HIC#: insert number
COMPOUND AUTHORIZATION AND CONSENT FOR PARTICIPATION IN A
RESEARCH PROJECT
200 FR. 4 ( 2016-2)
Specify both the Yale University academic research entity, and, if applicable, the nonacademic partner, e.g.:
YALE UNIVERSITY SCHOOL OF MEDICINE – YALE-NEW HAVEN HOSPITAL
YALE UNIVERSITY SCHOOL OF MEDICINE – YALE-NEW HAVEN HOSPITAL:
SAINT RAPHAEL CAMPUS
YALE UNIVERSITY SCHOOL OF MEDICINE – YALE-NEW HAVEN HOSPITAL:
SMILOW CANCER CENTER
YALE UNIVERSITY SCHOOL OF MEDICINE—CONNECTICUT MENTAL HEALTH
CENTER
YALE UNIVERSITY SCHOOL OF PUBLIC HEALTH
YALE UNIVERSITY SCHOOL OF NURSING—YALE NEW HAVEN HOSPITAL
YALE UNIVERSITY SCHOOL OF MEDICINE—THE APT FOUNDATION
YALE UNIVERSITY SCHOOL OF NURSING
Be sure to delete any entities that do not apply.
INSTRUCTIONS: This template is designed to provide guidance in the development of a consent form that also incorporates and satisfies the elements required of a HIPAA
Research Authorization Form (RAF). (The combination of these 2 forms is known as a
Compound Authorization Form). Italicized sections include suggested text and further instruction and guidance. Note that sections shown in square brackets must be edited for each specific protocol. Not all sections will apply to every protocol. Therefore, delete those which do not apply as well as this and other instruction paragraphs prior to submitting the form(s) to the HIC.
Study Title: [Insert title of the study.]
Principal Investigator: [Insert name and mailing address.]
Funding Source: [Insert name of company, agency or department.]
[ If the study involves different populations or study arms, identify the population or group/arm as a subtitle of the study here. Example Healthy Controls Form vs. the Form for Non-treatment
Seeking Substance Abusers ]
Invitation to Participate and Description of Project
Suggested Text:
You are invited to take part in a research study designed to look at [ state what the study is designed to discover or establish.
] You have been asked to take part because [ explain briefly
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HIC#: insert number why the prospective subject is eligible to participate ]. [ If appropriate, state the approximate number of subjects and/or research sites involved in the study .]
In order to decide whether or not you wish to be a part of this research study you should know enough about its risks and benefits to make an informed decision. This consent form gives you detailed information about the study, which a member of the research team will discuss with you. This discussion should go over all aspects of this research: its purpose, the procedures that will be performed, any risks of the procedures, possible benefits and possible alternative treatments. [Note: If the protocol is not a treatment protocol, delete “and possible alternative treatments”].
Once you understand the study, you will be asked if you wish to participate; if so, you will be asked to sign this form.
Description of Procedures
Guidelines:

Describe the procedures using simple, lay language, short sentences and short paragraphs. The use of subheadings may help to organize this section and improve readability.

Define and explain medical and scientific terms in ordinary language (for example, the amount of blood to be drawn should be given in terms of teaspoons, tablespoons or ounces). A medical or scientific term, drug name, etc. may be used throughout the consent form once it has been introduced and explained in lay language.

Distinguish clearly between any procedures that are experimental and those that are part of the subject’s standard clinical care. Specify the subject’s assignment to study groups, length of time for participation in each procedure, the total length of time for participation, frequency of procedures, location of the procedures to be done, etc.

For research involving randomization of subjects into different groups, specify (and explain) the randomization procedures.

For research involving the use of placebo, clearly define the term placebo.

For research involving interviews, surveys, questionnaires, etc., clearly describe the purpose and content of the instruments. It may also be helpful to provide a representative sample of the types of questions subjects will be asked.

For research involving review of subject’s medical record, the consent form should explain what types of information will be collected, and why.

Under HIPAA the consent form and HIPAA Research Authorization form (RAF) can be combined for the same study, e.g., a single research purpose. (Example: the collection of blood in a clinical trial to evaluate response to ALS treatment.) HIPAA also allows combining the consent and authorization for a study with authorization for the creation or maintenance of a research database or repository. Combining study authorization with database or repository authorization requires that these distinct uses must be clear and must allow for the research subject to provide separate authorization for the database or repository. Example: the subject is given the option to provide permission for sharing information for purposes related to the ALS trial AND in a separate statement, the subject provides a ‘second” permission to bank the biologic material for use in future research studies. If selecting this option, investigators are reminded to retain the
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HIC#: insert number signed combined form for the full duration that the banked data or biologic sample will be retained for future research purposes.

When relevant, any plans to return information to subjects, to medical records, to primary care physicians, or others must be made explicit in the consent form.
Suggested Text:
If you agree to take part in this study, you will be asked to [ describe the study procedures clearly, in roughly chronological order .]
If this is a Phase II or III controlled clinical trial with FDA oversight, or a c ontrolled trial with health outcomes of an FDA regulated device, the following language is required by the FDA.
This language can also be used for NIH-supported clinical trials registered at clinicaltrials.gov:
A description of this clinical trial will be available on http://www.ClinicalTrials.gov
, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
(For more information on registering clinical trials, contact YCCI.)
>If appropriate, add:
You will be told of any significant new findings that are developed during the course of your participation in this study that may affect your willingness to continue to participate.

For research involving optional genetic or related testing, the consent form should describe the scope of the research that will be performed with subject’s DNA or tissue (e.g., cancer, aging, mental health, etc.). If the genetic testing is not optional, revise the wording
as appropriate.
>If appropriate, include:
Risks and Inconveniences
Guidelines:

Identify all reasonably foreseeable risks, discomforts or inconveniences associated with the study, and describe how they will be managed.

For studies where the primary risk is breach of confidentiality, use this: There are no physical risks associated with this study. However [some questions may make you uncomfortable and] there is the possible risk of loss of confidentiality. Every effort will be made to keep your information confidential; however, this cannot be guaranteed.

Risks should be listed in hierarchical order, from most likely to least likely to occur.

When relevant, risks to pregnant women or to a fetus should be explicitly stated.

For studies taking place at the YNHH-Saint Raphael campus the r eproductive risks section of the consent document should instruct study participants to practice "family planning methods"
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HIC#: insert number acceptable to the study investigator.” The terms “contraception” and “birth control” may not be used.
 In addition to physiological risks/discomforts, describe any psychological, social, legal or financial risks that might result from participating in the research.

Where such information is available, the consent form should state the likelihood of risks occurring. For example, “most subjects in a similar study had headaches and felt nauseous,” or “10 out of 100 people who took drug X felt dizzy.”

If appropriate (e.g., if the research involves an experimental intervention or therapy), please include the following statement: “
Participation in this study may involve risks that are currently not known.
”

Include only those risks that are associated with the research. Risks associated with standard clinical procedures that would be done whether or not the patient is in the study should not be listed.

For studies involving investigational drugs or devices, the consent form should describe a means whereby information about the drug or device may be obtained in emergency situations.

For research involving genetic or related testing, subjects must be informed of any risks associated with the genetic information that may result [see sample language in preceding ‘future storage’ section] Such risks could include reduced access to or retention of benefits or entitlements (e.g., insurance, educational opportunities, employment, etc.); stigmatization; psychological distress in response to information; or detection of biological relationships within a family.

Include the following:
There is a federal law called the Genetic Information Nondiscrimination Act (GINA) that, in general, makes it illegal for health insurance companies, group health plans, and most employers, except those with fewer than 15 employees, to discriminate against you based on your genetic information. However, it does not protect you against discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.
 For studies using the Magnetic Resonance Research Center (MRRC) at The Anlyan
Center (TAC), the following language should be included:
Risks and Inconveniences
Magnetic resonance (MR) is a technique that uses magnetism and radio waves, not xrays, to take pictures and measure chemicals of different parts of the body. The United States
Food and Drug Administration (FDA) has set guidelines for magnet strength and exposure to radio waves, and we carefully observe those guidelines.
You will be watched closely throughout the MR study. Some people may feel uncomfortable or anxious. If this happens to you, you may ask to stop the study at any time and we will take you out of the MR scanner. On rare occasions, some people might feel dizzy, get an upset stomach, have a metallic taste or feel tingling sensations or muscle twitches. These sensations usually go away quickly but please tell the research staff if you have them.
There are some risks with an MR study for certain people. If you have a pacemaker or some metal objects inside your body, you may not be in this study because the strong magnets in
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HIC#: insert number the MR scanner might harm you. Another risk is the possibility of metal objects being pulled into the magnet and hitting you. To lower this risk we require that all people involved with the study remove all metal from their clothing and all metal objects from their pockets. We also ask all people involved with the study to walk through a detector designed to detect metal objects. It is important to know that no metal can be brought into the magnet room at any time. Also, once you are in the magnet, the door to the room will be closed so that no one from outside accidentally goes near the magnet.
We want you to read and answer very carefully the questions on the MR Safety
Questionnaire related to your personal safety. Take a moment now to be sure that you have read the MR Safety Questionnaire and be sure to tell us any information you think might be important.
This MR study is for research purposes only and is not in any way a healthcare examination of the brain. The scans performed in this study are not designed to find abnormalities. The principal investigator, the lab, the MR technologist, and the Magnetic
Resonance Research Center are not qualified to interpret the MR scans and are not responsible for providing a healthcare evaluation of the images. If a worrisome finding is seen on your scan, a radiologist or another physician will be asked to review the relevant images. Based on his or her recommendation (if any), the principal investigator or consulting physician will contact you, inform you of the finding, and recommend that you seek medical advice as a precautionary measure. The decision for additional examination or treatment would lie only with you and your physician. The investigators, the consulting physician, the Magnetic Resonance Research
Center, and Yale University are not responsible for any examination or treatment that you receive based on these findings. The images collected in this study are not a healthcare MR exam and for that reason, they will not be made available for healthcare purposes.
If contrast is used, also include the following:
Contrast Risks and Procedures Statements.
Having an intravenous (IV) line placed is a very safe procedure. There is a slight chance that multiple needle-sticks will be needed to make sure the IV is placed correctly. You might feel a small amount of pain when the IV is placed but it does not last very long. A bruise or a minor infection might develop where the IV is placed. A bruise will go away by itself and it might help if you wrap a warm towel around your arm. Infections can also be treated if necessary.
The FDA approves the contrast agent Gadolinium for use with human participants. You need to know that there are certain risks associated with the use of that contrast. Some healthy subjects (fewer than 3%) may experience mild nausea, headache or dizziness after the injection.
These side effects usually go away themselves without need for treatment. There is also a risk of allergic reaction (less than 1%). An allergic reaction can cause hives and itching or difficulty breathing. In individuals with kidney dysfunction, the gadolinium can cause a serious condition called nephrogenic systemic fibrosis. This is why prior to your MR study you will have to undergo blood work to make sure that your kidney function is normal. Detailed information on the contrast agent Gadolinium can be provided to you at your request.
You should tell your principal investigator: (1) if you are pregnant or breast feeding, (2) if you have a history of allergic reactions to MR or CT contrast agents, (3) if you have a history
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HIC#: insert number of kidney disease, seizure, asthma, or allergic respiratory disorders, and (4) if you have anemia or disease that affects red blood cells.

For studies using radiation, include the following language:
Risks Associated with Radiation
This research study involves exposure to radiation from [Describe: e.g., research required extra head CT scan]. Please note that this radiation exposure is not necessary for your medical care and is for research purposes only. Although each organ will receive a different dose, the amount of radiation exposure will receive from this study is equal to a uniform whole-body exposure of
[ XX] rem. This calculated value is known as the “effective dose” and is used to relate the dose received by each organ to a single value.
This amount of radiation is well below the dose guidelines established by the federal government and adhered to by the Yale-New Haven Hospital Radiation Safety Committee for research subjects. To give you an idea about how much radiation you will get, we will make a comparison with an every-day situation. Everyone receives a small amount of unavoidable radiation each year. Some of this radiation comes from space and some from naturally-occurring radioactive forms of water and minerals. This research gives your body the equivalent of about YY extra years' worth of this natural radiation.
( Note: average natural exposure is 300mrem or 0.3rem, so compare XX to 0.3rem
)
Benefits
Guidelines:

Describe any benefits that can be reasonably expected to result from the research.
Please note that benefits include those that accrue directly to the subject (e.g., improved health outcomes), to the population the subject represents (e.g., a better understanding of the subject’s condition that may lead to new treatments), or to society at large (e.g., general advancement of scientific knowledge).

If there is no likelihood that subjects will benefit directly from their participation, this should be stated.

Financial rewards for participating in research are not considered a benefit, and should not be included in this section.

Please note that, by definition, the benefits of research are unproven. Therefore, subjects should be told that participation “may,” rather than “will” yield benefit.
Economic Considerations
Guidelines:
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HIC#: insert number

Describe any compensation that will be made to subjects (including direct monetary payment, payment in the form of a gift, or reimbursement for costs such as travel, parking, childcare, etc.), and the conditions for receiving this compensation.
 For studies that compensate subjects, include the following statement: ‘
According to the rules of the Internal Revenue Service (IRS), payments that are made to you as a result of your participation in a study may be considered taxable income.’

If payment will be prorated for subjects who do not complete the study, this should be clearly explained. If payment is conditional on completing the study, this should be clearly explained.
 Clearly describe the subject’s costs associated with participation in the research. If it is possible that research procedures or tests will not be covered by the subject’s insurance, health plan benefits, or other third party payers, this should be indicated. If the subject will be receiving standard of care treatment as well as the research intervention, add the following: You will still be responsible for any co-pays required by your insurance company for standard treatment.
 Clearly describe the parts of the research (drugs, tests, procedures, etc.) that will be provided at no cost to the subjects.

Subjects may be offered an estimate of the charges they will be expected to cover.
Treatment Alternatives/Alternatives
(Note: This paragraph is a required element of informed consent for all research involving treatment or therapeutic intervention. Certain non-treatment protocols may also require an “Alternatives” section detailing appropriate treatment or procedures that are available outside of the research. Investigators may also choose to state that the only alternative is to decline participation in the study. If the “Alternative Treatments” section does not apply to your study, you may omit this entry and delete the heading.)
Guidelines:

Describe any appropriate alternative therapeutic, diagnostic or preventive procedures that should be considered before the subject decides whether or not to participate in the study.

Please note that alternatives are not limited to curative procedures. For chronic or terminally ill subjects, alternatives may include procedures for symptom management, improving the ability to function, or palliative care.
Confidentiality and Privacy
Guidelines:
 Please state whether identifiers will be maintained and if so please describe why it is necessary to maintain the identifiers, the length of time they will be kept and how access to identified data will be secured. For example, will the participant’s data be coded with the linking code stored separately from the data?
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HIC#: insert number
If study information will be entered into the subject’s Electronic Medical Record (EMR), insert the following language: Information about your study participation will be entered into your
Electronic Medical Record (EMR). Once placed in your EMR, these results are accessible to all of your providers who participate in the EMR system. Information within your EMR may also be shared with others who are appropriate to have access to your EMR (e.g. health insurance company, disability provider.)

If information will be released to any other party for any reason, identify the person/agency to which the information will be furnished, the nature of the information, and the purpose of the disclosure. Examples include legal reporting requirements for child or elder abuse, or identification of reportable infectious diseases.

Any FDA-regulated clinical research study may be subject to an inspection. Funding agencies and industrial sponsors may also conduct inspections, therefore the following must be included: “Authorized representatives of the Food and Drug Administration
(FDA) [or a funding agency, such as the National Institutes of Health ] and the manufacturer of the [ drug/device ] being tested [ insert name of company ] may need to review records of individual subjects. As a result, they may see your name; but they are bound by rules of confidentiality not to reveal your identity to others.”
 If the research involves audio or videotaping, describe the subject’s right to review or edit the tapes, and indicate when they will be erased.

If the research requires a Certificate of Confidentiality, refer to 400 PR.2 Certificate of
Confidentiality for alternative language for the first paragraph below.
Suggested Text:
Any identifiable information that is obtained in connection with this study will remain confidential and will be disclosed only with your permission or as permitted by U.S. or State law. Examples of information that we are legally required to disclose include abuse of a child or elderly person, or certain reportable diseases. [Describe the methods used to safeguard the confidentiality of subjects’ data (e.g., coding data or samples with numbers, storing research materials in locked cabinets, password-protecting data stored on a computer, etc.] When the results of the research are published or discussed in conferences, no information will be included that would reveal your identity unless your specific consent for this activity is obtained.
We understand that information about you obtained in connection with your health is personal, and we are committed to protecting the privacy of that information. If you decide to be in this study, the researcher will get information that identifies you and your personal health information. This may include information that might directly identify you, such as your name and [ list other direct identifiers as appropriate and if required ]. This information will be deidentified at the earliest reasonable time after we receive it, meaning we will replace your identifying information with a code that does not directly identify you. The principal investigator will keep a link that identifies you to your coded information, and this link will be kept secure and available only to the PI or selected members of the research team. Any information that can identify you will remain confidential. [Describe additional methods used to safeguard the confidentiality of subjects’ data (e.g., storing research materials in locked cabinets, password-
protecting data stored on a computer, etc.] The research team will only give this coded information to others to carry out this research study. The link to your personal information will
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HIC#: insert number be kept for [ state time in months or years ], after which time the link will be destroyed and the data will become anonymous. The data will be kept in this anonymous form [indefinitely / for X months/years until it is destroyed ].
The information about your health that will be collected in this study includes: (Specify as appropriate, delete what is not appropriate)

Research study records

Medical and laboratory records of only those services provided in connection with this
Study.

The entire research record and any medical records held by [Institution] created from:
_________ to: ________

The following information: [Complete with specific information that is being collected]
Suggested Text (add and delete as appropriate) :

Records about phone calls made as part of this research

Records about your study visits
[Select additional information sources from below as appropriate]
Information obtained during this research regarding
HIV / AIDS
Hepatitis infection
Sexually transmitted diseases
Other reportable infectious diseases
Physical exams
Laboratory, x-ray, and other test results
Diaries and questionnaires
The diagnosis and treatment of a mental health condition
Use of illegal drugs or the study of illegal behavior

Records about any study drug you received

Records about the study device
Information about you and your health which might identify you may be used by or given to:

The U.S. Department of Health and Human Services (DHHS) agencies

Representatives from Yale University, the Yale Human Research Protection Program and the Yale Human Investigation Committee (the committee that reviews, approves, and monitors research on human subjects), who are responsible for ensuring research compliance. These individuals are required to keep all information confidential.

Those providers who are participants in the Electronic Medical Record (EMR) system.

Those individuals at Yale who are responsible for the financial oversight of research including billings and payments

The Principal Investigator [Insert Name]
Select as appropriate the following additional groups with whom the data may be shared and delete those that do not apply.
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HIC#: insert number

The U.S. Food and Drug Administration (FDA) This is done so that the FDA can review information about the new drug product [or device] involved in this research. The information may also be used to meet the reporting requirements of drug regulatory agencies.

The study sponsor or manufacturer of study drug/device

Drug regulatory agencies in other countries

Governmental agencies to whom certain diseases (reportable diseases) must be reported

Health care providers who provide services to you in connection with this study.

Laboratories and other individuals and organizations that analyze your health information in connection with this study, according to the study plan.

Co-Investigators and other investigators

Study Coordinator and Members of the Research Team

Data and Safety Monitoring Boards and others authorized to monitor the conduct of the
Study: List any separate or local committees not in the protocol, if applicable

Others as noted:
By signing this form, you authorize the use and/or disclosure of the information described above for this research study. The purpose for the uses and disclosures you are authorizing is to ensure that the information relating to this research is available to all parties who may need it for research purposes.
All health care providers subject to HIPAA (Health Insurance Portability and Accountability
Act) are required to protect the privacy of your information. The research staff at the Yale
School of Medicine and [Specify health care facility, e.g., Yale-New Haven Hospital, the
Connecticut Mental Health Center ] .
are required to comply with HIPAA and to ensure the confidentiality of your information. Some of the individuals or agencies listed above may not be subject to HIPAA and therefore may not be required to provide the same type of confidentiality protection. They could use or disclose your information in ways not mentioned in this form. However to better protect your health information, agreements are in place with these individuals and/or companies that require that they keep your information confidential.
[If appropriate to your study:]
The sponsor will see the research information we collect about you when they come to Yale to monitor the conduct of this research study. The “Sponsor” includes any persons that work for or are hired by the sponsor to conduct research activities related to this study. For this study the sponsor includes [insert the company name or CRO here] . Yale researchers will also send the sponsor your health information during the study or at the end of the study. When Yale researchers send information about you to the sponsor, they will not send information that directly identifies you such as your name or [include other direct identifiers such as street address and social security number, if appropriate.] [Add the following sentence ONLY when a research contract, agreed to by Yale, specifies the use of subject information for future research conducted by the sponsor and the contract provides confidentiality and privacy safeguards regarding the protection of the information for the secondary use. Example of appropriate language: The sponsor may also use the information about you for other purposes related to this research or to similar research studies.]
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HIC#: insert number
You have the right to review and copy your health information in your medical record in accordance with institutional medical records policies. [If study involves blinding include the following] However, by deciding to take part in a single or double blinded treatment study and sign this permission form, you will not be allowed to look at or copy your study related information until after the research is completed.
This authorization to use and disclose your health information collected during your participation in this study will never expire.
In Case of Injury
[ Note: This paragraph is a required element of informed consent for all research presenting greater than minimal risk. It should also be used for minimal risk research that presents the potential for physical harm (e.g., research involving blood draws).
If the “In Case of Injury” section does not apply to your study, please omit this entry and delete the heading.
However, the sentence,
“You do not give up any of your legal rights by signing this form.” must then be included in the Voluntary Participation section.]
Guidelines:

For studies sponsored by for-profit entities, the sponsor is encouraged to provide funds for the treatment of injuries sustained as a direct result of participation in the research.
Per HIC policy, sponsors are expected to cover expenses without first seeking payment from the subject’s insurance. The following text should be used.
If you are injured while on study, seek treatment and contact the study doctor as soon as you are able.
If you become ill or are physically injured due to the study [drug/device] [ provide name of agent ] or any investigational procedure specifically required by the plan for this study, you will not be responsible for the costs required to diagnose or treat such injury. The costs of diagnosis and medical care for any complication, injury, or illness caused by the study [drug/device] or properly performed non-standard of care investigational procedure required by the study will be covered by the Sponsor as long as you have followed the directions of the study doctor.
If you receive a bill for any costs related to the diagnosis or treatment of your injury, please contact the study doctor.
You will not receive any other kind of payment. There are no plans to pay you for such things as lost wages, disability, or discomfort as part of this study. You do not give up any of your legal rights by signing this consent form.

For studies sponsored by a non-profit entity (e.g., investigator’s own funds, federal funding, or a private non-profit organization), the following text should be used:
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HIC#: insert number
If you are injured while on study, seek treatment and contact the study doctor as soon as you are able.
Yale School of Medicine and [Specify health care facility, e.g., Yale-New Haven
Hospital, the Connecticut Mental Health Center ] do not provide funds for the treatment of research-related injury.
If you are injured as a result of your participation in this study, treatment will be provided. You or your insurance carrier will be expected to pay the costs of this treatment. No additional financial compensation for injury or lost wages is available.
You do not give up any of your legal rights by signing this form.
Voluntary Participation and Withdrawal
Guidelines:

Subjects should be informed whether they will have the ability to withdraw their data from the research once it is collected. Unlike tissue samples, which often can be withdrawn and destroyed, data derived as part of the research usually will not be covered by an option for withdrawal. If data or samples will be unable to be withdrawn
(for example, if they have been de-identified), subjects should be apprised of this fact in the consent form.

If there are medical needs required by the subject upon withdrawal, these should be stated. Any follow-up procedures or assessments accompanying the withdrawal should be clearly explained.
Suggested Text:
Participating in this study is voluntary. You are free to choose not to take part in this study.
Refusing to participate will involve no penalty or loss of benefits to which you are otherwise entitled (such as your health care outside the study, the payment for your health care, and your health care benefits). However, you will not be able to enroll in this research study and will not receive study procedures as a study participant if you do not allow use of your information as part of this study.
Withdrawing From the Study
If you do become a subject, you are free to stop and withdraw from this study at any time during its course. ( Tailor the statement about the ability to withdraw from participation to the specifics of the study. For example, in a study on an experimental device or surgery, the subject who has received the intervention can withdraw from the follow-up portion of the study, but the device will not be remoyed and the surgery cannot be undone.)
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HIC#: insert number
To withdraw from the study, you can call a member of the research team at any time and tell them that you no longer want to take part. This will cancel any future appointments (if applicable) .
The researchers may withdraw you from participating in the research if necessary. [ Describe the conditions under which a subject might be withdrawn from the research (e.g., progression of disease/poor response to treatment, development of serious side effects, or subject noncompliance).
]
Withdrawing from the study will involve no penalty or loss of benefits to which you are otherwise entitled. It will not harm your relationship with your own doctors or with [Specify health care facility, e.g., Yale-New Haven Hospital, the Connecticut Mental Health Center ] . [ If applicable: “We would still treat you with standard therapy or, at your request, refer you to a clinic or doctor who can offer this treatment.” ]
Withdrawing Your Authorization to Use and Disclose Your Health Information
You may withdraw or take away your permission to use and disclose your health information at any time. You may withdraw your permission by telling the study staff or by writing to [Enter name and address of the data repository’s principal investigator] at the Yale University
_______________________________New Haven, CT 06520.
If you withdraw your permission, you will not be able to stay in this study.
When you withdraw your permission, no new health information identifying you will be gathered after that date. Information that has already been gathered may still be used and given to others until the end of the research study, as necessary to insure the integrity of the study and/or study oversight.
Questions
We have used some technical terms in this form. Please feel free to ask about anything you don't understand and to consider this research and the consent form carefully – as long as you feel is necessary – before you make a decision.
Optional Specimens for Future Storage/Genetic Testing
You are invited to allow some of your samples (called specimens) and related information to be stored (banked) for future research [for X purpose]. This may help researchers in the future learn more about how to prevent, find and treat [X disease(s)/condition(s)].
Your specimens will be stored for an unlimited time [If specific dates of storage are known, describe], and may be used to make a cell line that will live indefinitely. Future research may look at your genes, which are the units of inheritance that are passed down from generation
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HIC#: insert number to generation. Genes are responsible for many things about you such as eye color, hair color, blood type and hundreds of other traits. Future genetic analysis may possibly include finding out the details of how your DNA is put together, such as whole exome or genome sequencing, or genome wide association studies (that is, looking at genes other than those associated with a specific disease). The materials at some point may be injected into animals in some of the research. We expect that there will be widespread sharing of these specimens and associated information. (Exclude what is inapplicable to your type of research: e.g., in pharmacogenetic research, genome sequencing and animal studies are unlikely.)
When your specimens and information are stored, we are careful to try to protect your identity from discovery by others. Your samples and information will receive a unique code.
Other researchers will only receive coded samples and information, and will not be able to link the code to you. Strict security safeguards are in place to reduce the chance of misuse or unplanned release of information.
Using your specimens for research will probably not help you. We do hope the research results will help people in the future.
There is a risk that your information could be misused [Give examples]. The chance of this happening is very small. We have protections in place to lower this risk[Describe]. There can also be a risk in uncovering genetic information. New health information about inherited traits that might affect you or your blood relatives could be found during a research study. Very rarely, health or genetic information could be misused by employers, health insurance companies, and others. There is a federal law called the Genetic Information Nondiscrimination
Act (GINA) that, in general, makes it illegal for health insurance companies, group health plans, and most employers (except those with fewer than 15 employees) to discriminate against you based on your genetic information. However, it does not protect you against discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.
Your specimens and information will only be used for research and will not be sold.
There is a possibility that this research may lead to development of products that will be commercialized. If this happens, there is no plan to share any financial gain with you.
Research results will not be returned to you or your doctor. If research results are published, your name and other personal information will not be given.
If you know that your study will involve a GWAS analysis and depositing to the NIH
GWAS repository, include the following:
Your specimen will also be given to the National Institutes of Health Genome-Wide
Association Studies (GWAS) repository. GWAS studies look at the genetic differences that exist along the human genome, which is the complete set of human genes. These studies look for common traits, such as blood pressure or weight, or for the presence or absence of a disease or condition.
The NIH GWAS repository stores genetic information from many studies and shares that information with researchers. We will send the genetic information about you and other
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HIC#: insert number participants in this study to the NIH GWAS repository. It will be coded and de-identified. NIH will not identify or make any attempt to identify information as coming from you or any other individual. NIH will share the collected information with researchers who submit applications to
NIH. Special data sharing committees will review those applications and decide whether or not to share the genetic information. The researchers who receive data must promise to keep the data confidential and to use it only for the purpose approved by NIH.
The goal of GWAS studies is to look for genetic connections which may explain how to identify, prevent, and treat health problems. For example, GWAS data may be used to find out:
• who is more likely to develop a certain illness, such as asthma, cancer, or diabetes, or a condition like high blood pressure or obesity;
• what genes affect the progress of a certain disease or condition; and
• what genes may affect treatments which now may or may not work in certain people.
GWAS research will not directly benefit you, but could lead to a greater understanding of the interaction between genes and health. This knowledge could help others in the future.
The choice to take part is up to you. You may choose not to let us store and use your samples, and your care will not be affected by this decision. If you decide that your samples can be kept, you may change your mind at any time. Contact the study staff by phone or mail at [XX phone, XX address] to let them know you do not want your samples used any longer. Your samples will either [Researcher should choose one or allow subject to indicate choice] be destroyed, or made anonymous (the code linking them to you will be destroyed).
I agree to allow my samples and information to be stored and used for future research as described above: (initial your choice)
_____YES ______No
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HIC#: insert number
Authorization and Permission
I have read (or someone has read to me) this form and have decided to participate in the project described above. Its general purposes, the particulars of my involvement and possible hazards and inconveniences have been explained to my satisfaction. My signature also indicates that I have received a copy of this consent form.
By signing this form, I give permission to the researchers to use [and give out] information about me for the purposes described in this form. By refusing to give permission, I understand that I will not be able to be in this research.
Name of Subject:_____________________________
Signature:___________________________________
Date:______________________________________
___________________________________________
Signature of Principal Investigator or
___________________
Date
___________________________________________
Signature of Person Obtaining Consent
___________________
Date
If after you have signed this form you have any questions about your privacy rights, please contact the Yale Privacy Officer at 203/432-5919 .
If you have further questions about this project or if you have a research-related problem, you may contact the Principal Investigator [cite name and full telephone number] . If you would like to talk with someone other than the researchers to discuss problems, concerns, and questions you may have concerning this research, or to discuss your rights as a research subject, you may contact the Yale Human Investigation Committee at (203) 785-4688 .
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