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AUTORIZACIÓN Y CONSENTIMIENTO PARA PARTICIPACIÓN EN UN
PROYECTO DE INVESTIGACIÓN
100 FR 4a
Especificar la entidad de investigación académica de la Universidad de Yale y si aplica, indicar
las entidades no académicas, como por ejemplo:
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 CENTERYALE 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.
200 FR. 4 ( 2013-1)
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.
Título del Estudio: [Insert title of the study.]
Investigador Principal: [Insert name and mailing address.]
Fuente de Financiamiento: [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
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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
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,
Invitación para Participar y Descripción del Proyecto
Usted ha sido invitado a participar en este estudio de investigación el cual ha sido
diseñado para [state what the study is designed to discover or establish];[escriba para que fue
sido diseñado este estudio de investigación]. A usted se la invitado a formar parte de este
estudio de investigación porque [explain briefly why the prospective subject is eligible to
participate]; [explique brevemente las razones por las cuales el sujeto es elegible para
participar]. [If appropriate, state the approximate number of subjects and/or research sites
involved in the study.]; [Si es apropiado, explique el número aproximado de sujetos o de lugares
que están involucrados en este estudio.]
Para decidir si desea o no participar este estudio, usted debe conocer suficiente
información acerca de los riesgos y beneficios de participar en este estudio de investigación.
Este consentimiento contiene información detallada acerca del estudio. También un miembro
del equipo de investigación discutirá la información con usted. Se discutirán todos los aspectos
relacionados a este estudio de investigación: el propósito, los procedimientos que se llevarán a
cabo, los riesgos de los procedimientos, los posibles beneficios y alternativas de tratamiento.
[Note: If the protocol is not a treatment protocol, delete “and possible alternative treatments”].
Una vez usted entienda el estudio, le preguntaremos si desea participar. Si usted decide
participar en este estudio, se le solicitará que firme este documento.
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
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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.
 HIPAA dictates that the consent form and HIPAA Research Authorization form (RAF)
can only 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.) Therefore,
the researcher must prepare a second HIPAA RAF should the investigator want to also
bank the biologic sample (or data collected from the clinical trial) for future or
secondary use. In lieu of a second RAF, the researcher has the option of distinctly
separating the two research purposes in the same compound form. 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 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 controlled 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.)
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>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:
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 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
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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.
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 at [XX phone] 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). You must follow up this request with a written request,
mailed to [X address].
I agree to allow my samples and information to be stored and used for future research as
described above: (initial your choice)
_____YES
______No
Descripción de los Procedimientos
Texto Sugerido:
Si usted decide participar en este estudio, a usted se le solicitará que [describa los
procedimientos del estudio claramente y en orden cronológico]; [describe the study procederes
clearly in roughly chronological order].
If this is a Phase II or III controlled clinical trial with FDA oversight, or a controlled 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:
Una descripción de este ensayo clínico estará disponible en la siguiente dirección electrónica:
http://www.ClinicalTrials.gov, según requerido por la ley de los Estados Unidos. Esta página
cibernética no incluirá información personal que pueda identificarlo(a). Esta página cibernética
puede incluir un resumen de los resultados. Usted puede accesar esta página cibernética en
cualquier momento.
(Para más información acerca de cómo registrar ensayos clínicos, favor contactar YCCI)
> Si aplica, añadir [If appropriate add]:
Durante su participación en este estudio, a usted se le notificará todo nuevo hallazgo que pueda
afectar su disposición de continuar participando en este estudio.
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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.
> Si aplica, incluir [If appropriate include]:
Especímenes Opcionales para Almacenamiento Futuro/Estudio Genético
Texto Sugerido:
Usted ha sido invitado para permitir que algunas de sus muestras (llamadas especímenes) e
información relacionada sean almacenadas (en un banco de muestras) y utilizadas en
investigaciones futuras [con el propósito X] [for X purpose]. Esto puede ayudar a los
investigadores a aprender acerca de cómo prevenir, identificar y tratar [X enfermedad o
condición] [X disease(s)/condition(s)] en el futuro.
Sus especímenes se almacenarán por tiempo ilimitado [Si se conocen las fechas específicas de
almacenamiento, favor describir]; [If specific dates of storage are known, describe], y se podrán
utilizar para crear cepas celulares que pueden vivir indefinidamente. Los estudios investigativos
futuros pueden enfocarse en estudiar sus genes. Los genes son las unidades hereditarias que se
pasan de generación en generación. Los genes son responsables de muchas características
personales tales como el color de ojos, el color del pelo, el tipo de sangre y cientos de otras
características. Los análisis genéticos futuros pueden incluir buscar detalles acerca de cómo el
DNA mantiene su estructura; por ejemplo un exoma o una secuencia del genoma o estudios de
asociaciones del genoma (eso significa buscar otros genes además de los que están asociados con
una enfermedad específica). En algún momento, como parte de ciertos proyectos de
investigación, los materiales podrían ser inyectados a animales. (Exclude what is inapplicable to
your type of research: e.g., in pharmacogenetic research, genome sequencing and animal studies
are unlikely.)
Nosotros haremos todos lo posible para proteger su identidad al momento de guardar sus
especímenes e información. Sus muestras e información tendrán un código, el cual será único.
Otros investigadores sólo recibirán muestras e información codificada y no podrán relacionar el
código con usted como individuo. Tenemos estrictas medidas de seguridad puestas en vigor para
reducir los riesgos del mal uso o de la divulgación de información no deseada.
El uso de sus especímenes o muestras para propósitos investigativos probablemente no será
beneficioso para usted. Sin embargo, esperamos que los resultados de estos estudios puedan
ayudar a otras personas en el futuro.
Existe el riesgo de que su información sea mal utilizada [Give examples]; [Proveer ejemplos].
La probabilidad de que esto ocurra es mínima. Nosotros hemos tomado medidas de protección
para reducir este riesgo [Describe]; [Describir]. También existe el riesgo de revelar
información genética. En el estudio de investigación puede descubrirse información sobre su
salud y ciertas características heredables que pueden afectarlo(a) a usted o a sus familiares
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consanguíneos. Raramente, la información sobre su salud o genética podría ser mal utilizada por
patronos, compañías de seguros médicos y otros. Existe una ley federal llamada Información
Genética Ley de No Discriminación (GINA por sus siglas en inglés), la cual establece que es
ilegal de parte de compañías de seguros médicos, grupos de seguros médicos y la mayoría de los
patronos (excepto patronos con menos de 15 empleados) el discriminar hacia un individuo por
razón de su información genética. Sin embargo, esta ley no provee protección contra el
discrimen por parte de compañías que venden seguros de vida, seguros de incapacidad o seguros
de cuidado prolongado.
Sus especímenes e información serán utilizados solamente para propósitos investigativos y no
serán vendidos. Existe la posibilidad de que esta investigación lleve al desarrollo de productos
que serán comercializados. Si esto ocurre, no hay planes de compartir los ingresos económicos
con usted.
Los resultados de este estudio no se le entregarán ni a usted ni a su médico. Si los resultados del
estudio son publicados, su nombre y su información personal no serán revelados.
La opción de participar en este estudio es suya. Si usted decide no entregar sus especímenes o
muestras para ser almacenadas, su cuidado médico no se verá afectado por esta decisión.
Aunque usted decida ahora que podemos almacenar sus muestras, usted puede cambiar de
parecer en cualquier momento. Usted puede contactar al personal del estudio al siguiente
número de teléfono [XX phone] para indicarle que usted no desea que sus muestras sean
utilizadas. En ese caso, sus muestras serán [Researcher should choose one or allow subject to
indicate choice] destruidas o hechas anónimas (el código que las relacionaba a usted se
destruirá). Usted debe darle seguimiento a esta solicitud enviando una solicitud por escrito al
siguiente correo electrónico [X address].
Estoy de acuerdo en que se almacenen y utilicen mis muestras e información en investigaciones
futuras según descrito anteriormente: (inicie su preferencia).
______SI
______NO
Risks and Inconveniences
Magnetic resonance (MR) is a technique that uses magnetism and radio waves, not xrays, to take pictures and measure chemicals of various 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
the MR scanner might harm you. Another risk is a metallic object flying through the air toward
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the magnet and hitting you. To reduce this risk we require that all people involved with the
study remove all metal from their clothing and all metal objects from their pockets. Nothing
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 clinical examination
of the brain. The scans performed in this study are not designed to find abnormalities. The
primary 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 diagnostic
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 primary 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 solely 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 clinical MR exam and for that reason, they
will not be made available for diagnostic purposes.
Riesgos e Inconvenientes
La Resonancia Magnética es una técnica que utiliza el magnetismo y las ondas de radio, no los
rayos x, para obtener imágenes y medir las sustancias químicas de diferentes partes del cuerpo.
La Administración de Medicamentos y Alimentos (FDA por sus siglas en inglés) de los Estados
Unidos ha establecido guías con respecto a la intensidad del magnetismo y la exposición a las
ondas de radio. Nosotros seguimos estas guías cuidadosamente.
Mientras se lleva a cabo el estudio de Resonancia Magnética lo observaremos cuidadosamente.
Algunas personas se pueden sentir incómodas o ansiosas. Si esto le ocurre, usted puede pedir
que se detenga el estudio en cualquier momento y nosotros lo sacaremos de la máquina de
Resonancia Magnética. En raras ocasiones, algunas personas pueden experimentar: mareos,
malestar estomacal, sabor metálico, hormigueo o contracciones musculares. Estas sensaciones
tienden a desaparecer rápido, sin embargo, infórmele al personal si usted experimenta estas
sensaciones como resultado del estudio.
Existen algunos riesgos relacionados a los estudios de Resonancia Magnética que ciertas
personas pueden experimentar. Si usted tiene un marcapaso o algún objeto de metal dentro de su
cuerpo, usted puede ser excluido de este estudio debido a que el introducir objetos magnéticos
dentro de la máquina de Resonancia Magnética puede ser perjudicial para usted. Otro riesgo
potencial es que un objeto metálico se desplace hacia la máquina de MR (por sus siglas en
inglés) y lo golpee. Para reducir este riesgo, requerimos que todas las personas involucradas en
este estudio se aseguren de remover todo tipo de metal de su ropa y de sus bolsillos. En ningún
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momento se deben traer objetos de metal al cuarto de MR. Además, una vez usted esté en este
estudio, la puerta del cuarto se cerrará para que nadie se acerque por equivocación al magneto.
Es importante que usted lea y conteste cuidadosamente las preguntas del Cuestionario de
Seguridad de la Resonancia Magnética. Por favor, en este momento asegúrese que leyó el
Cuestionario de Seguridad de la Resonancia Magnética y asegúrese de decirnos cualquier tipo de
información que usted considere importante.
Este estudio de MR es sólo para propósitos investigativos y de ninguna manera representa una
evaluación clínica de su cerebro. Las imágenes obtenidas en este estudio no son hechas con el
propósito de encontrar anomalías. El investigador principal, el laboratorio, el tecnólogo de
Resonancia Magnética y el Centro de Investigación de Resonancia Magnética no están
calificados para interpretar las imágenes de MR y no son responsables de proveer evaluaciones
diagnósticas acerca de las imágenes. De haber un hallazgo preocupante en sus imágenes de
Resonancia Magnética, un radiólogo u otro médico revisarán las imágenes. Basado en su
recomendación (si alguna), el investigador principal o un médico consultor lo contactará a usted,
le informará acerca del resultado y le recomendará buscar una consulta médica como medida de
precaución. Sólo usted y su médico determinarán si se llevarán a cabo estudios o tratamientos
adicionales. Los investigadores, el médico consultor, el Centro de Investigación de Resonancia
Magnética y la Universidad de Yale no nos hacemos responsables de ninguna evaluación o
tratamiento que usted reciba basado en estos hallazgos. Las imágenes obtenidas en este estudio
no son parte de una evaluación clínica de Resonancia Magnética y por tal razón, no serán
utilizadas con fines diagnósticos.
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 necessary 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 resolve 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 inform 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 of kidney disease, seizure, asthma, or allergic respiratory disorders, and (4) if you have
anemia or disease that affects red blood cells.
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Riesgos por el uso del Contraste y otros Procedimientos
El procedimiento de colocar una vía intravenosa (IV por sus siglas en inglés) es bien seguro.
Existe una mínima posibilidad de que sea necesario pincharlo múltiples veces con la aguja para
asegurarse que la vía intravenosa esté colocada correctamente. Usted puede experimentar un
dolor leve cuando se coloque la vía intravenosa, pero el dolor no debe durar mucho. Puede
formarse un hematoma o una infección menor en el área en la cual se colocó la vía intravenosa.
El hematoma va a desaparecer por si mismo; cubrirlo con una toalla tibia puede ayudar. Se
ofrecerá tratamiento para las infecciones de ser necesario.
La Administración de Medicamentos y Alimentos (FDA por sus siglas en inglés) aprueba el uso
del contraste llamado Gadolinio en sujetos humanos. Usted debe saber que existen ciertos
riesgos asociados con el uso de este contraste. Algunos sujetos saludables (menos del 3%)
pueden experimentar nauseas, dolor de cabeza o mareos luego de la inyección. Estos efectos
adversos usualmente se resuelven por si mismos sin la necesidad de tratamiento. También existe
el riesgo de reacciones alérgicas (menos del 1%). Una reacción alérgica puede causar ronchas,
picor o dificultad al respirar. En individuos con problemas del riñón, el gadolinio puede causar
una enfermedad seria llamada fibrosis sistémica nefrogénica (del riñón). Por esta razón, antes de
llevar a cabo el estudio de MR, le haremos pruebas de sangre para asegurarnos de que sus tengan
una función normal. Si usted lo solicita, se le puede entregar información detallada acerca del
Gadolinio.
Usted debe informar al investigador principal lo siguiente: (1) si usted está embarazada o
lactando (2) si usted tiene historial de reacciones alérgicas a agentes de contraste utilizados en
MR o CT (Tomografía Computarizada), (3) si usted tiene historial de enfermedad renal,
convulsiones, asma o alergias respiratorias y (4) si usted tiene anemia o enfermedades de las
células de la sangre.
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.
Beneficios
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Economic Considerations
Guidelines:
 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.
 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.
Consideraciones Económicas
 Si aplica incluir: [If the subject will be receiving standard of care as well as research
intervention, add the following]:
Usted es responsable de todo co-pago requerido por su seguro médico relacionado a tratamientos
estándares o rutinarios.
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.
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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?
 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.
 When the research records may be subject to inspection by FDA, a funding agency, or an
industrial sponsor, 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-
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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
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 theYale 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 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
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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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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.
Confidencialidad y Privacidad
Texto Sugerido:
Cualquier información identificable que se obtenga en relación a este estudio es considerada
confidencial y será revelada solamente con su autorización o según lo permitido por las leyes del
Estado o de los Estados Unidos. Algunos ejemplos de información que legalmente estamos
obligados a divulgar son: maltrato o presunto maltrato de menores de edad, maltrato o presunto
maltrato de ancianos y ciertas enfermedades reportables. [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.] Si los resultados de la investigación son publicados o presentados en conferencias, no se
divulgará ninguna información que pueda revelar su identidad. Para revelar su identidad es
necesario obtener un consentimiento específico para ello.
Entendemos que la información sobre su salud obtenida en relación con este estudio es privada y
estamos comprometidos en proteger la privacidad de esta información. Si usted decide participar
en este estudio, los investigadores recopilarán información que lo identifica a usted y a la
información sobre su salud. Esto puede incluir información que lo identifique directamente
como por ejemplo, su nombre y [list other direct identifiers as appropriate and if required]. Esta
información será de-identificada lo mas rápido y razonablemente posible luego que sea recibida.
Esto significa que vamos a reemplazar su información identificable con un código que no lo
identifique a usted directamente. El investigador principal guardará un enlace que lo identifica
tanto a usted como a su código y este enlace se mantendrá en un lugar seguro. Solamente el
investigador principal y unos miembros seleccionados del grupo de investigación tendrán acceso
a este enlace. Toda información que pueda identificarlo se mantendrá en confidencialidad.
[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.] El equipo de investigadores solamente divulgará esta información codificada para
propósitos investigativos. El enlace a su información personal se guardará por [state time in
months or years], y luego esta conexión se destruirá y los datos se harán anónimos. Los datos se
guardarán de forma anónima [indefinitely / for X months/years until it is destroyed].
La información sobre su salud que se recopilará en este estudio incluye: (Specify as appropriate,
delete what is not appropriate)

Expedientes del estudio de investigación.
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HIC#: insert number

Expedientes del laboratorio y expedientes médicos limitados a los servicios que se provean
como parte de este estudio.
 El expediente completo del estudio de investigación y cualquier expediente médico
guardado por [Institution] y creado por: _____________ a _______________
 La siguiente información: [Complete with specific information that is being collected]
Texto Sugerido (añadir o eliminar según aplique):
 Expedientes de las llamadas efectuadas como parte de este estudio.
 Expedientes de las visitas efectuadas durante su participación en este estudio.
Seleccionar la información adicional según aplique:[Select additional information sources from
below as appropriate].
Información obtenida en este estudio acerca de:
 VIH/SIDA
 Hepatitis
 Enfermedades de Transmisión Sexual
 Otras enfermedades infecciosas reportables
 Exámenes físicos
 Laboratorios, rayos x y otros resultados
 Diarios y cuestionarios
 El diagnóstico y tratamiento de una condición de salud mental
 Uso de drogas ilegales o el estudio de comportamiento ilegal
 Expedientes acerca de cualquier medicamento que usted haya recibido como parte un
estudio.
 Expedientes acerca del dispositivo que usted haya recibido como parte de este estudio.
La información personal y sobre su salud que pueda identificarlo, puede ser utilizada o
revelada a las siguientes entidades o individuos:
 El Departamento de Salud y Servicios Humanos (DHHS por sus siglas en inglés) de
los Estados Unidos.
 Los representantes de la Universidad de Yale, al Programa de Protección de
Investigaciones Humanas de Yale y al Comité de Investigaciones Humanas de Yale
(el comité que revisa, aprueba y controla la investigación con sujetos humanos), el
cual es responsable de asegurar el cumplimiento de la investigación. Estas entidades
e individuos deben mantener toda esta información confidencial.
 Los individuos en Yale que son responsables de supervisar los aspectos financieros
del estudio de investigación incluyendo las facturas y los pagos.
 El investigador principal [Insert Name]
Seleccione y elimine los grupos adicionales a los cuales se puede divulgar información según
apliqué:
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La Administración de Medicamentos y Alimentos (FDA por sus siglas en inglés). Esto se
lleva a cabo para que la FDA pueda revisar la información acerca de un nuevo medicamento
[o dispositivo] bajo investigación. La información solamente puede ser utilizada para
cumplir con los requisitos de reportar el medicamento a las agencias reguladoras.
La compañía que manufactura el medicamento o el dispositivo que se está investigando.
Las agencias reguladoras de medicamentos de otros países.
Las agencias gubernamentales a las cuales ciertas enfermedades (enfermedades reportables)
deben ser reportadas.
Proveedores de servicios de salud que le haya provisto servicios relacionados a este estudio.
Laboratorios, otros individuos y organizaciones que analizan la información médica
relacionada con este estudio de acuerdo con el plan del estudio.
Co investigadores y otros investigadores.
El Coordinador del Estudio y los Miembros del Equipo de Investigación.
La Junta de Seguridad de Datos y Vigilancia (DSMB por sus siglas en inglés) y otras
entidades autorizadas a controlar la conducta del Estudio: List any separate or local
committees not in the protocol, if applicable
Y otros:
Al firmar este documento, usted autoriza el uso y/o la divulgación de la información descrita
anteriormente para ser utilizada en este estudio. El propósito de los usos y las divulgaciones que
usted está autorizando es asegurar que la información relacionada con este estudio esté disponible
para todas las partes involucradas que la necesiten para fines investigativos.
Todos los proveedores de salud que deban cumplir con el Código de Portabilidad del Seguro de
Salud y Contabilidad (HIPAA por sus siglas en inglés) están obligados a proteger la privacidad de
la información sobre su salud. El personal de investigación de la Escuela de Medicina de Yale y
[Specify health care facility, e.g., Yale-New Haven Hospital, the Connecticut Mental Health
Center], debe cumplir con la ley HIPAA y asegurar la confidencialidad de su información.
Algunos individuos o entidades mencionadas anteriormente no tienen la obligación de cumplir
con la ley HIPAA y por ende, no tienen que proveer el mismo tipo de protección de la
confidencialidad. Estos podrían utilizar o divulgar su información de maneras que no hayan sido
mencionadas en este documento. Sin embargo, para optimizar la protección de la información
sobre su salud, se están llevando a cabo acuerdos con estos individuos y/o entidades para
requerirles que mantengan su información confidencial.
[Incluir si aplica:]
Cuando el patrocinador venga a Yale a supervisar este estudio de investigación, el patrocinador va a
revisar los datos que recopilamos acerca de usted. El ‘Patrocinador” incluye a cualquier persona
que trabaje para o que esté contratado(a) por el patrocinador para llevar a cabo investigaciones
acerca de este estudio. En el caso de este estudio, el patrocinador incluye a [insert the company
name or CRO here]. Los investigadores de Yale también le enviarán la información sobre su salud
al patrocinador, sin embargo, no enviarán información que lo pueda identificar a usted directamente
como por ejemplo, su nombre o [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
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HIC#: insert number
sponsor and the contract provides confidentiality and privacy safeguards regarding the
protection of the information for the secondary us.]. Además, el patrocinador puede utilizar su
información personal para otros fines relacionados con éste o con estudios de investigación
similares.
Usted tiene el derecho de inspeccionar y solicitar una copia de la información sobre su salud
documentada en su expediente médico de acuerdo a las políticas institucionales concernientes a
los expedientes médicos. Sin embargo, si usted decide participar en un estudio ciego o doble
ciego en el cual se provee tratamiento, al firmar esta autorización, usted no podrá inspeccionar u
obtener una copia de la información relacionada con el estudio hasta después de que el estudio
sea completado.
La autorización parar utilizar y divulgar la información sobre su salud que fue recopilada en este
estudio nunca expira.
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.
 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 the study is sponsored by a non-profit entity (e.g.,
investigator’s own funds, federal funding, or a private non-profit organization), the
following paragraph should be used: “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.”
Suggested Text:
If you are injured as a result of your participation in this study, [indicate whether
treatment will be made available, and who will be responsible for its cost.]
En Caso de Daños
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HIC#: insert number
Guías:
La Escuela de Medicina de Yale y [Specify health care facility, e.g., Yale-New Haven Hospital,
the Connecticut Mental Health Center] no proveen fondos para el tratamiento de daños
relacionados con estudios de investigación. En el caso de que el estudio sea patrocinado por una
entidad sin fines de lucro, (por ejemplo, por fondos del mismo investigador, fondos federales o
una corporación privada sin fines de lucro), si usted se lesiona como resultado de su
participación en este estudio, se le proveerá tratamiento. Usted y su aseguradora de servicio de
salud serán responsables de pagar los costos del tratamiento. No hay compensaciones
económicas disponibles ni adicionales por motivo de daños o pérdida de su salario.
Texto Sugerido:
Si usted experimenta algún daño como resultado de su participación en este
estudio,[indicate whether treatment will be made available, and who will be responsible for its
cost.]
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:
You are free to choose not to take part in this study. Your health care outside the study, the
payment for your health care, and your health care benefits will not be affected if you do not
agree to participate. 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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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).]
If you choose not to participate or if you withdraw 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.”]
Participación Voluntaria y Retiro del Estudio
Texto Sugerido:
Usted tiene la libertad de escoger no participar en este estudio. Si usted decide no participar en
este estudio, el cuidado de su salud fuera del estudio, el pago de sus servicios de salud y sus
beneficios no se verán afectados. Sin embargo, si usted decide no autorizar el uso de su
información en este estudio, usted no podrá inscribirse en este estudio y tampoco podrá recibir
los procedimientos como participante del estudio.
Para Retirarse del Estudio
Si usted decida participar como sujeto en este estudio, sepa que usted puede decidir retirarse del
estudio en cualquier momento. (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.)
Para retirarse del estudio, usted puede comunicarse con uno de los miembros del equipo de
investigación en cualquier momento y decirle que usted ya no desea participar. Las citas
subsiguientes se cancelarán (si aplica).
Los investigadores pueden excluirlo de participar en este estudio de ser necesario (Por ejemplo
por: la progresión de la enfermedad/pobre respuesta a tratamiento, la presentación de efectos
secundarios severos o el pobre cumplimiento con el tratamiento)].[[Describe the conditions
under which a subject might be withdrawn from the research.]
Si usted decide descontinuar su participación o retirarse del estudio, esta decisión no afectará
negativamente su relación con sus médicos o con [Specify health care facility, e.g., Yale-New
Haven Hospital, the Connecticut Mental Health Center].
[If applicable: “Nosotros
continuaremos proveyéndole el cuidado médico siguiendo las guías estándares de tratamiento y
de usted solicitarlo, será referido(a) a una clínica o médico que ofrezca dicho tratamiento.”]
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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 do this by sending written notice to the study doctor [insert name and address
from page 1 of this form]. 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.
Revocación de la Autorización para Utilizar y Divulgar su Información de Salud
En cualquier momento, usted puede revocar o cancelar el permiso para que se utilice y divulgue
la información sobre su salud. Usted puede hacerlo enviando una notificación por escrito al
médico del estudio[insert name and address from page 1 of this form]. Si usted decide revocar
su permiso, usted no podrá continuar participando en este estudio.
A partir del momento que usted revoque esta autorización, no se generará ninguna nueva
información sobre su salud que pueda identificarlo. La información que se haya recopilado
anteriormente podrá ser utilizada y divulgada a otros hasta que culmine el estudio de
investigación, según sea necesario para mantener la integridad del estudio y/o según lo requiera
la supervisión del estudio.
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.
Preguntas
Hemos utilizado algunos términos técnicos en este documento. Por favor, siéntase en la libertad
de preguntar cualquier cosa que usted no entienda. Evalúe este estudio y el consentimiento
cuidadosamente - por el tiempo que usted entienda necesario - antes de tomar una decisión.
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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 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 [Add country code, if applicable].
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[Add country code, if
applicable].
THIS FORM IS NOT VALID UNLESS THE FOLLOWING BOX
HAS BEEN COMPLETED IN THE HIC OFFICE
THIS FORM IS VALID ONLY THROUGH:
___________________________________
INITIALED:
_______________________________________
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HIC#: insert number
Autorización y Permiso
He leído (o alguien me ha leído) este documento y he decidido participar en el proyecto descrito
anteriormente. Se me han explicado adecuadamente las metas generales, los particulares de mi
participación y los potenciales daños e inconvenientes del estudio. Mi firma también indica que
he recibido una copia de este consentimiento.
Al firmar este documento, estoy otorgando permiso a los investigadores para que utilicen y
divulguen mi información personal con los fines descritos previamente en este documento. Si
rehúso otorgar el permiso, entiendo que no podré participar en este estudio.
Nombre del Sujeto: _______________________
Firma del Sujeto: _________________________
Fecha: _________________________________
Firma de la Persona que Obtuvo el Consentimiento: ____________________
Fecha:_____
Si luego de firmar este documento, usted tiene alguna pregunta acerca de sus derechos de
privacidad, puede contactar al Oficial de Privacidad de Yale al siguiente número de teléfono:
203/432-5919 [Add country code, if applicable].
Si usted tiene alguna otra pregunta acerca de este proyecto o si usted experimenta un problema
relacionado con este estudio, usted puede contactar al Investigador Principal [cite name and full
telephone number]. Si usted desea hablar con alguien que no sea un investigador para
comunicarle un problema, preocupación o para hacerle preguntas acerca de este estudio, o para
discutir sus derechos como sujeto de investigación, usted puede contactar al Comité de
Investigaciones Humanas de Yale al siguiente número de teléfono:
(203) 785-4688[Add
country code, if applicable].
ESTE DOCUMENTO NO ES VALIDO SI EL SIGUIENTE APARTADO NO HA SIDO
COMPLETADO EN LA OFICINA DE HIC
THIS FORM IS NOT VALID UNLESS THE FOLLOWING BOX
HAS BEEN COMPLETED IN THE HIC OFFICE
ESTE DOCUMENTO ES VÁLIDO SÓLO
DURANTE EL SIGUIENTE PERÍODO:
___________________________________
INICIALES:
_______________________________________
Page 23 of 24
HIC#: insert number
Page 24 of 24