INFORMED
CONSENT FORM TO TAKE PART IN A RESEARCH STUDY
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Title of Research Protocol: |
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Principal Investigator: |
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Co-Investigators: |
INTRODUCTION:
You are invited to
take part in a research study about . [insert
a very brief statement of purpose – delete
this instruction]
You are being
asked to take part in this study because you have / are [name condition here or state “because you are
a healthy volunteer.” If the study does
not involve investigation of a disease process, provide a brief appropriate
description of the individuals who are being approached for the study. For example, the study may involve surveying
students, residents, faculty or staff].
Research studies include only people who choose to take part. Please read this consent form carefully and
ask the investigators or study staff to explain any words or information that
you do not clearly understand. We
encourage you to talk with your family and friends before you decide to take
part in this research study.
Ø
Your participation is voluntary;
Ø
You may or may not benefit from participating in the
study. However, your participation may
help others in the future as a result of knowledge gained from the research;
Ø
You may leave the study at any time;
Ø
If you choose not to take part, or if you leave the
study, your decision will in no way harm your relationship with your doctor [doctor may be
replaced with supervisor or colleagues, as appropriate if the research subjects
are faculty, students or staff] or with Beth Israel Deaconess
Medical Center.
Once you read this consent form and understand what your
participation in this study will involve, you will be asked to sign this form
if you wish to take part. You will be
given a signed copy of the form to keep for your records.
DISCLOSURE OF SPECIAL INTERESTS OF BIDMC AND
INVESTIGATORS
This study is
being conducted by [indicate PI] and
is funded by [indicate
sponsor name]. The funding
agency in this study [indicate sponsor name] is
paying
WHY THIS STUDY IS BEING DONE
[For Phase I or Phase II studies, select the
appropriate paragraph]
For Phase I Studies:
The main purpose
of this study is to find the highest dose of the new drug/intervention [select whichever
term is appropriate and then provide the name of drug/ intervention], that can be tolerated safely. In addition, we hope to learn what kinds of
side effects will be caused by the new drug/intervention, and how severe those
side effects will be. This means that
you may experience the side effects listed in the Risks section of this consent
form.
For Phase II Studies:
We have already
determined what the highest safe dose of [drug] is through earlier human research
studies. The main purpose of this study
is to test the safety of [drug/intervention] by looking at the side
effects, and possibly the effects on this disease/condition.
We are also
conducting this study to [be sure to also list secondary purposes or aims].
The [drug, device,
agent] involved in this study, [name of drug/device/intervention] is
investigational. This means that the
study [drug,
device, agent] is still being tested in research studies and is not
approved by the Food and Drug Administration [FDA] [at
all, or for the way that it /they is/are being used in this study]. If
applicable, add: This
particular investigational agent, [name], has been approved the FDA for use in
other diseases or conditions, but we do not yet know if it is useful or safe as
a treatment for [specify
condition being studied].
For other studies (e.g. social, behavioral, or
educational studies that do not involve the use of a drug, device): Replace the language above with a description
of the purpose of the study, including information as to whether any
procedures, curricula, surveys or assessment tools being used are standard or
new.
If the purpose of this application is to
create a data or tissue repository
for research purposes, the purpose should include a description of the
repository to be established (i.e. what type of data and/or tissue will be
collected), and the kinds of future research projects that will make use of the
tissue/data in this repository. Please
be as specific as possible when describing the future anticipated
research. If collecting data for a
repository, describe the type of data that will be collected and the source of
that data.
For
any research application that involves human genetic testing, please consult
Part K for further consent form instructions.
WHO WILL PARTICIPATE IN THE STUDY
Approximately [indicate number]
people will take part in this study at
WHAT WILL HAPPEN DURING THE STUDY
[You may want to use a time line and detail
the step-by-step procedures to describe what is going to happen to the
subject. Describe and clearly indicate any
procedures that are experimental (e.g. methods or procedures that are not
standard of care). Use subheadings as
appropriate. For complex protocols,
consider using a chart or table showing which procedures/tests are performed at
each visit.]
If you agree to be
in this study, you will be asked to read and sign this consent form. After you sign the consent form, the
following things will happen:
1.
Screening Procedures:
Screening procedures are tests and procedures that will be done to
determine if you are eligible to take part in the research study. For this research study, the screening
procedures include: [Describe screening procedures such as
physical exam and medical history, vital signs, blood tests (state specifically
and explain what is being tested)), radiology procedure (describe what the
subject will experience) etc. If there are no screening procedures, delete the
section entirely]
2. Randomization Procedures:
[For
randomized studies, standard wording describing randomization follows. Modify as needed (e.g. to properly reflect
randomization scheme or if the subject is not being randomized
drug/device/intervention. If the study
design does not require randomization, delete this section.]:
For Phase I and II Studies:
You will be randomly assigned (like the flip of a coin) to receive
either [Arm 1]
or [Arm 2]. You have a [ ] in [ ]
chance of receiving [either one of the drugs/devices/therapies]. You will not be able to choose the study
group to which you will be assigned.
For Phase III (and some Phase IV) Studies: It
is not clear at this time which of the treatments [or drugs, diet programs, devices, etc: delete
this instruction] in this study would be better for you. For this reason, the treatment plan offered
to you will be picked by chance [like the flip of a coin]. You will not be able to choose which
treatment you receive. The chances of
receiving either of the treatments are approximately equal [or state the chance, i.e. “an X
in Y chance”]. After the randomization, you will
be assigned to one of the following groups:
A)
B)
If one treatment arm is found to be
less effective then the other while you
are taking part in the study, you will informed and further treatment will be
discussed.
Placebo: If the study uses a
placebo:
Depending upon the group to which you
are assigned, you may receive a placebo instead of the study drug. A placebo is an inactive pill that looks like
the study drug, but a placebo contains no active medication. Placebos are used to help determine if the results
of the study are truly from the study drug.
You will not know whether you will be receiving the study drug or the
placebo. However, this information can
be learned in case of an emergency.
Double-blind study: If this
is a double-blind study, include the following statement:
Neither you nor your [physician/surgeon/investigator/research
doctor, etc. delete this instruction]
will know which [drug,
device, agent] you are receiving.
However this information can be learned in case of an emergency.
3. Research Procedures:
If you qualify to take part in this research study, you will undergo
these research procedures: [Be sure to include
both experimental procedures and those procedures which are standard of care,
or commonly accepted practice, but which would not normally be conducted
without the subject’s participation in this study.]
4. Monitoring/Follow-Up Procedures.
Procedures performed to evaluate the effectiveness and safety of the
research procedures are called “monitoring” or “follow-up” procedures. For this research study, the
monitoring/follow-up procedures include:
Also describe in this section any samples or questionnaires that
may be applicable to the study. Please
see “Recommended ICF language for standard wording of standard procedures such
as MRI, HIV Testing, etc.
If the purpose of this application is to create a data or tissue repository for research
purposes, describe the process for collecting the data or tissue, as well as
procedures for the operations of the repository. This description should include, at a
minimum: how the data/tissue will be
collected; what will happen to data/tissue after collection (e.g. DNA extracted
from a blood sample or tissues linked to medical records); how the data/tissue
will be stored and handled; how long the data/tissue will be stored; procedures
for protecting the privacy of subjects and maintaining the confidentiality of
the data; whether or not the results will become part of the subjects’ medical
record; whether or not any information obtained about the subject will be
shared with the subject; and the conditions under which specimens will be
released to recipient investigators.
For
any research application that involves human genetic testing, please consult
Part K for further consent form instructions.
POSSIBLE
RISKS, SIDE EFFECTS, AND DISCOMFORTS
Risks of the Research Study
Please include only those risks that are associated with the study
itself. For example, if the patient is
undergoing a standard surgical procedure as part of the study that they would
not otherwise be having, that is a study procedure and the risks must be
included. Risks of standard of care
procedures, or commonly accepted practices, that the subject would be
undergoing regardless of their participation in the study should not be
included in the consent form. For
studies involving drugs, devices, or biologics, list all known side effects,
using the categories described below (more common, less common, rare). Be sure to include all known side effects,
possible drug interactions (including interactions with alcohol), and warn
about activities that may be dangerous (e.g. driving). If
there are risks associated with loss of confidentiality, or if psychological
risks are possible, these must be listed in this section.
If the
purpose of this application is to create a data
or tissue repository for research purposes, then the risks associated with
study participation should include breach of confidentiality, and be limited to
those risks associated with the research aspect of the data/tissue collection.
For example, if a subject will be undergoing a biopsy as part of his/her
standard of care, and the excess tissue will be contributed to the bank, then
those risks associated with the biopsy procedure need not be classified as a
risk associated with the study procedure.
As a result of your participation in
this study, you are at risk for side effects listed in this section. You should discuss these with the
investigator and with your regular doctor if you choose.
For Phase I and II studies: A risk to taking
part in this study is the likelihood of receiving a drug or dose of a drug that
may not be effective in helping to treat your disease. This means that you may spend time and
experience side effects taking a drug that may not provide you with any
health-related benefits.
The [drug/device/agent] may cause some, all or none
of the side-effects listed below. [Be sure to include
psychological risks (e.g. depression or confusion) that may be side effects of
the study drug].
More Common [insert more common side effects, >5% occurrence]
Less Common [insert less common side effects, >1% but <5%
occurrence]
Rare [insert less common side effects, <1% occurrence]
If the drug/device/agent is investigational, you must include the
following: Since
this [drug/combination
of drugs/procedure/device] is so new, there may also be other side
effects that we cannot predict [state why: i.e., because it is not possible to predict all potential
side effects, or because this is the first time the drug is being used in
humans, or because the combination has never been used before, etc.]
Include reproductive risks if applicable. See “Recommended ICF Language” for CCI
standard language related to pregnancy.
Please see “Recommended ICF language for standard wording for risks
associated with MRI, HIV Testing, and venous blood draw.
Loss of Confidentiality
There is the potential for loss of
confidentiality by participating in this study.
Every effort will be made to protect the confidentiality of your
identifiable information. However, if
your participation becomes known, it could create a problem or hardship for you
depending upon the type of information disclosed.
Please consider carefully if
the following statement applies to your study.
If it does not, please delete.
In some situations, it is possible that
you would be placed at risk for legal criminal prosecution or other legal
problems.
There may also be damage to your future
financial standing, health care, employment, professional standing or ability
to get access to health or other insurance.
[Include
only those risks listed which may be applicable, and delete those that are not
applicable].
For genetic research [identified or coded]: Participation
in this study may indicate that you are a carrier of a specific gene under
study. The results of genetic analysis
performed for purposes of this research study will not appear in your medical
record. [State otherwise if this is the case] However, if you tell your regular
doctor about participating in this study, this information may then become part of your medical record. An insurance company might consider that your
participation in this study implies that a genetic condition runs in your
family. This then might hurt your access
to health or other insurance.
Refer to Part K for further
instruction regarding human genetic research.
Psychological
Stress:
Be sure to include all psychological distresses that might be
expected to occur as a result of study participation such as side effects to
drugs, or results of being confined in an enclosed space, breathing through a
mask, completing long and/or personal questionnaires, scheduling frequent
visits, etc.
For studies that involve surveys or interviews: Some of the questions we will ask you
as part of this study may make you feel uncomfortable. You may refuse to answer any of the questions
and you may take a break at any time during the study. You may stop your participation in the study
at any time.
POSSIBLE BENEFITS
Any potential direct benefit to participants, or lack thereof, must
be explained in this section. Potential
direct benefits to the subject and potential societal benefits should be
clearly stated. Information about free
medical care or medication, and other such financial considerations should be
included in the section on Cost and Payment, NOT in the benefits section. Do not
indicate improved diagnosis or treatment as a direct benefit to a subject if
the effectiveness of such is a question being investigated by this study. Do not include close follow-up or frequent
physician visits unless there is proof that they are more beneficial than the
standard of care. Suggestions regarding
wording include:
It is not possible to predict whether
you will benefit directly from participation in this study. However, your participation may help others
in the future as a result of knowledge gained from the research.
OR
There is no direct benefit to you from
being in this study. However, your
participation may help others in the future as a result of knowledge gained
from the research.
OR, IF PREVIOUS STUDIES INDICATE
__________________ has been shown to be
effective against ______________in prior studies. You may benefit by _____________. However, this result cannot be
guaranteed. The investigators do not
expect to cure your disease or condition with the study treatments.
OR, IF PROVEN
___________has been shown to be
effective against ______________by other Phase __studies. You may also benefit, but this cannot be guaranteed.
Other Available Options
State any and all possible alternatives to being part of this
study, including choosing not to participate in this study. You must include all options that are
currently available and commonly used in the treatment of the condition under
study. These may include the following:
·
Include, when applicable,
that subjects can get the same drug(s) off study. If the trial is studying a
drug/device/treatment that has been approved by the FDA for another indication
or age group, but its off-label use is commonly prescribed by the medical
community in the same dose and formulation for the condition under study, you
must include the fact that the drug/device/treatment is available outside the
trial in the consent document. However,
the subject should be informed that all health insurance companies may not pay
for the cost of the drug prescribed for off-label use.
·
As appropriate, include
palliative care, other investigational agents/trials [mention the type[s] only - do
not list the titles or study numbers] and what the common/routine
treatments are for the eligible population.
·
If this study does not
include a treatment/intervention, clearly state that the alternative is not to
enroll in the study
Taking part in this study is voluntary. Instead of being in this study, you have the
following options:
List all appropriate alternatives:
No therapy at this time. You will, however, be provided with care to
help you feel more comfortable.
It is important to note that it is
possible to get _____________ [study treatments/drugs at this institution and other
locations] even if you do not take part in the study. [If available via off-label prescription
only, state: _________ [name study drug]
has not been approved by the FDA for treatment of your condition, however, many
doctors in the community commonly prescribe the drug to treat _________ [name of disease]. Please be aware that not all doctors may
agree to prescribe this drug for you, and that not all health insurance
companies will pay for the drug when it is prescribed for _________ [name of
disease/condition].
We recommend that you discuss these and
other options with the investigator and your regular doctor so that you can
make a well-informed decision about participating in this study.
IF
YOU DECIDE NOT TO TAKE PART IN THE STUDY
Participation in this study is
voluntary. You have the right to decide
not to take part in this study. If you
choose to participate, you have the right to leave the study at any time. However, please be aware that there may be
risks to leaving the study before it has been completed. If you decide not to participate in the study
or decide to leave the study early, your decision will not affect your
relationship with your doctor [doctor may be replaced with supervisor
or colleagues, as appropriate if the research subjects are faculty, residents,
students or staff] or with
Beth Israel Deaconess Medical Center.
The investigators will tell you about new information that may affect
your willingness to stay in this study.
The investigators have the right to end
your participation in this study if they determine that you no longer qualify
to take part, or if it would be dangerous for you to continue, or if you do not
follow study procedures as directed by the investigators.
This research study is not meant to
diagnose or treat medical problems [at all or “not specifically stated in this informed consent
document”]. Participation in this research study does not
take the place of routine physical examinations or visits to your regular
doctor.
COSTS
AND/OR PAYMENTS TO YOU
Costs Covered by Study
You will not be charged for [insert details
about appropriate tests, procedures, medications] that are part of
this research study. However, you and
your insurance company will be charged for other tests, procedures or
medications of this study that are considered standard treatment for your
medical condition. [If your study does not involve medical procedures or
treatments that are standard of care and appropriately billable as standard of
care, you may delete this last sentence.]
Co-Payment/Deductible Statement
You will be responsible for any
co-payments or deductibles that are standard for your insurance coverage. [If your study does not involve medical procedures or
treatments that are standard of care and appropriately billable as standard of
care, you may delete this section.]
Cost of Research Related Injury:
If the study is a minimal risk study, involves no medical
intervention such that there is no risk of study related medical injury, then
this section may be omitted.
[Insert the appropriate language by selecting one of the two
options below – delete this instruction]
For Industry Sponsored Studies
[delete]:
If you are injured as a direct result
of your participation in this study, you should contact the Investigator at the
number provided under the section “Who to Call if You Have Questions” in this
form. You will be offered the necessary
care to treat your injury. You or your
insurance company will be billed for medical care and/or hospitalization
related to this injury. You will be responsible
for all co-payments and deductibles required under your insurance. BIDMC will determine whether any serious
injury is directly related to the use of the study drug, device or study
protocol. If BIDMC determines that it is
related and that you followed the instructions of the study staff, and the cost
is not covered by your insurance or another third party, the sponsor will
reimburse you. The sponsor will not
reimburse you for items such as lost wages or lost time from work. By signing this consent form you have not
given up any legal rights.
For All Other Studies [delete]:
If you are injured as a direct result
of your participation in this study you should contact the Investigator at the
number provided under the section “Who to Call if You Have Questions” in this
form. You will be offered the necessary
care to treat your injury. You or your
insurance company will be billed for medical care and/or hospitalization
related to this injury. You will be
responsible for all co-payments and deductibles required under your
insurance. BIDMC will consider
reimbursement of injury related expenses not covered by your insurance on a
case-by-case basis. No other
reimbursement will be provided for items such as lost wages or lost time from
work. By signing this consent form you
have not given up any legal rights.
Payments to You:
[If subjects are to be paid for participation, the total amount and
the schedule for payment should be included in the consent form. If it is a
long-term study, payment CANNOT be withheld until the end of the study.
Describe additional non-monetary compensation (e.g. parking vouchers, travel
reimbursement).]
CONFIDENTIALITY
Information learned from your
participation in this study and from your [medical/academic/employment record – select those that
apply] may be reviewed and photocopied by the Food and Drug
Administration (FDA) and/or other federal and state regulatory agencies, and by
the drug [or
device] manufacturer, [identify by name], accreditation agencies and
the Committee on Clinical Investigations of the Beth Israel Deaconess Medical
Center with protection of confidentiality so far as permitted by applicable
law. Information resulting from this
study and from your [medical/academic/employment record – select those that
apply] may be used for research purposes and may be published;
however, you will not be identified by name in such publications.
If this study involves research on violence, abuse or
self-inflicted injury, include the following: Massachusetts law
requires that certain trained individuals (mandated reporters) disclose to the
proper authorities any information shared with them about abuse of the elderly,
abuse of mentally ill or developmentally disabled persons, child abuse, or
child sexual abuse. [Indicate if one or more of the investigators
conducting this project is a mandated reporter.] The investigators may also be required by law
to report threats of harm that you make, either to yourself or to others.
Certificate of Confidentiality
If the investigators have obtained a Certificate of Confidentiality
include the following text. If not obtaining a certificate of
confidentiality, delete this section.
A Certificate of Confidentiality has been
obtained from the Department of Health and Human Services. This will help further protect information
that may identify you. The Certificate
prevents the investigator from being forced to disclose information that may
identify you for use in court.
A Certificate of Confidentiality does
not prevent you or anyone you tell from voluntarily releasing information about
yourself or your involvement in this research.
The investigator may not withhold information if you give your health
insurance company or employer permission to receive information about your
participation in this research. This
means that you and your family must also actively protect your own privacy.
Finally, the investigator can take
steps, including reporting to authorities as required by law, to prevent
serious harm to yourself or others.
There is a possibility that information
that identifies you will be given to the
If this study involves specimen collection, additional
confidentiality language and a statement regarding commercial development may
be required. Sample language is below.
USE OF
YOUR TISSUE AND/OR DATA FOR COMMERCIAL DEVELOPMENT
As part of this research program, samples of your tissue
and information about your medical history may be provided to other researchers
and/or outside collaborators without identifying you by name. They may use your
tissue and information in other scientific research, product testing or
commercial development. It is unknown whether a product will ultimately be
developed from any such work that may be performed. In signing this
consent form, you are acknowledging and voluntarily consenting to the possibility
that your tissue may be used for commercial purposes. You also understand
and agree that tissue
obtained from you in this research may be used to establish a cell line that
could be patented and licensed.
If your study does not involve patients or accessing, using or
disclosing protected health information for research subjects, authorization
language may not be applicable to your study and can be deleted.
AUTHORIZATION
FOR USE AND DISCLOSURE OF YOUR PROTECTED HEALTH INFORMATION
As part of this study, we will be
collecting and sharing information about you with others. Please review this section carefully as it
contains information about the federal privacy rules and the use of your
information.
Protected Health Information [PHI]
By signing this informed consent
document, you are allowing the investigators and other authorized personnel to
use [internally at BIDMC] and disclose [to people and organizations outside the
BIDMC workforce identified in this consent] health information about you. This may include information about you that
already exists such as [include all that apply such as; your medical records,
mental health records [describe mental health information to be used in very
specific detail], demographic information, laboratory tests; delete this instruction]
as well as any new information generated as part of this study through [include all that
apply; questionnaires, tests, procedures, delete this instruction] we
may ask you to undergo. This is your
Protected Health Information.
People/Groups at BIDMC Who Will Use Your Protected
Health Information
Your Protected Health Information may
be shared with investigators listed on this consent form as well as the
supporting research team [i.e. research assistants, statisticians, data
managers, lab oratory personnel, administrative assistants]. Your Protected Health Information may also be
shared with the Committee on Clinical Investigations of Beth Israel Deaconess
Medical Center as it is responsible for reviewing studies for the protection of
the research subjects.
People/Groups Outside of BIDMC With Whom Your
Protected Health Information Will Be Shared
We will take care to maintain
confidentiality and privacy about you and your Protected Health
Information. We may share your Protected
Health Information with the following groups so that they may carry out their
duties related to this study:
·
The
funding source of this study [please name; delete
this instruction] and their clinical research organizations
·
The
other hospitals and medical centers taking part in this study [please name; delete this instruction]
and research collaborators at those institutions. (Note that this is particularly important if
the purpose of this research application is to establish a data/tissue
repository)
·
Laboratories
not affiliated with BIDMC [please name; delete
this instruction]
·
Statisticians
and other data monitors not affiliated with BIDMC [please name; delete this instruction]
·
Centralized
data collectors [please
name; delete this instruction]
·
Your
health insurance company
·
The
Food and Drug Administration [FDA], the Department of Health and Human Services
[DHHS], the National Institute of Health [NIH], and the Office for Human
Research Protections [OHRP] [please include any other agency that may have regulatory
oversight for your study; delete this
instruction]
·
Hospital
and Clinical Research Accrediting Agencies
·
Data
and Safety Monitoring boards that oversee this study (if applicable)
Those who receive your Protected Health
Information may make further disclosures to others. If they do, your information may no longer be
covered by the federal privacy regulations.
Why We Are Using and Sharing Your Protected Health
Information
The main reason for using and sharing
your Protected Health Information is to conduct and oversee the research as
described in this Informed Consent Document.
We also shall use and share your Protected Health Information to ensure
that the research meets legal, institutional and accreditation requirements and
to conduct public health activities.
No Expiration Date – Right to Withdraw Authorization
Your authorization for the use and
disclosure of your Protected Health Information in this Study shall never
expire. However, you may withdraw your
authorization for the use and disclosure of your Protected Health Information
at any time provided you notify the Principal Investigator in writing. If you would like to take back your
authorization so that your Protected Health Information can no longer be used
in this study, please send a letter notifying the Principal Investigator of
your withdrawal of your authorization to [name Principal Investigator; delete this instruction] at 330 Brookline
Ave., Boston, MA 02215 [or other
appropriate address; delete this
instruction]. Please
be aware that the investigators in this study will not be required to destroy
or retrieve any of your Protected Health Information that has already been used
or disclosed before the Principal Investigator receives your letter.
Refusal to Sign
If you choose not to sign this informed
consent document and authorization for the use and disclosure of your Protected
Health Information, you will not be allowed to take part in the research study.
Right to Access and Copy your PHI [JCAHO requires that
all treatment related research informed consent documents be filed with the
medical record. Delete this section
only if a copy of the signed consent form will not be made a part of the subject’s medical record. [Delete
this instruction.]
If you wish to review or copy your
Protected Health Information as it is made part of your medical record, you may
do so after the completion or termination of the study by sending a letter to
the Principal Investigator requesting a copy of your Protected Health
Information. You may not be allowed to
inspect or copy your Protected Health Information until this study is completed
or terminated.
Notice of Privacy Practices
In addition to signing this document,
you may also be asked to sign a BIDMC General Agreement form acknowledging that
you have received the BIDMC Notice of Privacy Practices.
WHOM
TO CALL IF YOU HAVE QUESTIONS OR PROBLEMS
If you have any questions about this
research or experience any problems, you should contact _________________ at
[617] xxx-xxxx. If you have questions
regarding your rights as a research subject, you may contact the Chairman of
the
ICF
REVISION DATES:
Insert dates of ICF revisions and the reason for the revisions
(e.g. sponsor amendment, adverse event, continuing review requirements):
THE
FOLLOWING PARAGRAPHS CONTAIN SOME STANDARD INFORMATION WHICH GENERALLY APPLIES
TO INDIVIDUALS PARTICIPATING IN A RESEARCH STUDY.
CONSENT FORM FOR CLINICAL RESEARCH
I have read the
previous page[s] of the consent form and the investigator has explained the
details of the study. I understand that
I am free to ask additional questions.
If I wish additional
information regarding this research and my rights as a research subject, or if
I believe I have been harmed by this study, I may contact the Chair of Beth
Israel Deaconess Medical Center’s Committee on Clinical Investigations [CCI] at
[617]667-0469
I am aware that this
is a research project and that unforeseen side effects may occur.
I understand that the
I understand that
participation in this study is voluntary and I may refuse to participate or may
discontinue participation at any time without penalty, loss of benefits, or
prejudice to the quality of care which I will receive.
I acknowledge that no
guarantees have been made to me regarding the results of the treatment involved
in this study, and I consent to participate in the study and have been given a
copy of this form.
WITNESS DATE STUDY SUBJECT DATE
PARENT
OR LEGAL GUARDIAN DATE
[If subject is a minor, or subject is
unable to give consent
The subject has been given the
opportunity to read this consent form and to ask questions before signing, and
has been given a copy.
PRINT INVESTIGATOR’S/CO-Investigator’s
NAME DATE SIGNATURE OF INVESTIGATOR/Co-Investigator DATE