Functions 1
As opposed to just being a static document, IRBs emphasize the importance of informed consent being a _________?
What is a process?
In addition to protecting 'objective' determinants of welfare, in allowing subjects to rely on their own insight into what is good for them, informed consent also protects what other kind of participant welfare?
What are 'subjective' determinants of welfare?
Informed consent comprises these two distinct research activities.
What are:
1) informing (the identification of a particular set of information as likely to be important to anyone trying to make the decision about participation); and
2) consenting (an engagement between and individual and a research team member that both facilitates and verifies understanding of what it means to enroll int he research)
The Common Rule's requirements for informed consent can be found in 46 CFR 46.___.
What is 116?
Informed Consent must begin with a concise and focused presentation of key information, except for in this occurrence.
What is, when broad consent is obtained?
This ethical function of informed consent involves providing potential subjects with necessary information about the research to evaluate the acceptability of the risks
What is Transparency?
This ethical function of informed consent prohibits enrollment without authorization or forced participation in research.
What is Respecting Subjects' Autonomy?
Requiring that informed consent be written to facilitate understanding demands thinking about the consent process from the perspective of _______.
Who are potential subjects?
Understanding who will be requesting consent, and the relationship of that individual to the potential subject, is necessary for the IRB to protect against this.
What are 'undue influence' and 'coercion'?
Allowing the researcher to facilitate the consent process can lead to what problematic outcomes?
'Informed' consent is shorthand for "informed, __________, and capacitated consent".
What is Voluntary?
What consent requirement can "objectively" protect subject welfare by preventing studies that produce generalizable knowledge but would involve excessive risks to subjects?
What is the requirement for a reasonable risk/benefit ratio?
To ensure that information is provided in language understandable to the subject or LAR, IRBAs must consider these two things.
What are:
1) That the consent is written in the participant's language of understanding (i.e. Spanish); and
2) That the language is at the appropriate comprehension level for the potential subjects
Although this standard has been a fixture in tort law for years, it was a new addition to the 2018 Common Rule, and little guidance has been provided regarding how IRBs should assess it.
What is the 'reasonable person' standard?
Beyond just providing facts, the key information section is explicitly written to facilitate decision making by doing this.
What is, helping participants understand the reasons why they might or might not want to participate in research.
What are:
1) Protecting subjects welfare by focusing their attention on risks / benefits
2) Respecting autonomy by signaling personal commitment to the decision to participate
3) Increasing transparency by amplifying scrutiny and focusing attention on the consent process
4) Reinforcing public trust when a clean-cut mark of consent is expected
In addition to the principles of Respect for Persons, Beneficence and Justice, the Belmont Report also sets out the following three requirements for HSR to guide IRBs.
What are: 1) Informed Consent, 2) Assessment of Risks and Benefits, and 3) Fair Subject Selection?
Informed consent requirements forbid the inclusion of this.
What is 'exculpatory language', through which subject is asked to waive any of their legal rights or to release the study sponsor or other parties from liability.
If an IRB finds that a particular additional element is applicable to the research study, the reviewer must take one of these two possible actions.
What are:
1) ensuring that the element is included in the consent form; or
2) undertaking the process set forth in the regulations for waiving or altering consent.
The 2018 Common Rule changed the requirement that language simply be 'understandable', to requiring that information be presented in a way that does this.
What is 'facilitates comprehension'?
In studies involving deception, which cannot practically be carried out after an informed consent process, DHHS recommends this to preserve transparency.
What is providing 'pertinent information' to subjects after the fact?
In studies involving high welfare and autonomy risks, it may be important to sacrifice full disclosure to avoid this.
What is 'therapeutic misconception'?
What is, return of research results to subjects?
Until regulations are harmonized (as directed by DHHS in the 21st Century Cures Act of 2016), these four elements of consent that are present in the Common Rule remain absent from FDA regulations.
What are:
1) Basic Element 45 CFR 46.116(b)(9): One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
(i) A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility;
or (ii) A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
2) Additional Element 46.116(c)(7): A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;
3) Additional Element 46.116(c)(8): A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
4) Additional Element 46.116(c)(9): For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).
The regulatory text does not specify what information is key, but the preamble identifies these 5 categories of information that are likely to be considered key for most studies.
What are:
1) The fact that consent is being sought for research and that participation is voluntary
2) The purposes of the research, the expected duration the prospective subject's participation, and the procedures to be followed in the research
3) The reasonably foreseeable risks or discomforts to the prospective subject
4) The benefits to the prospective subject or to others that may reasonably be expected from the research; and
5) Appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the prospective subject