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Dep ar t me n t/ Se ct io n o f Dep a rt men t o r S ec tio n Na m e
STUDY TITLE
Assent Form Age 16-17 to Participate in Research
First Name Last Name, Degree, Principal Investigator
INTRODUCTION
You are invited to be in a research study. Research studies are designed to gain scientific
knowledge that may help other people in the future. You are being asked to take part in this
study because you have condition or reason the subject is being recruited. Your participation is
voluntary. Please take your time in making your decision as to whether or not you wish to
participate. Ask your study doctor or the study staff to explain any words or information
contained in this informed consent document that you do not understand. You may also discuss
the study with your friends and family.
WHY IS THIS STUDY BEING DONE?
The purpose of this research study is to Describe the Reason the Study is Being Done
[Example Applicable text:]
Phase 1 studies:
test the safety of drug/intervention and see what effects (good and bad) it has on you and your
condition.
or find the highest dose of drug that can be given without causing severe side effects.
Phase 2 studies:
find out what effects (good and bad) drug/intervention has on you and your condition.
Phase 3, and comparative phase 4 and post-marketing studies:
compare the effects (good and bad) of new drug/intervention with commonly-used
drug/intervention to see which is better.
[Other text describing the purpose of the study should be used as appropriate]
[For studies involving an investigational drug or device]
Investigational/Experimental drug or device is an investigational drug/device. This means it has
not been approved by the U.S. Food and Drug Administration (FDA). Drugs and devices that do
not have approval by the FDA cannot be sold or prescribed by your physician.
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[For studies involving FDA approved drugs or devices used in an unlabeled manner]
Drug or Device Name has been approved by the US Food and Drug Administration (FDA), but it
has not been approved for use in this manner, at this dose, for this condition, for administration
by this route or other text as appropriate.
[For studies involving the use of placebo]
In this study drug or device name will be compared to placebo. A placebo is a substance, like a
sugar pill, that is not thought to have any effect on your disease or condition. In this study you
will either receive the active study medication, drug or device name or placebo which is not
active. Placebos are used in research studies to see if the drug being studied really does have an
effect.
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
number people at number of research sites will take part in this study, including approximately
number people at this research site. Optional Sentence if applicable: In order to identify the
(insert number) subjects needed, we may need to screen as many as (insert number) because
some people will not qualify to be included in the study.
WHAT IS INVOLVED IN THE STUDY?
[Provide simplified schema and/or calendar such as “At your first study visit you will …”]
[For randomized studies:]
You will be randomized into one of the study groups described below. Randomization means
that you are put into a group by chance. It is like flipping a coin. You will have an equal/one in
three/etc. chance of being placed in any group.
[For blinded studies]
Neither you nor the investigator will know which study drug, device, procedure, treatment, etc.
you are receiving. This is done so that a fair evaluation of results can be made. This information
is available to the researchers if needed in an emergency.
[Modify as appropriate for single blind studies]
[For all studies describe step-by-step, what will be required of, or done to, the research subject.
The description should be in lay language, defined as language understandable to the people
being asked to participate (usually 6th to 8th grade). The use of second person (e.g., “You will
receive…”) is generally required; the use the first person (e.g., "I understand that...") is
generally not allowed.]
If you take part in this study, you will have the following tests and procedures:
[List study procedures and their frequencies, differentiating between those that will be
performed solely for research or investigational purposes, and those that represent standard of
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care. For randomized studies, list the study groups and under each, describe procedures. Include
whether a patient will be at home, in the hospital, or in an outpatient setting. List the research
medications that will be administered and the method, dose and frequency of administration.
Indicate the number frequency and duration of visits. For studies involving non-FDA approved
drugs or devices indicate whether the subject will have access to them following the completion
of the study. Indicate other specific requirements such as post-treatment follow-up, diary cards,
and questionnaires.]
[Blood drawing]
You will have approximately (state amount in teaspoons or tablespoons) of blood withdrawn
from a vein (state frequency or number of occasions). The total amount of blood withdrawn
during the study will be approximately (state amount in teaspoons or tablespoons or ounces).
[For studies involving photography/video and audio taping as part of the study procedures]
As part of this research study, you will be photographed/videotaped/audiotaped. This is being
done [brief description of why this is necessary]. You understand that you may request the
filming or recording be stopped at any time during the course of the research study. You can also
withdraw your consent to use and disclose the photograph/videotape/audiotape before it is used.
You should also understand that you will not be able to inspect, review, or approve the
photographs, videotapes, audiotapes or other media (including articles containing such) before
they are used in this study.
Please choose one of the following regarding the use and disclosure of the
photograph/videotape/audiotape used in this research study:
_____ I would like the photographs/videotapes/audiotapes of me to be destroyed once their use
in this study is finished.
____ The photographs/videotapes/audiotapes of me can be kept for use in future studies provided
they are kept secure and any future study will be reviewed by an IRB. I understand that I will
not be able to inspect, review or approve their future use.
[For studies that plan on sending test results or findings to the subject’s personal physician
include the following: NOTE: THE FOLLOWING TEXT IS REQUIRED FOR STUDIES WHICH ARE REQUIRED TO
ADHERE TO ICH-GCP STANDARDS
We can send copies of your test results to your personal physician. Even if you do not wish to
have any of your medical information sent to your physician, you can still participate in this
research study.
Do you request that we send important medical findings from your study tests/exams to your
personal physician?
[ ] Yes
[ ] No
___________ Initials
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[If your study involves genetic testing, you must include the following text:]
As part of this study, a blood sample will be obtained and DNA from your blood sample will be
purified. DNA, or deoxyribonucleic acid, stores and transmits inherited traits, such as eye color
or blood type. As part of this research project, your DNA will be studied in an effort to find out
if there are genes that contribute to medical conditions that are part of this study. Because we do
not know how the results of this DNA study relate to your individual health, the results of the
research will not be given to you or your doctor without your permission. These results will also
not be placed in your medical records.
[If your study involves storage of biological material for future, undesignated research, you
must include the following text:]
Storage of Biological Tissue
If you agree to participate in this study, we will (draw X amount of the blood or take tissue from your X)
to use for future research. This sample will be kept and may be used in future research to learn more
about other diseases. Your sample will be obtained (in what department) at Wake Forest University
Baptist Medical Center. The sample will be stored (where) and it will be given only to researchers
approved by (PI of study). An Institutional Review Board (IRB) must also approve any future research
study using your tissue sample. In order to participate in this study, you must be willing to provide this
sample for future research. (If providing a sample is NOT required, then the additional optional biospecimen consent form must be used for those who agree to provide samples)
(Use this text for samples stored with a unique identifier)
Your blood/tissue sample will be stored with a unique identifier and will not include any
identifiable information about you such as your name, address, telephone number, social security
number, medical record number or any of the identifiers outlined in the HIPAA Privacy Rule.
The unique identifier will be a randomly assigned number and only the principal investigator will
have access to the code that links the unique identifier to you. Your name, address, social
security number, etc., will never be disclosed to future researchers and neither will the code that
links your identifiers to the sample.
(Use this text for samples stored de-identified)
Your blood/tissue sample will be stored de-identified, which means that no identifying
information will be stored with it. Researchers will not know the name, date of birth, medical
record number, social security number, etc., of the person who donated the sample.
The research that may be performed with your blood/tissue sample is not designed to help you
specifically. There is no personal benefit to you from taking part in this aspect of the research
study. It might help people who have diseases at some point in the future, but it is not known if
this will happen. The results of the research performed with your blood /tissue will not be given
to you or your doctor. The results will not be put in your medical record. The research using your
blood/tissue sample will not affect your care.
Your blood/tissue sample will be used only for research and will not be sold. The findings from
this research may result in the future development of products that are of commercial value.
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There are no plans to share any of the profits with you which may occur as a result of the
research.
(Use this text ONLY if samples are stored with identifiers)
In the future, people who do research may need to know more about your health. While the study
investigator may give reports about your health, he/she will NOT be given your name, address,
phone number, or any other identifying information about who you are, unless you agree to be
contacted in the future.
____YES you many contact for future research studies
____NO I do not want to be contacted regarding future research studies.
[If your study involves whole genome testing, you must include the following text:]
As part of the genetic study, a sample of your DNA may have Genome Wide Association Studies
(GWAS) performed. This analysis creates a very detailed picture of your DNA for researchers.
[If you are submitting samples/data to the NIH GWAS Repository, you must include the
following text:]
In addition, information regarding your DNA and clinical information about you will be sent to
the National Institute for Health’s Genome Wide Association Study (GWAS) data repository,
where it will undergo genome-wide analysis and be shared with other investigators for research
purposes. DNA and information sent to the GWAS will help researchers better understand how
genes affect the risk of developing diseases such as asthma, cancer, diabetes, and heart disease,
and may lead to better methods to select the best treatment options. Before your information is
sent to the GWAS data repository it will be de-identified, which means that we will remove any
identifying information such as your name, date of birth, address, etc. Thus, researchers using
your DNA and clinical data will not be able to link this information back to you.
HOW LONG WILL I BE IN THE STUDY?
You will be in the study for about months/weeks, until a certain event.
[Where appropriate, state that the study will involve long-term follow up.]
You can stop participating at any time. If you decide to stop participating in the study we
encourage you to talk to the investigators or study staff first to learn about any potential health or
safety consequences. [Describe any serious consequences of sudden withdrawal from the study.]
WHAT ARE THE RISKS OF THE STUDY?
Being in this study involves some risk to you. You should discuss the risk of being in this study
with the study staff. Risks and side effects related to the procedures, drugs, or devices we are
studying include:
[Describe the immediate and long-term physical, psychological, social and reproductive
risks/discomforts of participating in the study. Highlight or otherwise identify those that may be
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irreversible, long-term or life threatening. Provide an estimate of the frequency of the
risks/discomforts. If possible categorize risks/discomforts as Common, Uncommon, Rare, etc., as
opposed to a long unbroken list of every side effect ever noted. ]
In addition, there is a slight risk of a breach of confidentiality. We will do our best to protect
your confidential information. There also may be other side effects that we cannot predict. You
should tell the research staff about all the medications, vitamins and supplements you take and
any medical conditions you have. This may help avoid side effects, interactions and other risks.
[If the study involves the use of placebo, the possible consequences of not receiving active
therapy must be discussed.]
[If the study involves the withdrawal of active treatment for any reason (e.g. run-in phase,
washout, changing therapy from standard active treatment to study treatment, or crossing over
from one study arm to another) the consequences and risks of withholding, withdrawing or
changing treatment must be discussed.]
[For studies involving radiation]
If you participate in this study, you will be exposed to amounts of radiation above what you
would normally receive in daily life. To be sure that you do not receive an unhealthy amount of
radiation from your participation in this study, you should let your study doctor know if you have
had, or are going to have, any other scans or x-rays as part of your medical or dental care. It is
very important that you let your study doctor know if you already are participating in, or plan to
participate in, any other research study that involves radiation exposure.
[If the study meets the definition of minimal risk:]
The risk of harm or discomfort that may happen as a result of taking part in this research study is
not expected to be more than in daily life or from routine physical or psychological examinations
or tests. You should discuss the risk of being in this study with the study staff.
[Security of confidentiality and privacy should be included for most studies]
Taking part in this research study may involve providing information that you consider
confidential or private. Efforts, such as coding research records, keeping research records secure
and allowing only authorized people to have access to research records, will be made to keep
your information safe.
[For studies that involve psychological tests or interview questions related to depression,
suicidal ideations, abuse, illegal behavior, or other information that may require reporting to
authorities outside of the study, the following should be included:]
As part of this study, you will be asked questions about [include the appropriate language
depending on the test or activities to be performed] If we learn that you or someone else is in
danger of harm, the study team is required to report that information to the proper authorities.
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[When a Data Safety and Monitoring Committee exists:]
A Data Safety and Monitoring Committee, an independent group of experts, will be reviewing
the data from this research throughout the study.
[For blood draws, include the following:]
You may experience discomfort, bruising and/or bleeding where the needle is inserted.
Occasionally some people become dizzy lightheaded or feel faint. Infection may occur on rare
occasions. Frequent donation of blood can result in low iron in your blood (iron deficient
anemia).
[Optional – use only if applicable]
If you donate blood to the American Red Cross, you should talk with the study doctor about
whether or not it is safe to do so while participating in this study. You should not donate blood
more than 2 times per week and no more than approximately one pint (about 500 ml) of blood in
an eight week period.
Reproductive Risks and other Issues to Participating in Research
[Include the following if subjects include women of childbearing potential, and drug
fetotoxic/fetocidal (or unknown), and illness non-terminal:]
Due to unknown risks and potential harm to the unborn fetus, sexually active women of
childbearing potential must use a reliable method of birth control while participating in this
study. Reliable methods of birth control are: abstinence (not having sex), oral contraceptives,
intrauterine device (IUD), DepoProvera, tubal ligation, or vasectomy of the partner (with
confirmed negative sperm counts) in a monogamous relationship (same partner). An acceptable,
although less reliable, method involves the careful use of condoms and spermicidal foam or gel
and/or a cervical cap or sponge. We encourage you to discuss this issue further with your
physicians if you have any questions.
[If immediate treatment is required (less than 15 days from diagnosis), include the following
phrase:]
Pregnant women are excluded from participation in this study. Because some methods of birth
control are not 100% reliable, a pregnancy test is required at least 10 days from your last normal
menstrual period, if you are a sexually active woman of childbearing potential.
[If immediate treatment is NOT required, include the following phrase:]
Pregnant women are excluded from participation in this study. If you are a sexually active
woman of childbearing potential and have not been using a reliable method of birth control, two
negative pregnancy tests performed 15 days apart are required to check for possible early
pregnancy prior to starting treatment.
[If male subjects are included, and drug fetotoxic/fetocidal (or unknown) include the following
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phrase:]
Contraceptive Measures for Males
Your participation in this research study may damage your sperm, which could cause harm to a
child that you may father while on this study. Such harm may be currently unforeseeable. If you
are sexually active, you must agree to use a medically acceptable form of birth control in order to
be in this study and for (specify period of time following study participation if applicable)
months afterwards. Medically acceptable contraceptives include: (1) surgical sterilization (such
as a vasectomy), or (2) a condom used with a spermicide. Contraceptive measures such as Plan B
(TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use.
You should inform your partner of the potential for harm to an unborn child. She should know
that if pregnancy occurs, you will need to report it to the study doctor, and she should also
promptly notify her doctor.
[For studies that involve HIV, Hepatitis or testing for other communicable diseases which
require reporting to the NC State Board of Health:]
As part of this study, you will be tested for [include the appropriate language depending on the
test or tests to be performed] HIV (human immunodeficiency virus, which is the virus that causes
the acquired immunodeficiency syndrome [AIDS]); Hepatitis A, B, or C. You will be told of the
results of the testing, and counseled as to the meaning of the results, whether they are positive or
negative. If the test indicates that you are infected with [insert disease], you will receive
additional counseling about the significance of your care and possible risks to other people. We
are required by law to report all positive results to the North Carolina State Board of Health. The
test results will be released only as permitted by applicable law. If you do not want to be tested
for [insert disease], you should not agree to participate in this study.
ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
[If the individual subject will receive no direct benefit from participating in the study]
You are not expected to receive any direct benefit from taking part in this research study. We
hope the information learned from this study will benefit other people in the future.
[If the individual subject may receive some direct benefit from participating in the study]
If you agree to take part in this study, there may or may not be direct benefit to you. We hope the
information learned from this study will benefit other people in the future. The benefits of
participating in this study may be: [Describe the benefits an individual subject could reasonably
expect from participating in the study. Payments, incentives, or other forms of remuneration
offered to potential subjects should not be considered a benefit to be gained from research.]
[When appropriate:]
Based on experience with [drug, procedure, device, etc.] in [animals, other research studies,
patients with other disorders, patients with similar disorders], researchers believe [it may be as
good as standard therapy you could receive without being in the study but with fewer side
effects, it may be of benefit to subjects with your condition, or other appropriate text]. Because
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individuals respond differently to therapy, no one can know in advance if it will be helpful in
your particular case.
WHAT OTHER CHOICES ARE THERE?
You do not have to be in this study to receive treatment. You should talk to your doctor about all
the choices you have. Instead of being in this study, you have these options:
[List commonly available alternatives]
[If the study involves non-investigational treatments]
You could be treated with study treatments/drugs even if you do not take part in the study.
[If the study is a non-therapeutic study where the only option is to not participate]
This is not a treatment study. Your alternative is to not participate in this study.
THE FOLLOWING TEXT IS REQUIRED FOR STUDIES WHICH ARE REQUIRED TO ADHERE TO ICH-GCP
STANDARDS:
List the most common standard of care alternative procedures and most substantial risks and
benefits of the standard of care procedures.
WHAT ARE THE COSTS?
[Use one of the following paragraphs as appropriate:]
All study costs, including any study medications and procedures related directly to the study, will
be paid for by the study. Costs for your regular medical care, which are not related to this study,
will be your own responsibility.
[If there is any standard of care billing, in addition to research charges, include the following
paragraph:]
Taking part in this study may lead to added costs to you or your insurance company. We will
give you an estimate of what the added cost may be based on your particular situation and
insurance coverage.
[For studies utilizing a medical device, please insert the most appropriate option from the ones
listed below:]

Device provided by Sponsor (and professional services to implant device will (or will not) be
billed to patient/insurer):
“Neither you nor your insurance company will be billed for the investigational
device. You and/or your insurance company will (or will not) be billed for the
cost of any surgical procedure(s) necessary to implant the (name of device).”

Device to be billed to patient/insurer:
“You or your insurance company will be billed for the investigational
device. You and/or your insurance company will (or will not) be billed for the
cost of any surgical procedure(s) necessary to implant the (name of device).”
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
Billing of device is dependent upon randomization:
If you are assigned to the (Name of Device) group, you will not be charged
for the (Name of device) device.”
If you are assigned to the (Name of device) group, you will be charged for the
(Name of device) device.”
WILL YOUR RESEARCH RECORDS BE CONFIDENTIAL?
The results of this research study may be presented at scientific or medical meetings or published
in scientific journals. Your identity and/or your personal health information will not be disclosed
unless it is authorized by you, required by law, or necessary to protect the safety of yourself or
others. There is always some risk that even de-identified information might be re-identified.
Participant information may be provided to Federal and other regulatory agencies as required.
The Food and Drug Administration (FDA), for example, may inspect research records and learn
your identity if this study falls within its jurisdiction.
[If this study falls within the jurisdiction of the Food and Drug Administration, include following
statement:]
The purpose of this research study is to obtain data or information on the safety and/or
effectiveness of (insert name of drug, device, etc.); the results will be provided to the sponsor,
the Food and Drug Administration and other federal and regulatory agencies as required.
[For studies that involve the recording of audio or video, describe how the recordings will be
stored, how long the recordings will be retained and include a statement that during study
activities subjects may request that recordings be stopped at any time.]
[For studies that involve group interviews or focus groups, include a statement explaining that
subjects do not have to use their real name during the discussions. They can use a fictitious
name. In addition, include a statement explaining that subjects participating in group interviews
or focus groups must agree not to disclose any information talked about in the group to protect
the confidentiality of all participants.]
[For clinical trials or other studies involving health-related tests or interventions that could
affect clinical care, include the following statement:]
If you choose to participate in this study, your medical record at Wake Forest University Baptist
Medical Center will indicate that you are enrolled in a research study. Information about the
research and any medications or devices you are being given as a participant may also be
included in your medical record. This part of the medical record will only be available to people
who have authorized access to your medical record. If you are not a patient at this Medical
Center, a medical record will be created for you anyway to ensure that this important information
is available to doctors in case of an emergency.
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WILL YOU BE PAID FOR PARTICIPATING?
[If compensation for participation is available, list conditions, such as dollar amount per visit or
payment upon study completion.]
You will be paid $$ if you complete all the scheduled study visits. If you withdraw for any
reason from the study before completion you will be paid $$ for each complete study visit.
[Include the following for studies where compensation is more than $50]
To receive payment, you must provide your social security number, name and address so that we
can comply with IRS (Internal Revenue Service) reporting requirements. When payments are
reported to the IRS we do not let them know what the payment is for, only that you have been
paid. If you do not wish to provide this information you can still take part in this study but you
will not be paid.
[If no payment for participation is available, including the following:]
You will receive no payment or other compensation for taking part in this study.
[Unless no commercial development is expected to arise from the study including the following:]
The findings from this research may result in the future development of products that are of
commercial value. There are no plans to provide you with financial compensation or for you to
share in any profits if this should occur.
WHO IS SPONSORING THIS STUDY?
This study is being sponsored by [Name of the drug or device company, the National Institutes of
Health, Wake Forest University Health Science, etc.]. The sponsor is providing money or other
support to Wake Forest University Health Sciences to help conduct this study. The researchers
do not, however, hold a direct financial interest in the sponsor or the product being studied.
[When appropriate, the last sentence should be modified or expanded to disclose the nature of
any potential or actual conflict relating to the study]
WHAT HAPPENS IF YOU EXPERIENCE AN INJURY OR ILLNESS AS A
RESULT OF PARTICIPATING IN THIS STUDY?
[For research studies involving no greater than minimal risk of harm a statement is not required
regarding whether any compensation and any medical treatment(s) are available if injury
occurs.]
[For all industry sponsored research studies (drugs and devices) include the following
paragraph or the single-sentence response indicating that the injury language will provided
following sponsor and G&CA approval]
[SPONSOR] shall reimburse for reasonable and necessary medical expenses (the “Covered
Expenses”) incurred by research subjects for medical care, including hospitalization, in the
treatment of adverse reactions arising from study drugs, devices, intervention, procedures and
tests following their administration or use in accordance with the protocol, which expenses were
not caused by negligence or misconduct of any person in the employment of Wake Forest
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University Health Sciences or to your own failure to follow instructions. The [SPONSOR] is not
responsible for expenses that are due to pre-existing medical conditions or underlying disease.
If you are injured, the sponsor may require information such as your name, social security
number, and date of birth in order to pay for your care. This is because the sponsor is required
by law to report any payments made to cover the care of any persons who are members of a
government insurance plan to the Department of Health and Human Services.
[The single-sentence response below indicating that the injury language will provided following
sponsor and G&CA approval should be used only if the template above has already been
rejected by the sponsor and negotiation of appropriate language is not yet complete]
Injury language will be provided following completion of negotiation and approval by
Sponsor and WFUHS.
[For NIH, Foundation and Departmentally Sponsored Studies greater than minimal risk include
the following paragraph]
Should you experience a physical injury or illness as a direct result of your participation in this
study, Wake Forest University School of Medicine maintains limited research insurance
coverage for the usual and customary medical fees for reasonable and necessary treatment of
such injuries or illnesses. To the extent research insurance coverage is available under this policy
the reasonable costs of these necessary medical services will be paid, up to a maximum of
$25,000. Wake Forest University Baptist Medical Center holds the insurance policy for this
coverage. It provides a maximum of $25,000 coverage for each claim and is limited to a total of
$250,000 for all claims in any one year. The Wake Forest University School of Medicine, and
the North Carolina Baptist Hospitals, Incorporated do not assume responsibility to pay for these
medical services or to provide any other compensation for such injury or illness. Additional
information may be obtained from the Medical Center’s Director of Risk and Insurance
Management, at (336) 716-3467.
If you are injured, the insurer may require information such as your name, social security
number, and date of birth in order to pay for your care. This is because the insurer is required by
law to report any payments made to cover the care of any persons who are members of a
government insurance plan to the Department of Health and Human Services.
You do not give up any legal rights as a research participant by signing this consent form. For
more information on medical treatment for research related injuries or to report a study related
illness, adverse event, or injury you should call PI’s Name at telephone number (also include
after hours number.]
What About My Health Information?
Select text in red italics as applicable. Provide information highlighted in yellow.
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In this research study, any [new information we collect from you] and/or [information we get
from your medical records or other facilities] about your health or behaviors is considered
Protected Health Information. The information we will collect for this research study includes:
[List information that will be collected].
If this research study involves the diagnosis or treatment of a medical condition, then Protected
Health Information collected from you during this study will be placed in your medical record,
and may be used to help treat you, arrange payment for your care, or assist with Medical Center
operations. (Use “may” if there is no intention to collect clinically relevant information and place
it in the medical record and “will” if the study is intended to produce or address clinically
relevant information that should be included in the medical record for subject health).
We will make every effort to keep your Protected Health Information private. We will store
records of your Protected Health Information in a cabinet in a locked office or on a password
protected computer.
Your personal health information and information that identifies you (“your health information”)
may be given to others during and after the study. This is for reasons such as to carry out the
study, to determine the results of the study, to make sure the study is being done correctly, to
provide required reports and to get approval for new products.
Some of the people, agencies and businesses that may receive and use your health information
are the research sponsor; representatives of the sponsor assisting with the research; investigators
at other sites who are assisting with the research; central laboratories, reading centers or analysis
centers; the Institutional Review Board; representatives of Wake Forest University Health
Sciences and North Carolina Baptist Hospital; representatives from government agencies such as
the Food and Drug Administration (FDA), the Department of Health and Human Services
(DHHS) and similar agencies in other countries.
Some of these people, agencies and businesses may further disclose your health information. If
disclosed by them, your health information may no longer be covered by federal or state privacy
regulations. Your health information may be disclosed if required by law. Your health
information may be used to create information that does not directly identify you. This
information may be used by other researchers. You will not be directly identified in any
publication or presentation that may result from this study unless there are photographs or
recorded media which are identifiable.
THE FOLLOWING TEXT IS REQUIRED FOR STUDIES WHICH ARE REQUIRED TO ADHERE TO ICH-GCP
STANDARDS:
1) Monitors, auditors, IRB or other regulatory agencies will be granted direct access to the
participant’s original medical record for verification of clinical trial procedures or data,
without violating confidentiality of the participant and to the extent permitted by other
applicable laws.
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2) When a study involves the use of a drug, device, or FDA regulated product insert:
Representatives from government agencies such as the US Food and Drug
Administration (FDA), the Department of Health and Human Services (DHHS), and [List
specific agencies].
3) When a study involves funding from a government agency insert: Representatives from
government agencies such as the Office for Human Research Protections and other
similar agencies.
4) [List other individuals, organizations, agencies, etc as applicable for the particular study.]
If required by law or court order, we might also have to share your Protected Health Information
with a judge, law enforcement officer, government agencies, or others. If your Protected Health
Information is shared with any of these groups it may no longer be protected by federal or state
privacy rules.
Any Protected Health Information collected from you in this study that is maintained in the
research records [will be kept for at least six years after the study is finished. At that time any
research information not already in your medical record will either be destroyed or it will be deidentified] or [will be kept for an indeterminate period of time. This authorization does not
expire] and/or [Any research information entered into your medical record will be kept for as
long as your medical record is kept by the Medical Center]. You will not be able to obtain a
copy of your Protected Health Information in the research records until all activities in the study
are completely finished. (The first option should be selected if Wake Forest investigators are
conducting the study and will determine the end-date. The second option should be used if the
study is sponsored and it is unclear when the data will no longer be need in support of a new
drug, device, or other medical improvement – and/or if there are video tapes or images being
collected that will not be destroyed following the completion of the study. The third sentence
should be included if there is a likelihood that data will be included in the subject’s medical
record).
You can tell [Principle Investigator's Name ] that you want to take away your permission to use
and share your Protected Health Information at any time by sending a letter to this address:
Principal Investigator Name
Address
City, State, Zip
However, if you take away permission to use your Protected Health Information you will not be
able to be in the study any longer. We will stop collecting any more information about you, but
any information we have already collected can still be used for the purposes of the research
study.
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By signing this form you give us permission to use your Protected Health Information for this
study.
[If this study is a Clinical Trial the following language should be included]
If you choose to participate in this study, your medical record at Wake Forest University Baptist
Medical Center will indicate that you are enrolled in a clinical trial. Information about the
research and any medications or devices you are being given as a participant may also be
included in your medical record. This part of the medical record will only be available to people
who have authorized access to your medical record. If you are not a patient at this Medical
Center, a medical record will be created for you anyway to ensure that this important information
is available to doctors in case of an emergency.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required
by U.S. Law. This website will not include information that can identify you. At most, the
website will include a summary of the results. You can search this Web site at any time. (This
language is required by the FDA for all applicable clinical trials.)
[For studies involving tests or procedures that may be scheduled or reported using the Medical
Center computer system the investigator should include the following]
Laboratory test results and other medical reports created as a result of your participation in the
research study may be entered into the computer systems of Wake Forest University Health
Sciences and North Carolina Baptist Hospital. These will be kept secure, with access to this
information limited to individuals with proper authority, but who may not be directly involved
with this research study.
A North Carolina Baptist Hospital (NCBH) medical record will be created for all study
participants. Information about your participation in the study will be placed in the NCBH
medical record, along with any routine medical test results that were obtained at NCBH as part
of this study.
WHAT ARE MY RIGHTS AS A RESEARCH STUDY PARTICIPANT?
Taking part in this study is voluntary. You may choose not to take part or you may leave the
study at any time. Refusing to participate or leaving the study will not result in any penalty or
loss of benefits to which you are entitled. If you decide to stop participating in the study we
encourage you to talk to the investigators or study staff first to learn about any potential health or
safety consequences. The investigators also have the right to stop your participation in the study
at any time. This could be because [List circumstances, such as, it is in your best medical
interest, your condition worsened, new information becomes available, you had an unexpected
reaction, you failed to follow instructions, or because the entire study has been stopped].
You will be given any new information we become aware of that would affect your willingness
to continue to participate in the study.
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If you are recruiting medical or graduate students, please include the following paragraph:
This study will be enrolling students from the ___________ campus (choose Wake Forest
University and/or Wake Forest University Medical Center). In addition to your rights as a
research participant noted in the previous section, as a student, you are under no obligation to
participate in this study. You may refuse to participate or withdraw from the study at any time
and for any reason without affecting your grades, performance evaluations, or assignments. You
will not be pressured into participating in this research study by any statements or implied
statements that your grades, performance evaluations or assignments will be affected by your
willingness to enroll in the study. Your medical records/information will not be used by the
faculty, administration or study staff to make decisions regarding the status of your medical
benefits. If you have questions regarding your enrollment in the study and your status as a
medical student, please contact the Office of Student Services for additional information.
Whom Do I Call if I Have Questions or Problems?
For questions about the study or in the event of a research-related injury, contact the study
investigator, Name at telephone number (also include after hours number).
The Institutional Review Board (IRB) is a group of people who review the research to protect
your rights. If you have a question about your rights as a research participant, or you would like
to discuss problems or concerns, have questions or want to offer input, or you want to obtain
additional information, you should contact the Chairman of the IRB at (336) 716-4542.
You will be given a copy of this signed assent form.
SIGNATURES
I agree to take part in this study. I authorize the use and disclosure of my health information as
described in this assent and authorization form. If I have not already received a copy of the
Privacy Notice, I may request one or one will be made available to me. I have had a chance to
ask questions about being in this study and have those questions answered. By signing this
assent and authorization form, I am not releasing or agreeing to release the investigator, the
sponsor, the institution or its agents from liability for negligence.
Subject Name (Printed):_________________________________
Subject Signature: _____________________________________ Date: ________Time:____am pm
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Person Obtaining Assent (Printed):_____________________________
Signature of Person Obtaining Assent:_______________________ Date:_________Time:____ am pm
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