Instructions are provided in yellow-highlighted italics. Delete all instructions (except in the Compensation for Injury section), or replace with the indicated information in bracketed sections, before submitting the consent form(s) to the UW Human Subjects Division.

Text. Most of the text provided below is example wording that can be replaced by other wording that conveys the same information. For example, the sponsor may have alternative wording. The few places where specific wording is required and cannot be changed are clearly indicated with red text. Example text should be included only after careful assessment of its relevance to your study, and may require revision to fit your study.

Yellow highlighted areas include instructions and suggested language.

Blue highlighted areas include instructions about elements that are not allowed and/or language that is not acceptable.

Sections and section headings. All sections are required except where explicitly stated. Section headings may be changed, or formatted as questions, if desired.

RESEARCH SUBJECT INFORMATION AND CONSENT FORM

TITLE:[The UW requires that this be the same as the protocol title.]

SPONSOR PROTOCOL #:[Insert sponsor’s protocol number.]

WIRB® Protocol #:[To be inserted by WIRB.]

HSD#:[To be inserted by WIRB.]

SPONSOR:[Insert sponsor’s name.]

INVESTIGATOR:[Insert principal investigator’s name and address.]

STUDY-RELATED

PHONE NUMBER(S):[Insert applicable study related phone numbers.]

For studies involving more than minimal risk, the UW requires that a 24-hour emergency telephone number be provided here, together with the name or position of the 24-hour contact person, immediately after any other study-related phone numbers.

Add the following statement or similar text only if the study protocol expressly allows the enrollment of subjects not capable of consenting for themselves: A person who takes part in a research study is called a research or study subject. In this consent form “you” always refers to the research subject. If you are a legally authorized representative, please remember that “you” means the research (study) subject.

SUMMARY

Summarize for the subject what the informed consent process will tell them, including:

  • How research differs from regular health care.
  • The rights and responsibilities of research subjects.
  • Information subjects should have before joining a research study.

The language provided here is an example.You are being asked to be in a research study. The purpose of this consent form is to help you decide if you want to be in the research study.

You should not join this research study until all of your questions are answered.

Things to know before deciding to take part in a research study: remove any that do not apply

  • The main goal of a research study is to learn things to help patients in the future.
  • The main goal of regular medical care is to help each patient.
  • The decision to join or not join the study will not cause you to lose any medical benefits. If you decide not to take part in this study, your doctor will continue to treat you.
  • Parts of this study may involve standard medical care. Standard care is the treatment normally given for a certaincondition or illness.
  • Other parts of this study may involve experimental (investigational) drugs, devices or procedures that are being tested for a specific condition or illness. An investigational [drug, device, vaccine] is one that has not been approved by the U.S. Food & Drug Administration (FDA).
  • After reading the consent form and talking with the research staff, you should know which parts of the study are experimental andwhich parts are standard medical care. You should also know what parts you would receive even if you weren’tin the study.
  • Your medical records may become part of the research record. If that happens, your medical records may be looked at or copied by the sponsor of this study. They may also be looked at or copied by government agencies or other groups associated with the study.
  • Your medical insurance may be billed for any standard medical care you receive during the study. If your insurance company is billed then it may have access to the research records. Insurance companies may not pay for treatment that is part of a study. Taking part in a study could affect your current or future insurance coverage.

If you take part in this research study, you will be given a copy of this signed and dated consent form.

PURPOSE OF THE STUDY

In simple language, explain the following:

  • Why the research is being done
  • What the experimental components are

PROCEDURES

In simple language and in a simple bullet format (whenever possible), explain the following:

  • The tests and procedures that will be done
  • Which procedures/drugs are standard care that would be done even if the person does not enroll in the study and which procedures (whether standard care or investigational) are for research purposes only
  • Whether a placebo or sham procedure will be involved
  • The chances of being assigned to various study arms
  • The method of assignment (random, etc.)
  • The expected duration of the subject’s participation. This may or may not include the time required for specific procedures or visits.
  • If it may be relevant to a subject’s decision about participation, describe the approximate number of subjects involved in the study.

RISKS AND DISCOMFORTS

In simple language and in a simple bullet format (whenever possible), explain the possible risks and discomforts:

Start with the side effects for the experimental drugs, devices, or procedures. List, for example:

  • most common
  • less common
  • rare

Follow with risks and side effects for all other drugs, devices or procedures used in the study.

If appropriate, include this statement. There may be side effects that are not known at this time.

Describe other risks of the study, if any. The language provided here is an example.Your condition may not get better or may get worse during this study.

If study drug is taken home, insert this or similar language. Only you should take the study drug. It must be kept out of the reach of children or anyone else who may not be able to read or understand the label.

If applicable, include any risks relative to pregnancy for both men and women. The language provided here is an example.Women who are pregnant or nursing a child may not take part in this study. Before entering the study, you and your study doctor must agree on the method of birth control you will use during the entire study. If you think that you have become pregnant during the study, you must tell your study doctor immediately. Pregnant women will be taken out of the study.

Men who are in this study should not get a sexual partner pregnant while taking the study drug If applicable, also add the following:and for [specify amount of time] after the last dose of study drug. The effect of the study drug on sperm is not known.

NEW INFORMATION Include this section if appropriate for the study.

The language provided here is an example.You will be told about any new information that might change your decision to be in this study. You may be asked to sign a new consent form if this occurs.

BENEFITS

In simple language indicate the possible benefit for the subject and others (such as futurepatients). Examples are provided here.

Your [name of condition] may improve while you are in this study; however, this cannot be promised. The results of this study may help people with [insert name of condition] in the future.

OR

It cannot be promised that you will receive any medical benefits from being in this study.

COSTSInclude this section if appropriate for the study.

In simple language state:

  • What will be billed to the subject or to their insurance
  • Do not use exculpatory language)

Example language is provided here.

[Sponsor Name]will provide the study [drug/device]free of charge during this study. Tests and procedures that are done only for the study will not be billed to you or your insurance company.

You or your insurance company may be billed for:

  • Any standard medical care given during this research study.
  • List other costs as necessary.

You may want to talk with your insurance company about its payment policy for standard medical care given during a research study. If your insurance company does not pay, you may be billed for those charges.

You might have unexpected expenses from being in this study. Ask your study doctor to discuss the costs that will or will not be covered by the sponsor. This discussion should include who will pay the costs of treating possible side effects.

PAYMENT FOR PARTICIPATIONInclude this section only if subjects will be paid or if the sponsor requires subjects to be told that they will not be paid. It should describe the pro-rated payment for each visit. Example language is provided here.

You will be paid [insert dollar amount or other form of payment] for each completed study visit. If you do not complete the study, you will be paid for the visits you have completed.

ALTERNATIVE TREATMENT

Disclose appropriate alternative procedures or treatments, if anythat might be appropriate for the subject. Example language is provided here.

If you decide not to enter this study, there are other choices available. These include: [List the major ones such as drugs/devices/procedures/supportive care].Ask the study doctor to discuss these alternatives with you. You do not need to be in this study to receive treatment for your condition.

OR

This is not a treatment study. Your alternative is not to be in this study.

FINANCIAL INTEREST

The following section and the exact text providedarerequired when any investigator (as defined by UW policy GIM 10) has a Financial Conflict of Interest as defined by UW policy GIM 10. If no one has a Financial Conflict of Interest, this section should be omitted. Complete the appropriate paragraphs for the type of financial interest and remove any paragraphs that do not apply. Note that the UW standard for a financial conflict of interest is different than WIRB’s standard as described in the WIRB submission form.

Income that is associated with a Financial Conflict of Interest

[Name] has a financial or leadership relationship with [company], who is [Describe the role of the company in the study.Examples: the study sponsor, supplying the drug, etc.]. [Name] is a [founder, scientific advisor, consultant, member of the board, chief scientific officer, other officer, etc.]. Add if applicable[Name] receives compensation for these activities in addition to [his/her] salary from the University of Washington. This financial interest and the design of the study have been reviewed and approved by the University of Washington. A Management Plan has been developed in response to this review.

Equity that is associated with a Financial Conflict of Interest

[Name] has [stock, stock options, an equity position] in [company], who is [describe the role of the company in the study; examples: study sponsor, supplying the drug, etc.][Name] may benefit financially, depending on the results of the study. This financial interest and the design of the study have been reviewed and approved by the University of Washington. A Management Plan has been developed in response to this review.

Inventor role that is associated with a Financial Conflict of Interest

[Name] contributed to the development of the [drug,device, technology, treatment, program, etc.] being studied and may benefit financially, depending on the results of the study. This financial interest and the design of the study have been reviewed and approved by the University of Washington. A Management Plan has been developed in response to this review.

CONFIDENTIALITY

The University of Washington does not allow the HIPAA authorization to be embedded in the consent form. This section should not contain any HIPAA specific elements.

This section should describe:

  • Who will have access to identifiable information about the subject
  • How the confidentiality of the information will be maintained (if applicable)
  • For FDA-regulated studies: the possibility that the FDA may inspect the records

For clinical trials that must be registered at ClinicalTrials.gov, include the following required statement (without any revision): A description of this clinical trial will be available on , 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.

If your research involves the use of clinical services, items, or tests through UW Medicine, UW Physicians (UWP), the Seattle Cancer Care Alliance (SCCA), or most uses of the UW Clinical Research Center (CRC), state:Your participation in this study will be noted in your UW medical record.

Example language is provided here.Information from this study will be given to the sponsor. “Sponsor” includes any persons or companies that are contracted by the sponsor to have access to the research information during and after the study.

The information may also be given to the U.S. Food and Drug Administration (FDA). It may be given to governmental agencies in other countries where the study [drug or device]may be considered for approval. Medical records which identify you and the consent form signed by you will be looked at and/or copied for research or regulatory purposes by:

  • the sponsor,

Delete the following if no CRO or SMO.

  • [CRO name],an agent for the sponsor, and
  • [SMO name],an agent for the study doctor,

and may be looked at and/or copied for research or regulatory purposes by:

  • the FDA,
  • Department of Health and Human Services (DHHS) agencies,
  • governmental agencies in other countries,
  • The University of Washington, and
  • Western Institutional Review Board® (WIRB®).

Absolute confidentiality cannot be guaranteed because of the need to give information to these parties. The results of this research study may be presented at meetings or in publications. Your identity will not be disclosed in those presentations.

COMPENSATION FOR INJURYIf the study involves more than minimal risk, this section is required and must inform the subjects what medical treatment is available if any injury occurs, how to obtain it, and who will pay for it.Insert language supplied by sponsor.

When submitting the consent form to the sponsor/CRO for approval, retain the instructions in this section so that the sponsor/CRO is aware of their responsibilities concerning this section.

Sponsor and PI Responsibilities as expected by the University of Washington:

  • Ensuring that the Compensation for Injury section is consistent with the negotiated contract, and
  • Ensuring that the Compensation for Injury section does not contain language inconsistent with the Medicare Secondary Payer (MSP) rule. The MSP rule states that Medicare does not have primary payment responsibility when another entity has promised to pay. If the contract states that the sponsor will cover the costs of treating research injuries (i.e., making them the primary payer), the consent form cannot state that the subjects’ insurance will be charged. If the contract states that the subjects’ insurance will be charged first (primary payer) and that the sponsor will pay any remaining costs, then the contract and consent form must explicitly exclude federally funded insurance (i.e., Medicare, Medicaid, and Tricare) from this arrangement.

The following are examples of acceptable language by which the subjects’ insurance may be charged before the sponsor. This language should be used only if the contract statesthat subjects’ insurance will be charged:

  • YOU MAY USE THE FOLLOWING LANGUAGE.“If you do not have health care coverage or insurance, or if your coverage is provided by a federally-funded governmental program such as Medicare, Medicaid, or Tricare, the sponsor will pay for the cost of treating your illness or injury. If you have private health coverage, your insurer will be billed for the treatment.”
  • YOU MAY USE THE FOLLOWING LANGUAGE.“If you sustain physical illness or injury as a result of the study drug, the sponsor will reimburse the institution for the costs of your medical treatment for this physical illness or injury. This reimbursement will only be made for costs not covered by your own third-party non-governmental insurance.”

The following are examples of language not allowed by the UW because it puts Medicare in the position of being the primary payer when another entity has also promised to pay: