Designing the Consent Process
- Purpose and Applicability
- Section 1 – General Requirements for Consent
- Section 2 – Elements of Consent
- Section 3 – Waivers and Alterations of Consent
- Section 4 – Formatting and Signature Requirements for Written Forms
- Section 5 – Considerations for Multi-institutional Research
- Related Materials
- Version Table
Purpose and Applicability
This webpage provides researchers with detailed information for designing a consent process and form. An abbreviated checklist of this same information can be found in the worksheet describing Consent Requirements and Waivers.
In this guidance “consent” refers to adult consent as well as consent from a legally authorized representative or parent/guardian on behalf of a minor.
This guidance does not address consent requirements for (1) the emergency medicine research exception to informed consent (EFIC); (2) single patient emergency use of an investigational drug or device; (3) single patient compassionate use of a device; (4) clinical use of a Humanitarian Use Device (HUD); (5) Department of Defense (DoD) research; (6) Department of Justice (DoJ) research; or (7) child assent (WORKSHEET Children).
Section 1 – General Requirements for Consent
Research consent must adhere to general requirements that are laid out in the Common Rule (45 CFR 46) and, when applicable, the FDA regulations (21 CFR 50). These requirements cannot be waived by the IRB.
Requirement: Consent must be legally effective according to the laws in the location where the research is conducted.
Required by: 45 CFR 46.116(a)(1); 21 CFR 50.20
Legally effective consent may differ among U.S. states and in different countries. For example, the age at which an individual reaches the legal age of majority may depend on the age of the individual, marital status, whether the individual has children, and culture-specific factors. Researchers are responsible for understanding local context issues for their research.
Requirement: Consenting circumstances must minimize the possibility of coercion or undue influence.”
Required by: 45 CFR 46.116(a)(2); 21 CFR 50.20
Undue influence may occur through an excessive offer of something valuable or desirable that influences decision-making in inappropriate ways. Coercion occurs when an overt or implicit threat of harm is intentionally presented by one person to another to obtain compliance. With current research regulations, coercion is rare. IRBs often consider undue influence when subjects will receive significant payment for participation. It is important to remember that IRBs are tasked with minimizing, not eliminating the possibility of undue influence or coercion.
Review the consent guidance on Undue influence and coercion for a more complete discussion.
Requirement: There must be sufficient opportunity for discussion with, and to ask questions of, the study team. There must be sufficient opportunity to consider whether or not to participate.”
Required by: 45 CFR 46.116(a)(2); 21 CFR 50.20
Consent is a continuous, dynamic, and interactive process. The study team must be available to prospective subjects to answer questions. For some studies, it may be important to allow prospective subjects to review consent materials with family, friends, or a physician before making an enrollment decision. These opportunities must be available throughout the subject’s participation in the research.
Requirement: Consent must begin with a concise and focused presentation of the Key Information that is most likely to assist a prospective subject in understanding the reasons why one might or might not want to participate. It must be organized in a way that facilitates comprehension.
Required by: 45 CFR 46.116(a)(5)(i)
Identifying a study’s Key Information will depend on the nature of the study, the other information presented as part of the consent process/form and, primarily, the subject population. Key Information is the information that is most likely to assist the specific subject population with making a decision to participate in the research.
Accurately identifying Key Information can be difficult and for high risk studies and/or studies that include vulnerable populations, it may require consulting with members of the proposed study population or with community groups. If you want assistance with making a plan for identifying Key Information, you can contact the UW IRB.
Per UW IRB policy, consent documents that are 2,000 words or less meet the requirement of being sufficiently concise and focused that they don’t need a separate Key Information section. Consent forms longer than 2,000 words are required to have a separate Key Information section. Based on this distinction, researchers may opt to use either the consent template with a Separate Key Information section or the template with No Separate Key Information section when designing their consent form(s).
Review the consent guidance on the Key Information Requirement for additional details.
Requirement: Consent must provide the information that a reasonable person would want in order to decide whether or not to participate.
Required by: 45 CFR 46.116(a)(4)
It is not possible for researchers to provide information that every individual participant would consider helpful in making an enrollment decision. Rather, researchers are expected to use the “reasonable person standard” to identify the information that most individuals in the specific subject group would want to know in order to be able to make an informed decision. The opportunity to ask questions during the consent process allows for individual differences in information needs to be met.
Requirement: Consent as a whole must present information in sufficient detail and in a way that facilitates understanding about why an individual may want or not want to participate.
Required by: 45 CFR 46.116(a)(5)(ii)
Consent information should be presented in a logical sequence and in a way that allows for real-time review during discussion between the prospective subject and study staff. Providing context that is meaningful and language that is familiar, and at an appropriate reading level for the particular study population will make the content easier for subjects to understand.
Written consent materials should make use of reader-friendly formatting, including sufficient margins and line spacing, readable font of adequate size, and the use of sub-headings, bullets, tables, flow charts, etc. to break up dense text.
Requirement: Consent will not include exculpatory language through which the subject is made to waive or appear to waive any legal rights, or releases or appears to release the researcher, sponsor, institution or its agents from liability for negligence.
Required by: 45 CFR 46.116(a)(6); 21 CFR 50.20
This requirement is specific to ensuring consent language does not free an individual or entity from malpractice, negligence, blame, fault, or guilt.
Exculpatory: “I waive any possibility of compensation, including any right to sue, for injuries that I may receive as a result of participation in this research.”
Non-exculpatory: “The UW does not normally provide compensation for harm except through its discretionary program for medical injury. However, the law may allow you to seek other compensation if the harm is the fault of the researchers. You do not waive any right to seek payment by signing this consent form.”
Requirement: Consent information must be provided in language understandable to the prospective subject.
Required by: 45 CFR 46.116(a)(3); 21 CFR 50.20
This means conducting the consent process and providing consent forms that are in the prospective subject’s preferred language (e.g., English, Spanish) but also refers to the reading level of the language and (when written consent is provided) the general readability, font size and color, and formatting of the forms.
Section 2 – Elements of Consent
What is this study about?
UW IRB Policy Element: The University of Washington named in the consent form/process.
Required by: UW IRB policy for some studies (read discussion)
The purpose of this requirement is to help subjects identify the organization responsible for conducting the research. When multiple institutions are involved in conducting the research, this information only needs to be provided on consent materials for subjects at sites directly overseen by UW investigators.
Required for studies: (1) where there is no other institution involved; or (2) when the UW is one of the sites in a multi-site study where each site is conducting the protocol.
Optional for: (1) collaborative studies involving another institution when it and the UW are dividing up the procedures/roles; or (2) studies occurring at a site other than UW campus or UW Medicine facilities and that involve other institutions.
“This study is being conducted by researchers at the University of Washington.”
Required Element: A statement that the activity is research and an explanation of the purpose of the research.
Required by: 45 CFR 46.116(b)(1); 21 CFR 50.25(a)(1)
This element ensures prospective subjects know they are being asked to participate in research and provides them with a brief and clear description of why the research is being conducted. This element may be satisfied using the word research or similar words such as study or investigation.
For consent forms that require a separate Key Information section, it is likely that this element would be included in Key Information and not repeated elsewhere in the consent form.
“We are looking for people who own childcare centers to sign up for our study looking at the ways in which the COVID-19 pandemic and an increase in remote work has impacted your business.”
“You are being asked to answer some questions that will help our investigation into what people know about the availability of PrEP (pre-exposure prophylaxis) for preventing HIV in your community.”
“Our research will compare two methods of treating post-traumatic stress disorder (PTSD).”
What will you be asked to do?
Required Element: A description of the study procedures, identification of any procedures that are experimental, and the expected duration of the subject’s participation.
Required by: 45 CFR 46.116(b)(1); 21 CFR 50.25(a)(1)
Subjects should be provided with a clear description of what they will experience if they enroll in the study. The consent process/form should focus on the procedures and information that would be most likely to influence the subject’s decision about whether to enroll in the study. For more complicated studies, this means consent may not need to describe every procedure. However, it is important that all experimental procedures are listed. For some studies, using a table or diagram may be the clearest way to list procedures. Remember that consent is a process and if the consent process/form describes only the most influential procedures, a complete procedure table, or other summary, can be provided afterward.
Depending on the study, prospective subjects may be interested in knowing the time commitment. For a cross-sectional study, that might mean providing an estimate of how long it will take to complete the survey (e.g., “You will be asked to complete a one-time survey that will take about 30 minutes.”). For a longitudinal study, it might be more appropriate to describe the time commitment at a higher level, (e.g., “You will be asked to complete surveys and provide a blood sample every 6 months for up to 3 years.”).
If the research includes use of investigational drugs or devices, the consent form must describe the drug or device as experimental, investigational, unapproved or some other comparable term and note that the item is not FDA approved for clinical use or for this particular research use. For investigational device studies, it may be appropriate to describe whether the device will be removed at the end of the study, whether the device will be replaced if it is removed for safety or other reasons, and if the device is subject to life-long tracking requirements.
For consent forms that require a separate Key Information section, the procedures most likely to influence a subject’s decision to participate should be described there. A more complete description of the procedures and/or additional details about the procedures may be described later in the consent process/form. Generally, information presented in the Key Information section should not be repeated later in the consent form.
The language and format used to describe study procedures will be specific to the study and subject population. Review these Example Consent Forms for a demonstration of some of the ways procedures can be described.
Why might you want, or not want, to participate?
Required Element: A description of any reasonably foreseeable risks or discomforts to the subject.
Additional Element: For studies enrolling pregnant women, information about the reasonably foreseeable impact of the research on the fetus or neonate.
Required by: 45 CFR 46.116(b)(2); 21 CFR 50.25(a)(2); 45 CFR 46.204(f)
HSD’s consent guidance, provides detailed information on Identifying and Describing Reasonably Foreseeable Risks. Briefly, those risks that are very frequent/very common or frequent/common should generally be included in the consent process/form, as should “serious” risks. Risks should be described in a way that is understandable to the subject population. Careful consideration of “reasonably foreseeable” risks is particularly important when there are risks associated with drugs, devices, or complex procedures. For investigational drug and device studies, the consent form should include the risk information in the investigator brochure. For device studies, the consent form should also describe the risks of implants and the possible need to remove them. In higher risk studies, including all possible risks may detract from the subject’s ability to focus on the risks most relevant to their decision about whether to enroll. For minimal risk research, risks or burdens that are immaterial or obvious can be omitted (e.g., subjects don’t need to be told that needle sticks might cause minor pain or that they might get bored completing a survey). It is not necessary to state the absence of risk where none exists.
Prospective subjects who are pregnant should be informed about any reasonably foreseeable risks to the embryo or fetus.
For consent forms that require a separate Key Information section, the risks most likely to influence a prospective subject’s decision should generally be included in Key Information. For a particularly complicated and/or high-risk study, a more complete description of the risks and/or additional details about the risks may be described later in the consent process/form. Generally, information presented in the Key Information section should not be repeated later in the consent form.
Review these Example Consent Forms for additional example language and for ideas about how to structure this section of the consent process/form.
“If you sign up for this study, there is a risk that the [insert experimental test/drug/device/approach/treatment] may not be as good as [insert standard of care approach] at treating [insert disease/condition].”
“There is a risk you could have side effects from [insert experimental test/drug/device/approach/ treatment]. Those side effects might be worse or different than what you would get with the usual approach to treat [insert disease/condition]. Some common side effects are [insert the most likely side-effects and consider using bullets, tables, or some other visual rather than a dense block of text]. [If appropriate] There may also be risks that the researchers don’t yet know about.”
Additional Element: Statement that the particular treatment or procedure may involve currently unforeseeable risks to the subject (or embryo/fetus).
Required by: 45 CFR 46.116(c)(1); 21 CFR 50.25(b)(1)
Prospective subjects should be informed if the research may involve unforeseeable risks.
Prospective subjects who are pregnant should be informed about any unforeseeable risks to the embryo or fetus. If long-term safety studies (e.g., animal testing) are not complete, subjects should be told that researchers have not completed studies that may identify potential risks such as cancer risk or fetal abnormalities.
“In addition to the risks already listed, the research may involve previously unknown risks or side effects.”
Additional Element: For studies enrolling prisoners, a statement that participation in the research will have no effect on their parole.
Required by: 45 CFR 46.305(a)(6)
This element applies when the study is enrolling prisoners, and parole is relevant. For example, in Washington State, parole is not available to non-federal prisoners sentenced after 1982.
Depending on the consent design, it might make sense to include this statement with the other information about reasonably foreseeable benefits.
“Participating in this research study will have no effect on your parole.”
Required Element: Disclosure of appropriate alternative procedures or treatments if any, that may be advantageous to the subject.
Required by: 45 CFR 46.116(b)(4); 21 CFR 50.25(a)(4)
This element will only apply to some studies. Prospective subjects should be aware of all the choices they have, including those outside the research. For research that includes medical treatment, alternatives might include receiving standard treatment outside the study or palliative care rather than an intervention.
“You may want to consider other options outside of the research. You should discuss possible options with your doctor, which may include [insert possible alternative therapies here].”
Required Element: A description of any benefits to the subject or to others that may reasonably be expected from the research.
Required by: 45 CFR 46.116(b)(3); 21 CFR 50.25(a)(3)
Known benefits should be accurately described and not exaggerated. For potential or uncertain benefits, describe clearly what is known about the uncertainty or likelihood of the benefits. Payment for participating in research should not be described as a benefit.
For consent forms that require a separate Key Information section, it is likely that this element would be included in Key Information. For some studies, a more complete description of benefits and/or additional details about benefits may be described later in the consent process/form. Generally, information presented in the Key Information section should not be repeated later in the consent form.
“You will not benefit directly from this study. We do hope that this research will add to our understanding about [insert as appropriate] in the future for people like you.”
“Possible benefits you may get from participating in this study include [insert as appropriate].”
UW IRB Policy Element: Other reasons an individual may or may not want to participate.
Required by: UW IRB policy when applicable
There are reasons outside of risks, benefits, and alternatives that individuals may or may not want to enroll in a study. For example, they may experience barriers to participation such as having difficulty getting time off work, finding transportation, and/or securing childcare or eldercare in order to attend in-person study visits. For studies that involve randomization, some people may not want to participate if they know they might be assigned to a placebo group and not receive the treatment/intervention. Or they may not be willing to spend an entire day at the study clinic per the protocol.
If subjects may incur costs of the research, that may be listed here. Subject payment cannot be described as a benefit of the research, but it may be a reason why a subject may want to participate and could potentially be listed in this section.
Researchers should carefully consider the perspective of their particular subjects to identify the reasons why they may want or not want to enroll in study and clearly describe them in the consent process and form.
“If you enroll in this study, you may be assigned to the control group which means you will not receive the intervention.”
“If you enroll in this study, you will need to be able to attend all six in-person clinic visits at Harborview Medical Center. Each visit is 4 hours long.”
Additional Element: Any additional cost to subjects that may result from the research participation.
Required by: 45 CFR 46.116(c)(3); 21 CFR 50.25(b)(3)
These issues may be complex and it may be appropriate to refer the subject to a financial counselor to explain the costs, insurance, and reimbursement prior to signing the consent form.
Prospective subjects should be made aware if they may incur costs as a result of participation. Costs for research procedures should be distinguished from those resulting from clinical care. Depending on the study, it may be appropriate to note that costs may be billed to subjects’ health insurance. Subjects should be informed if they will be responsible for deductibles or copayments if their insurance is charged. If the study will provide funds to cover the costs not covered by insurance or other forms of reimbursement, the consent form should describe how those funds will be made available to the subject and how they can obtain more information. Subjects should be informed that insurance may not fund their medical care because they are participating in research.
It may also be appropriate to inform subjects about indirect costs they may incur, such as loss of income if they have to take time off work to participate or transportation costs.
Costs may vary across study location sites in multi-institutional research. Care should be taken to provide information specific to subjects at different locations.
Note – This language might overlap with the example language we provide for injury compensation (below). In these cases, try to harmonize the language as much as possible to avoid repetition.
[Include the language below if the research is a clinical trial that involves the use of clinical services, items, or tests and there may be costs to study subjects or their insurers.]
“The costs of the experimental [choose as appropriate drug/device] and/or the costs of some research procedures may be billed to you, or your health insurance as would normally be the case for clinical care. In some cases, your health insurance company may not pay for costs associated with a research study. You can talk with the research team and/or contact your health insurance company directly to identify what will and will not be covered.”
UW IRB Policy Element: Description of payment that subjects may receive for participation (e.g., reimbursement, compensation, incentive).
Required by: UW IRB policy
The purpose of this requirement is to address a common subject question. The consent process/form should include the following information about the payment: total amount/value; schedule/timing; purpose (e.g., reimbursement, compensation, incentive); and whether it will be pro-rated.
Subjects may be interested in knowing the form the payment will take (e.g., check, cash, gift card). This information can be listed in the consent form or provided as part of the consent discussion if you think it will be important to the subjects.
When course credit is offered for participating in research, students should be offered an alternative way to earn that same credit without participating in the research.
This information may vary across locations for multi-institutional research. Refer to Section 5 for additional information.
Full details can be found in HSD’s Subject Payment guidance.
“You will not receive payment for participating in this study. But we hope that the results will add to our understanding about [insert information about the goal of the research].”
“At the end of the study, you will be entered into a drawing for one of five, $50 gift cards. We hope to enroll 300 subjects in our study which means you’ll have approximately a 1 in 60 chance of winning a gift card. We plan to leave enrollment open for 3 months. If you win a gift card, we will contact you within 4 months of completing the study procedures. We will not contact you if you don’t win a gift card, but you’re welcome to reach out to the study team at any time.”
“You will receive a $5 gift card for every survey you complete. If you withdraw early from the study, you will be paid for the surveys that you completed. You will receive the gift card by email within two weeks of completing each survey. If you don’t have email, we will work with you to make other arrangements.”
“If you prefer not to earn extra credit by participating in the research, you can visit this website [insert url] for non-research options that will earn you the same credit.”
[When subjects will receive $600 or more for participation, include the following statement.] “If you earn $600 or more in research payments from the UW during a calendar year, the UW will report this to the Internal Revenue Service as miscellaneous income. For this reporting, we will request that you provide us with your Social Security number.”
How will we protect the information you provide?
Required Element: Description of the extent, if any, to which confidentiality of records identifying the subject will be maintained.
Additional Element: For FDA-regulated studies, a statement indicating that the U.S. Food and Drug Administration (FDA) may review the study data, including identifiable study information.
UW IRB Policy Element: To satisfy the requirements of some funding agencies (e.g., NIH), it is UW IRB policy to require a statement indicating that the Sponsor agency and its authorized representatives may review the study data, including identifiable study information.
UW IRB Policy Element: A statement that the UW may need to access study data and when applicable, a statement that information about study participation will be placed in the subject’s medical record.
Required by: 45 CFR 46.116(b)(5); 21 CFR 50.25(a)(5); 21 CFR 50.25(b)(2); UW IRB policy
Provide subjects with information about who will have access to the data and the extent to which confidentiality will be protected. Do not include statements that only the research team will have access to the data/specimens. This cannot be guaranteed due to the many possible secondary uses and multiple organizations and offices that have a right to monitor or audit the study.
It is not necessary or recommended to provide a detailed description of all the study’s data security measures. Think about what a meaningful description of a study’s confidentiality protections would be for the subject.
Include any limits to confidentiality. For example, if the information subjects provide may trigger mandatory reporting requirements such as child or elder abuse (Mandatory State Reporting guidance).
If the study is FDA-regulated, prospective subjects should be aware that their identifiable study records may be inspected by the FDA.
If the study is funded (sponsored) by a non-UW entity (e.g., Bill & Melinda Gates), it is possible that the Sponsor may want to inspect identifiable study records. Prospective subjects should be made aware of this possibility.
If the research involves use of clinical care services, items, or tests (e.g., UW Medicine, UW Physicians), subjects should be informed that information about the study and their individual research results will be placed in their medical record so that they can consider the confidentiality aspects of their information being located in a non-research location.
If information about or from the study will be placed into other medical records (e.g., at another institution) describe the details in the consent process/form.
Depending on the study specifics, it might make sense to combine this element with the one describing the possibility of secondary research.
“The information you provide will be anonymous. This means that your name will not ever be connected to the data.”
“We will protect your confidentiality. We will store your name and other identifiable information separate from the study data. Access to your identifying information will be limited to certain members of the study team and individuals from the UW [If applicable Food and Drug Administration (FDA)], [If applicable list the Sponsor (e.g., NIH)], or other agencies that may need to audit study records. When we publish the results of this study, we will not use your name. [If applicable] If we learn you intend to harm yourself or others, we must report that to the appropriate authorities. [If applicable] Information about the study and your study results may be placed in your [insert as appropriate, e.g., UW or other medical record]. This means people outside the research, such as health insurers, health care providers, and anyone you have given permission to access your records may be able to find out you participated in this study.”
[If you think it is important for your particular study to eventually anonymize the data, you can include the statement below. Be aware of records retention requirements from sponsors or federal agencies that might apply to study identifiers.] “The link between your identifiers and the research data will be destroyed (at the end of the study) [OR] (after the records retention period required by state and/or federal law).”
Required Element: For research that includes collection of identifiable private information or identifiable specimens, include the appropriate statement describing the possibility of secondary research:
- A statement that identifiers might be removed from identifiable private information/samples, after which the information/samples may be used for future research studies or distributed to another investigator for future research studies without additional consent from the subject – OR –
- A statement that the subject’s information/samples will not be used or distributed for future research studies, even if identifiers are removed.
Required by: 45 CFR 46.116(b)(9)
Often, research data is used for future studies and many funding agencies require sharing as a condition of the award. Prospective subjects should be made aware of possible future use of their data. If there are existing or known plans to store or share data and/or specimens for future research these plans should be described, especially if data/specimens will be shared broadly through repositories or shared in identifiable form. HSD encourages writing in flexibility for future use of research information.
“The information and/or samples that we obtain from you for this study might be used for future studies. We may remove anything that might identify you from the information/samples. If we do so, the information/samples may then be used for future research studies or given to another investigator without getting additional permission from you. It is also possible that in the future we may want to use or share study information/samples that might identify you. If we do, a review board will decide whether or not we need to get additional permission from you.”
Other Element: Description of federal Certificate of Confidentiality (CoC) protections.
Required by: Condition of award for NIH, CDC, and other federal agencies.
If the study has a federal CoC, HSD recommends inserting the Example Language, below into the consent form. The IRB may be able to approve revised template language, but it cannot be waived.
CoC protections apply to data stored in the U.S.
“We have a Certificate of Confidentiality from the U.S. federal [insert institution, e.g., National Institutes of Health] which allows us to protect identifiable research information stored in the U.S. from legal proceedings or in response to a legal request unless you give us permission to release it. You or a member of your family can share information about yourself or your part in this research if you wish.
There are some limits to this protection, including reporting things like child or elder abuse, monitoring by the agencies conducting the research, and others as listed elsewhere in this consent form.
[If research information will be added to the subject’s medical record, include these two sentences.] Research information that is placed in your medical record may not be protected by this Certificate. Ask a member of the study team for information about what research information will be placed in your medical record.
[For studies that are granted an automatic CoC as a condition of the award, include this paragraph.] “The Certificate expires when the [insert agency] funding for this study ends. Currently this is [date of funding expiration; if there are multiple grants, pick the expiration date furthest out]. Any data collected after expiration is not protected as described above. Data collected prior to expiration will continue to be protected.”
[For studies that obtain a CoC from applying to the federal agency, include this paragraph.] “The Certificate expires when the study ends. Data collected prior to expiration will continue to be protected.”
What if you want to stop being in the study, or if the researcher decides you should no longer participate?
Additional Element: Statement that significant new findings developed during the research which may relate to willingness to continue participation will be provided to the subject.
Required by: 45 CFR 46.116(c)(5); 21 CFR 50.25(b)(5)
Subjects need to be informed if new information arises during the course of the research which may impact their willingness to continue participation. This element is particularly important for investigations of first use in humans, novel therapies, complex clinical investigations with significant risk, and other instances where knowledge of risks is limited.
- Example: Subjects should be informed if an unexpected adverse event occurs, or an adverse event occurs at greater frequency or severity than subjects were previously told.
- Example: If an experimental drug becomes FDA approved during the study, subjects may want to withdraw from the study and take the drug as part of clinical care.
“While you are taking part in this study, we may learn new information about the study drug. If this happens, we will contact you to talk about the new information so you can decide if you want to stay in the study.”
Additional Element: The consequences of a subject’s decision to withdraw and the procedures for orderly termination.
Additional Element: Description of circumstances under which the subject’s participation may be terminated by the investigator.
Required by: 45 CFR 46.116(c)(2,4); 21 CFR 50.25(b)(2,4)
For some studies, such as those with a treatment intervention, subjects may experience adverse health or welfare effects if they withdraw from the study without taking certain precautions.
For some studies, the research team may need to terminate a subject’s participation due to subject risk, a change in eligibility criteria, site withdrawal from the study, or some other reason. The study sponsor or a DSMB may recommend stopping the study early. The anticipated circumstances that would trigger termination of a subject’s participation should be listed in the consent form.
In any case, the consent form should describe the procedures for safe withdrawal from the study, including why those procedures are important to the subject’s welfare and whether the procedures may include follow-up care. If a subject’s participation is terminated, the researcher should explain the reason for the termination and discuss other treatment or research options.
“If you decide you want to stop being in this study, be sure to contact the study team. If we discover that [insert reasons why a subject’s participation may be terminated] we can choose to choose to end your participation in the study. If you stop participating and are no longer receiving the study therapy, you may experience [describe any adverse health or welfare effects subjects might experience]. We want to make sure you have the resources you need to be cared for outside of the research [insert details as appropriate].
How will we test, store, and share your information and biospecimens?
Additional Element: For research involving biospecimens a statement that the subject’s biospecimens may be used for commercial profit and whether the subject will or will not share in this commercial profit.
Required by: 45 CFR 46.116(c)(7)
Consider sources of profit for this study as well as any future potential uses. Future uses might include adding specimens to a repository for use by other groups.
“The samples we collect as part of this research may be used for commercial profit, such as developing new tests or products [inset other details as appropriate]. [Choose one as is appropriate] There is no plan to share this profit with you. [OR] There is a plan to share this profit with you [insert details].”
Additional Element: For research involving biospecimens a statement about whether the research will or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimens with the intent to generate the genome or exome sequence of that specimen).
Required by: 45 CFR 46.116(c)(9)
Subjects should be made aware if there is a possibility that whole genome sequencing will be conducted on their specimens. Genome sequencing and the analysis that will occur should be described in the consent form using lay language. Depending on the study design, it might make sense to combine this element with the element describing data sharing.
“We will study your DNA as part of this study. DNA is in nearly every cell of the body and it tells your body how to grow, develop, and function using structures called genes. Genes are inherited from your parents. The genes you inherit may explain some of the differences in the way people respond to different diseases. For this study, we may look at your entire DNA code. This is called “whole genome sequencing”. This will help us understand whether certain genes explain [insert information about what you hope to discover].”
[The NIH National Human Genome Research Institute provides sample consent language and additional information about requirements and considerations for genomic research.]
Other Element: Information about sharing data through NIH or other repositories.
Required by: NIH condition of award
Broad sharing of data through NIH repositories in de-identified form. If data, such as genomic data, information about a medical condition, or other study data will be submitted to NIH repositories, the consent form must explain that study data may be used for future research and broad sharing. It must also describe the circumstances under which the information will be shared, risks and benefits associated with broad sharing of the information, whether results will be returned to participants and whether the data can be withdrawn. HSD recommends inclusion of the example language below which can be modified as appropriate.
When sharing data through other repositories or in identifiable form, adapt the NIH example language and see additional guidance, below.
In order to comply with the NIH Genomic Data Sharing (GDS) policy, refer to the Consent Requirements and Expectations for Genomic Data Sharing worksheet for a list of consent elements that must be included in the consent form. Note that the example language below meets the GDS consent requirements.
[For broad sharing of data through NIH repositories in de-identified form, use the example language below. Note that this template language is designed to obtain broad consent for future uses and sharing of data. However, sometimes tiered or specific consent approaches may be more appropriate. For example, the consent could limit the use of data to the study of specific diseases or conditions.]
“The National Institutes of Health (NIH) has developed data (information) banks that collect study data. The NIH will store your de-identified information in these data banks for other researchers to use in future studies on any topic. The researchers could be from government, academic, or commercial institutions.
[Include this language if data will be stored in an unrestricted access database] The information from this study will be stored in a public unrestricted data bank that anyone can use. This public information will not include your name or other information that could identify you.
[Include if participants will not receive results] You will not receive any results from allowing your data to be placed in the NIH data banks.
[Include if data can be withdrawn] You can withdraw your consent any time you don’t want your data in the NIH data banks. There will be no consequences for withdrawing consent. However, data that has already been sent to researchers cannot be retrieved.
[Include if data cannot be withdrawn] You will not be able to withdraw your information after it has been submitted to the NIH data banks.
[Include any applicable risks associated with broad sharing of the data. Note that this is not a complete list and other risks may need to be included.] Risks associated with sharing information data through NIH data banks include:
- It is possible that your information could be used to identify you when combined with information from other public sources.
- Others may be able to trace this information back to you or close biological relatives. The current risk of this happening is small but may grow in the future as new technologies are developed.
- If this should happen, someone might use this information to learn something about your health or genetic heritage. If linked to a medical condition and inappropriately shared with someone, it could affect your ability to get or keep some kinds of insurance.
- There is a possibility that this information could affect family members because certain conditions and traits run in families and are inherited through genes. This could hurt family or other relationships.
- There is a risk that your information could become known to the public, employers, or law enforcement agencies. The information may be used to enforce negative stereotypes.
- There may be other risks that are not yet known.
[Include this language when sharing of data will be optional (i.e., not a condition of participating in the research)] It is your choice whether or not to have your information placed in NIH data banks for use research in the future. If you say “No,” you can still fully participate in this study. Do you agree to have your information shared through NIH data banks?
[Insert yes/no checkbox or some other method for indicating choice.]
[Include this language if participants will be given the option of receiving results of medical importance.] In general, you will not receive any individual results from future research conducted with information placed in the NIH data banks, but in rare circumstances researchers may find something that may be of medical importance. If this happens, do you want to receive these results?
[Insert yes/no checkbox or some other method for indicating choice.]”
[When sharing data through other repositories or in identifiable form. If there are plans to store or share data and/or specimens for future research through non-NIH repositories or in identifiable form, describe those plans here by adapting the above language. For additional guidance and sample language, review the NIH resource: Informed Consent for Secondary Research with Data and Biospecimens.]
Will you get to know your research results?
Additional Element: Statement whether clinically relevant research results, including individual research results, will be disclosed to subjects and if so, under what conditions.
Required by: 45 CFR 46.116(c)(8)
UW IRB policy requires researchers to provide results to subjects when the study will produce clinically relevant results.
Review HSD’s Return of Individual Results guidance for more information.
[Review HSD’s guidance on Return of Individual Results for details about how to describe: (1) whether results will be given to subjects; (2) if so, under what conditions; and (3) whether/how subjects can opt out of receiving results.]
[The Global Alliance for Genomics and Health provides guidance for genomic and health-related data sharing.]
Requirements about your research decision.
Other Element: Human fetal tissue obtained from elective abortion.
Required by: NIH NOT-OD-19-128 & NOT-OD-19-137; applies to all research, regardless of funding per UW IRB policy
This is required only for research that will collect fetal tissue donated from elective abortions. It is UW IRB policy to apply this requirement to all research, regardless of NIH funding/support. This language cannot be altered.
[This language cannot be altered.]
“We will obtain your consent to donate fetal tissue only after you have already provided written consent to have an abortion. Your research consent will not be obtained by the same person who obtained your abortion consent. Being in this research will not affect the method used for your abortion.
No payment or other financial benefits, gifts, or incentives can be provided to you for having an abortion or for donating the tissue for research.”
Other information about this study.
Required Element: Statement that participation is voluntary and that the individual may refuse to participate or discontinue participation at any time without penalty or loss of benefits to which they are otherwise entitled.
Required by: 45 CFR 46.116(b)(8); 21 CFR 50.25(a)(8)
Prospective subjects should be made aware that there is no obligation to participate in research.
“Being in this study is voluntary. This means that you can refuse to sign up. It also means that if you do sign up for the study, you can decide to stop being in the study at any time without penalty.”
UW IRB Policy Element: Source of any external funding for the study.
Required by: UW IRB policy
The purpose of this requirement is to inform subjects who is paying for the study. This UW IRB policy requirement is in line with federal guidance suggesting that the consent form/process should include the source of funding for the research.
“We are receiving [financial support OR describe other type of support such as “the study drug”] from [insert sponsor name].”
Required Element: For research with greater than minimal risk, an explanation as to whether compensation and/or medical treatments are available if injury occurs and if so, what it consists of and where further information may be obtained.
Required by: 45 CFR 46.116(b)(6); 21 CFR 50.25(a)(6)
It is important to provide subjects with information about the medical treatments and financial compensation that is or is not available to them in the case that they are harmed from the study.
Medical treatment: if the research is taking place at a medical facility, the language may simply state that the subject can be seen at the facility. If it is not taking place at a medical facility, more detailed information about where subjects should go should be provided. If no medical treatment is available, this should be stated.
Compensation: If there is not an explicit plan in place to provide financial compensation or to cover the costs of treatment, subjects will likely bear these costs themselves. Unless there is a specific plan in place, it should not be assumed that the institutions conducting the research or the funding agencies will cover these costs. If subjects or their insurers might bear the costs of obtaining treatment, this must be stated.
Available compensation may come from a variety of sources related to the study such as an industry sponsor, an insurance policy taken out by the study team, institutional programs such as the UW Human Subjects Assistance Program or governmental programs such as the Countermeasures Injury Compensation Program (CIP). The research team should identify any sources that apply to the research and include this information in the consent materials. Statements guaranteeing payment should not be made unless it is explicitly guaranteed by the source of the compensation.
In all cases, the language must inform subjects that they do not waive any right to seek payment by signing the consent form.
For studies not funded by an industry sponsor and for which the procedures associated with the risks are performed by a UW employee, student, or agent the consent form must contain the template language for the UW discretionary Human Subjects Assistance Program (HSAP) as listed in the example language, below. This language cannot be altered.
For studies involving other institutions, insert any compensation language required or recommended by the institution. HSD and the UW IRB will not review or modify the language for accuracy or completeness. For multi-institutional studies, refer to Section 5.
For studies funded by an industry sponsor, consult with HSD.
Note – This language might overlap with the example language we provide for research costs that subject might have to pay (above). In these cases, try to harmonize the language as much as possible to avoid repetition.
[UW HSAP language for greater than minimal risk research with medical risks. It cannot be altered.]
“The costs of the treatment may be billed to you or your health insurance [for international studies, refer to national health insurance or health service or program] just like other medical costs, or it may be covered by the UW’s discretionary Human Subjects Assistance Program (HSAP), depending on a number of factors. The researcher may request HSAP coverage by following established procedures. If you wish to request HSAP coverage yourself, contact the researcher or the UW Human Subjects Division at email@example.com or 206-543-0098. Ask the researcher if you would like information about the limits and conditions of the HSAP. The UW does not normally provide any other form of compensation for injury. However, the law may allow you to seek payment for injury-related expenses if they are caused by malpractice or the fault of the researchers. You do not waive any right to seek payment by signing this consent form. [If appropriate, also add these two sentences] We will bill your health insurance for treating problems that result from your [insert name of disease or underlying condition] or from standard clinical care. If you have no health insurance or your insurance refuses to pay, we will bill you.”
[UW HSAP language for research without medical risks. It cannot be altered.]
“The UW does not normally provide compensation for harm except through its discretionary program for medical injury. However, the law may allow you to seek other compensation if the harm is the fault of the researchers. You do not waive any right to seek payment by signing this consent form.”
Additional Element: ClinicalTrials.gov statement for studies that are considered by the FDA to be ‘applicable clinical trials’ and for NIH-funded clinical trials.
Required by: 21 CFR 50.25(c); NIH condition of award
This language is required and cannot be altered for all FDA-regulated applicable clinical trials and for NIH-funded clinical trials.
[This language cannot be altered.]
“A description of this clinical trial will be available on https://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.”
Additional Element: Approximate number of subjects in the study.
Required by: 45 CFR 46.116(c)(6); 21 CFR 50.25(b)(6)
A subject’s decision about whether to participate may be impacted by the knowledge that the study involves a small initial trial of an experimental drug or device where only a small number of subjects will be enrolled.
“We plan to enroll [insert number] people in this study.”
“There are [insert number] sites in this study across the U.S. We plan to enroll [insert number] people at the UW site.”
UW IRB Policy Element: Description of any financial conflicts of interest.
Required by: UW IRB policy
The purpose of this requirement is to provide subjects with information about any financial conflicts that may be present and about how they have been managed. This UW IRB policy requirement is in line with federal guidance suggesting that the consent form/process should include any financial interests of the researchers and any plans for managing conflict of interest. These conflicts are typically managed through a conflict management plan. These may be plans that have been developed in order to comply with Public Health Service policy or under other institutional policies. The Office of Research issues these plans for UW investigators. Non-UW investigators should follow their own institutional policies to obtain a plan.
[For UW investigators]
“[Investigator name] has a financial or other relationship with [company name]. The University of Washington developed a Conflict Management Plan to reduce the possible effects of this relationship on your safety or welfare.”
[For non-UW investigators: The language above may be modified and used, however other institutions may have their own required language which may need to be incorporated.]
[For institutions: In the case of institutional conflicts of interest (e.g., the institution has a patent or intellectual property rights), special language may be required. Work with the issuer of the conflict management plan to identify the disclosure requirements].
Other Element: For studies obtaining electronic documentation of consent, include the following elements:
- 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.
- Information regarding how a participant can request a paper copy of the form at no cost
- Information regarding how a participant can withdraw consent.
Required by: Electronic Signatures in Global and National Commerce (E-Sign) Act
Studies obtaining electronic consent must provide subjects with the bulleted information listed above. The example language below is applicable when using UW DocuSign and UW ITHS REDCap and may apply to other situations. The language may be modified, as needed.
“A copy of the consent form will be emailed to you at an email address that you provide. It will be a “PDF” document. Most computers already have PDF viewer software installed, which will allow you to open, read, or print the consent form. The email we send you will include a link to PDF viewer software (such as Adobe Acrobat Reader) in case your computer doesn’t already have it. If you would prefer to receive a paper copy of the consent form at no cost to you, please contact the researcher(s) listed in this consent form.”
What can you do if you want more information?
Required Element: Statement informing subjects about who to contact for answers to questions about the research and who to contact in the event of a research-related injury.
Required by: 45 CFR 46.116(b)(7); 21 CFR 50.25(a)(7)
Subjects should almost always be directed to contact a member of the research team if they have questions, complaints, or concerns about the study or if they’ve experienced harm as a result of participating. For high-risk studies, subjects should be provided with a phone number where they can reach someone 24 hours a day to report injury. Generally, this should be a dedicated “on-call” person who will be expecting to receive these types of calls. The IRB is not the appropriate contact for these situations.
“We are here to help you understand the study. Please ask us any questions you may have, even about things that are not in this document. It is our responsibility to give you the information you need to make a decision and give you time to think about whether or not you want to sign up. If you feel you have been harmed by participating, you can contact us about that too at [insert phone and email].”
Required Element: Statement informing subjects about who to contact with questions about subjects’ rights.
Required by: 45 CFR 46.116(b)(7); 21 CFR 50.25(a)(7)
Subjects should be directed to contact the IRB of record (i.e., the IRB that has reviewed and approved the study) with questions about subjects’ rights.
In some cases, non-UW institutions may require that contact information for their IRB or HRPP office be listed. In these cases, this contact information should be provided in addition to the UW IRB’s information.
“If you want to talk about the study with someone who is not part of the study team, talk about your rights as a research subject, or to report problems or complaints about the study, contact the UW Human Subjects Division at (206) 543-0098 or firstname.lastname@example.org.”
Section 3 – Waivers and Alterations of Consent
The regulations require researchers to document the consent process by having subjects sign an IRB-approved consent form that includes all required elements of consent. Alternatively, the IRB can consider the regulatory criteria for waiving consent entirely or altering consent so that certain elements can be omitted. The IRB may also consider waiving the requirement to document consent (i.e., get signatures on the form). The criteria for waiving or altering consent are listed below.
Conditions for Waiving or Altering Consent/Parental Permission
Condition: Information/biospecimens obtained for recruiting, screening, or determination of eligibility. This is an exception to informed consent rather than a waiver.
Regulatory citation: 45 CFR 46.116(g)
At least one of these criteria must be met.
- The researcher will obtain information through oral or written communication with the prospective subject or legally authorized representative
- The researcher will obtain private information or identifiable biospecimens by accessing records or stored identifiable biospecimens
This is a Common Rule exception to the requirement for informed consent rather than a waiver. Federal regulators have noted that these preparatory-to-research activities are limited in nature, involve limited risk, and are important to identifying subjects. The IRB must include these activities in their consideration of the Criteria for Approval, including ensuring adequate protections for subject privacy and confidentiality.
Screening tests and procedures are not considered by FDA to be part of the clinical investigation unless they are performed solely for determining study eligibility.
Condition: Minimal risk to subjects.
Regulatory citation: 45 CFR 46.116(f)(3); FDA Guidance, July 2017; 21 CFR 50.55(d)
All of these criteria must be met.
- The research involves no more than minimal risk to subjects
- The waiver or alteration will not adversely affect the rights and welfare of the subjects
- The research could not be reasonably be carried out without the waiver or alteration
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation
- If the research involves using private, identifiable information/biospecimens, the research could not reasonably be carried out without using such information/biospecimens in an identifiable format [this Common Rule criterion applies only to studies approved after 01/21/2019]
When assessing whether the research is minimal risk and that the waiver will not adversely affect subjects’ rights and welfare, the IRB must consider: (1) the minimum necessary information to achieve research goals, including whether it is necessary to obtain identifiers; (2) the sensitivity of the information; and (3) the researcher’s plan to protect subject privacy and confidentiality.
The IRB might determine that the research could not reasonably be carried out without the waiver if, for example: (1) requiring consent could introduce bias into the sample selection and threaten scientific validity; (2) subjects’ behavior or responses would be altered and could potentially bias the conclusions; (3) requiring consent could present an additional or sole threat to subject privacy; (4) there is a risk of inflicting harm by contacting individuals or their families. Logistical issues such as cost, convenience, or speed can be considered secondarily but alone are not justification for waiving informed consent.
A total waiver of consent is usually appropriate for medical records reviews where there is never an opportunity for contact between the researcher and subjects and where adequate data security and confidentiality measures will be put in place.
It is common for the IRB to alter consent (i.e., waive particular elements) when they don’t apply to the research. For example:
- The IRB will often waive the inclusion of the research purpose when researchers need to deceive subjects in order to avoid bias.
- For very low risk and simple studies, the IRB may consider waiving elements that are not particularly relevant for that type of research such as the requirement to list a contact for research-related injury.
- If there are no experimental procedures or alternatives to participation, those elements should be omitted rather than stating that they don’t apply. Those elements do not need to be waived because they should only be included in the consent process/form if they apply.
Condition: Parental permission is not a reasonable requirement.
Regulatory citation: 45 CFR 46.408(b); not allowed for FDA-regulated research
All of these criteria must be met.
- Parent/guardian permission is not a reasonable requirement to protect the subjects of the research, because of the research conditions or subject population (e.g., abused or neglected children).
- There is an appropriate substitute mechanism for protecting the children who will participate. The choice of an appropriate mechanism depends on the nature and purpose of research procedures, the risks and anticipated benefits, and the subjects’ age, maturity, status, and condition.
- The waiver is not inconsistent with federal, state, or local law.
It may be appropriate to waive parental permission for adolescent subjects who are mature enough to discuss sensitive, personal information (e.g., sexuality or gender) and who may be uncomfortable or unable to discuss those issues when a parent is involved.
Condition: Public benefit and service programs.
Regulatory citation: 45 CFR 46.116(e)(3); not allowed for FDA-regulated research
All of these criteria must be met.
- The research must be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (1) public benefit or service programs; (2) procedures for obtaining benefits or services under those programs; (3) possible changes in or alternatives to those programs; or (4) possible changes in methods or levels of payment for benefits or services under those programs.
- The research could not reasonably be carried out without the waiver or alteration.
Conditions for Waiving Documentation of Consent/Parental Permission
Condition: Minimal risk to subjects.
Regulatory citation: 45 CFR 46.117(c)(1)(ii); 21 CFR 56.109(c)(1)
All of these criteria must be met.
- The research involves no more than minimal risk to subjects.
- The research involves no procedures for which written consent is normally required outside of the research context.
In most cases, documentation of consent may be waived for minimal risk research. The UW IRB encourages waiving documentation of consent whenever it meets the criteria as it reduces the administrative burden of research and the likelihood of research noncompliance and adds no additional protections for subjects participating in minimal risk research. The waiver is particularly useful in situations where subjects are participating remotely (e.g., online surveys) and implementing electronic documentation of consent would require unnecessary work for the researcher and subject.
Condition: Breach of confidentiality from consent is the principal foreseeable harm.
Regulatory citation: 45 CFR 46.117(c)(1)(i); not allowed for FDA-regulated research
All of these criteria must be met.
- The only record linking the subject and the research would be the consent document.
- The principal risk is potential harm resulting from a breach in confidentiality.
- Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern.
Condition: Members of a distinct cultural group or community.
Regulatory citation: 45 CFR 46.117(c)(1)(iii); not allowed for FDA-regulated research
All of these criteria must be met.
- The subjects are members of a distinct cultural group or community in which signing forms is not the norm.
- The research involves no more than minimal risk to the subjects.
- There is an appropriate mechanism for documenting that consent was obtained.
Section 4 – Formatting and Signature Requirements for Written Forms
These formatting requirements apply to all written consent forms that are provided to subjects, regardless of whether documentation (i.e., a signature) is being obtained.
Required by: UW IRB policy
- All written consent materials must have a unique title and include version number or date in the header or footer. This ensures accurate revision and tracking for IRB review and when using them with subjects.
- Include page numbers when the document is more than 2 pages long. This improves researcher communication with subjects and the IRB.
- The name and contact information for the PI and subject contact person must be listed. This ensures subjects know who to contact with questions.
Signature requirement for studies obtaining documentation of consent.
Most minimal risk studies qualify for a waiver of documentation of consent. If documentation has not been waived, refer to the table below for guidance about when to insert: (1) a space for a printed name; (2) a signature line; and/or (3) a space to write the date.
The signature serves as documentation that consent was obtained, the printed name ensures the consent form is linked to the appropriate individual, and obtaining the date is considered best practice.
Required by: UW IRB policy
|Adult Subject||The subject must sign the form unless consent is provided by a legally-authorized representative.
The consent form should include a space for subject: printed name, signature, date.
|Legally-Authorized Representative (LAR)||A LAR may provide consent on behalf of adult subjects with decision-making impairments. Review HSD’s consent guidance on Diminished or Fluctuating Consent Capacity and Use of a LAR for full details.
The consent form should include a space for LAR: printed name, signature, date, relationship to subject.
|Parent/Guardian||Unless waived by the IRB, a parent or guardian must provide consent on behalf of a subject who has not reached the legal age of consent for the jurisdiction in which the research is being conducted.
The consent form should include a space for parent/guardian: printed name, signature, date.
|Witness||A witness signature may be required in certain circumstances such as when the short form consent process is used (Short Form Consent Requirements guidance).
The consent form should include a space for witness: printed name, signature, date.
|Assent||In some cases, it may be appropriate to obtain assent from subjects who have not reached the legal age of consent or from decisionally-impaired adults. Review our guidance on Assent for full details.
Whether a child or decisionally-impaired adult should sign an assent form depends on the specifics of the population and study procedures. Review the guidance listed above for details.
|Researcher||When the research is greater than minimal risk, UW IRB policy requires the person obtaining consent to print their name and the date on the form. A signature is not required in most cases. The printed name may be added prior to the consent interaction but it is best practice to date the form at the time consent is obtained.
For greater than minimal risk research, the consent form should include a space for consent presenter: printed name, date.
Section 5 – Multi-Institutional Research
There are special considerations when designing consent materials for studies in which multiple institutions are collaborating to conduct the research. This is because there may be differences in the consent information that must be given to subjects participating at different locations. This section describes considerations and options for consent materials for multi-site or collaborative research when the UW is the Single IRB. This information may also be helpful when the research will be reviewed by multiple IRBs.
Elements of Consent That are Likely to Vary Across Sites
Due to local requirements and conditions, several elements of consent are likely to vary across sites. These are typically:
- Costs to subjects
- Compensation for injury
- Whom to contact in case of injury or with questions about the research
- Subject payment
- Financial conflicts of interest
- Confidentiality of data including mandatory reporting of test results and/or child and elder abuse
- Language about radiation exposure
- HIPAA Authorization language requirements
- Signature lines for obtaining consent
There may be other variations due to study design and state and local laws and policies. Researchers leading multi-institutional research should work with their site investigators to understand any differences prior to submitting for IRB review and to develop a plan for how the correct information will be communicated to subjects. This typically requires the creation of site-specific consent materials and/or careful planning for how the information will be presented to subjects.
Options for Creating Multi-institutional Consent Materials
Options Without a Template
Allow all sites to generate their own, site-specific documents based on their own local templates, previous materials they have used for other studies, or the UW consent form approved by the IRB. The UW IRB will review each consent form as they are submitted. These materials may vary significantly across sites and the IRB does not review a study-specific template.
- UW lead team does not need to create a consent template for sites.
- Allows sites the most flexibility to customize to their local needs.
- Sites are often more familiar with using their own templates and don’t need to become familiar with something different.
- Can be faster for very simple studies with a small number of sites.
- The IRB will need to review each full consent form to make sure it includes all of the required elements of consent. If the study is greater than minimal risk, this may require review of each consent form by the convened IRB, especially if language about risks is different.
- Modifications to the overall protocol that change the consent elements will need to be made to each site’s consent document every time. This will require multiple modifications to enact the change across all sites.
- Information about the study may be described differently to subjects across the study sites leading to bias in enrollment or other scientific issues.
- Each site’s consent form would need to be translated when enrolling subjects with limited English proficiency. This could increase translation costs.
Best to use when the study
- Has a small number of sites.
- Is minimal risk.
- Has few procedures and you don’t anticipate needing to modify very often after initial approval.
- Has procedures that will differ among sites and/or the sites have significant local requirements for consent information and format.
A 3-site study whose procedures are a low-risk venous blood draw and a review of medical records. Paper-based consent will be obtained from inpatients. All site investigators have performed similar studies previously and have prior consent materials they can draw from while creating their materials. No modifications to the study are anticipated and consent materials will not be translated.
All sites use the same unified consent form. All site-specific information is included in the form. For example, all of the investigator contact information for all sites is listed on the document which will be presented to subjects at all sites. The IRB only reviews one form. The IRB does not review a study-specific template.
- UW lead team does not need to create a consent template for sites.
- Simplifies coordination of document versions across sites.
- Can be faster for very simple studies.
- Can minimize costs of translation.
- If there is site-specific information that must be included and does not apply to all subjects, this can make the consent document and process less subject friendly and difficult to coordinate. The person obtaining consent must take care to make sure that subjects understand what information does and does not apply to them.
- Extremely challenging to coordinate when HIPAA Authorization is required due to variations in site requirements for HIPAA language.
Best to use when
- Multiple engaged institutions are collaborating to act as one site and the site-specific information for all institutions must be given to all subjects.
UW, Seattle Children’s, and Fred Hutch are collaborating on a study of RSV infection in children in the Puget Sound region. Subjects will be seen at both UW and Seattle Children’s facilities. Although three institutions are involved, subjects will interact with them as one study team.
Options With a Template
Generate a consent template with site-specific sections to be completed by the sites. Other sections, such as the description of procedures and risks typically cannot be edited by sites unless procedures will be different.
- Very common way of developing site-specific materials. Sites who have previously participated in multi-institutional research may be more familiar with this process.
- The core consent information presented to subjects is the same across all sites.
- UW PI and/or the coordinating center have direct control over most of the information that is included in the consent materials.
- Can limit the cost of translation for planned recruitment of subjects with limited English proficiency because the core consent information will not differ across sites.
- Takes time to develop.
- Clear instructions must be given to site study teams about which sections are editable and which are not.
- Can make modifications challenging. When changes are made to the core consent information, a separate modification to change each site’s consent form must be submitted in Zipline. For example, a 10-site study would require 10 separate modifications.
Best to use when the study team
- Is familiar with this method and the number of sites and/or anticipated modifications is low.
A 5-site study of early genetic testing in children with rare disorders. Because standards of care vary significantly across the states where the sites are located study procedures and the associated risks could vary. However, the team wishes to have other consent information presented as uniformly across sites as possible.
A 2-part consent form where the part one document includes all elements of consent that are the same across all sites and the part two document includes site specific elements. Part one is used by all sites and cannot be modified by the relying sites. Each site has its own part two which can be edited as needed to address local information.
- The core consent information presented to subjects is the same across all sites.
- UW PI and/or the coordinating center have direct control over most of the information that is included in consent materials.
- Minimizes modifications. Modifications to the part one consent document only need to be submitted once in Zipline. After approval, that document can be used immediately by all sites.
- Can limit the cost of translation for planned recruitment of subjects with limited English proficiency because core consent information will not differ across sites.
- Takes time to develop.
- New model of presenting consent information. Other review bodies may be unfamiliar with a two-part consent form.
- Can require more planning and attention to detail to make sure that the information is presented to subjects in a way that makes sense.
- Difficult to incorporate site differences in procedures, especially when standards of care differ among sites.
Best to use when the study
- Is a large multi-site clinical trial where all sites are performing the same procedures.
A 15-site study of an FDA regulated treatment for hospitalized COVID patients. The study will translate the consent form into 4 other languages.
CHECKLIST Exception From Informed Consent (EFIC)
GUIDANCE Consent Elements for Externally Reviewed Studies
GUIDANCE Department of Defense
GUIDANCE Humanitarian Use Device
GUIDANCE Mandatory State Reporting
GUIDANCE Return of Individual Results
GUIDANCE Single Patient Emergency and Compassionate Use
GUIDANCE Subject Payment
GUIDANCE Human Subjects Assistance Program (HSAP)
WORKSHEET Consent Requirements and Expectations for Genomic Data Sharing
WORKSHEET Consent Requirements and Waivers
- 21 CFR 50
- 21 CFR 56
- 45 CFR 46
- OHRP Draft Guidance, “Exculpatory Language in Informed Consent”, August 2011
- OHRP Guidance, “Financial Conflict of Interest”, 2004
- FDA Draft Guidance, “Informed Consent, Additional Elements of Informed Consent”, July 2014
- SACHRP Recommendations, “Attachment D: Informed Consent and Waiver of Consent”, January 2013
- Global Alliance for Genomics and Health, “Regulatory and Ethics Toolkit”
- NIH Resource, “Informed Consent for Secondary Research with Data and Biospecimens”, May 2022
- NIH, National Human Genome Research Institute, “The Informed Consent Resource”
Open the accordion below for version changes to this guidance.
|Version Number||Posted Date||Implementation Date||Change Notes|
|1.2||09.18.2023||10.01.2023||Add information to “Why might you want, or not want, to participate?”; other minor updates.|
|1.1||08.31.2023||10.01.2023||Add instructions about requirements for describing procedures, risks, study withdrawal, and costs for experimental device research.|
|1.0||06.01.2023||10.01.2023||Newly published guidance|