout the document

• All appearances of the term “subject” have been replaced with “participant.”
• Most orange boxes indicating ICH-GCP -specific instructions have been revised to pertain to all research as applicable.
• Office of Technology Transfer’s name change to Innovation Partnerships  has been incorporated.
• IRBMED has developed new approach to addressing participation in sub-studies, depending on whether the substudy/ies involve factors, such as procedures or risks, that differ significantly from those in the main study. 
• To better organize consent document information by clearly separating main study information from all information about data and biospecimen storage, future use, and sharing, this document contains a new section, which is numbered section 12. 
• The signature section (formerly section 12) is shifted down to a new section 13.

Changes to instructions and as-applicable template text (blue/orange boxes)

• The orange box has been changed to blue and references to ICH-GCP have been removed
• The text of a former orange ICH-GCP box has been incorporated into body text
• In section 1.1 (key information), sample descriptions of clinical trial phases have been rewritten.
• Also in section 1.1, new help text guides researchers in choosing which study risks represent key information and which needn’t be included in this section.
• In section 4.1, guidance on blinded studies has been narrowed to apply only to certain scenarios.
• Sub-studies that involve factors, such as procedures or risks, that are similar to those in the main study, or that involve only storage and/or use of samples and information gathered in the main study, appear in section 4.1 or the new section 12. These instances are expected to be the most common.
• Sub-studies that involve factors, such as procedures or risks, that differ significantly from those in the main study should now appear in an appendix added to very end of the template. These instances are expected to be relatively uncommon.
• In section 5.1 (risks), help text pertaining to efforts to mitigate study risk has been rewritten.
• Also in 5.1, risk language regarding COVID-19 vaccination has been inserted.
• Recommended language regarding study benefit (section 5.2) has been revised.
• In section 8.1, which addresses costs of study participation, help text regarding costs of treatment for study-related injury has been revised by the Calendar Analysis and Review Office (CRAO) to reflect changes in university policy. These policy changes affect investigator-initiated and federally sponsored research only.
• The blue box guiding researchers on explaining mitigation of confidentiality risk in section 9.1 has been augmented with new language about protecting electronic data, including data stored on cloud servers.
• Language in section 9.1 regarding Certificates of Confidentiality has been revised.
• Language in Section 9.1 regarding adult and child abuse has been revised to clarify who required reporters will include, for what Michigan law requires reporting, and a revision to the policies linked in the blue boxes.
• Help text on HIV testing has been both condensed and moved from what was formerly 11.2 (Which documents will I receive?) to section 4.1 (study procedures). The move was prompted by changes in Michigan law that no longer require researchers to provide subjects undergoing HIV testing with an informational pamphlet.

Changes to document body text

• In section 1.1 (key information), language regarding duration of study participation has been revised.
• Section 4.1 (procedures): This template instructs researchers to mark any procedures or risks included in the consent document but completed as part of standard clinical treatment with a “[not research]” tag. This is not required for all studies but can be used when research and standard clinical procedures overlap.
• Section 5.1: The passage beginning “Additionally, there may be a risk of loss of confidentiality or privacy” is new.
• Section 5.1 also now includes language pertaining to the risks associated with premedications.
• Section 7.2: The three-paragraph passage beginning “You are free to partially or completely end your participation in the study” is new.
• Language in section 7.2 regarding the risks of discontinuing study participation has undergone revision.
• Section 8.3 (“Who could benefit financially from information learned in the study?”) now contains prompt language researchers should use to disclose the source of funding for the University of Michigan study.
• Language about basic (non-HIPAA) privacy and confidentiality measures in section 9.1 have been added.
• Language to be added if adult or child abuse may be revealed during the study has been updated.
• 9.2: In the list of entities that may see subjects’ data, the bullet addressing use of research data by federal agencies and other entities for safety oversight purposes now closes with the phrase: “and for quality improvement purposes.”
• 9.2: In the list of entities that may see subjects’ data, the bullet about collecting subjects’ Social Security numbers has been revised by the Human Subjects Incentives Program (HSIP) to reflect their new expectations and policies . See also Research A-Z Payment to Research Participants , heading "Incentive," subheading "HSIP."
• The statement in section 9.2 about the expiration or termination of HIPAA Authorization has been revised. Representatives of the Compliance Office reviewed and approved these changes.
• Section 11: Language from a former orange box has been added indicating participants will receive a copy of the  signed and dated informed consent document.
• The template’s signature section, formerly section 12, is now numbered Section 13.
• Signature boxes pertaining to optional aspects, such as unspecified future use and participation in sub-studies, were altered to contain yes/no boxes, but with a note instructing researchers to collect subjects’ signatures only when they select the yes box.

New section: data and biospecimen storage, future use, and sharing

To better organize consent document information by clearly separating main study information from all information about data and biospecimen storage, future use, and sharing, this document contains a new section. The new section 12 shifts the signature section to a new section 13.

• 12.1: Explaining the concepts of storage, use, and sharing.
• 12.2: Detailed description of each possible type of storage, use, and sharing, each enclosed in its own blue help text box, as follows.
• 12.2-A: Storage, future use, and sharing of information permitted by the revised Common Rule and applicable to most research under IRBMED oversight The language (previously in Section 4.4) has been updated to include a selection for industry sponsored or investigator-initiated research; all research submitted to IRBMED must include one of these two statements. This segment alerts potential participants that any data that have been used, placed in the medical record, or, in the majority of cases, shared with others cannot be retrieved and destroyed even if consent to their storage and use is withdrawn. See also Research A-Z Retention of Research Data/Biospecimens , heading "C. Retention for Future Research."
• 12.2-B: Storage, use, and sharing of data per NIH policy—both the data management and sharing (DMS) policy and the genomic data sharing (GDS) policy Language relating to the new DMS policy is new whereas language relating to the GDS policy was previously found in Section 4.1.
• 12.2.C: Storage, future use, and sharing of subjects’ data and/or biospecimens as a necessary condition of participation in the main study This language includes the caution that data may not be retrievable or destructible under certain circumstances. It also clarifies that subjects who withdraw consent to storage, future use, and sharing will be withdrawn from the main study. This language was previously found in Section 4.1.
• 12.2-D: Genomic data sharing in non-NIH-sponsored research This covers scenarios in which researchers are not obliged by policy to share genomic data but choose to do so. This language was previously found in Section 4.1.
• 12.2-E: Optional storage, unspecified future use, and sharing of subjects’ data and/or biospecimens The guidance prompts researchers to caution subjects that if they withdraw their consent to this optional activity, the researchers will attempt but may be unable to retrieve and destroy data and specimens that have been shared with other researchers. It also states that data and materials that have already been used in research, or data that has been placed within the medical record, cannot be retrieved and destroyed. This language was previously found in Section 4.1.

When uploading your informed consent form in eResearch

• New Applications:  Please make sure to delete all instruction boxes, comments, and headers from the original working template. Also be sure to proofread the document for spelling, grammar, and formatting errors.
• Edit the most recent version of the CLEAN informed consent document found in 10-1.1. 

Turn on “Track Changes” feature in Word.

Save “Track Changes” version in .docx or .doc format.

Upload ONLY "Track Changes" document on the previous tracked-changes stack in 10-1.1 using the ellipsis (three dots) next to the version number column. 

• Use the standard naming conventions for stacks from the  Document Revision Guidance, Naming Convention, and Version Control  statement of practice. Also be sure to proofread the document for spelling, grammar, and formatting errors.
• For informed consent documents that are uploaded in eResearch but are no longer in use, please simply change the document file name by adding the phrase “X - Not in use” or "X - Out of Date" to the file name. Do not delete these documents from the eResearch application.

Contact us at  [email protected]  or 734-763-4768 / (Fax 734-763-1234) 2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available through our website .

Edited By: [email protected] Last Updated: April 15, 2024 9:00 AM

Related Documents

Templates by topic / unit.

Office of Research University of Michigan Medical School 1301 Catherine Street SPC 5624 Ann Arbor, MI 48109

North Campus Research Complex (NCRC) 2800 Plymouth Road Building 520, 3rd Floor Ann Arbor, MI 48109-2800

Phone: 734-615-1332 Fax: 734-615-9458 Email: [email protected]

Informed Consent Templates

As part of our continued efforts to improve the IRB application and review process, we have developed new ICF templates that address the issues identified by our stakeholders:

• Different templates have been created for  different types of studies  (SBER, Biomed, etc.).
• Guidance language has been added to each template to  reduce confusion  about which template to use, as well as how to complete sections.
• The  Key Information  section has been simplified.
• An  Assent Template  has been created, with guidance included to identify applicable populations.
• All language utilized is at the  8th grade reading level , and has been improved to promote clarity of instructions.
• The template has been  shortened and simplified  to facilitate completion.
• All  signatures have been moved  to the end of the document.

These new and improved ICF templates replace all previous versions posted to our site as of May 17th, 2023; any new intakes  initiated  within WRG-HS as of June 12th, 2023, must utilize these new templates.

• WCM Assent Template
• WCM Biomedical Informed Consent Template
• WCM Humanitarian Use Device Informed Consent Template
• WCM Informed Consent Addendum Template
• WCM Intermediate-Size Investigational Treatment Informed Consent Template
• WCM Pregnant Partner Non-Subject Informed Consent Template
• WCM Pregnant Partner Research Subject Informed Consent Template
• WCM Repository Informed Consent Template
• WCM SBER Informed Consent Template
• WCM Single Patient Investigational Treatment Informed Consent Template

Make sure your Informed Consent Form is a readable document!

See our Guidance Document on how to prepare a readable consent form .

See our list of Medical Terms in Lay Language for use in Informed Consent Forms.

Refer to the  Program for Readability in Science & Medicine (PRISM) Readability Toolkit

Refer to the MRCT Research Glossary for easy-to-understand clinical research definitions.

Frequently Asked Questions (FAQs)

Will i have to start using these new consents today.

Any new studies initiated in WRG-HS starting 6/12, must use the new ICF templates.

Do I have to transition my existing study consent(s) to these new templates?

Any existing study using the previous consent templates can continue to use their IRB-approved consent. Any new studies initiated in WRG-HS starting 6/12, must use the new ICF templates.

Do these new ICF templates need to be used under a ceded/sIRB study with an external IRB as the IRB of record?

Studies with an external IRB are expected to use consent forms provided by the lead IRB. Once the externally reviewed ICF is provided to the WCM IRB, we will conduct a local context review to confirm any required language (i.e. research-related injury, NYS Genetic testing requirements, etc.). The new WCM ICF templates are available as a resource if needed, but not required for externally reviewed studies.

If I am updating my protocol and the change requires an update to the ICF, will I need to use the new ICF templates?

You can continue to use the same ICF.

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Consent Templates

The templates below were created to help you create the documents you will need to communicate to participants what they will do in the study. The documents you provide participants will range from recruitment materials to post-debrief consent forms, and you need to submit everything that you provide to a participant to our Board for review. For more information about the consent process see  Consent .

• General Consent Template : This form covers all of the basic elements that are required for a consent document. Even if you don't plan to use this exact document, refer to it to ensure that you have all of the appropriate elements in place in your consent procedure.
• Electronic Consent Template :  This form is modeled after the General Consent Template with some modifications that make it more appropriate for an online format. For more information about this template, see Electronic Consent . 
• Parent Consent : If you are including minors in your study, you will need to provide a consent form for parents and an age appropriate assent form for minors. This form is a guide for creating a parent informed consent document. This form can also be used as a guide for surrogate consent procedures.
• Minor Assent (for ages 13-17) : This template provides the basic elements required for older minors to provide assent and could also be used as a model for higher functioning individuals with diminished mental capacity.
• Minor Assent (for ages 7-12) : This template provides the basic elements required for younger minors to provide assent and could also be used as a model for higher functioning individuals with diminished mental capacity. For children younger than 7, assent forms are not required but include information in the consent section regarding what you will say to them about the study (where appropriate).
• Capacity to Consent Template : For some participant populations, it may be necessary to determine if a participant is able to provide consent; if not, a surrogate can be used (you will also need a surrogate consent form and participant assent form, similar to the parent/child consent/assent forms).
• GDPR Informed Consent Addendum : If you are collecting data from citizens of the European Union or the United Kingdom, you will need to provide additional information to your participants, per the GDPR. For more information, see the Research in an International Setting and/or Location and International Research Data Source .  
• Study Information Sheet : While many studies do not require researchers to collected signed consent forms, we generally require that participants receive a Study Information Sheet to provide them with information about the study. This information can be provided as a paper document at the beginning of a survey.
• Electronic Study Information Page : This template is similar to the Study Information Sheet with modification for an electronic delivery. For more information about this template, see Electronic Consent .  
• Parent Notification Template : Typically used for studies in an educational setting (particularly where the study is exempt but parent notification is still required), this template is a guide for creating a notification letter to send home to parents.
• Oral Consent Card : Typically used in anthropology studies where the participant may be uncomfortable with a form and/or unable to use it, the Oral Consent Card provides all of the elements required for consent in a bullet format so that the researcher can refer to each point as he or she is obtaining consent from the participant.
• Oral Consent Template : This form is also used in situations where the participant is uncomfortable with a form and/or unable to use it. It is more suited to non-anthropology research (though anthropologists are welcome to refer to it as well).
• Sample Debriefing Form : A debriefing form is a summary of the study given to a participant in a deception study and/or a study that includes students from a participant pool. The purpose is to educate participants about the study and to provide them with resources, particularly if the study is upsetting.
• Advertising Flyer Template : Recruitment materials are part of the consent process and it is important that participants are accurately informed about the study throughout the process. You are not required to use this flyer template (it is a model appropriate for a flyer posted around campus), but it is important that you follow the  guide provided in Recruitment .
• ResearchMatch Advertising Template : The NIH funds a free and secure recruitment tool called ResearchMatch that helps to connect researchers with volunteers that are interested in participating in studies. If you are interested in using ResearchMatch to help advertise for your study, complete this ResearchMatch Advertising Template and upload.
• Materials Release Form : The data you collect from your participants may be useful in other spheres, such as an educational tool and/or library archive. Using data in this manner is beyond the scope of the study and you should seek additional permission to use the participant's data in this way. This form allows a participant to declare how they would like their materials to be used by the researcher if the researcher wants to use the materials in situations beyond the study.
• Data Release Form : This form is similar to the Post-Debrief Consent Form; it is used when a participant has been recorded or photographed without their knowledge.
• Post-Debrief Consent Form : This form is used in a deception study after the deception is revealed to the participant. The participant is given an opportunity to decide if they still want to participate after the true purpose of the study is revealed.
• The title of protocol must match the title on all consent forms.   The title must be relevant, appropriate, and easy to understand. Include the project title on all pages of the consent form.
• List the page numbers on all pages of the consent form  in the standard format: Page 1.
• Delete all colored text from the final copy of your form.   The colored text is for explanation purposes only.
• Make sure that the form matches the descriptions in the protocol  and vice versa.
• Include all relevant information in the consent form  rather than referring to previous verbal explanations.  The consent form should provide a complete explanation of what the participant is agreeing to do in the study.
• Be aware of the needs of the participant.  Avoid using jargon and acronyms that the participant may not understand; make sure the reading comprehension level is appropriate.
• Do not use statements that make implicit demands on participants to participate , e.g., "You will enjoy and benefit from participating in this study."
• Prepare the consent forms in the standard format provided in the template,  with all headings addressed. Use the standard language provided on the template where appropriate.
• Please proofread the consent forms  for grammar and spelling errors.
• Do not use language that revokes a participant’s legal rights .  A consent form is not a legal document.
• Do not require the participants to sign consent to long statements written in first person , e.g., “I agree to participate in this research study.  I understand that the risks are minimal and that I will receive no benefits.  I know how to withdraw from this study.  I will receive $X in payment for participating.  I understand that if I withdraw from the study before my participation is complete, I will receive prorated payment according to the following schedule . . .  I agree not to hold the researchers liable for any injuries resulting from participation in this study. . .”   DO ask participants to sign consent to a simple agreement statement  at the end of the consent form:  “I agree to participate in the research study described above.”

Consent, Assent, and Screening Templates

Biomedical Research Consent Templates

Minimal Risk Research Consent Templates (Expedited or Exempt)

These templates are appropriate for social, behavioral, and educational ("SBER") research that does not include any biomedical procedures.

• Study Information Sheet (no signature)
• Consent Form (includes signature)
• Consent Form for Federally Funded Research
• Parent Permission Form (parents provide permission for child to participate)
• Parent Consent Form (parents complete research procedures themselves)
• Oral Consent Script Outline
• Sample Debriefing Script

Biomedical Research Informed Consent Templates

• Biomedical Research Consent Template
• Consent Template for Expanded Access Research
• Right to Try Consent Template
• Humanitarian Use Device Consent Template

Child and Adolescent Assent Templates

• Child Assent Template (Age 7-12)
• Adolescent Assent Template for Non-Treatment Studies (Age 13-17)

Addendum Consent Templates

• Addendum Consent Template for Non-Treatment Studies  (for new procedures, risks)
• Addendum Consent Template for Treatment Studies  (for new procedures, risks)

Screening Scripts

• Screening Script for non-Treatment Studies
• Screening Script for Treatment Studies

Consent Standards and Sample Language

• Social, Behavioral & Educational ("SBER") Consent form Standards and Template Language
• Biomedical Research Consent Form Standards and Sample Language

Comprehension Tools

• PRISM Readability Tool Kit
• Self-Certification of Surrogate Decision Makers for Potential Research Subject's Participation in UC Research  (For use  only  in studies the IRB has reviewed and explicitly approved for surrogate consent)
• Decision-Making Capacity Assessment Tool  (for potential subjects who may have cognitive impairments)

Other References

• Research Participant Bill of Rights/Experimental Subjects Bill of Rights  - available in 34 languages
• Conducting Risk-Benefit Assessments
• Obtaining and Documenting Informed Consent  (v. 07-28-11)
• Requesting Waivers and Exceptions to Informed Consent  (v. 07-28-11)
• Child Assent and Permission by Parents or Guardians  (v. 09-06-11)
• The Use of Legally Authorized Representatives or Surrogate Consent  (v. 06-21-10)
• Recruitment and Screening Methods and Materials  (v. 09-05-11)

We appreciate your suggestions for improving templates and/or adding sample language to the standards documents. Please email  OHRPPEQI@research.ucla.edu to provide your feedback.

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• Required Elements of Informed Consent

Drafting the Informed Consent Form

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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.

UCL Research Ethics

• Advice on writing an information sheet and consent form

Writing a Participant Information Sheet and Consent Form

Recruitment documents help people make informed choices about whether to participate in a research study. Find out how to write a Participant Information Sheet, example forms and further guidance.

Writing a Participant Information Sheet

Participant Information Sheets must be designed to assist participants to make informed choices. Potential recruits must be given sufficient information to allow them to decide whether or not they want to take part. The process of obtaining consent and the accompanying documentation must be approved by a research ethics committee and, where only verbal consent to research is contemplated include consideration of an appropriate process for witnessing the consent.

Researchers must take the steps necessary to ensure that all participants in the research understand the process in which they are to be engaged, including why their participation is necessary, how it will be used, and how and to whom it will be reported so that the prospective participant can make an informed decision about whether they really do want to take part.

It is highly recommended that the information provided is presented on headed paper and is accurate, clear and simple so that someone with a reading age of 8 would understand the contents (use short words, sentences and paragraphs). The information should be specific to the proposed research and appropriate for the social and cultural context in which is it being given. It is important to avoid technical terms, jargon and abbreviations, bias, coercion or any inappropriate inducements.

What should the Participant Information Sheet include?

• A friendly invitation to participate.
• A brief and simple explanation of the purposes of the research and a statement explaining how the participant was chosen and how many other participants will be involved in the study.
• A statement that participation is voluntary; refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled; and the participant may discontinue participation at any time without penalty or loss of benefits.
• A thorough explanation of the expected duration of participation in the research and the procedures to be followed.
• A description of any reasonably foreseeable risks or discomforts and any benefits to the participant. For research involving more than minimal risk, an explanation as to whether any compensation or any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
• A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.
• It is considered good practice for researchers to debrief participants at the conclusion of the research and to provide them with copies of any reports or other publications arising from their participation.
• If appropriate, a statement indicating that the data might be used for additional or subsequent research.
• An explanation of who to contact for answers to pertinent questions about the research and the rights of the participant and who to contact in the event of a research-related injury to the participant.
• If applicable, a statement declaring that each researcher who may have access to children (aged under 18) or vulnerable adults has undergone a satisfactory criminal records check.
• Remember to thank your participant for considering taking part in the study and include a statement indicating that the research study has been approved by the UCL Research Ethics Committee.

Language and layout

It is highly recommended that the information provided is presented on headed paper and is accurate, clear, and simple. The information should be specific to the proposed research and appropriate for the social and cultural context in which is it being given. It is important to avoid technical terms, jargon, and abbreviations, bias, coercion, or any inappropriate inducements.

The following points should be considered when writing an information sheet:

• Use clear, non-technical language. We recommend that you refer to the  Plain English Campaign
• Use appropriate language for the target audience. For example, consider the different ways needed to communicate with primary school children as opposed to their teachers, or people with expertise in the area of study as opposed to people with no such knowledge
• Divide the text into paragraphs for ease of reading
• Consider using sub-headings for clarity, such as questions and answers
• Make sure the font and font size are legible.

Ask someone else to review your information sheet before it is circulated.

Further guidance

• Guidance on obtaining consent from research participants online (for online and in-person study designs) , Authors: Dr Pippa Lally, Behavioural Science and Health, and Jack Hindley, Information Services Division, UCL
• Recording & Obtaining Consent , UCL Research Ethics Committee Guidance Note 2: Extract from Nuffield Council on Bioethics website

Example forms (annotated)

• Template Participant Information Sheet  (Word)
• Template Consent Form  (Word)

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Templates for informed consent forms

Notes to researchers

The language used throughout form should be at the level of a local student of class 6th/8th

Please note that these are templates developed by the WHO ERC to assist the Principal Investigator in the design of their informed consent forms (ICF). It is important that Principal Investigators adapt their own ICFs to the outline and requirements of their particular study. The logo of the Institution must be used on the ICF and not the WHO logo.

The informed consent form consists of two parts: the information sheet and the consent certificate.

Do not be concerned by the length of these templates. They are long only because they contain guidance and explanations which are for you and which you will not include in the informed consent forms that you develop and provide to participants in your research.

These templates include examples of key questions that may be asked at the end of each section, that could ensure the understanding of the information being provided, especially if the research study is complex. These are just examples, and suggestions, and the investigators will have to modify the questions depending upon their study.

In these templates:

• square brackets indicate where specific information is to be inserted;
• bold lettering indicates sections or wording which should be included;
• standard lettering is used for explanations to researchers only and must not be included in your consent forms. The explanation is provided in black, and examples are provided in red in italics. Suggested questions to elucidate understanding are given in black in italics.

Download 'informed consent' form templates

• Informed consent for clinical studies
• Consent for storage and future use of unused samples
• Informed consent for qualitative studies
• Informed assent for children/minors
• Informed parental consent for research involving children (qualitative)
• Informed parental consent for research involving children (clinical)

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• v.14(2); 2018 Jun

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.