Informed Consent Flashcards
2 Methods of Informed Consent
-Subject or LAR sign by hand or electronically, given a copy
-Consent is done orally in langauge, documented by impartial witness, short form & written both IRB approved, summary (given to subject), signed by witness and person obtaining consent, short form signed by subject and witness
3 Key features of Informed Consent
-Disclosing Information Needed to make an informed decision
-Facilitating the understanding of what has been disclosed
-Promoting the volunariness of decision to participate
45 CFR 46 G
Waiver for Screening, Recruiting, or determing Elgibility
Investigator will obtain info or biospecimens for screening, recuriting, or determining elgibility w/out informed consent if either condition is met:
-Investigator will obtain info through oral or writing communication with the subject or LAR
-Investigator will obtain identifable private info or biospecimens by accessing records or stored identifable biospecimens
9 Basic Elements of Consent (#1 has 5 parts)
- Statement that study involves research a. Explanation of purposes, b.The expected duration, c. A description of procedures, d. Identification of experimental procedures
- Description of any resonably forseeable risks or discomforts to the subject
- Description of any benefits to subject or others or that there are no direct benefits what hope to learn, knowledge might help field or others
- Disclosure of appropraite alternative procedures or treatment, if any
- Statement describing extent to which confidentiality will be maintained
- Explanation of treatments if injury occurs, compensation
- Explanation of whom to contact for questions, rights, injury
- Statement that participation is voluntary, resfusal has no penalty, and can stop at any time
- Statement that private info or biospecimens will be saved for future research with no identifies or that no future research will be done
Additional Elements of Consent
- Statement that treatment has risks that are currently unforseeable
- Anticipated circumstances under which the subject’s participation may be terminated by investigator
- Additional costs
- Consequesences of subject’s decision to withdraw
- Significant new findings that would relate to subject’s willingness to continue will be provided
6.Approximate # of subjects - Statement that if biospecimens are used for commerical profit, subject will or will not share in profit
- Whether clinicall relevant reserach results will be disclosed to subjects
9.Whether biospecimens research includes whole genome sequencing
Additional Restrictions for Broad Consent
-IRB may not omit or alter requirements of broad consent
-IRB may not waive consent if individual already said no to broad consent
Basic Elements of consent added for ICH
- Randomization
- # of Subjects
- Expenses
- Will it go in medical records
5.Responsibilities, tie, payment, committments
Broad Consent Elements Required
- Risks
- Benefits
- Confidentiality
- Voluntary
-General Description of types of research that mmy be conducted
Essential Points of Information for Informed Consent
-Purpose of the Research
-Description of What Subject will be expected to do
-Any forseeable risk or harm
-Participation is voluntary & subjects are free to withdraw at any time
Examples of Reconsent Required Situations
- Increase in or new risks
- New unknown serious side effect
- Decrease in benefit or new SOC option
- Changes to treatment if injured by IP
- CHange in dosage/device application
- Change in exposure to drug/device
- Change in duration, significant increase in the # of subjects
- Change in the use of samples
Exculpatory language
Subjects may not be asked to waive or appear to waive any of their legal rights or release a researcher, sponsor, or institution from liability for negligence
FDA Alteration of Informed Consent January 22, 2024 21 CFR 50
-IRB can approve for minimal risk
-Can not be practicably carried out without the waiver
Private info/identifable biospecimens need to be included as it couldn’t be carried on without
-Waiver/alteration does not affect the rights/welfare of subjects
-Provide subjects/LAR with additional pertinent info after participation
FDA Waiver of Documentation of Consent (Process)
- Consent orally
- Approved by IRB
- Minimal risk with no procedures outside the context of a research study
- Still provide the subject with the info required by regulations and written materials as instructed by the IRB
ICF signature requirements ICF vs. FDA
I
ICH Consent Process
- Go through all aspects
- give time to reveiw the ICF & take home
- answer all questions
- subject signs and dates
- Unlike FDA, person conduction the discussion must sign on the last page, should have a line stating the person conducting informed consent, not investigator’s signature
- Must be delegated tasks on the DOA
- Give subject signed and dated copy
If a participant can speak/understand the local language but not read or write
-can make a mark on the consent when consistent with applicable law
-document should detail how cosnent was obtained & an impartial witness should sign the ICF
Informed Consent ICH
Purpose, risks/benefits, duration, costs/expenses, study procedures, alternative care options, research subjects’ rights
Minimum Consent Requirements from the Belmont Report
Information, Comprehension, Voluntariness
US Common Rule, Additional Consent Requirement
Key Information
Waivers of Elements of Consent (Alteration) 45 CFR 46f
-Omit 1 or more elemts of consent process information
-Only allowed if all 5 criteria are met:
1.The research involves no more than minimal risk to the subjects.
2. The research could not practicably be carried out without the requested waiver or alteration. (ex. disclosing purpose could influence how subjects respond)
3. If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format.
4. The waiver or alteration will not adversely affect the rights and welfare of the subjects. (ex. not tricked into participating if they find it objectionable)
5.Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation (provides opportunity for subject to withdraw, but not required in situations where it would do more harm then good).
Waivers of Documentation of Consent
- Principal risks are breach of confidentiality & consent is only document linking subject w/ research
- Study presents minimal risk of harm, no procedures outside context of participating
- Members of a distinct cultural group/community that signing forms is not the norm, no more than minimal risk, and there is appropriate alternative to documenting consent obtained
-IRB may require that you offer subjects information about the study in writing.
Waivers of Parental Permission & Child Assent
Same Criteria as adults, no required elements of assent, up to IRB if assent is required, what elements must be present, if it must be documented
What is Documentation of Consent?
A record that the consent process took place. Usually a signed form but could be documented by audio or video recording if IRB approved.
Who can consent for studies with children (peds) that are treament studies?
Only MD/DO doctors
Who does the FDA require signs the consent form?
Just the subject or LAR
