Relevant IRB Policies and Procedures
- Informed Consent (Policy 2.11)
- Recruitment and Compensation (Policy 2.0)
- Research Involving Special Populations (Policy 2.15)
- Identification and Use of Legally Authorized Representatives (Policy 2.25)
- Privacy and Confidentiality (Policy 2.12)
- Use of Interpreter Services and Translated Documents (Policy 2.13)
Rooted in the principle of respect for persons, informed consent is not just a form but a process that begins with subject recruitment, progresses to the consent discussion and review of the consent form, and continues through the duration of a subject's participation in the study and beyond. During a study, all communication (including both oral and written) with research participants is part of the process of informed consent.
The IRB must approve not only all written documents shared with research participants, but also the plans for approach, recruitment, and other interactions during the study as well as any verbal scripts used for communicating with participants. Unless the IRB grants a waiver of informed consent, investigators are responsible for obtaining legally effective informed consent prospectively from each research participant, or participant's legally authorized representative, as required by Fred Hutch IRB and the regulations for the protection of human research subjects. Refer to 45 CFR 46.116 and 46.117 for federally funded research, and 21 CFR 50 Subpart B for FDA-regulated research.
Note: Fred Hutch IRB does not currently review or allow Broad Consent. Investigators must consult the IRO Director prior to considering the use of broad consent, because it would likely impact other investigators’ use of all other clinical data under a waiver.
Consent
Obtaining informed consent is a basic ethical obligation for researchers. The process of consent should ensure that potential subjects are provided with information about the research project that is understandable and permits the subject to make an informed and voluntary decision about whether or not to participate. The amount of information and the manner of presentation are generally related to the complexity and risk involved in the research study. While the initial consent process is prospective and takes place prior to any research activity, consent should also be an ongoing educational interaction between the investigator and the research subject that continues throughout the study and even beyond, if pertinent information comes to light that should be shared with the former participant.
The consent process is not an exercise in persuasion. If an investigator has a relationship with potential subjects (physician-patient, instructor-student, employer-employee), care must be taken to avoid recruitment methods that may be coercive due to the existing relationship between parties.
Consent is also a legal concept. Only legally competent adults can give legally effective informed consent. Legal competency and capacity to consent is determined by the law of the state in which the research is conducted. For research studies approved by the Fred Hutch IRB the presiding law related to competency is the law of the jurisdiction in which the research is conducted. That law will also control when determining who is capable of acting as the legal representative for a research participant. For assistance in determining who may act as the "legally authorized representative" or "LAR" for a prospective research participant, refer to the IRB Policy 2.25 on the Identification and Use of Legally Authorized Representatives or contact the Institutional Review Office or General Counsel.
Assent
Children and those individuals who are not competent to provide consent should be given the opportunity to assent to participate in the research project. Assent is a knowledgeable agreement to participate in the project. Adequate provisions should be made for soliciting the independent, non-coerced assent from children or cognitively impaired persons who are capable of a knowledgeable agreement. In general, the IRB recommends that children age seven and older, and most cognitively impaired adults, be given the opportunity to assent.
In cases where assent is obtained from a cognitively impaired subject, permission must also be obtained from a legally authorized representative. In studies involving children, the parent(s) or legal guardian must provide consent.
If the person from whom assent is sought refuses to participate in the research, the investigator should respect the decision of the child or cognitively impaired adult, even when the parent/guardian or legally authorized representative gives permission. The IRB may make an exception to affirmative assent in studies of children with life-threatening illnesses who are eligible for research treatment protocols. Additionally, if the person from whom assent is sought agrees to participate, the person may not be enrolled if the parent/guardian or legally authorized representative does not give permission. In cases where questions arise as to who may act as a legally authorized representative, it is recommended that you seek assistance from the Fred Hutch General Counsel.
A separate assent form may be used when the investigator recruits subjects who, by age or circumstance, are not able to give legally effective informed consent. When legally effective informed consent cannot be obtained, the investigator should obtain the assent of the child or cognitively impaired adult subject. An assent form documents the child's or cognitively impaired adult subject's knowledgeable agreement, or assent, to participate in a research project. For studies involving children, the IRB recommends that an assent form be used with children who are in the 7-13 age range, but it may also be used when teenagers are being recruited to enhance their comprehension if the study involves complicated procedures. Alternatively, for children aged 14 and above or for adults with impaired decision making, the PI may propose that the consent form also serve as an assent form with the addition of assent signature lines.
Requirements
Information to Be Provided
The elements listed below must generally be included in each consent form. The federal regulations on informed consent describe general requirements as well as “basic” elements and “additional” elements. Basic elements must always be included unless the IRB grants a waiver or alteration of informed consent. Additional elements should be included unless they are not applicable. Other requirements apply, depending on the study, to protect the rights and welfare of human subjects and to meet institutional standards.
General Requirements
Required by 45 CFR 46.116 or 21 CFR 50.20.
- Prospective subjects or their representatives must have sufficient opportunity to consider whether or not to participate.
- Subjects or their representatives should not be coerced or unduly influenced to participate.
- The subject or the representative must be given information in a language understandable to the subject or the representative.
- No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
2018 Requirements of the Common Rule
The 2018 Requirements of the Common Rule added the following general requirements for informed consent:
- The prospective participant or the LAR must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.
- Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective participant or LAR in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.
- Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective participant’s or LAR’s understanding of the reasons why one might or might not want to participate.
Basic Elements of Consent
These basic elements must always be included in the consent form unless the IRB grants a waiver or alteration of informed consent.
Common Rule 45 CFR 46.116(b) | Basic Element | FDA | Basic Element |
|---|---|---|---|
(1) | A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental | (1) | Same |
(2) | A description of any reasonably foreseeable risks or discomforts to the subject | (2) | Same |
(3) | A description of any benefits to the subject or to others that may reasonably be expected from the research | (3) | Same |
(4) | A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject | (4) | Same |
(5) | A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained | (5) | A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records. |
(6) | For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained | (6) | Same |
(7) | An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject | (7) | Same |
(8) | A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled | (8) | Same |
(9) [2018 Requirements] Required for studies approved on or after January 21, 2019 | One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens: (i) A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or (ii) A statement that the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies. | No Equivalent | N/A |
Common Rule | Additional Element | FDA | Additional Element |
|---|---|---|---|
(1) | A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable | (1) | Same |
(2) | Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's or the legally authorized representative's consent | (2) | Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent |
(3) | Any additional costs to the subject that may result from participation in the research | (3) | Same |
(4) | The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject | (4) | Same |
(5) | A statement that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject | (5) | Same |
(6) | The approximate number of subjects involved in the study | (6) | Same |
(7) [2018 Requirements] | A statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit | No Equivalent | N/A |
(8) [2018 Requirements] | A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions | No Equivalent | N/A |
(9) [2018 Requirements] | For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen) | No Equivalent | N/A |
No Equivalent
However, according to NIH policy, if the clinical trial is NIH-funded, the consent document must also include the www.ClinicalTrials.gov statement. | N/A | 21 CFR 50.25(c) | When seeking informed consent for applicable clinical trials, as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be provided to each clinical trial subject in informed consent documents and processes. This will notify the clinical trial subject that clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank under paragraph (j) of section 402 of the Public Health Service Act. The statement is: “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.” |
Fred Hutch IRB Institutional Requirements - If Fred Hutch IRB is Reviewing
These elements are generally required to be included in the consent form if the Fred Hutch IRB is the IRB of record for the research.
- Heading includes Fred Hutchinson Cancer Center
- Name, affiliation and telephone number of the principal investigator (the Fred Hutch IRB only requires the PI to be listed on the consent form; however, if other investigators or research staff are listed, their affiliations and telephone numbers must also be included)
- Name and telephone number of contact(s) for participants to call in case of an emergency if it is a greater than minimal risk study
- In the “Costs” section, clearly state what the participant and/or the sponsor are responsible for. For example, “Sponsor will only provide the drugs at no cost.”
- A financial contact number is included in the “Costs” section
- Statement that Fred Hutch Cancer Center has access to research participants' records
- IRO Director title and contact information for participants to contact with questions about their rights as a research participant (find generic contact infomration in the Fred Hutch consent templates at the bottom of this webpage)
- The attestation statement for the person obtaining consent should reference a discussion of “risks” took place
- The Purpose section should refer to the patient population, not the individual participant
- If radioactive material is used, the additional risk(s) are outlined in the risks section
- If the study involves genetic testing, the consent form should include risks of genetic testing and information about the federal Genetic Information Nondiscrimination Act (GINA)
- If the research will involve a federal Certificate of Confidentiality, a statement explaining the certificate and the additional protections that will be provided to the participant
For institutional requirements when Fred Hutch relies on an external IRB: See Fred Hutch Consent Requirements for External IRB Studies.
UW Consortium Studies
These elements must be included in the consent form if the University of Washington is engaged in the research. The [JCK1] study team is responsible for ensuring that any applicable UW elements are included in the consent materials to be reviewed by the Fred Hutch IRB (although IRO staff will prompt these to be added if we identify them as missing).
Also see https://www.washington.edu/research/policies/guidance-consent-elements-externally-reviewed-studies/ and consult with UW’s Human Subjects Division if there are question about UW’s requirements.
- The University of Washington name must be included in the header.
- The compensation/cost section must include one of the UW template language statements available from the UW guidance document linked above.
- UW policy does not allow the HIPAA authorization to be embedded within a consent form. The stand-alone UW HIPAA Authorization form must be used.
- Information about fetal tissue from elective abortions, if the portion of the research involving UW will collect fetal tissue donated from elective abortions.
- That information about study participation will be placed in the subject’s medical record (this note is made for patient safety and to facilitate billing under the UW Medicare Clinical Trials Policy).
- If e-consent will be used:
- A statement that a copy of the consent information (e.g., consent form) will be provided electronically, including a description of the hardware and software requirements necessary to access/read the document.
- How a subject can request and receive a paper copy of the consent form and whether there is a cost.
Documentation of Informed Consent
Required by 45 CFR 46.117 or 21 CFR 50.27.
The purpose of a consent form is to provide subjects with a written source of information for future reference and to document the fact that the initial process of informed consent occurred prior to the subject's participation. The consent form generally serves as a basis for the initial presentation of the study to the potential subject. With few exceptions, informed consent is documented by using the written consent document approved by the IRB and signed and dated by the subject or the subject's legally authorized representative at the time of consent. A copy of the consent form should be given to the subject. Unless the investigator has been granted a waiver of documentation of consent, the subject's signature on a consent form is required prior to beginning any study procedures (with the exception of IRB approved screening procedures involving looking at data or specimens or in the presence of an IRB approved waiver of consent).
When using an assent form, the child or adult with limited decision-making capacity should sign the assent form, to indicate knowledgeable agreement (assent) to participate. In addition, the parent/guardian or legally authorized representative should sign the full consent form to document his/her permission for the child or adult with limited decision-making capacity to participate.
A signature line for a PI or researcher is strongly recommended, in general, and required for research that needs to comply with International Conference on Harmonization guidelines. Pre-signed consent forms must never be used.
Model Consent Form Templates
Use the templates below to develop your consent forms. If you need assistance with development of a study-specific consent, or if you have questions regarding use of the model consent form, contact an IRB analyst or IRO@fredhutch.org. The IRO can provide sample consent documents that were previously IRB-approved and serve as good examples for specific types of research activities.
Consent for Clinical Research
For clinical research studies; contains sample language.
Consent for Minimal/Low Risk Studies
For studies that involve minimal or low risk to participants.
Model Consent: Minimal Risk (Consent R)
For use when taking samples involves no more than minimal risk to research participants.
Public Health Sciences Consent for Research
For use for PHS research studies that are more than minimal-risk; contains sample language.
Public Health Sciences Consent for Minimal Risk Studies
For use for PHS minimal-risk research studies.
Assent for Participants Aged 7-13
For use when pediatric subjects will participate in research; sample language is for giving extra blood for research.
Short-Form Consent to Participate in a Research Study
For use when subjects cannot read English and the study did not expect to enroll participants that speak that language. The short form consent is available in a variety of languages.
UW Model Consent Forms
May be used in Cancer Consortium research studies.
Translation of Consent Forms
For information about enrolling non-English speaking participants, refer to the Non-English Speaking Participants webpage.