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Eight Basic Elements of Informed Consent (45 CFR 46.116) (1) A statement that the study involves _______, an explanation of the _______of the research and the expected _______of the subject's participation, a description of the _______to be followed, and
identification of any procedures which are _______
(2) A description of any reasonably foreseeable _______or _______to the subject
(3) A description of any _______to the subject or to others which may reasonably be expected from the research
(4) A disclosure of appropriate _______ procedures or courses of treatment, if any, that might be advantageous to the subject (5) A statement describing the extent, if any, to which _______ of records identifying the subject will be maintained
(6) For research involving more than minimal risk, an explanation as to whether any _______or any _______ are available if injury occurs and, if so, what they consist of or where further information may be obtained; (7) An explanation of _______ for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a _______ injury to the
subject
(8) A statement that participation is _______, refusal to participate will involve _______ or _______ to which the subject is otherwise entitled, and the subject may _______ participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
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(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and
identification of any procedures which are experimental
(2) A description of any reasonably foreseeable risks or discomforts to the subject
(3) A description of any benefits to the subject or to others which may reasonably be expected from the research
(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
(6) For research involving more than minimal risk, an explanation as to whether any compensation or any medical treatments are available if injury occurs and, if so, what they consist of or where further information may be obtained; (7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the
subject
(8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
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Additional Elements of Informed Consent When Appropriate (1) A statement that the particular treatment or procedure may involve _______to the subject (or to the _______or _______, if the subject is or may become pregnant) which are currently _______
(2) Anticipated circumstances under which the subject's participation may be _______ by the investigator without regard to the subject's consent
(3) Any additional _______ to the subject that may result from participation in the research (4) The consequences of a subject's decision to _______ from the research and procedures for orderly termination of participation by the subject;
(5) A statement that significant _______ developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject
(6) The approximate number of _______ involved in the study.
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(1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable
(2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent
(3) Any additional costs to the subject that may result from participation in the research (4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
(5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject
(6) The approximate number of subjects involved in the study.
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Documentation Of Informed Consent Informed consent shall be documented by the use of a _______ form approved by the _______and signed by the _______
with a _______ given to the subject signing the form.
Section _______ (45 CFR 46, Subpart A)
Section _______ (21 CFR 50)
FDA requires language that the FDA may _______the records
ICH requires language that allows _______, the
_______and/or _______and the _______representatives to
inspect the records
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Informed consent shall be documented by the use of a written
consent form approved by the IRB and signed by the subject
with a copy given to the subject signing the form.
Section 46.117 (45 CFR 46, Subpart A)
Section 50.27 (21 CFR 50)
FDA requires language that the FDA may inspect the records
ICH requires language that allows regulatory authorities, the
sponsor and/or representatives and the IRB representatives to
inspect the records
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Waiver of Written Documentation of Consent HHS regulations permit _______ by the IRB of documentation for
purpose of confidentiality (45 CFR 46.117) under defined conditions.
An IRB may waive the requirement for the investigator to obtain a
signed consent form for some or all subjects if it finds either:
(1) That the only record linking the subject and the research would
be the _______ document and the principal risk would be
potential harm resulting from a _______ ; or
(2) That the research presents no more than _______ risk of harm to
subjects and involves no _______ for which written consent is
normally required outside of the research context.
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HHS regulations permit waiver by the IRB of documentation for
purpose of confidentiality (45 CFR 46.117) under defined conditions.
An IRB may waive the requirement for the investigator to obtain a
signed consent form for some or all subjects if it finds either:
(1) That the only record linking the subject and the research would
be the consent document and the principal risk would be
potential harm resulting from a breach of confidentiality; or
(2) That the research presents no more than minimal risk of harm to
subjects and involves no procedures for which written consent is
normally required outside of the research context.
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Waiver of Informed Consent An IRB may approve a consent procedure which does not
include, or which alters, some or all of the elements of informed
consent set forth in this section, or waive the requirements to
obtain informed consent provided the IRB finds and documents
that:
(1) the research involves no more than _______ risk to the
subjects;
(2) the waiver or alteration will not adversely affect the _______
and _______ of the subjects;
(3) the research could not practicably be carried out without
the _______ or _______ ; and
(4) whenever appropriate, the subjects will be provided with
additional pertinent _______ after participation.
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An IRB may approve a consent procedure which does not
include, or which alters, some or all of the elements of informed
consent set forth in this section, or waive the requirements to
obtain informed consent provided the IRB finds and documents
that:
(1) the research involves no more than minimal risk to the
subjects;
(2) the waiver or alteration will not adversely affect the rights
and welfare of the subjects;
(3) the research could not practicably be carried out without
the waiver or alteration; and
(4) whenever appropriate, the subjects will be provided with
additional pertinent information after participation.
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Experimental Subject's Bill of Rights a. To be told what the study is trying to _______ out.
b. To be told about what will _______ in the study and whether
any of the procedures, drugs or devices is _______ from what
would be used in standard medical practice.
c. To be told about the _______ , _______ or _______ of the
things that may happen to the subject.
d. To be told if the subject can expect any _______ from
participating and, if so, what the _______ might be.
e. To be told what other _______ are available and how they may
be _______ or _______ than being in the study. f. To be allowed to ask any _______ concerning the study both
before agreeing to be involved and during the course of the
study.
g. To be told what sort of medical treatment is _______ if any
complications arise.
h. To refuse to participate at all, either before or after the study
is started. This decision will not affect any _______ to receive the
standard medical care.
i. To receive a signed and dated copy of the _______ and the
_______ .
j. To be allowed to _______ to consent or not to consent to
participate without any _______ being exerted by the
investigators or others.
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a. To be told what the study is trying to find out.
b. To be told about what will happen in the study and whether
any of the procedures, drugs or devices is different from what
would be used in standard medical practice.
c. To be told about the risks, side effects or discomforts of the
things that may happen to the subject.
d. To be told if the subject can expect any benefit from
participating and, if so, what the benefit might be.
e. To be told what other choices are available and how they may
be better or worse than being in the study. f. To be allowed to ask any questions concerning the study both
before agreeing to be involved and during the course of the
study.
g. To be told what sort of medical treatment is available if any
complications arise.
h. To refuse to participate at all, either before or after the study
is started. This decision will not affect any right to receive the
standard medical care.
i. To receive a signed and dated copy of the consent form and the
Subject's Bill of Rights.
j. To be allowed to decide to consent or not to consent to
participate without any pressure being exerted by the
investigators or others.
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Obtaining Informed Consent: First Step First step: _______ the study to the prospective subject verbally,
providing all pertinent _______
[purpose, procedures, risks, benefits, alternatives to
participation, etc.]
and must allow the prospective subject ample opportunity to
_______ .
This step is sometimes accomplished on the _______ or
whenever _______ with prospective participant occurs?
WHO DOES THIS?
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First step: Explain the study to the prospective subject verbally,
providing all pertinent information
[purpose, procedures, risks, benefits, alternatives to
participation, etc.]
and must allow the prospective subject ample opportunity to
ask questions.
This step is sometimes accomplished on the telephone or
whenever first contact with prospective participant occurs?
WHO DOES THIS?
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Obtaining Informed Consent: Second Step Second step:
Provide a _______ _______ form and
Give sufficient _______ to consider whether or not to
participate in the research.
["Sufficient _______ " can range from _______ to _______ , depending on
how long it reasonably takes to evaluate _______ , potential _______
and _______ treatments.]
WHAT IF THE STUDY INVOLVES SEVERAL QUESTIONNAIRES?
WHAT IF THE STUDY INVOLVES AN INVESTIGATIONAL DRUG?
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Second step:
Provide a written consent form and
Give sufficient time to consider whether or not to
participate in the research.
["Sufficient time" can range from hours to days, depending on
how long it reasonably takes to evaluate risks, potential benefits
and alternative treatments.]
WHAT IF THE STUDY INVOLVES SEVERAL QUESTIONNAIRES?
WHAT IF THE STUDY INVOLVES AN INVESTIGATIONAL DRUG?
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Obtaining Informed Consent: Third Step Third step:
An appropriately qualified __________ [either the __________ or a __________ ] must
meet with the potential subject
review the __________ document
and __________ any questions s/he may have.
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Third step:
An appropriately qualified investigator [either the Lead
Researcher or a co-investigator] must
meet with the potential subject
review the consent document
and answer any questions s/he may have.
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Obtaining Informed Consent: Fourth Step Fourth step: Signing the consent document
An _______ must sign the consent form - assures that the _______ meets all study criteria
- subject was _______ and _______ consented
- subject _______ the requirements of the study
Usually, the investigator and subject sign at the _______ time
The investigator's signature cannot _______ the subject's
signature
Usually whomever obtains the participant signature on the final
informed consent document, that _______ will sign as the
investigator on the study.
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Fourth step: Signing the consent document
An investigator must sign the consent form - assures that the subject meets all study criteria
- subject was correctly and appropriately consented
- subject understands the requirements of the study
Usually, the investigator and subject sign at the same time
The investigator's signature cannot pre-date the subject's
signature
Usually whomever obtains the participant signature on the final
informed consent document, that co-investigator will sign as the
investigator on the study.
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Simply asking a subject to read and sign a consent form, without
an _______ and _______ , does not qualify as
informed consent.
Subjects must be given a copy of the _______ reviewed and approved
_______ and/or _______ documents, containing the official IRB
approval _______ .
Failure to use an IRB reviewed and approved consent or assent
document constitutes a serious _______ of regulatory compliance.
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Simply asking a subject to read and sign a consent form, without
an oral presentation and discussion, does not qualify as
informed consent.
Subjects must be given a copy of the IRB reviewed and approved
consent and/or assent documents, containing the official IRB
approval stamp.
Failure to use an IRB reviewed and approved consent or assent
document constitutes a serious breach of regulatory compliance.
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New Information During Course of Study When new information is discovered in the course of the study
that may affect the subjects’ decision to continue participating
in the study [information about _______ , _______ , or
availability of new _______ treatments, etc.] subjects must be
asked to consider whether or not to continue their _______
in the study, based upon the new information provided.
If the subject decides to continue participation in the study, s/he
may be asked to sign a new _______ (or a_______ ).
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When new information is discovered in the course of the study
that may affect the subjects’ decision to continue participating
in the study [information about adverse events, drug efficacy, or
availability of new alternative treatments, etc.] subjects must be
asked to consider whether or not to continue their participation
in the study, based upon the new information provided.
If the subject decides to continue participation in the study, s/he
may be asked to sign a new informed consent (or a re-consent
cover memo).
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Personnel Qualified to Carry Out Informed Consent Unless otherwise approved by the IRB, only the _______
or _______ of record [who are intimately familiar with
the research protocol and able to effectively discuss with
potential subjects the risks, benefits, and alternatives to
participation in the study], are to obtain informed consent from
subjects.
Staff, other faculty, residents, medical students and other
individuals not _______ on the IRB approved consent cannot obtain
informed consent from a prospective subject.
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Unless otherwise approved by the IRB, only the Lead Researcher
or co-investigators of record [who are intimately familiar with
the research protocol and able to effectively discuss with
potential subjects the risks, benefits, and alternatives to
participation in the study], are to obtain informed consent from
subjects.
Staff, other faculty, residents, medical students and other
individuals not listed on the IRB approved consent cannot obtain
informed consent from a prospective subject.
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Subjects Who Seem Hesitant About Participating If a subject seems hesitant or unsure about whether they wish to
participate do not _______ with the study.
• Encourage the subject to take_______ before deciding.
• Can _______ that some subjects need additional time before deciding
whether to participate or not.
• Call subject back within a _______ days if it’s okay with the subject to do so.
For subjects who are still interested, re-schedule an informed
consent discussion.
For subjects who have decided not to participate, _______ this in
their file.
Do not have any further contact with the subject unless they
_______ the contact.
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If a subject seems hesitant or unsure about whether they wish to
participate do not proceed with the study.
• Encourage the subject to take more time before deciding.
• Can state that some subjects need additional time before deciding
whether to participate or not.
• Call subject back within a few days if it’s okay with the subject to do so.
For subjects who are still interested, re-schedule an informed
consent discussion.
For subjects who have decided not to participate, record this in
their file.
Do not have any further contact with the subject unless they
initiate the contact.
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What To Include In IRB Protocol? Acknowledge that informed consent from subject will always be
_______ if possible
If _______ (DMC) is questionable, the
investigator should:
• Describe research to subject and perform a _______ assessment
relevant to this study-specific information
If _______ is lacking:
• Inform the subject of intent to seek _______ consent
• Resistance or dissent to participation or use of surrogate
mandates _______ from the study
• Otherwise, proceed with documentation of _______ assessment
and initiate identification of _______
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Acknowledge that informed consent from subject will always be
obtained if possible
If decision-making capacity (DMC) is questionable, the
investigator should:
• Describe research to subject and perform a DMC assessment
relevant to this study-specific information
If DMC is lacking:
• Inform the subject of intent to seek surrogate consent
• Resistance or dissent to participation or use of surrogate
mandates exclusion from the study
• Otherwise, proceed with documentation of DMC assessment
and initiate identification of surrogate
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Surrogate Consent in Longitudinal Research If appropriate, identify and include surrogate as _______ as
possible, even for those subjects who have _______ at the beginning
of the study that may likely change during the course of the
study.
Reaffirm _______ of surrogate choice at each longitudinal visit.
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If appropriate, identify and include surrogate as early as
possible, even for those subjects who have DMC at the beginning
of the study that may likely change during the course of the
study.
Reaffirm stability of surrogate choice at each longitudinal visit.
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Obtaining Consent From Surrogate Describe detailed research plan to the surrogate, including
_______and _______decisions to be made
Surrogate completes the _______ form (this form stays
with consent)
• Verifies _______of surrogate to serve
• Details _______of surrogate to subject
• Surrogate’s _______demonstrating reasonable
knowledge of subject (_______ only)
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Describe detailed research plan to the surrogate, including
present and future decisions to be made
Surrogate completes the Self-Certification form (this form stays
with consent)
• Verifies willingness of surrogate to serve
• Details relationship of surrogate to subject
• Surrogate’s qualifications demonstrating reasonable
knowledge of subject (Non-ER only)
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Obtaining Consent From Surrogate Self-certification form
• If a person exists of a _______order in the hierarchy, the
investigator is responsible to contact such individuals to
determine if they want to serve as surrogate
If surrogate of higher priority is later identified, investigator must
defer to person who is _______in the hierarchy
– _______ is required
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Self-certification form
• If a person exists of a higher order in the hierarchy, the
investigator is responsible to contact such individuals to
determine if they want to serve as surrogate
If surrogate of higher priority is later identified, investigator must
defer to person who is higher in the hierarchy
– re-consent is required
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What About Re-Consenting of Subjects? Consenting is an _______ process
Known triggers for re-consenting still apply
• New _______ becomes available
• Significant _______ changes have been made and approved
by the IRB
• New _______ is identified
• Investigator has the option to re-consent for _______
data collection time points
If subject regains _______ ability, they must consent to continue
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Consenting is an ongoing process
Known triggers for re-consenting still apply
• New information becomes available
• Significant protocol changes have been made and approved
by the IRB
• New surrogate is identified
• Investigator has the option to re-consent for longitudinal
data collection time points
If subject regains cognitive ability, they must consent to continue
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RECRUITMENT FOR RESEARCH Active vs. Passive Recruitment Strategies
Active Recruitment – any time that we make _______ approach and
contact with participants for the purpose of research
- sending _______ to specific patients from our clinic
- approaching _______ during medical appointment
- using a _______ waiver of HIPAA authorization to access
medical records for recruitment purposes
Passive Recruitment – no _______ approach to participants, but
rather using _______ , etc., where participants contact the
research team
- UCIMC clinical trials website
- posting a _______ in the clinic that invites interested
individuals to contact the team
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Active vs. Passive Recruitment Strategies
Active Recruitment – any time that we make direct approach and
contact with participants for the purpose of research
- sending letter to specific patients from our clinic
- approaching patients during medical appointment
- using a partial waiver of HIPAA authorization to access
medical records for recruitment purposes
Passive Recruitment – no direct approach to participants, but
rather using advertisements, etc., where participants contact the
research team
- UCIMC clinical trials website
- posting a flyer in the clinic that invites interested
individuals to contact the team
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Recruitment
Recruitment plan in the protocol narrative, section ___
- recruitment activities are considered an _______ of
the informed consent and subject selection processes
- all aspects of the _______ must be approved by the IRB
before implementation
- this includes the _______ (locations, methods, etc.) as well
as the actual _______ tools (flyers, brochures, letters to
participants, newspaper or website advertisements, telephone
scripts)
- write the plan to be _______ as much as possible
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Recruitment plan in the protocol narrative, section 5
- recruitment activities are considered an extension of
the informed consent and subject selection processes
- all aspects of the plan must be approved by the IRB
before implementation
- this includes the plan (locations, methods, etc.) as well
as the actual recruitment tools (flyers, brochures, letters to
participants, newspaper or website advertisements, telephone
scripts)
- write the plan to be open-ended as much as possible
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Content of all recruitment tools
The name of the _______ (University of California Irvine or University of California Irvine Medical Center), the name of the _______ or _______ ;
The name of the _______ (and faculty sponsor, when applicable), and the name of a _______ person with a telephone number (including area code) to call for information about the study;
The _______ of the research and, in summary form, the _______ criteria that will be used to admit subjects into the study (e.g., adults on medication for high blood pressure, diabetic patients on insulin; normal, healthy adults; etc.);
A straightforward, truthful description of the _______ , if any; and
The _______ of the research and _______ commitment, if appropriate (e.g., subjects will have to come to the UCI campus on 4 separate occasions; the research will take 2 hours on one day, etc.)
If _______ compensation is offered, it must not be presented as an _______ to participate.
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The name of the institution (University of California Irvine or University of California
Irvine Medical Center), the name of the Department or Division;
The name of the Lead Researcher (and faculty sponsor, when applicable), and the
name of a contact person with a telephone number (including area code) to call for
information about the study;
The purpose of the research and, in summary form, the eligibility criteria that will be
used to admit subjects into the study (e.g., adults on medication for high blood
pressure, diabetic patients on insulin; normal, healthy adults; etc.);
A straightforward, truthful description of the benefits, if any; and
The location of the research and time commitment, if appropriate (e.g., subjects will
have to come to the UCI campus on 4 separate occasions; the research will take 2
hours on one day, etc.)
If monetary compensation is offered, it must not be presented as an inducement to
participate.
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IRB Review of Recruitment Materials
What are the IRB concerns in reviewing recruitment materials?
• Is the language _______ or _______ ?
• Any _______ language?
• Any implication or direct language about investigational agent
_______ or _______ to approved agents?
• Using the word “_______ ” for investigational (implies approved)
• Claims that differ from _______ approved language
• Compensation cannot include a _______ on the future
approved drug, device, biologic
• _______ is not over-emphasized (bold print)
• No promise of _______ medical care
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What are the IRB concerns in reviewing recruitment materials?
• Is the language misleading or coercive?
• Any exculpatory language?
• Any implication or direct language about investigational agent
equivalence or superiority to approved agents?
• Using the word “new” for investigational (implies approved)
• Claims that differ from FDA approved language
• Compensation cannot include a discount on the future
approved drug, device, biologic
• Payment is not over-emphasized (bold print)
• No promise of free medical care
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Recruitment Tools
All recruitment tools receive an _______ stamp and approval _______ and are uploaded into the Document Depot
Any changes to IRB-approved recruitment tools require _______ and approval by the IRB via eMod submission
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All recruitment tools receive an IRB stamp and approval date and
are uploaded into the Document Depot
Any changes to IRB-approved recruitment tools require rereview
and approval by the IRB via eMod submission
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