ICF Flashcards
ICF process
process by which a person VOLUNTARILY agrees to participate in a research study after being fully informed about it
process starts when a prospective subject is informed about the possibility to participate in a clinical trial
process ends when subject completes all study related activities according to the schedule described in the protocol or time of full consent withdrawal
PI responsibilities
investigator is responsible for informing the subject about the study (or person on DOA log)
person conducting the informed consent must be TRAINED on obtaining and documented informed consent and delegated by the PI
PI must evaluate that the potential participants ability to understand both written and verbal information about the study
PI should give potential participant time to think and process info and discuss with family and friends
Subjects have the right to ask any questions about the trial and all questions must be answered to the subjects satisfaction
informed consent can take up to two visits
Key element pieces of information
trial involves research
purpose of the trial
trial treatments
trial procedures
participants responsibilities
experimental trial aspects
foreseeable risks and inconveniences
expected benefits
alternative procedures or treatments
compensation in case of trial related injury
payments to participants (only healthy volunteers and phase 0/1 studies)
expenses for participant
participation is voluntary and subject can withdraw at any time
Monitor, auditor, EC’s and RA’s, will be granted direct access to the participants medical records
willingness and voluntary
individuals must participate in clinical research voluntarily
their decision must be free of coercion or influence
it is the PIs obligation to protect the subjects autonomy
Documented
signed and dated ICF by the subject and person who conducted the ICF discussion
must be documented in medical records or source files
ICF should be signed in two copies - one for the site records and one to give to the subject
ICF consists of two parts
Patient information sheet - descriptive part with the information about the study for potential participants
Consent form - formal patient statement of intent ad included the signatures for patient and person obtaining consent
Requirements to be followed: ICH GCP, local regulations (CFR), EC or IRB, Sponsor/CRO/site SOP, consistent with protocol
Consent forms: legal documents signed by legally authorized people
Assent forms: not legally binding but are used to signify agreement of potential subject ex: minors or adults with mental impairment (sometimes required by local regulations/IRB)
Documentation of consent process
when and how consent was obtained
identification of form version signed
confirmation that consent was obtained before study procedures
statement that a copy of the consent was obtained before study procedures
statement that a copy of the consent document was given to subject
time given to participant to consider research participation
vulnerable subjects: who was present during the consent process, participant’s level of comprehension and decision making capacity.
Re-consenting
Re-consenting is required if subject would like to continue in the study if there are revisions to the ICF
documentation requires all same elements of the initial consent
Verification of ICF process
verify existence of signed ICF and that it occurred prior to any study procedures
ICF must be verified first to ensure participants gave consent to provide access to their medical documentation
verification should occur in the first MV after consent was obtained and if:
new info was discussed
updated ICF was provided
subject signed re-consent or refused to sign re-consent
process of reconsenting is described in medical records (occurs on first MV after re-consent)
Items to verify on ICF
signed ICF is at the site
current version/update
all pages in signed ICF are present
All additional required info is present (PI name, site address, et)
ICF contains full and clear name of the patient (an LAR/impartial witness if applicable) and person obtaining consent
how is impartial witness assigned
if form was personally dated and signed by patient/impartial witness/investigator: check if the subjects handwriting is different from handwriting of person taking consent and if same as previous versions of the ICFs signatures
time of consent is not later than any procedure time or implementation of amendment change
additional tick boxes are checked or forms completed to consent for optional procedures
other study specific/country specific requirements are met
consent is free of changes or handwritten corrections
if corrections were made in compliance with GCP
if consenting was noted in source documentation
for pediatric studies: signatures from parent were obtained and there is a child assent if applicable, informed consent was obtained from the subject when they turned 18
Special populations
vulnerable subjects: individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation of benefits associated with participation or retaliatory response from authority figures in case of refusal
e.g. children, pregnant women, prisoners, cognitively impaired, foreigners, terminally ill, deaf or blind people, financially impaired
ICH GCP 4.8.13: non therapeutic trials with no anticipated benefits to the subject should only be conducted in subjects who are able to personally give consent and who sign and date the written informed consent form
* ie: in phase 0 and 1 trials (non-therapeutic) no impartial witness or LAR can be engaged in the consent process
* No such clinical trials with vulnerable subjects
ICH GCP 4.8.14: Other Clinical Trial Phases can be conducted in vulnerable populations if they meet certain conditions
* Objectives of the trial cannot be met by means of a trial in subjects who can give informed consent personally
* The foreseeable risks to the subjects are low
* The negative impact on the subject’s well-being is minimized and low
* The trial is not prohibited by law
* The approval/favorable opinion of the IRB/EC is sought on the inclusion of such subjects
ICH GCP 4.8.12 and 4.8.14: when a non therapeutic trial is to be carried out with the consent of the subject’s LAR, the IRB/IEC should determine that the proposed protocol and other documents adequately address relevant ethical concerns and meets applicable regulatory requirements for such trials
Cognitively impaired/incapacitated
re-consenting should occur if changes in mental capacity occur during course of the trial
follow re-consenting procedures w/ the following options:
continuation of participation in the study
withdrawal from the study and allowance to continue usage of data and specimens
investigators responsibility to assess if the subjects capacity to consent
Minors
Should only be included if:
- the relevant knowledge cant be gained through adults
- is approved by EC/IRB
-either the participant has give assent if possible or if consent has been given by both parents or a guardian and participant doesn’t object/appear to object
information should always be provided to the children to the extent at which they can understand and appropriate level of information
o Assent usually not required for infants/children under 5
o For older children verbal children is required
o For 14+ verbal and written assent are required
–> no international minimum age, usually depends on the IRB/EC
—> must check local laws
* If written assent is required, the assent form should be approved by IRB/EC –> multiple versions may exist if there is a broad age range
* If child disagrees, they cannot be forced to join a trial
o Unless: there is a direct benefit that is important to the child’s health and only available in the context of research
* In long term studies: when child reaches 18 they should be re-consented
Emergency situations
when prior informed consent is not possible
most vulnerable study subjects as they have no capacity to consent but there is an emergency circumstance that requires prompt action and there is insufficient time and opportunity to locate and obtain consent from the potential subject’s LAR
enrollment of the subject should require measures described in the protocol that has been approved by the IRB/IEC
subjects LAR should be informed as soon as possible
- they should consent to continue
-and/or subject becomes conscious then the trial should be discussed and consent to continue will be requested
if LAR consents first, as soon as subject regains cognition, they should be re-consented
NR/IRB/EC may also require:
obtaining advice and counsel of a physician independent of the trail with expertise in the area
or
prompt notification to the EC about emergent enrollment in the trial
IRB/EC needs to ensure protocol provides adequate ethical concerns when the enrollment in emergency situations is allowed
Patients unable to read and/or write
individuals may speak and understand and also must be able to:
-comprehend the concepts of the study and understand the risks and benefits of the study as it is explained verbally
and
- to indicate approval or disapproval for study enrollment
- impartial witness must be present during the entire informed consent discussion before enrollment into a clinical trial
- after consent is verbally provided, the witness should personally sign and date the consent form
— to attest that the study has been adequately explained and understood by the subject and verbal informed consent was freely provided
process needs to be documented in the medical/research records and include:
- method of communication
- way agreement was communicated
- name of impartial witness
