INFORMED CONSENT FORM
The informed consent form is
the document that participants must sign before participating in a clinical
research study and before any screening procedures are undertaken.
Informed consent is a process by
which a subject voluntarily confirms his or her willingness to participate in
the clinical trial. It is the cornerstone of ethics in clinical research. The process must provide sufficient
opportunity for the participant to consider whether to participate or not.
Informed consent process provides essential trial information to potential participants and empowers them to make a rational and informed decision about participation. Informed consent is documented by means of a written, signed and dated informed consent form.
Purpose
of informed consent
Informed
consent is important in protecting the legal rights of participants. It helps in educating a participant about the purpose, risks, benefits, and
alternatives of clinical trial.
To make an informed decision about whether to participate or not
in a clinical trial, people need to be informed about:
·
what will be done to them,
·
how the protocol (plan of research) works,
·
what risks or discomforts they may experience,
·
Participation being a voluntary decision on their part.
Before enrolling in a clinical trial, the following information must be
given to each potential research subject:
·
A statement explaining that the study involves research.
·
An explanation of the purposes of the research.
·
The expected length of time for participation.
·
A description of all the procedures that will be completed
during enrollment on the clinical trial.
·
Information about all experimental procedures the will be
completed during the clinical trial.
·
A description of any predictable risks.
·
Any possible discomforts (e.g., injections, frequency of blood
test etc.) that could occur as a result of the research.
·
Any possible benefits that may be expected from the research.
·
Information about any alternative procedures or treatment (if
any) that might benefit the research subject.
·
A statement describing:
o the confidentiality of
information collected during the clinical trial,
o how records that identify the
subject will be kept
o The possibility that the FDA
may inspect the records.
·
For research involving more than minimal risk information including an
explanation as to whether any compensation or medical treatments are available
if injury occurs, what they consist of, or where more information may be found.
·
questions about the research,
·
research subjects' rights,
·
Injury related to the clinical trial.
·
Research subject participation is voluntary,
·
Research subjects have the right to refuse treatment and will
not losing any benefits for which they are entitled,
·
Research subjects may choose to
stop participation in the clinical trial at any time without losing benefits
for which they are entitled.
·
Contact information will be provided for answers to :
When Appropriate, one or more of the following elements of information
must also be provided in the informed consent document:
·
A statement that the research treatment or procedure may involve
unexpected risks (to the subject, unborn baby, if the subject is or may become
pregnant).
·
Any reasons why the research subject participation may be ended
by the clinical trial investigator (e.g., failing to follow the requirements of
the trial or changes in lab values that fall outside of the clinical trial
limits).
·
Added costs to the research subject that may result from
participating in the trial.
·
The consequence of leaving a trial before it is completed (e.g.
if the research and procedures require a slow and organized end of
participation).
·
A statement that important findings discovered during the
clinical trial will be provided to the research subject.
·
The approximate number of research subjects that will be
enrolled in the study.
A potential research subject must have an opportunity to:
·
Read the consent document,
·
Ask questions about anything they do not understand.
Usually, if one is considering participating in a clinical
trial, he or she may take the consent document home to discuss with family,
friend or advocate.
An investigator should only get consent from a potential
research subject if:
·
enough time was given to the research subject to consider
whether or not to participate
·
The investigator has not persuaded or influenced the potential
research subject.
The information must be in language that is understandable to
the research subject.
Informed consent may not include language
that:
·
the research subject is made to ignore or appear to ignore any
of the research subject's legal rights,
·
Releases or appears to release the investigator, the sponsor,
the institution, or its agents from their liability for negligence.
Special Consent Requirements for Vulnerable Populations
There are unique consent requirements as well
as some other special regulatory requirements for research that
involves certain vulnerable populations:
Children
and minors:
Federal regulations include requirements for parental permission
(consent) and assent from children.
Pregnant
women, fetuses, neonates or human in vitro fertilization:
Consent may be required from only the woman or the woman
and the father. See the guidance page for specific requirements, as well
as info to include in the consent form.
Prisoners:
There are a number of restrictions on research involving
prisoners, and these studies require extra review time.
Individual
with cognitive impairments:
You need to assess whether
subjects have the capacity to consent for themselves or use surrogate consent.
References
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5543760/
https://www.ncbi.nlm.nih.gov/books/NBK430827/
https://irb.ucsf.edu/special-consent-requirements-vulnerable-populations#Children-and-minors
Student ID: CSRPL_STD_IND_HYD_ONL/CLS_217/112023
Qualification: Pharm. D
e-Mail ID: dasarikavyashree@gmail.com
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