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SUBJECT: Informed Consent,
Permission, and Assent
PURPOSE:
To establish
guidelines for conducting the informed consent process and for obtaining the
consent for human subjects to participate in research activities.
POLICY: Obtaining informed consent
is a process. The procedures used to obtain informed consent are
designed to educate the human subject about the research project in terms that
he/she can understand. Prospective subjects are given sufficient
information about the research and its risks and benefits to reach an informed
decision as to whether they will voluntarily participate.
Investigators must obtain the informed consent of prospective subjects before
they can be included in research.
Various
templates/waiver forms
are available at the end of this SOP.
SCOPE:
To approve
research, the IRB must determine that legally effective informed
consent is sought
from each prospective subject or the subject's legally authorized
representative, unless the informed consent requirements can be waived or
altered under federal regulations.
RESPONSIBILITY: The Principal Investigator (PI) is responsible for
explaining the consent process, the research, and the consent form to the
subject in language he/she can understand and for obtaining the signed
consent. The PI is responsible for determining if the human subject has
the legal, mental, and emotional ability to understand the consent process;
otherwise, the subject's legally authorized representative must be contacted.
The PI must also ensure that the informed consent process is followed,
regardless of which member(s) of the research team are authorized to actually
obtain the consent and that the consent is documented properly. The PI is
responsible for assuring that the informed consent contains all required
elements and it is approved by the IRB prior to utilizing the
form. All informed consents should have the pages numbered and a place for
the subject to initial any page that does not have a signature (i.e.
Initials____). Any changes to the informed consent must also be approved by the
IRB prior to utilizing the changed informed consent.
The IRB
Chairperson and IRB members are responsible for ensuring that the
informed consent document contains all required elements and additional
elements when appropriate. They are also responsible for ensuring
that the informed consent process is properly carried out by the investigator
or a properly trained member of the research team. IRB Chairperson Contact
Information is:
IRB#1
IRB#2
Dr. Henry Driscoll
Dr. Stephen Cooper
Phone: (304)
696-7320
Phone: (304) 696-4303
The Director
of the Office of Research Integrity (ORI) or his/her designee is responsible
for the periodic monitoring of the informed consent process and for auditing
the informed consent documents that are maintained in the investigator¡¯s files.
The IRB
Coordinator is responsible for maintaining a copy of all approved informed
consent documents. She is also responsible for documentation of
exceptions from Informed Consent requirements for emergency use of a test
article in the IRB records, when applicable.
PROCEDURE: To approve research activities, the IRB must determine that a legally effective informed consent is sought from each prospective subject or the subject's legally authorized representative unless waiver of consent or waiver of documentation of consent is approved according to federal regulations. The IRB must determine whether consent by the subject's legally authorized representative is allowed.
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For VAMC research, if someone other than the investigator conducts the interview and obtains consent, the investigator must formally delegate this responsibility and the person so delegated must have received appropriate training to perform this activity.
Legal Counsel - for access to legal counsel for assistance in applying laws other than federal to research involving humans as participants, contact the Marshall University Office of General Counsel.
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DEFINITIONS:
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Child (DHHS/FDA): Persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.
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Guardian (DHHS/FDA): An individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.
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Legally Authorized Representative (DHHS/FDA): Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. This definition is the same for DHHS and FDA.
For VAMC Research: A legally authorized representative is an individual or body authorized under applicable law to provide permission on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. A legally authorized representative includes not only a person appointed as a health care agent under a Durable Power of Attorney for Health Care (DPAHC), a court appointed guardian of the person, but also next-of-kin in the following order of priority unless otherwise specified by applicable state law: spouse, adult child (18 years of age or older), parent, adult sibling (18 years of age or older), grandparent, or adult grandchild (18 years of age or older).
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Legally Authorized Representatives (LAR) in WV, Ohio, and Kentucky may consent to research on behalf of a participant only in those instances authorized by state law and MU Research Policies. LARs include those who are:
a. the judicially-appointed guardian of the person, if the guardian has been appointed and if medical decisions are within the scope of the guardianship;
b. the attorney-in-fact named in a durable power of attorney, if the durable power of attorney specifically includes authority for health care decisions;
c. the parent or spouse of the person;
d. if the person is incompetent, an adult child of the person, or if the person has more than one (1) child, the majority of the adult children who are reasonably available for consultation;
e. the nearest living relative of the person, or if more than one (1) relative of the same relation is reasonably available for consultation, a majority of the nearest living relatives.
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Under WV, Ohio, and Kentucky law, the individuals who meet the DHHS and FDA definition of ¡°guardian¡± include those who are:
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a. the judicially-appointed guardian of the child, if the guardian has been appointed and if medical decisions are within the scope of the guardianship;
b. the attorney-in-fact named in a durable power of attorney, if the durable power of attorney specifically includes authority for health care decisions;
c. the legally authorized representative of the child as defined above.
In order to give informed consent to treatments or procedures involved in research, a person must be legally competent to do so and be eighteen years old. In West Virginia, Kentucky, and Ohio, Subpart D of 45 CFR 46 applies to all research involving individuals under the age of 18 unless the individual is emancipated under state law (i.e. by court order, marriage, or is on active military duty). In these three states these are the individuals who meet the Subpart D definition of a "child."
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If research is to be conducted in other states with legally authorized representatives, children, or guardians, then the investigator must provide the IRB with the state law that describes who would fall under the Subpart A of 45 CFR 46 and 21 CFR 50,56 definitions of ¡°legally authorized representative¡±, the Subpart D of 45 CFR 46 and 21 CFR 56 definitions of "children" or the Subpart D of 45 CFR 46 and 21 CFR 56 definitions of "guardian," respectively. The IRB determines whether the information is adequate and may consult legal counsel.
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Informed Consent
Informed
consent may only be sought under circumstances that provide the subject (or the
legally authorized representative) with sufficient opportunity to consider
whether or not to participate and that minimize the possibility of coercion or
undue influence.
For example:
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(1) Informed consent information must be presented in language that is
understandable to the subject (or the legally authorized representative).
(2) No informed consent process may include any exculpatory language
through which the subject is made to waive, or appear to waive, any of the
subject¡¯s legal rights or through which the investigator, the sponsor, Marshall
University, or the University¡¯s employees or agents are released from liability
for negligence, or appear to be so released.
(3) Informed consent must be obtained prior to initiation
of any clinical screening procedures that are performed solely for the purposes
of determining eligibility for research.
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The Informed Consent form must be used and must contain the required eight (8) elements:
(an informed consent checklist is available at the end of this SOP to help determine if you have included all the elements)
Required Element #1: Research Statement
Informed consent information must include the following:
(1) A statement that the study involves research.
(2) An explanation of the purposes of the research.
(3) An explanation of the expected duration of subjects¡¯
participation.
(4) A description of what procedures will be followed.
(5) Identification of any procedures that are experimental.
If the treating physician is also the research investigator, some
subjects may not realize they are participating in research, but believe they
are just being treated for their condition. By specifying the purpose of
the research and describing experimental procedures, it is intended that
subjects will be able to recognize the difference between research and
treatment.
Required Element #2: Reasonably
Foreseeable Risks or Discomforts
Informed consent information must describe any reasonably
foreseeable risks or discomforts associated with the research. Risks
should be listed in descending order of probability and magnitude (risk of
death, even if remote) before risks associated with blood draw, for example). If possible, categorize
risks/discomforts as Likely, Less Likely, Rare but Serious as opposed to a long
unbroken list of every side effect ever noted.
Required Element #3: Reasonably
Expected Benefits to Subjects or Others Informed consent information must describe any benefits to
subjects or to others that may reasonably be expected from the research.
However, care must be taken not to overstate the benefits and create an undue
influence on subjects. Payment for subject¡¯s participation in a research
project is not to be considered as a benefit of the research.
Required Element #4: Appropriate
Alternatives
Informed consent information must include a disclosure of
any appropriate alternative procedures or courses of treatment that may be
advantageous to the subject. Enough detail must be presented so that the
subject can understand and appreciate the nature of any alternatives. It
is not sufficient simply to state, for example, ¡°The doctor will discuss
alternatives to participating.¡±
Required Element #5: Extent of
Confidentiality
Informed consent information must describe the extent to which confidentiality of records
identifying the subject will be maintained (or not maintained). Research
often poses the risk of loss of confidentiality to subjects who
participate. Many persons who would not otherwise have access to
identifiable, private information about the subject may be involved in the
research process. Consent information should describe any procedures that the
research team will use to protect subjects¡¯ private records. In some
research, loss of privacy may be the greatest risk of participation.
For FDA-regulated research the consent must inform the participant that the FDA may choose to inspect and copy medical or research records that identify individual research subjects.
A comparable statement is recommended for any research that
is subject to audit or inspection by any funding agency or sponsor.
Where research involves the collection of highly sensitive information about individually identifiable subjects, the IRB may determine that special protections are needed to protect subjects from the risks of investigative or judicial processes. In such situations, the IRB may require that an investigator obtain a Department of Health and Human Services (DHHS) Certificate of Confidentiality (CoC). A Certificate of Confidentiality (CoC) protects against the involuntary release of sensitive information about individual subjects for use in Federal, state, or local civil, criminal, administrative, legislative, or other legal proceedings. The CoC does not prohibit voluntary disclosure of information by an investigator, such as voluntary reporting to local authorities of child abuse or of a communicable disease. The CoC does not protect against the release of information to VA, DHHS, or FDA for audit purposes. Consequently, the IRB requires that the conditions for release be stated clearly and explicitly in the informed consent document.
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For studies not funded by DHHS, if there is an Investigational New Drug Application (IND) or an Investigational Drug Exemption (IDE), the sponsor can request a CoC from the FDA.
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Disclosure of mandatory reporting is required when research involves circumstances that lead to such disclosure. The IRB should consider disclosing this information for issues, such as child abuse, elder abuse, HIV results, and disease reporting.
Required Element #6: Compensation or
Treatment for Injury
Informed consent information for research involving more than minimal risk must include
explanations regarding:
(1) Whether any compensation is available if injury occurs.
(2) Whether any medical treatments are available if injury occurs.
(3) A description of any such compensation or medical treatments or where more
information about them is available.
(4) A description of any applicable state law.
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Required Element #7: Contact
Information
Informed consent information must include details,
including telephone numbers, about whom to contact for the following
situations:
(1) For answers to questions about the research or to express concerns
or complaints. The principal
investigator and other members of the research team are appropriate contacts
for this information.
(2) For answers to questions about subjects¡¯ rights. The IRB
Office or Patient Advocate Office is the appropriate contact for this
information.
(3) In the event a research-related injury occurs. Depending upon the nature of the research, the research team, the emergency services department, or the risk management office may serve as appropriate contacts for this information.
(4) Provide participants with contact information for a person independent of the research team to:
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Obtain answers to questions about the research.
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Voice concerns about the research.
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Voice complaints about the research.
(5) Provide participants with contact information for a person independent of the research team in the event that:
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The research staff could not be reached.
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The participant or representative wishes to talk to someone other than the research staff.
It is particularly important for subjects and prospective
subjects to understand and have complete confidence that failure to participate
will not jeopardize any ongoing care. Informed consent information must
contain clear statements of the following:
(1) Participation in the research is voluntary.
(2) Refusal to participate will involve no penalty or loss of benefits
to which the subject is otherwise entitled.
(3) The subject may discontinue participation at any time without penalty
or loss of benefits to which the subject is otherwise entitled.
Additional Elements Where Appropriate
Where appropriate, the regulations require that one or more
of the following six additional elements are included in the informed consent
information:
(1) Unforeseeable Risks to Subjects, Embryos, or Fetuses.
(a) If the particular treatment or procedure might involve risks to the participant, which are currently unforeseeable. If the research involves an investigational article or involves procedures whose risk profile in humans is not well known.
(b) If the participant is or becomes pregnant, the particular treatment or procedure might involve risks to the embryo or fetus, which were currently unforeseeable. If the research involves pregnant women or women of childbearing potential, and involves procedures whose effects on a pregnancy are not well known.
(2) Investigator-Initiated Termination of Participation. There may be instances that
would require investigators to terminate the participation of particular
subjects (e.g., subject non-compliance with research, subject not benefiting
from research). The informed consent information must specify these
circumstances.
(3) Additional Costs. If subjects must bear any additional costs (transportation, time
away from work, health costs, etc.), these must be disclosed in the informed
consent information. Any such costs must be consistent with Federal laws
concerning veterans' eligibility for medical care and treatment.
(4) Early Withdrawal/Procedures for Termination. Subjects have the right to
withdraw from the research. However, some studies involve medications or
procedures that would be dangerous for subjects to discontinue abruptly.
For studies of this nature, the informed consent information must provide
subjects with knowledge of the consequences affecting a decision to
withdraw. In addition, if there are procedures regarding how to withdraw
safely from the research, these must also be described. It is not
appropriate for research staffs to administer any additional research-oriented
questionnaires or interventions that do not affect the safety of subjects who
have decided to withdraw.
(5) Significant New Findings. During the course of research, significant new
knowledge, findings about the medication or test article or the condition
under study may develop. Since the new knowledge or findings may affect
the risks or benefits to subjects or subjects¡¯ willingness to continue in the
research, the informed consent information must detail the procedures for
contacting subjects regarding this new information and for affirming their
continued participation.
(6) Approximate Number of Subjects. If known, the informed consent
information should disclose the approximate number of subjects to be enrolled.
Additional
Information.
In some circumstances the informed consent information should include the
following, where appropriate:
(1) Authorization for Use of Bodily Fluids, Substances, or Tissues. If the investigator believes that
bodily fluids, substances, or tissues could be part of or lead to the
development of a commercially viable product, the informed consent information
should include the following statement:
¡°I authorize the use of my bodily fluids, substances or
tissues in this research. It is possible that commercially profitable
products may someday be developed from these bodily fluids, substances, or
tissues. There are no plans to share any profits from such products with
the subjects who were the source of these bodily fluids, substances, or
tissues.¡±
Payment for Participation. The informed consent information
should include a clear statement describing any payment the subject is to
receive for participation, the required conditions for payment, and the payment
schedule. Since federal regulations at 38 CFR 16.116(a)(8), the Common
Rule, and FDA regulations all stipulate that subjects may withdraw from
research at any time without penalty of loss of benefits to which they are
otherwise entitled, completing the research may not be made a condition of
payment. For this reason there should be a description of how payment
will be prorated and calculated for subjects who withdraw early.
Obtaining Consent from Non-English Speakers. Regulations require that informed consent be obtained in language that is understandable to the subject (or the subject¡¯s legally authorized representative). The IRB requires that informed consent conferences include a reliable translator when the prospective subject does not understand the language of the person who is obtaining consent. The IRB requires that appropriately translated consent documents be submitted to the IRB for review and approval prior to their use in enrolling subjects. The IRB may utilize expedited review procedures in approving such documents if the English language consent document has already been approved, and the investigator attests in writing to the accuracy of the translation. When a short-form consent document is used, the short form itself must be written in a language understandable to the subject, although the summary may be in English. The translator who took part in the informed consent conference may serve as the witness.
Short Form Consent
A short form written consent is a document stating that the elements of informed consent required by 45CFR46.116 have been presented orally to the subject or the subject¡¯s legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed and dated by the subject or the representative. However, the witness shall sign and date both the short form and a copy of the summary, and the person actually obtaining consent shall sign and date a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.
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To use the Short Form Consent you must:
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Obtain IRB approval prior to using the short form consent
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Provide a summary document (i.e. the full informed consent)
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Provide the short form consent document (see below sample)
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These documents must accompany a new protocol application or be submitted as an amendment to an existing protocol.
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The following are the required signature requirements:
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Ensure that the short form document is signed and dated by the subject (or the subject¡¯s legally authorized representative)
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Ensure that the short form and the summary are signed and dated by the person obtaining consent as authorized under the protocol (i.e. the oral presenter)
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Ensure that the short form document and the summary document are signed and dated by a witness.
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A copy of the signed and dated short form and the summary will be given to the participant or the representative.
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For VA research, consent will be documented through the use of VA Form 10-1086.
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Short Form
Consent Template
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Understanding
the Informed Consent
Human
subjects are at risk of not being able to make a truly informed decision as to their
desire and willingness to participate in research when he/she does not
understand the informed consent. The language in the informed consent
must be at the reading level of the subject.
Waiver
or Alteration of Informed Consent Requirements:
The IRB
may approve a consent procedure which does not include or which alters some or
all of the required elements of the consent, or to waive the requirement to
obtain informed consent altogether. To approve such a waiver or
alteration, the IRB must find and document that:
- The research involves a public benefit program study conducted by a state or local government. This is only applicable for research being conducted with the approval of local government officials. The IRB must also find and document that:
(1) The research or demonstration project is designed to study, evaluate, or otherwise examine
Public benefit or service programs
Procedures for obtaining benefits or services under those programs
Possible changes in or alternatives to those programs or procedures, or
Possible changes in methods or levels of payment for benefits or services under those programs
(3) The research does not involve non-viable neonates.
(4) The research is not subject to FDA regulation.
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- For Minimal Risk Research:
(1) The research involves no more than minimal risk to the subjects.
(2) The waiver or alteration shall not adversely affect the rights and
welfare of the subjects.
(3) The research could not practically be carried out without the
waiver or alteration.
(4) Whenever appropriate, the subjects shall be provided with additional pertinent information after participation.
(5) The research does not involve non-viable neonates.
(6) The research is not subject to FDA regulation.
These
findings and their justifications will be clearly documented in IRB minutes
when the IRB exercises this waiver provision. This waiver provision is
not applicable to research governed by FDA regulations, and the IRB cannot
approve such alterations or waivers for FDA-regulated research. Under FDA
regulations, if consent is not deemed feasible and thus, is not obtained, the
investigator and another physician not otherwise participating in the clinical
investigation must certify, in writing, the same information as outlined in the
section below on ¡°Documentation of Exceptions from informed consent
requirements for emergency use of a test article.¡±
Waiver of Documentation of Consent. The IRB may waive the requirement
to obtain written documentation of informed consent. (Note:
This provision can be used only for the waiver of documentation of
consent, not for waiver or alteration of consent itself.) The IRB must
review a written description of the information that would be provided to
participants. For example, the IRB might require a consent document to be
created without a signature block. The IRB is required to systematically
consider requiring the investigator to provide participants with a written
statement regarding the research. To approve
such a waiver, the IRB must find and document either of the following
conditions:
(1) 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. In this case, each subject will be asked
whether the subject wants documentation linking the subject with the research,
and the subject's wishes will govern. (The waiver provision is not
applicable to FDA-regulated research).
(2) The research presents no more than minimal risk of harm to
subjects and involves procedures or activities for which written consent is not
normally required outside of the research context. In cases in which the
documentation requirement is waived, the IRB may require the principal
investigator to provide subjects with a written statement regarding the
research. This policy is also applicable to FDA-regulated research.
IRB minutes will clearly reflect this waiver provision and the justification
for its use.
(3) Examples of research in which the IRB may permit a waiver of
obtaining documentation of consent include the following:
A. Studies in which the subject is contacted only by
mail. For survey-type studies that involve completion and return of
printed materials, the elements of informed consent may be integrated directly
into the material collected.
B. Studies in which the subject is contacted only by
telephone. For some studies conducted entirely by phone, the IRB may
permit informed consent to be obtained verbally. However, if the content
of the survey is extremely personal or potentially compromising for the
subject, prior signed, written informed consent may be required. Studies
proposing to obtain verbal consent by phone should provide a detailed phone
script that includes:
(1) All
applicable elements of the informed consent process:
(2) Explicit statements about how the data will
be used, how personal the questions
are, what will be done to maintain privacy of the data, and the subject¡¯s right
to terminate the interview and withdraw from the study at any time;
(3) An explicit statement that participation in the study represents implicit consent for the answers to be used as research data.
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Completion of this informed consent process must be
explicitly documented in the enrollment note for each subject.
(4) Studies eligible for Exemption from Informed Consent
If studies are determined to be exempt by the IRB under
federal guidelines [45CFR46.101(b)(1)-(6)] there is no
need to waive documentation or waive consent, although the IRB can add these as
additional requirements. In general, this would apply to
studies that use only documents, records, or specimens (tissue, blood, urine,
etc.) that (1) existed before the project begins, and (2) were collected
for other purposes than the proposed research. These sources must be
publicly available or the investigator records the information such that
subjects cannot be identified, directly or through identifiers linked to
subjects.
Waiver of Parental or Guardian Permission. If the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements of the parent or guardian, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with Federal , State, or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition. A request for this kind of waiver must be submitted in writing and included in the initial protocol packet.
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New
Findings and Additional Risks require changes in the Informed Consent
If
additional risks are identified during the course of the research, the consent
process and documentation will require revisions to inform the subjects as they
are recontacted or newly contacted. If
the event is serious and unexpected, the risks section of the consent form
should be revised to include the possibility and likelihood of the event.
If subjects are currently enrolled in the study, a consent addendum may need to
be drafted. A revised consent form may be submitted at the time of AE
reporting, if the PI believes such action is warranted prior to IRB review.
The
Informed Consent should have 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 participant.
Documentation
of Informed Consent
To
approve research, the IRB must determine that informed consent is appropriately
documented, unless waiver of documentation under the Common Rule, FDA and VA
regulations can be granted. An appropriately designed informed consent
document is used and must be signed and dated by the subject (or the subject¡¯s
legally authorized representative), and a copy must be given to the person
signing the form. The written consent document must embody the basic and
required additional elements of disclosure and it must be approved by the IRB. If applicable, a progress note in the patient¡¯s medical
record must document his voluntary participation in the research study.
The original signed consent form must be filed in
the patient¡¯s medical record, a copy will be given to the patient, a copy will
be retained for the Principal Investigator¡¯s files under conditions of
confidentiality and a signed copy will be sent to Pharmacy Service, if research
drug is involved. FDA regulations require that the signature be dated.
When
changes are made to any page of the informed consent, a new complete informed
consent must be submitted and placed in the research protocol file. The
original signed consent document must remain in the subject¡¯s chart (patient
record) and copies must be retained in the research file under conditions of
confidentiality. The consent form must be stamped and dated with the IRB
approval stamp and each page of the form must be initialed and dated by the
subject. Any future changes to the consent form must be approved by the
IRB prior to implementation. Once the form is approved, the new
form must be utilized. All old consent forms must be destroyed to ensure
they are not utilized, by mistake.
Documentation
of Exceptions from informed consent requirements for emergency use of a test
article
A test
article is any drug, biological product for human use, medical device for
human use, human food additive, and color additive, electronic product subject
to FDA regulations.
FDA
regulations permit the use of a test article without the informed consent of
the subject (or the subject¡¯s legally authorized representative) where the
clinical investigator and a physician not otherwise involved in the research certify
in writing that:
(1) The subject is confronted with an
immediately life threatening emergency necessitating the use of the test article;
(2) Informed consent cannot be obtained from the participant because of an inability to
communicate with, or obtain legally effective consent from the participant;
(3) Time is not sufficient to obtain
consent from the subject¡¯s legally authorized representative; and
(4) There is no alternative approved or generally recognized therapy that provides equal or greater likelihood of saving the subject. If time is not sufficient to obtain an independent physician¡¯s determination that the four conditions above apply, the clinical investigator should make the determination and within 5 working days after the use of the article, have the determination reviewed and evaluated in writing by an independent physician.
This written certification must be submitted to the IRB within 5 working days of the use of the test article. The Director, ORI is required to
evaluate this report and communicate his/her findings with the IRB chair. This report will also be reviewed to determine that the circumstances of the exception followed FDA regulations.
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Planned emergency research is not reviewed by the MU IRB.
Consent
Monitoring
The IRB
may require special monitoring of the consent process by an impartial observer
(consent monitor) to reduce the possibility of coercion and undue
influence. Such monitoring may be particularly warranted where the
research presents significant risks to subjects, or if subjects are likely to
have difficulty understanding the information to be provided. Monitoring
also may be appropriate as a corrective action where the IRB has identified
problems associated with a particular investigator or a research project.
The IRB may also require that investigators include a ¡°waiting period¡± within
the consent process or use devices such as audio-visual aids or tests of
comprehension.
Understanding
the Process of ¡°Assent¡±
The
basic consent model when working with children is that parents (or
guardians) provide permission for their children (or wards) to participate in
research and permission to contact the children. Children then provide assent to become
subjects. Assent is a child¡¯s
affirmative agreement to participate.
The absence of dissent should not be construed as assent. Generally, parental permission can only
override a child¡¯s dissent when the health of the child is at stake. When
using an Assent form, the child signs the Assent to indicate knowledgeable
agreement (assent) to participate. In addition, the parents, guardian or
legally authorized representative signs and dates the full Informed Consent Document to
document legal permission.
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Obtaining
Consent/Assent from Vulnerable Subjects
There
must be special consideration to protecting the welfare of vulnerable subjects,
such as children, prisoners, pregnant women, mentally disabled persons, and
economically or educationally disadvantaged persons. For information on
the specific processes and responsibilities involved in consent/assent of
vulnerable subjects, please refer to the Marshall University Vulnerable
Subjects Standard Operating Procedures.
VA Medical Center Research
For VAMC research the consent process must disclose:
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That in the event of a research-related injury the VAMC must provide necessary medical treatment to a participant injured by participation in a research project approved by a VA Research and Development committee and conducted under the supervision of one or more VAMC employees.
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The VA's authority to provide medical treatment to participants injured by participation in a VA research project.
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A statement that a veteran-participant will not be required to pay for care received as a participant in a VA research project except in accordance with Title 38 United States Code (U.S.C.) 1710(f) and 1710(g) certain veterans are required to pay co-payments for medical care and services provided by VA. Veterans receiving medical care and services from VA that are not rendered as part of the VA-approved research study must pay any applicable co-payment for such care and services.
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For VAMC research the following is required:
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The use of VA Form 10-1086 for both the long and short forms of documentation of the informed consent process.
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The IRB must approve the wording of the consent to be documented through the use of a stamp on each page of the VA Form 10-1086 that indicates the date of the most recent IRB approval of the document.
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If the consent form is amended during the protocol approval period, policies and procedures require the form to bear the approval date of the amendment rather than the date of the approved protocol.
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A witness to the participant's signature or the participant's legally authorized representative's signature must sign and date the consent document.
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The person obtaining consent must sign and date the consent document.
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If the sponsor or IRB requires a witness to the consenting process in addition to the witness to the participant's signature and if the same person serves both capacities, a note to that effect is required to be placed under the witness's signature line.
For VAMC research involving persons with impaired decision-making capability, it may only be approved when the IRB determines that the following are true and document those findings in the minutes:
(1) Only incompetent persons or persons with impaired decision making capacity are suitable as research subjects. Competent persons are not suitable for the proposed research. The investigator must demonstrate to the IRB that there is a compelling reason to include incompetent individuals or persons with impaired decision-making capacity as subjects. Incompetent persons or persons with impaired decision-making capacity must not be subjects in research simply because they are readily available.
(2) The proposed research entails no significant risks, tangible or intangible, or if the research presents some probability of harm, there must be at least a greater probability of direct benefit to the participant. Incompetent people or persons with impaired decision-making capacity are not to be subjects of research that imposes a risk of injury, unless that research is intended to benefit that subject and the probability of benefit is greater than the probability of harm.
(3) Procedures have been devised to ensure that participant¡¯s representatives are well informed regarding their roles and obligations to protect incompetent subjects or persons with impaired decision making capacity. Health care agents (appointed under Durable Power of Attorney for Health Care (DPAHC)) and next-of-kin, or guardians, must be given descriptions of both proposed research studies and the obligations of the person¡¯s representatives. They must be told that their obligation is to try to determine what the subject would do if competent, or if the subject's wishes cannot be determined, what they think is in the incompetent person's best interest.
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(4) Such consent may be requested and accepted only when the prospective research participant is incompetent or has an impaired decision- making capacity, as determined and documented in the person's medical record in a signed and dated progress note. The determination must be made in accordance with the following requirements, or as established by a legal determination:
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Note: the consent requirements described in VA Handbook 1200.5 are not intended to preempt any applicable Federal, State or local laws that require additional information to be disclosed for the informed consent to be legally effective in accordance with 38CFR16.116(e).
(a) The practitioner, in consultation with the chief of service, or COS, may determine after appropriate medical evaluation that the prospective research subject lacks decision-making capacity and is unlikely to regain it within a reasonable period of time.
(b) Consultation with a psychiatrist or licensed psychologist must be obtained when the determination that the prospective research subject lacks decision-making capacity is based on a diagnosis of mental illness.
(c) Disclosures required by VA Handbook 1200.5 to be made to the subject by the investigator must be made to the subject¡¯s surrogate.
(d) If feasible, the practitioner must explain the proposed research to the prospective research subject even when the surrogate gives consent. Under no circumstances may a subject be forced or coerced to participate in a research study.
Before an incompetent person or persons with impaired decision-making capacity may be considered for participation in any VA research, the IRB must find that the proposed research meets all of the conditions contained in VA Handbook 1200.5, Appendix D, paragraph 6. For these type of studies, the IRB Chair will bring a copy of the Informed Consent SOP to the meeting, and review it, minutes will document each above required determination with protocol specific findings the IRB members provide to justify each determination.
The IRB must make a determination in writing of each of the criteria listed above. If these criteria are met, the IRB may approve the inclusion of incompetent subjects or subjects with impaired decision-making capacity in research projects on the basis of informed consent from authorized representatives as defined in the "Definitions" section of this SOP.
Both investigators and IRB members must be aware that for some subjects, their decision-making capacity may fluctuate. For subjects with fluctuating decision making capacity or those with decreasing capacity to give consent, a re-consenting process with surrogate consent may be necessary.
Although incompetent to provide informed consent, some persons may resist participating in a research protocol approved by their representatives. Under no circumstances may subjects be forced or coerced to participate.
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For VAMC research, a progress note must be placed in the participant's medical record that includes:
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Documentation of the consent process
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Participant entry
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Termination of participation
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Follow
Up Responsibility: Director, Office of Research Integrity
References: 38 CFR 16;
21 CFR 50;
21 CFR 56
OHRP Compliance Activities: Common Findings and Guidance #45, #65
FDA Information Sheets: A Guide to Informed Consent, Frequently Asked Questions
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Revised
IRB#1
Informed Consent Template
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IRB#2
Informed Consent Template
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IRB#2
Parental Permission/Consent Template
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Child¡¯s
Assent Template
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Anonymous Survey
Consent (Sample)
(Note: This template is not to be used for VA Research)
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Online Anonymous Survey
Consent (Sample)
(Note: This template is not to be used for VA Research)
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Verbal Informed
Consent (Sample)
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HIPAA
Consent Template
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VA HIPAA
Consent Template
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VAMC
Informed Consent Template
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Short Form
Consent Template
(this is used in addition to the normal consent
when you have to read the consent to a prospective participant)
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Waivers:
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Informed
Consent Waiver
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HIPAA
Consent Waiver
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The checklist below is for those who do not use the templates. This checklist will help to ensure that all of the required elements are included:
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Informed Consent Checklist
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