CONSENT TO ACT AS A STUDY PARTICIPANT IN THE GLOBAL PRADER-WILLISYNDROME REGISTRYAND TO SHAREDATA FOR FUTURE RESEARCH PURPOSES
Consent for a person with a Legally Authorized Representative (LAR) who is unable to consent
for him or herself
Title: Global Prader-Willi Syndrome RegistryPrincipal Investigator: Theresa Strong, Ph.D.

Experimental Research Subjects Bill of Rights
California law, under Health & Safety Code Section 24172, requires that any
person asked to take part as a subject in research involving a medical
experiment, or any person asked to consent to such participation on behalf ofanother, is entitled to receive the following list of rights written in a language
in which the person is fluent. The list includes the right to:
1. Be informed of the nature and purpose of the experiment.
2. Be given an explanation of the procedures to be followed in the medical
experiment, and any drug or device to be utilized.
3. Be given a description of any attendant discomforts and risks
reasonably to be expected from the experiment.
4. Be given an explanation of any benefits to the subject reasonably to be
expected from the experiment, if applicable.
5. Be given a disclosure of any appropriate alternative procedures, drugs
or devices that might be advantageous to the subject, and their relative
risks and benefits.
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6. Be informed of the avenues of medical treatment, if any, available to thesubject after the experiment if complications should arise.
7. Be given an opportunity to ask any questions concerning the experimentor the procedures involved.
8. Be instructed that consent to participate in the medical experiment may
be withdrawn at any time and the subject may discontinue participationin the medical experiment without prejudice.
9. Be given a copy of the signed and dated written consent form.
10. Be given the opportunity to decide to consent or not to consent to a
medical experiment without the intervention of any element of force,
fraud, deceit, duress, coercion, or undue influence on the subject’s
decision.
As the guardian or authorized representative for the Study Participant, we encourage you to
discuss the registry with the Study Participant to the extent compatible with their understanding.
If you or the Study Participant has any questions about the registry, please feel free to contact theregistry staff.
Definitions
For the purpose of this Consent form, “Study Participant” refers to the person diagnosed with
Prader-Willi Syndrome (“PWS”). Registry information will be collected on patients who are
diagnosed with PWS. “You” refers to the person providing the information, who may be a family
member or guardian who is legally responsible for the care and health of the patient. The
reference to “we” in this document refers to the research organization PWS.
Research Data Sharing
A patient Registry collects and stores patient medical information, family history and otherrelevant information for use in medical research.
On behalf of the Study Participant, you are invited to provide personal and medical informationin an online questionnaire format by answering surveys and uploading medical information. Thisdata and related information is to be stored (banked) in a research data database or Registrywhere it can be used for future research projects. The data collected in this Registry will be usedby researchers to study PWS with the following objectives and goals:
1) To characterize and describe the PWS population as a whole and to gain a better
understanding of the spectrum of clinical variants in individuals with PWS of all stages.
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This includes but is not limited to collecting information on: diagnosis, treatment,
medical history, socio-economic environment and outcomes.
2) To understand the changes of PWS over a lifetime as well as to gain information onclinical practice patterns and variations over the course of treatment.
3) To facilitate the development of best practice and management guidelines andrecommendations to optimize care, improve quality of life and outcomes and standards ofcare.
4) To provide information regarding ongoing research studies and clinical trials. You, on
behalf of the Study Participant, may consent to be contacted by researchers forrecruitment into Institutional Review Board (IRB) approved studies.
In order to decide whether or not you, on behalf of the Study Participant, wish to allow the Study
Participant’s data to be used for future research, you should know about the risks and benefits tomake an informed decision. This form gives you information about this Registry and how thedata may be used. Once you understand the data collection and sharing process, you will be
asked if you, on behalf of the Study Participant, wish to take part; if so, you will be asked to sign
this form.
How Study Participant Data Gets Into this Registry
The data obtained from you, on behalf of the Study Participant, for this Registry will be sent to
the data bank along with the following information about the Study Participant, which will beentered into a computer (the database) that is used for research purposes:
Data entered into this Registry includes, but is not limited to:Name, date of birth, diagnosis, grades in school and graduation information, treatment,
past and proposed, general medical information, blood level results.
How Study Participant Data Is Stored and Used for Future Research
The goal of the Registry is to share medical and other PWS-relevant information with scientists
and other researchers, while protecting the Study Participant’s privacy.
When the Study Participant’s information is stored, we are careful to try to protect the Study
Participant’s identity from discovery by others. Strict security safeguards are in place to reducethe chance of misuse or unplanned release of information.
Whenever possible, the researchers will use the Study Participant’s information in a de-identified
manner. De-identified means that the researchers will use the Study Participant’s information
without knowing his/her identity. In some cases, they may use some identifying information
about the Study Participant for research purposes, subject to an approval process through the
Global Prader-Willi Syndrome Registry Advisory Committee. At times, the researchers will use
the information with a code, instead of the Study Participant’s name; the code would allow
results of the research to be linked back to the Study Participant.
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Risks and Inconveniences
There are no physical risks to you or the Study Participant for allowing the Study Participant’s
data to be stored or used in future research studies. In the unlikely event that someone outside
the research team views the Study Participant’s information however, there is a risk of breach ofconfidentiality (see the Confidentiality section for an explanation of how the information isprotected). In the event that there is a breach in this Registry’s computer system, you will be
notified.
There is a risk that the Study Participant’s information could be misused. The chance of thishappening is very small. We have protections in place to lower this risk. There can also be arisk in uncovering genetic information. New health information about inherited traits that might
affect the Study Participant or his/her blood relatives could be found during a research study.
Very rarely, employers, health insurance companies, and others could misuse health or genetic
information. 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, andmost employers, except those with fewer than 15 employees, to discriminate against the Study
Participant based on his/her genetic information. However, it does not protect the Study
Participant against discrimination by companies that sell life insurance, disability insurance, or
long-term care insurance. There may be other risks we are not aware of at this time.
Benefits
Participation in this Registry is voluntary and may not result in direct benefit to you (or the Study
Participant) personally, medically or financially. However, we hope the research results will help
people with PWS in the future. We hope that the information we learn in future research studies
will increase our knowledge of human health and that this information will lead to better
prevention, diagnoses and treatments in the future.
Alternative
On behalf of the Study Participant, you do not have to participate in this study so your alternative
is to say “no.”Economic Considerations
Neither you nor the Study Participant will receive any payments for allowing the Study
Participant’s information to be stored in this Registry.
The Study Participant’s information will only be used for research. Should one of theresearchers use the Study Participant’s medical information to develop a commercial product,neither you nor the Study Participant should expect to receive any financial gain from these
efforts.

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Confidentiality
All identifiable information that is obtained in connection with this Registry will remain
confidential. This Registry aims to share detailed medical and other information with researchers
while protecting the Study Participant’s privacy. One way the Registry protects the Study
Participant’s information is to remove his/her name, address and other “identifying” informationfrom our medical information before providing it to researchers. This information is “deidentified” because it has had all the personal identifiers removed including the Study
Participant’s name, address, or other information that identifies the Study Participant or the
Study Participant’s family. The Study Participant’s Registry information will be labeled with acode number and stored on secured computers and servers and protected with encryption andpasswords. Only authorized people who work in this Registry will have access to the key to thecode and will be able to identify you or the Study Participant if needed. When the results offuture research are published or discussed in conferences, no information will be included thatwould reveal your or the Study Participant’s identity unless your specific consent is obtained.
This Registry will not share your or the Study Participant’s identifiable information with anyone
outside this Registry (unless you give permission to share it). Approved researchers andclinicians will be allowed to see only the de-identified information. Approved researchers andclinicians may use de-identified information to conduct research, including research unrelated to
PWS. They may also search the de-identified information to find patients for their studies. If apatient looks like a good match for a researcher’s study, the Global Prader-Willi Syndrome
Registry or Registry’s agent will contact you if you have given us permission to contact you
about research studies.
Your and the Study Participant’s de-identified PWS Registry information may be shared withother databases such as the Global Rare Disease Patient Registry Data Repository (GRDR). This
will allow more researchers to use the information to do research. The de-identified informationcollected and compiled by this Registry belongs to the PWS community. The Global PraderWilli Syndrome Registry is the guardian of the information contained within this Registry.
Third parties may seek access to data in the Global Prader-Willi Syndrome Registry. Third
parties may include, but are not limited to, researchers or companies conducting retrospective
studies or conducting research and/or clinical trials on new therapies. Third parties will only be
granted access to registry information upon review and approval of the Advisory Board. Suchapprovals shall be obtained prior to providing access to registry information; shall be based upon
considerations of scientific quality and validity; shall be granted for research studies related to
PWS; and shall be documented. Third parties seeking access to registry information for
retrospective studies will only have access to anonymous information identifiable only by theassigned unique identifier. Third parties seeking access to registry information for the purpose ofdetermining eligibility for participation in a research study or clinical trial must demonstrateevidence of IRB approval of the research study for which access is being requested
You will be asked to update your and the Study Participant’s Registry information at least once
per year by completing questionnaires, called surveys. You will be asked to update some surveys
more frequently. Based upon your preference for how you would prefer to be contacted, this
Registry will contact you to remind you to update your and the Study Participant’s data. The
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Registry may also ask you to upload the Study Participant’s genetic test results and other bloodwork or test results. Your Registry account can be updated whenever there is a change in the
Study Participant’s health, change in treatment, or new symptom.
Research results will not be returned to you or the Study Participant’s doctor. If research results
are published, your and the Study Participant’s names and other personal information will not begiven.
Representatives from the National Institutes of Health (NIH), U.S. Food and Drug
Administration (FDA) or National Organization for Rare Disorders (NORD) and from
Hummingbird IRB may inspect study records during auditing procedures to be sure that this
Registry is being protected according to regulations and policies. However, these organizations
and the individuals acting on their behalf are required to keep all donor information confidential.
Voluntary Participation and Withdrawal
Participating in this Registry is voluntary. Refusing to participate will involve no penalty or lossof benefits to which you/the Study Participant are otherwise entitled, (such as health care outside
the study, the payment for health care, and health care benefits). On behalf of the Study
Participant, you are free to choose not to donate the Study Participant’s data to research and if
the Study Participant does become a donor you are free to change your mind at any time, on
behalf of the Study Participant, but the researchers may still use the information collected before
you changed your mind in order to complete the research that has already started. Informationthat has already been shared with the GRDR or sent to a researcher for a specific study prior toyour request for removal cannot be retrieved or removed. The researchers will anonymize thedata by removing and destroying all identifiers and links to identifiers so that it cannot be
associated with you or the Study Participant, but the researchers will not destroy the data.
If you choose not to allow the Study Participant’s information to be stored and used, or if you
withdraw your permission, this will involve no penalty or loss of benefits to which you and/or
the Study Participant are otherwise entitled. This will not harm your or the Study Participant’s
relationship with the Study Participant’s doctors who may be involved with this Registry or
PWS.
This form and your permission will never expire unless you change your mind and withdraw it.
You may withdraw your permission by telling the Registry staff in writing to:
Jessica Bohonowych
Foundation for Prader-Willi Research5455 Wilshire Blvd., Suite 2020
Los Angeles, CA 90036
registry@fpwr.org
Participation of minors and adults unable to consent

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Registry information will be collected on patients who are diagnosed with a form of PWS.
Patients over the age of 18 who understand the consent form and legally provide their own
consent (and thus do not have a legal guardian) are eligible to join this Registry on their own.
Otherwise, the legal guardian or parent of the patient must sign the consent form for the patient
to join. When a minor Study Participant becomes 18 (and if they are able), consent will beobtained directly from them for continued participation.
Privacy Rights
The health-related information that we gather about the Study Participant in this study is
personal. The researchers are required by law to protect the privacy of information known asprotected health information (PHI). All reasonable efforts will be made to protect theconfidentiality of the Study Participant’s PHI, which may be shared with others to support thisresearch, to conduct public health reporting, and to comply with the law as required. Despite
these protections, there is a possibility that information about you or the Study Participant could
be used or disclosed in a way that it will no longer be protected.
By signing this form, you give permission on behalf of the Study Participant for this Registry tostore and use and/or disclose the information in this Registry database. You have a right torefuse to sign this form. The Study Participant’s health care outside the study, the payment for
his/her health care, and his/her health care benefits will not be affected if you do not sign thisform. You do not give up any of your or the Study Participant’s legal rights by signing this form.
User Submitted Content
NORD and the Global Prader-Willi Syndrome have the right to edit and delete any portion of theWebsite.
Use of the Data/Information Contained on the Website
All data collected by NORD and Global Prader-Willi Syndrome may be combined and sharedwith other NORD organizations or outside researchers. You are responsible for the accuracy ofthe data and its content. NORD and its affiliated organization will protect the data to the extent
possible and as described in this consent.
Consent from International Users of the Platform
For persons living outside the United States who choose to share information about themselves(or about a person for whom they serve as a Legally Authorized Representative), the same
protections for privacy and confidentiality are offered as in the United States. By signing thisconsent, you acknowledge that you are disclosing information that would otherwise be private.
Privacy laws in your country may have different protections than those provided in the UnitedStates.
GETTING ANSWERS TO YOUR QUESTIONS ABOUT THE STUDY
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We have used some technical terms in this form. Please feel free to ask about anything you don't
understand and to consider sharing your/the Study Participant’s information and the consent
form carefully – as long as you feel is necessary – before you make a decision. Please contact theRegistry staff as listed above.
An Institutional Review Board, for the purpose of protecting your/the Study Participant’s rights,
has reviewed this Registry. An institutional review board is a group of people who areresponsible for protecting the rights and welfare of people who participate in studies. For
questions about the rights of the Study Participant in this Registry or to discuss other study
related concerns or complaints with someone who is not part of this Registry team, you may
contact Hummingbird IRB, One Broadway, 14th Floor, Cambridge, MA 02142 at 1-855-4472123 (toll free). Review and approval of this Registry by Hummingbird IRB is not anendorsement of this Registry or its outcome.
Do not sign this form unless you have had a chance to ask questions and have received
satisfactory answers to all of your questions.
Because of the way data is collected and saved, to participate in this study, the participant or
person agreeing must be willing to agree to permitting data to be shared as described. If you
cannot agree to this, please do not participate in the study.
Please reference the following sections of the consent form for details on how data collected inthis study will be used.
•
•
•
•
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How Study Participant Data gets into the registry
How Study Participant Data is stored and used for future research
Confidentiality
Voluntary Participation and Withdrawal
Privacy Rights

Authorization
I have read this Consent and Authorization Form to donate data for future research purposes andhave decided to donate the Study Participant’s data to the Global Prader-Willi Syndrome
Registry. The general purposes of registry participation, details of my and the Study Participant’s
involvement and possible hazards and inconveniences have been explained to my satisfaction. I
understand that I will receive an electronic copy of this consent/authorization form.
If appropriate, select the category that best describes the Study Subject’s Legally Authorized
Representative who signed above:
Court-appointed guardian
Durable power of attorney
Health care proxy
Family member / next of kin (describe relationship below):
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Relationship to Study Subject: _______________________________CHECK all that apply (Yes or No)
I give permission on behalf of the Study Participant to provide research data to the Global
Prader-Willi Syndrome Registry only for the purposes described above. Yes ___ No ___I give permission on behalf of the Study Participant to provide research data that has been deidentified to the Global Prader-Willi Syndrome Registry for future, undefined research. Yes ___No ___

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