Informed Consent: Additional Model Language

Click on each subject topic to view model language

General

Assent and Parent/Guardian Permission Banking of Data and/or Biospecimens for Future Use Certificate of Confidentiality (COC)
ClinicalTrials.gov Commercial Products Conflict of Interest (COI)
Emailing to Communicate with Subjects Enrolling Students or Employees Genetic Information Nondiscrimination Act (GINA)
Genetic Research Genomic Data Sharing (GDS) Abuse or Neglect Reporting
Illegal Substance Use or Illegal Activities Reproductive Risks Sharing of Data, Specimens, Images for Research Purposes
Signature Sections Video, Audio Recordings, or Photos

Clinically Relevant Findings

Incidental Findings Psychological Assessments Results of Research Tests on Biospecimens
Sexually Transmitted/Communicable Disease Testing

Instructions:

When a study includes minors (<18 years of age) as participants, the consent form is used to document parent/guardian permission for the child to participate in research. The consent form may also be used to document assent from older adolescents (typically, for 15 – 17 years of age). In these situations, the consent form needs to identify clearly and consistently who it is addressing: the parent/guardian, the child participant, or both. How best to do this depends on the subject population. General recommendations:

  • For studies that enroll only young children, use “your child,” “he/she,” etc. throughout the parent/guardian permission form to refer to the minor participant.
  • For studies that enroll only older adolescents, use “you” throughout the form to refer to the minor participant. In this case, also add a signature section for the minor subject document their assent.
  • For studies that enroll both younger children and older adolescents, choose an approach that is appropriate for the majority of the subject population. For example, if most participants will be young children, using “your child,” “he/she,” etc. may be appropriate.
  • For some studies, it may be clearer to use age-appropriate assent forms for all child participants, rather than using the parent/guardian permission form to document assent.
  • If the parent/guardian also participates in study activities, clearly describe which activities are for the minor participant, which are for the parent/guardian, and which activities are for both the child and parent/guardian. For some studies, it may be clearer to use separate documents describing the parent/guardian’s and the child’s activities.

Use the following model language as a guide.


Model Language:

Add the following statement at the beginning of any Parent/Guardian consent form:

If you are the parent or legal guardian of a minor who is invited to take part in this study, your child can participate in the study only if you give your permission.

If assent from child participants is required for the study, add:

We will also ask your child if he/she is willing to take part in the study.

If the form is addressed to older adolescents, to document their assent as well as parent/guardian permission, add:

In this consent form, “you” means the child who takes part in the study.

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Instructions:

Include the following language for studies that include banking of biospecimens and/or data as a secondary aim of the study. If the study’s primary purpose is to create a data or biospecimen repository, the details of the banking procedures should be laid out in the main body of the consent form. (See Recruitment Registry, Data Repository, and Tissue Repository Guidance for more information about data and biospecimen repositories.) When describing banking for future research:

  • Clearly describe the biospecimens and/or data to be banked for future use (including data associated with biospecimens).
  • Clearly describe how the biospecimens and/or data will be obtained (e.g. biospecimens left over from routine tests or procedures vs. biospecimens collected specifically for banking, data from medical records vs. data from questionnaires conducted specifically for research). Make clear if collecting the biospecimens/data involves additional procedures that subjects will undergo only if they agree to banking.
  • Make clear whether the banking of their data/biospecimens is required, or whether it is an optional part of the study. If banking is an optional study component, describe it in an “Optional Studies” section at the end of the consent document. Note: Mandatory banking is typically acceptable only for non-treatment studies.
  • If there are research activities that will be performed only with banked data/biospecimens (e.g., genetic testing, creation of cell lines), describe these activities in this section.
  • If you may share the data/biospecimens outside your research team, state this. If the recipient investigators could be outside the University of Wisconsin-Madison, then state this.
  • Describe risks related to banking of biospecimens and/or data. Loss of confidentiality should always be identified as a risk of banking. However, if the information being stored is sensitive (e.g. a breach could damage the participant’s reputation, or pose legal risks), or if future research with banked biospecimens may generate sensitive data (e.g. identify predisposition to disease or other information that could affect the participant’s well-being, relationships, insurability, employability, etc.), then describe these possible consequences of a breach of confidentiality.
  • If you are banking biospecimens, Commercial Products language may apply; include the commercial products language in this section.
  • For optional banking, provide yes/no checkboxes that clearly describe each option. For example, if subjects can opt to allow banking of data OR banking of biospecimens, provide separate checkboxes for the subject to complete. If subjects can choose not to have extra biospecimens collected specifically for banking, but allow banking of left over biospecimens, provide separate check boxes for these choices.


Model Language:

What will happen to my [data / biospecimens / data and biospecimens] after my participation ends? We [will OR would like to, if optional] keep your [data / biospecimens / data and biospecimens] for [X period of time OR an indefinite period of time, meaning we have no plans of ever destroying your data / biospecimens]. Keeping data or biospecimens for future research is called “banking.” The banked [data / biospecimens] will be kept in a secure location for use by researchers.

This is what will happen with your banked [data / biospecimens / data and biospecimens]:

  • We will use the [data / biospecimens / data and biospecimens] in future research projects about [describe future uses, such as research on a specific disease]. We may also use them for other types of research.
  • If you may share the data/biospecimens outside your research team, add: The [data / biospecimens / data and biospecimens] may be shared with other researchers at the University of Wisconsin-Madison [if sharing outside UW, add: and outside the University. Outside researchers may be at other universities, private companies, or other kinds of organizations.

Text to include if banked data/biospecimens are coded; DELETE if not applicable:

  • The banked [data / biospecimens / data and biospecimens] will be labeled with a code instead of your name.
  • When we give your [data / biospecimens / data and biospecimens] to other investigators for research projects, they will not be able to use the code to figure out which [data / biospecimens / data and biospecimens] are yours.
  • The research team will maintain a link between your [data / biospecimens / data and biospecimens] and your identifiable information kept by the study team.
  • You can request to have your [data / biospecimens / data and biospecimens] removed from the bank by contacting the research team at any time.

Text to include if data/biospecimens will be anonymized for purposes of banking; DELETE if not applicable:

  • The banked [data / biospecimens / data and biospecimens] will be labeled in a way so that no one can identify which [data / biospecimens / data and biospecimens] came from you.
  • This means that if you decide at a later time that you do not want your [data / biospecimens / data and biospecimens] used for other research, we will not be able to remove your [data / biospecimens / data and biospecimens] from the bank.

This is what will NOT happen with your banked [data / biospecimens / data and biospecimens]:

  • Banked [data / biospecimens / data and biospecimens] will not be shared with your health care providers or used in your treatment outside this study.

Text to include if banking is optional. Include additional yes/no options if data and biospecimens are banked separately:

Please initial one of the lines below to indicate whether or not you agree to the optional [data / samples / data and samples] banking:

____     Yes, I agree to have my [data / biospecimens / data and biospecimens] banked for future research purposes.

____     No, I DO NOT agree to have my [data / samples / data and biospecimens] banked for future research purposes.

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Instructions: Consent forms should include information about Certificates of Confidentiality (CoCs) in the following circumstances:
  • The study is supported by National Institutes of Health (NIH) funds (whether directly funded or receiving funds indirectly, such as some grants from UW-Madison Institute for Clinical and Translational Research, ICTR), and approved on or after December 13, 2016. Such studies are automatically covered by a CoC.
  • The study is not NIH funded, but the IRB requires the study team to obtain a CoC because the study collects sensitive data which will remain identifiable.
For guidance on Certificates of Confidentiality, see
HS IRBs consent form templates now include a brief statement about CoCs in the confidentiality section.


If you are not using an HS IRBs consent template, add the following language to the confidentiality section of your consent form:

The study has a Certificate of Confidentiality from the [name of issuing agency, such as the National Institutes of Health or FDA]. A Certificate of Confidentiality prohibits researchers from disclosing information or biospecimens that may identify you in a legal proceeding or in response to a legal request without your consent.

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Instructions:

Include the following language for studies that must be registered on clinicaltrials.gov. When including this language:

  • Registration may be required due to Food and Drug Administration (FDA) requirements, NIH requirements for studies meeting the definition of clinical trials, or International Committee of Medical Journal Editors’ (ICMJE) requirements. Guidance on registration requirements can be found here.
  • If you have questions about whether your study should be registered, contact CT.gov Support, Office of Research Policy at (608) 890-1241 or ClinicalTrials.gov_Support@research.wisc.edu.


Model Language:

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.

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Instructions:

Include the following language whenever data, images, or samples collected for the project may be used to develop products that may have commercial value in the future.

  • In many cases, this language applies only to one component of the study (such as a sub-study or banking for future unspecified use) and should be included as part of the description of that study component.
  • If this language applies to the study as a whole, it should be included in the section “Will I be Paid or Receive Anything for Participating?”


Model Language:

Researchers may develop products from the samples and information you provide for this study. Some of these products may have commercial value. If the research team or others use your samples or information to develop products of commercial value, you will not receive any profits from products created from your samples or information.

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Instructions:

  • Include the following language when a member of the study team has a conflict of interest (COI) in an entity that is sponsoring the study or that owns or licenses a technology used in the study.
  • Add the disclosure to the funding information in the "Why are the researchers doing this study?" section.


Model Language:

A member of this research team has a personal interest in or might profit financially from the results of this study. This is called a “conflict of interest.” The University of Wisconsin-Madison manages conflicts of interest so that they do not affect study participants or the quality of the data collected. Include if person’s role on the study is limited: Researchers with a conflict are not allowed to obtain informed consent or recruit potential subjects. We are telling you about the conflict of interest in case it affects whether you want to take part in this study.

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Instructions:

The following is template language for consent forms that should be used whenever email will be used to communicate with subjects as part of a study. Language in blue should be updated with information specific to the study.


Model Language:

We are requesting your email address so we can [describe how email will be used in the study]. Email is generally not a secure way to communicate about your health as there are many ways for unauthorized users to access email. You should avoid sending sensitive, detailed personal information by email. Email should also not be used to convey information of an urgent nature. If you need to talk to someone immediately, please contact [Name, Title, Phone Number for appropriate contact person, such as the lead investigator or physician on call].You do not have to provide your email address to participate in this study.


Yes, you may use email to contact me for this study.

No, I do not want to be contacted by email.

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Instructions:

Use the following language if your study specifically targets UW students or UW employees as subjects, in place of the template paragraph that says the subject’s decision will not affect their treatment relationship with UW providers.


Model Language:

For studies targeting UW students:

If you decide not to take part in the study, or if you choose to leave the study, your choice will not affect your class standing at the University of Wisconsin-Madison. No matter what decision you make, and even if your decision changes, there will be no penalty to you. You will not lose any legal rights.

For studies targeting UW employees:

If you decide not to take part in the study, or if you choose to leave the study, your choice will not affect your employment at the University of Wisconsin-Madison, any organizations affiliated with UW-Madison, or UW Health. If you receive health care from UW Health, if you decide not to take part in the study, or if you choose to leave the study, your choice will not affect your care through UW Health. No matter what decision you make, and even if your decision changes, there will be no penalty to you. You will not lose any legal rights.

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Instructions:

  • Include the following language in the consent form for studies that involve genetic research relevant to the participant’s genome (as opposed to, for example, the genetics of a tumor cell).
  • Add GINA language to the risks section in the main body of the consent form when the genetic research is part of the main study.
  • Add GINA language to the Optional Studies portion of the consent document when the genetic research is part of optional sub-studies or banking for future research.


Model Language:

The Genetic Information Nondiscrimination Act of 2008 is a Federal law that is supposed to prevent health insurance companies and employers from discriminating against people based on genetic information. There are some limits to this law:

  • It does not apply to businesses that employ fewer than 15 people. So, if you work somewhere with fewer than 15 employees, your employer could fire you or make other decisions about employment using genetic information.
  • Regardless of where you work, it does not apply to life insurance, disability insurance, or long-term care insurance.
    • This means that if you had an abnormal genetic test result, and that result became known, then you could be denied or pay higher rates for life insurance, disability insurance, or long-term care insurance.

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Instructions:

  • Add this language to the main body of the consent form when genetic research is part of the main study.
  • Add this language to the Optional Studies portion of the consent document when the genetic research may be done as part of optional sub-studies or in future research using banked specimens.
  • Include the statement about whole genome testing if the research will (or might) include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).
  • See HS IRB Genetic Testing or Analysis guidance for more information about genetic risks.


Model Language:

Some of the tests we will perform on your [blood/tissue/etc.] will be genetic testing, which is done on your DNA. DNA, or deoxyribonucleic acid, carries the genetic instructions for the cells that make up your body. Genes tell your body how to do things like form your spine, or what color your eyes should be. Include the following for whole genome testing:We will do whole genome testing for this study. Your “genome” is the complete DNA instruction book. “Whole genome testing” means making a list of the entire order, or sequence, of the DNA in your genome.

Text to include in the risk section for any study involving genetic testing in families:

You should be aware that we might find instances of non-paternity. For example, if a person you believe is one of your parents is actually not your biological parent, the testing may reveal this. If this occurs, we will not tell you about it, but there is always a chance that someone outside of the study could find out about the results and you could still find out.

Text to include in the risk section if the study involves the release of samples to other researchers for what could include genetic testing:

The DNA samples and information sent to other researchers will not include personal information like your name or your birthdate. However, even without your name or other identifiers, your genetic information is unique to you, like a fingerprint. Scientists expect that over the next few years, researchers will be able to look at your genetic information and be able to trace the data back to you (and potentially also to your blood relatives).

Text to include in the risk section for studies enrolling hundreds of subjects, and involving genetic testing looking at incidence of disease:

Research has already shown that some populations are more likely to develop certain diseases than others. For example, sickle cell anemia is more common in people of African, African American, or Mediterranean heritage. By participating in this research, your genetic information could help researchers find out if members of a specific population are at greater risk for specific diseases. Some people have been concerned that this information could be used to stereotype all members of a population group, even if not everyone in that group is at risk for the disease common in their racial or ethnic heritage.

Text to include in the risk section for any study that is banking specimens for future unspecified or genetic research:

There may be other risks related to genetic testing that we don’t know about right now. This is because the field of genetics is moving forward very quickly.

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Instructions:

Include the language below if genetic data may be shared, now or at some time in the future, with public data repositories under the NIH Genomic Data Sharing (GDS) Policy. This includes:

  • NIH-funded studies
  • Studies likely to receive NIH funding in the future
  • Collaborative research with someone who has NIH funding
  • Studies that will voluntarily share data with public repositories


Model Language:

[At some point in the future], we are [may be] required to share genetic data with federal repositories. [Because this research receives funding from the National Institutes of Health (NIH), we will submit your genomic information to a public repository approved by NIH. NIH is a national research agency and is part of the federal government.] The NIH and other central repositories have developed special data (information) banks that collect the results of genetic studies, especially when the research looks at all or large sections of individual’s genetic code. This is often called whole genome sequencing. Genomic information relates to the structure and function of all of the genetic material in the body. These central banks will store your genetic information and give them to other qualified and approved researchers to do more studies. The data that we share with federal repositories will be coded in such a way that you would not be able to be identified. We will not share your name, birth date, or any other information that could directly identify you. The link to the code would be kept securely at the UW. Even so, there is a possibility that when your genomic information is combined with other information available to researchers, either now or in the future, they may be able to identify a group you belong to (like an ethnic group or a disease population) or, less likely, you personally. NIH prohibits people from trying to identify individuals whose genomic information is in an NIH-designated repository.

We do not think that there will be further risks to your privacy and confidentiality by sharing your genetic information with these banks. However, we cannot predict how genetic information will be used in the future. The genetic data could be used to study a wide variety of diseases.

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Instructions:

Because it is possible in any research study for the study team to observe or learn of situations that trigger mandatory reporting, the HS IRBs now require all consent forms to inform participants about reporting requirements. HS IRBs consent form templates include this information in the confidentiality section.


If you are not using an HS IRBs consent template, add the following statement to the confidentiality section of your consent form:

We may have to tell appropriate authorities, such as child protective services or health care providers, if we learn during the study that you or others are at risk of harm (for example, due to child or elder abuse, or suicidal thoughts).

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Instructions: Include this language in the consent form's risks section if your study collects identifiable data about subjects' illegal activities (e.g., illicit drug use, underage drinking) or retains identifiable results from toxicology tests.

The HS IRBs may require a Certificate of Confidentiality for studies that collect identifiable information about illegal activities. See Certificate of Confidentiality model language and guidance for more information.


Model Language:

This study involves [testing for  /  asking questions about] illegal [substances / activities (e.g., abusive behavior, driving drunk, drug use]. There is a chance that someone outside of the study could find out about the [results of the testing / answers to your questions]. If that happens, this could expose you to legal risks or damage your reputation. We will try to keep others from getting this information by [briefly describe of confidentiality protections].

For studies conducted in Wisconsin that include people who could become pregnant and involve asking questions about illicit drug use or alcohol abuse, or performing toxicology tests to obtain this information, add the following:

Pregnant people who abuse illegal drugs or alcohol may be reported by members of the research team to county social services under Wisconsin state law. Although this rarely happens, county social services may decide to place pregnant people found abusing drugs or alcohol to a severe degree in custody to protect the fetus.

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Instructions:

Include this language whenever a study involves drugs, devices, or procedures with potential risks to subjects’ reproductive potential, or to embryos, fetuses, or breastfeeding infants. When including this language:

  • If a study drug/device/procedure is a known teratogen, state that it is known to cause birth defects. If the risk to embryos or fetuses is unknown, say that the study drug/device/procedure may cause harm.
  • Specify if the study requires pregnancy testing.
  • If the protocol requires particular methods of contraception, describe the methods in general terms, such as barrier or hormonal methods. If the protocol requires avoiding pregnancy after active study treatment is stopped, inform subjects of this. Provide detailed instructions about contraception in a separate document, not in the consent form.
  • Avoid wording that assumes all subjects are heterosexual or sexually active.
  • If your study enrolls minors, see Health Sciences IRBs guidance on Pregnancy Testing in Minor Research Subjects and include study-specific information in the parental permission form.


Model Language:

Text to include when risks to embryos/fetuses are unknown, pregnancy testing is not required, and there are no specific requirements for male subjects:

The study [drug(s)/device(s)/procedure(s)] may harm a fetus or breastfeeding baby. If you are pregnant or breastfeeding you cannot take part in this study. If you think you may be pregnant, you should not volunteer for this study.

Text to include when pregnancy testing is required:

The study [drug(s)/device(s)/procedure(s)] may harm a fetus or breastfeeding baby. If you are pregnant or breastfeeding, you cannot take part in this study. If you are able to become pregnant, you must have a pregnancy test before you begin the study [if tests are repeated, add:and while you are in the study]. You should not get pregnant, breastfeed, or father a baby while in this study. All study participants must avoid becoming pregnant or causing a pregnancy while they are [on study treatment/going through study procedures/for X amount of time after treatment].

Text to include when MRIs are performed for research and the study does not propose to enroll pregnant women (female subjects only):

Although there is no evidence that MRI scans can cause harm to a fetus, there may be risks to a fetus that are not known at this time. For these reasons, this study is not approved for the enrollment of pregnant women. You should only take part in this study only if you are certain you are not pregnant.

I confirm that I am not pregnant and am not planning on becoming pregnant during this study.

_______________________________________

Signature of subject and date signed

Text to include when contraception is required:

Because taking the study drug during pregnancy may cause birth defects, safeguards are required to avoid becoming pregnant or causing a pregnancy. If you or your partner can get pregnant, it is important while on this study for you to either use birth control or not have sex that could result in pregnancy. Check with your study doctor about what kind of birth control methods to use and how long to use them. Some birth control methods might not be approved for use in this study.

Women should not breastfeed while on this study. Check with your doctor about how long you should wait to breastfeed after you stop study treatment.

Text to include when study drugs, devices, or procedures may damage subjects’ reproductive potential. If you will exclude a gender, delete the unnecessary language:

If you can become pregnant, the study [drugs/devices/procedures] may make it difficult or impossible for you to get pregnant in the future. If you can get your partner pregnant, the study [drugs/devices/procedures] may make it difficult or impossible for you to get your partner pregnant in the future.

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Instructions:

Include the following language in the “What will I do in this study?” section whenever data, specimens, or images will be shared outside of the University of Wisconsin-Madison. When including this language:

  • It should be clear whether the sharing is of identifiable or de-identified information. The definitions of “identifiable” and “de-identified” can be found here. Template language is provided for each scenario.
  • If data are being shared with the sponsor or publisher and that data may be made available to other researchers, the template language for sponsors/publishers should be included.


Model Language:

Text to include if sending de-identified data/samples/images to other researchers:

[Data/samples/images] will be sent to researchers outside of the UW-Madison for [explain why the samples are being sent outside of the UW]. Any personal information that could identify you will be removed before the [data/samples/images] are shared.

Text to include if sending identifiable data/samples/images to other researchers:

[Data/samples/images] will be sent to researchers outside of the UW-Madison for [explain why the samples are being sent outside of the UW]. The [data/samples/images] that are sent to these researchers will contain identifiable information including [describe the identifiable information that will be associated with the data]. Identifiable information is being sent to these researchers because [explain the purpose of sending identifiable data to researchers outside of the UW].

Text to include if sharing data with publishers/sponsors:

Data collected for this research may be [shared with the study sponsor or published in journals or magazines]. When the data are shared with [sponsors or publishers] it will not be shared in any way that can identify you personally. Data shared with [sponsors or publishers] may be used by other researchers outside of the University of Wisconsin-Madison, but only data that cannot identify you personally will be used. There are no limits on who might use these data or how the data may be used in the future.

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Instructions for studies including children (<18 years old):

    The consent form is used to document parent/guardian permission for the minor child to take part in the study. Only in rare situations are minors allowed to participate in research without parent/guardian permission.

  • For studies that are no more than minimal risk, or that are more than minimal risk but may offer direct benefit to the child, the IRB may find that the permission of one parent/guardian is sufficient.

  • Studies that are more than minimal risk but do not offer direct benefit to the child require permission from both parents/guardians unless one parent/guardian is deceased, unknown, incompetent, or not reasonably available, or when only one parent/guardian has legal responsibility for the care and custody of the child.
  • Older adolescents (typically 15 – 17 years old) may sign the parent/guardian consent form to document their assent to participate, along with the signature of their parent(s)/guardian(s).
  • If you are using one of the consent form templates that includes HIPAA language, include the text in blue to address HIPAA requirements.


Model Language:

Agreement to participate in the research study

You are making a decision whether or not to have your child participate in this study. You do not have to sign this form. If you refuse to sign, however, your child cannot take part in this research study.

If you sign the line below, it means that you have:

  • read this consent [and authorization] form describing the research study procedures, risks and benefits
  • had a chance to ask questions about the research study and your child’s participation, and received answers to your questions
  • decided to allow your child to participate in this study
  • given authorization for the person’s protected health information to be used and shared as described in this form

If ICH-GCP guidelines apply to the study, add: You will receive a signed and dated copy of this form for your records.

__________________________________________

Printed Name of Parent/Guardian

__________________________________________             _________________

Signature of Parent/Guardian                                                             Date

__________________________________________

Printed Name of Parent/Guardian

__________________________________________             _________________

Signature of Parent/Guardian                                                             Date

__________________________________________

Printed Name of Subject (age 15 – 17)

__________________________________________             _________________

Signature of Subject (age 15 – 17)                                                     Date

__________________________________________             _________________

Signature of Person Obtaining Parental/Guardian                             Date

Permission and Authorization and Child Assent


Instructions for studies including adults who lack capacity to consent:
  • An IRB must specifically approve inclusion of adults who lack consent capacity.
  • Adults who cannot provide informed consent may be enrolled in research only in certain situations per Wisconsin law.
  • University of Wisconsin-Madison policy follows state law, which specifies who may serve as a legally authorized representative (LAR) and provide surrogate consent on behalf of a person who lacks capacity.
  • The consent form must direct the LAR to base his/her decision about study participation on the subject’s wishes, or, if the subject’s wishes cannot be determined, on what the LAR believes to be in the subject’s best interest.
  • If you are using one of the consent form templates that includes HIPAA language, include the text in blue to address HIPAA requirements.


Model Language:

Agreement to participate in the research study

If you are a Legally Authorized Representative (LAR) for the person being invited to take part in this study, you are deciding whether the person can be in this research study. You do not have to sign this form. If you refuse to sign, however, the person cannot take part in this research study.If you sign the line below, it means that:

  • you believe the person wants, or would want, to be in the study;
  • OR, if you cannot find out if the person wants to take part, you believe that participating in the study is in the person’s best interest
  • you give authorization for the person’s protected health information to be used and shared as described in this form

If ICH-GCP guidelines apply to the study, add:You will receive a signed and dated copy of this form for your records.

__________________________________________

Printed Name of Study Participant

__________________________________________             _________________

Signature of Legally Authorized Representative                              Date

__________________________________________             _________________

Signature of Person Obtaining Consent                                           Date

and Authorization


Instructions for studies including adults who are unable to read:
  • This applies only to studies that are obligated to adhere to ICH-GCP guidelines.
  • If the study is likely to enroll adult subjects who are unable to read (or the subject’s LAR is unable to read), ICH-GCP requires that an impartial witness be present for the whole consent process, make sure everything is read correctly, and make sure that all the subjects’ questions are answered.
  • Per ICH-GCP guidelines, an impartial witness is a person who is independent of the trial, who cannot be unfairly influenced by people involved in the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.
  • In addition to the signature blocks for the subject and the person obtaining informed consent, the consent form must include a signature block for the impartial witness, with an explanation that this block is only to be used when necessary.
  • Note: An impartial witness should only be used when the subject (or subject’s LAR, if applicable) cannot read. If the subject/LAR can read in their native language, but not in English, ICH-GCP requires the consent form to be provided in a language that the subject can read and understand.


Model Language:

Use the signature area below only when necessary.

If the participant [participant’s LAR] cannot read, and you are the witness to the consent process, your signature indicates that:

  • you were present for the whole consent process;
  • you have made sure that the information in the consent form (and any other written information) was accurately explained to the participant [participant’s LAR];
  • all the participant’s [participant’s LAR’s] questions have been answered
  • the participant [participant’s LAR] freely consented to take part in the study.

__________________________________________

Printed Name of Impartial Witness

__________________________________________             _________________

Signature of Impartial Witness                                                             Date


Instructions for obtaining electronic signatures: Consent documents may be presented to potential participants in an electronic format. See HS IRBs Electronic Consent Guidance for detailed information. When signed consent is required, there are several acceptable methods for obtaining an electronic signature; these are detailed in the guidance document. Below is an example of one method of documenting informed consent in an electronic form.

  • Include blue text if you are using a consent template that includes HIPAA language.


Model Language:

Agreement to participate in the research study

You do not have to sign this form. If you refuse to sign, however, you cannot take part in this research study.

If you check the box and fill in your name below, it means that:

  • You have read this consent and authorization form.
  • You have had a chance to ask questions about the research study, and the researchers have answered your questions.
  • You want to be in this study.
  • You give authorization for your protected health information to be used and shared as described in this form.

Step 1. Check the box below

Step 2. Type in your name

First name:

Middle initial:

Last name:

Suffix:

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Instructions:

Include the following language whenever audio recordings, video recordings, or photographs of research participants are collected as part of a study. When including this language:

  • If recordings/photographs are a required component of the study, describe this activity in the main body of the consent document. If recordings/photographs are optional, describe this activity in an Optional Studies section at the end of the consent form.
  • Provide a detailed description of what recordings/photographs are being collected and the purpose of their collection.
  • Indicate if video or audio recordings will be transcribed.
  • Describe what will happen to the recordings after the study is completed. Three template options are provided and one of the three options should be selected. The options are 1) destroying recordings/photos, 2) retaining de-identified recordings/photos for future use, or 3) retaining identifiable recordings/photos for future use.


Model Language:

As part of the study we will collect [describe the audio/video recordings/photographs that are collected and when (e.g., photographs of your hand before and after you undergo surgery, video recordings of you during the interview procedures)]. The [audio/video/photographs] are being collected for [describe purpose of recordings/photographs]. If recordings are transcribed: A written copy of the recordings will be made for use in the research.

Choose one of the following to include:

Text to include if plan to destroy the recordings/photos:

[Recordings/photos] will be kept for [amount of time they will be stored] and destroyed following [transcription, analysis, completion of the study, etc.]. [Images/recordings] will not be used for purposes outside of the study or in any papers or publications.

Text to include if plan to retain de-identified recordings/photos:

[Recordings/photos] will be kept indefinitely (banked), meaning we have no plan to destroy the [recordings/photos]. The [recordings/photos] may be used in the future for [describe how recordings/photos may be used (e.g., educational purposes, future research, publications)]. The [recordings/photos] will be edited to remove all of your identifying information before they are banked.

Text to include if plan to retain identifiable recordings/photos:

[Recordings/photos] will be kept indefinitely (banked), meaning we have no plan to destroy the [recordings/photos]. The [recordings/photos] may be used in the future for [describe how recordings/photos may be used (e.g., educational purposes, future research, publications)]. When the [recordings/photos] are used in the future we will edit them whenever possible so that you cannot be directly identified in the [recordings/photos]. Include if retention of recordings/photos is optional: However, with your permission, we may use [images/recordings] that could identify you for [describe how identifiable recordings/photos may be used]. Please initial one of the lines below to indicate whether or not you agree to the use of your identifiable [recordings/photos]:

____ Yes, I agree that [recordings/photos] that can identify me can be used for the purposes described above.

____ No, I DO NOT want [recordings/photos] that can identify me to be used for the purposes described above.

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Instructions:

See Incidental Findings from Medical Imaging guidance for detailed HS IRBs guidelines regarding review of images for, and disclosure to subjects of, incidental findings.

  • Include the following model language in the consent form section "Will I receive the results of research tests?" for studies that involve imaging for research purposes, to describe how incidental imaging findings will be handled.
  • The model language below is intended primarily for studies involving research imaging of the brain, but can be adapted for other types of imaging.


Model Language:

Add the following statement if there will be no disclosure of any findings:

Possible Discovery of Findings Related to Medical Imaging

Whenever an [MRI, CT, X-ray, etc.] of the brain is done, there is the chance of finding something unexpected. There may be benefits to learning such results (such as early detection and treatment of a medical condition), but there are risks as well (such as problems with getting insurance or a job, or feeling worried about a finding for which no treatment is required or appropriate).

The [MRI, CT, X-ray, etc.] we are using in this research study is not the same quality as a [MRI, CT, X-ray, etc.] that you may have as part of your health care. The images from the [MRI, CT, X-ray, etc.] will not be reviewed by a physician who normally reads such images (such as a neuroradiologist). As a result, you will not be informed of any unexpected findings. The results of your [MRI, CT, X-ray, etc.] will not be placed in your medical record. If you believe you are having symptoms that may require clinical imaging, you should contact your primary care physician.

Add the following statement if there will be disclosure of findings of clinical significance ONLY:

Possible Discovery of Findings Related to Medical Imaging

Whenever an [MRI, CT, X-ray, etc.] of the brain is done, there is the chance of finding something unexpected. Unexpected findings can have clear clinical significance, or uncertain clinical significance. Clear clinical significance means that the [MRI, CT, X-ray, etc.] shows a problem that may be treatable and we generally know what the risks are of not treating the problem. Uncertain clinical significance means that the imaging shows something unusual in the brain, but we do not know if it might affect your health, and treatment may not be appropriate or possible. On this study, you will be informed of any findings of clear clinical significance that may be discovered during the imaging procedure, but you will not be informed if there are findings of uncertain clinical significance. In order to assist us in interpreting the results of your [MRI, CT, X-ray, etc.], we are also seeking your permission to review your medical records if you are or have been a patient at this hospital. The [MRI, CT, X-ray, etc.] and report from this research study will not be placed in your medical record.

There may be benefits to learning such results (such as early detection and treatment of a medical condition), but there are risks as well (such as problems with getting insurance or a job, or feeling worried about a finding for which no treatment is required or appropriate). The [MRI, CT, X-ray, etc.] we are using in this research study is not the same quality as a [MRI, CT, X-ray, etc.] that you may have as part of your health care. If you believe you are having symptoms that may require clinical imaging, you should contact your primary care physician.

If this study involves a series of research [MRIs, CTs, X-rays, etc.], the first [MRI, CT, Xray, etc.] you have will be reviewed by a physician who normally reads such images (such as a neuroradiologist), but each [MRI, CT, X-ray, etc.] after that will not necessarily be reviewed by such physician. As a result, we may only inform you of findings of clear clinical significance that we discover from the first [MRI, CT, X-ray, etc.].

If the images will be reviewed by a central reader, include the paragraph below:

While your [MRI, CT, X-ray, etc.] will be conducted here at [UWHC, UWMF, etc.], no UW physician will review the [MRI, CT, X-ray, etc.]. Rather, your images will be reviewed by a “central reader”, a physician designated by the sponsor of this trial to review all of the images. We will inform you of any findings of clinical significance that the central reader tells us about.

You may also choose to have your physician informed of any findings of clear clinical significance that we report to you by checking the box below. Please note, however, that if you choose to have your physician informed of findings of clinical significance, that report will likely be placed in your medical record.

Please indicate your preference by checking the appropriate box:

____     Yes, please inform my doctor of findings of clinical significance

OR

____     No, please do not inform my doctor of findings of clinical significance

Name of physician to contact

If you do wish us to report any findings to your physician, you must provide us with the name and location of your primary physician, prior to your [MRI, CT, X-ray, etc.].

Name of primary physician______________________________________

City or clinic__________________________________________________

Add the following statement if there will be there will be disclosure of findings of clinical significance and, if requested, of uncertain or no known clinical significance:

Possible Discovery of Findings Related to Medical Imaging

Include the previous paragraphs for findings of clinical significance as well as:

Findings of Uncertain or No Known Clinical Significance

There is a remote chance that the [MRI, CT, X-ray, etc.] may reveal something of uncertain or no known clinical significance. For example, people can be born with a variation in the structure of an organ for which no treatment may be required or appropriate. Because these are findings of uncertain or no known clinical significance, there may be little benefit to learning such results. As discussed above, there may be risks to learning such information (such as risks to your insurability or employability, or anxiety over a finding for which no treatment is required or appropriate). Whether or not you want to be informed of findings of uncertain or no known clinical significance is up to you.

Please indicate your preference by checking the appropriate box:

  Please inform me of findings of uncertain or no known clinical significance.

AND/OR

  Please inform my doctor of findings of uncertain or no known clinical significance.

OR

   Please do not inform me or my doctor of findings of uncertain or no known clinical significance.

Name of physician to contact

If you do wish us to report any findings to your physician, you must provide us with the name and location of your primary physician, prior to your [MRI, CT, X-ray, etc.].

Name of primary physician______________________________________

City or clinic__________________________________________________

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Instructions:

Include the following language in the "Will I receive results of research tests?" section whenever questionnaires/assessments are administered that may identify subjects with clinically-concerning depression or who are experiencing suicidal thoughts. This includes questionnaires that are used to identify depression symptoms, even if the questionnaires/assessments are not considered diagnostic tools.

  • When including this language, make clear whether subjects will be informed if their responses to the questionnaires/assessments suggest potential depression or suicidality and what follow-up will occur. A description of acceptable follow up plans is available here.
  • If the questionnaires/assessments will not be reviewed by qualified personnel in “real time,” and/or subjects will not be informed of the results, clearly state this. Template language is provided for this situation.


Model Language:

Text to include if follow-up plan being utilized:

The [questionnaires/assessments] you will complete in this study may show that you are experiencing symptoms of emotional distress such as [depression/suicidal thoughts/anxiety]. If the [questionnaires/assessments] show that you are experiencing [describe issue], we will [describe plan for handling the issue]. Include additional information if there is more than one issue that may be identified (e.g., depression and suicidality) or more than one plan for handling the issue (e.g., a plan for depression and a plan for suicidal ideation): If the [questionnaires/assessments] show that you are experiencing [describe issue], we will [describe plan for handing the issue.]

Text to include if no follow-up plan being utilized:

The [questionnaires/assessments] you will complete in this study ask about symptoms of emotional distress such as [depression/suicidal thoughts/anxiety]. We are using the [questionnaires/assessments] only for research, not to diagnose mental health issues. We will not tell you the results. If you are experiencing emotional distress, you should contact your physician or other health care provider, such as a mental health professional.

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Instructions:

Include the following model language in the consent form section Will I receive the results of research tests? if you will (or may) report results of research tests on biospecimens, to describe how these results will be handled. Choose the option(s) most appropriate for your study. DELETE options that do not apply:


Model Language:

  • We will tell you the results of the following tests or procedures that are part of the research study: [list specific tests/procedures, e.g. results of blood tests for cholesterol levels and the results of the ECG].
  • You can choose to receive results of the following tests or procedures: [list specific tests/procedures]. Please indicate your choice below.
    • Yes, please give me results from the tests/procedures listed above. (We will provide the results [explain how/when they will be provided, e.g. within X weeks by mail, within X weeks by phone, at your next study visit].)
    • Please also notify my health care provider of these results. My provider’s name and clinic are: ____________________________
    • No, DO NOT notify me or my provider of results from the tests/procedures listed above.
  • We will mail you a summary of your test results [add timeframe, e.g. 4 – 8 weeks after your study visit]. The summary will include [list specific tests/procedures, e.g. exercise tests and blood tests for cholesterol levels]. This summary of results is not a substitute for a thorough examination by your doctor.

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Instructions:

Include the following language in the "Will I receive results of research tests?" section whenever testing for reportable communicable diseases such as HIV, Hepatitis C, and Ebola is performed as part of a research study. Guidance on what diseases require reporting can be found at on the Wisconsin Department of Health Services (DHS) website. When including this language:

  • For HIV testing, Wisconsin Law (section 252.15) requires certain information be provided to subjects, orally or in writing, when HIV testing will occur. A description of those requirements can be found here. Sample fact sheets that meet the requirements of section 252.15 can be found under the “HIV Testing Resources for Clinicians” tab on the DHS website.
  • A description of how the findings will be reported should be provided and the reporting time frame. For example, sending a letter to the subject or following up by phone.
  • The study team is responsible for having a list of resource available if requested by the subject. Many of these resources can be found on the DHS website.


Model Language:

Text to include when reporting is required:

This study requires testing that may show you have [specify reportable disease or condition]. If the test indicates you have [disease or condition requiring reporting], we will inform you of the results of the test by [describe process for reporting results]. The results will also be placed in your medical record and reported to state or federal health officials as required by law. We can provide you with a list of resources to assist you in understanding the results.

Additional text to include if the study involves HIV testing performed in Wisconsin:

If you test positive for human immunodeficiency virus (HIV), the Wisconsin health department will be informed of the results. The health department may contact you to help with counseling, medical care and other services, if you need them and want them. You may be asked about sex and/or needle-sharing partners and you may be offered help notifying your partners about your positive HIV test. These are all common practices of the health department and apply to all individuals who test positive for HIV.

Additional text to include if the study involves hepatitis testing performed in Wisconsin:

If you test positive for hepatitis, the Wisconsin health department will be informed of the results. The health department may contact you with resources for counseling and medical care, if you need them and want them. You may be asked about sex and/or needle-sharing partners. These are all common practices of the health department and apply to all individuals who test positive for hepatitis.

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Keywords:informed consent, IC, ICF, consent, adventitious, certificate, confidentiality, CoC, assent, banking, conflict of interest, COI, CT.gov, commercial, genetic, email, status, student, reproductive, video, psychological, illegal, home visits, signature, GINA, GDS, state   Doc ID:73696
Owner:ANDREW D.Group:Health Sciences IRBs
Created:2017-05-31 15:42 CDTUpdated:2019-02-15 17:26 CDT
Sites:Health Sciences IRBs
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