Discussion

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.

Discussion

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.

Discussion

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.

Discussion

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.

Discussion

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.

Discussion

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.

Discussion

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.”

Discussion

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.

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.

Example language

“This study is being conducted by researchers at the University of Washington.”

Discussion

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.

Example language

“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).”

Discussion

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.

When subjects will undergo research procedures and clinical procedures, the consent process should first describe the care a patient would likely receive if they did not enroll in the research, if relevant, and then be presented with the information about the research procedures. For more information, refer to the discussion about disclosure of appropriate alternative procedures or treatments.

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.

Example language

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.

Discussion

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.

If the research includes use of investigational drugs or devices, the consent form cannot include statements that claim investigational drugs are safe or effective for the purposes of the investigation. Subjects should not be told that the FDA has given permission for or approved the clinical investigation.

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.

Example language

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.”

Discussion

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.

Example language

“In addition to the risks already listed, the research may involve previously unknown risks or side effects.”

Discussion

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.

Example language

“Participating in this research study will have no effect on your parole.”

Discussion

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 (e.g., drug administration, device implant, surgery, psychological therapy), the alternatives must include a description of the current standard of care they would be likely to receive if they choose not to participate in the research. This may vary depending on the research location and context. Alternatives might include approved therapies for the disease or condition, off-label use of a legally marketed drug or device, other forms of therapy such as surgery, or an alternative diagnosis. It could also mean receiving supportive or palliative care rather than a therapy or intervention.

The consent process should include a discussion of the alternative procedures or courses of treatment with the prospective subject. In this discussion, the prospective subject should be provided with information about the reasonably foreseeable risks or discomforts and the potential benefits of those treatments. This information does not need to be included in the research consent form and it may be more appropriate for the subject to talk to their primary care provider or another healthcare professional about participating in the research versus an alternative therapy.

Example language

[Include the language below if the research includes medical treatment.]

“If you choose not to participate in the research, the treatment/care available to you may include [list possible alternative treatment/care options here]. The research team will discuss these options with you and provide information about the risks and benefits. You may also wish to discuss these options with your doctor.”

Discussion

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.

Example language

“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].”

Discussion

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.

Example language

“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.”

Discussion

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.

Example language

[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.”

Discussion

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.

Example language

“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.”

[If it is important to provide subjects with more information about who has access to their financial information, include the following statement.] “In order to process your payment, we must input your name, contact information for payment (e.g., email address or mailing address) and social security number into the UW’s financial system. Your name and participation in this study will be visible to employees who handle financial transactions for the UW.” [For payments processed through non-UW institutions: If tax offices or others at the non-UW institution will have access to subject information, modify the language for UW to reflect that access.]

[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.”

Discussion

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.

Example language

“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).”

Discussion

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.

Example language

“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.”

Discussion

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.

Example language

“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.”

Discussion

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.

Example language

“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.”

Discussion

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.

Example language

“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].

Discussion

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.

Example language

“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].”

Discussion

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.

Example language

“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.]

Discussion

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 Genomic Data Sharing Certification 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.

Example language

[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.]

Discussion

First, review HSD’s guidance on Return of Individual Results to determine whether to return results. Then, use the information below to describe the return of results during the consent process.

The consent process provides participants with the information that they need to decide whether or not to participate in the research, but it should also be used to set clear expectations about the results that will be offered to participants. Participants may need help in deciding whether or not they want to receive the results and, even if a participant consented to receiving results at the start of the study, they should generally be given the opportunity to refuse or accept results when the results become available. The consent process should take into account the characteristics of the subject population, such as past experience and degree of health literacy. Depending upon the nature of the results that will be offered, the research design and the plan for returning results, consent may be a one-time event or an ongoing process involving a brief discussion of return of results at the start of the study and more details when results are found.

Consent information. HSD interprets the regulatory requirement to mean that the following information should be included in the consent form:

• An explanation of whether results will be returned, which results will be returned, whether the results are clinically actionable and if results will be returned only in specific circumstances. If there is no reasonable expectation of returning results, this should be stated. It may also be helpful to provide examples of the results that will be returned and appropriate reference information
• For studies that will only return results if indicated, information should be provided about the clinically actionable results that are known to be associated with a test or procedure and require return as well as an explanation of the likelihood of such findings
• For open-ended or hypothesis free studies where return of results is planned as part of the research objectives, information should be provided about the currently foreseeable results that will be offered
• A description of the process for communicating the results, including any plans to involve the participant’s healthcare provider
• The anticipated time-frame for when results will be available, if this can be known
• A statement about whether the results will be placed in the participant’s medical record and participant’s rights to access results from their medical record under HIPAA (which may be delayed until the end of the study when appropriate). It should also be made clear that results accessed in this way may not be meaningful to the participant without interpretation
• An explanation of the risks and benefits associated with receiving individual research results. It may be necessary to acknowledge the possibility that non-useful information or even incorrect information, such as false-positives, will be generated
• When relevant, an explanation of the participant’s option to have results shared with family members in the event the participant becomes incapacitated or deceased

Example language

“We will not provide you with your individual results for any of the research tests we run.”

“You will receive a link to a website where you can view the results of your flu test within a week of when your nose swab is collected. You can enter your nose swab barcode to view the results of your test when it is ready. The results will include advice on how to keep other people from getting sick and when you should see your doctor. You are not required to go to the website and look at your results if you do not want to. If you do not have access to the internet and would like to know your results, you can call us at (###) ###-####. We may not be able to give you your results if you lose your barcode.”

“When looking at your CT or MRI scans, there is a chance the study radiologists will find something unexpected that may require follow-up with your doctor. If that happens, we will contact you to by phone to talk about the results.
If you want, we can provide information about the results to your doctor or we will refer you to a doctor for follow-up. The CT and MRI that we are using for research may not be of the same quality as machines used for clinical care. Your doctor may require additional imaging. Costs for follow-up care will not be covered by the research study.
Learning about unexpected results like these may cause you to feel anxious. Information about your results will go in your medical record and will be accessible to people such as doctors and insurance companies. You may benefit if your results lead to early detection or treatment of a medical condition.”

Discussion

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.

Example language

[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.”

Discussion

Prospective subjects should be made aware that there is no obligation to participate in research.

Example language

“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.”

Discussion

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.

Example language

“We are receiving [financial support OR describe other type of support such as “the study drug”] from [insert sponsor name].”

Discussion

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.

In general:
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.

Example language

[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 hsdinfo@uw.edu 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.”

Discussion

This language is required and cannot be altered for all FDA-regulated applicable clinical trials and for NIH-funded clinical trials.

Example language

[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.”

Discussion

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.

Example language

“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.”

Discussion

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.

Example language

[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].

Discussion

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.

Example language

“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.”

Discussion

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.

Example language

“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].”

Discussion

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.

Example language

“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 hsdinfo@uw.edu.”

Criteria

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

Discussion

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.

Criteria

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 criterion applies only to studies approved after 01/21/2019]

Discussion

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.

Examples

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.

Criteria

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.

Examples

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.

Criteria

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.

Criteria

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.

Discussion

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.

Criteria

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.

Criteria

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.