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Informed ConsentInternational
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1. Informed Consent/International. Melody Lin, Ph.D. Deputy Director, OHRP. Director, OIA ... Insure that HS understand risk-benefit associated with participation ... – PowerPoint PPT presentation
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Title: Informed ConsentInternational
1
Informed Consent/International
- Melody Lin, Ph.D.
- Deputy Director, OHRP
- Director, OIA
- Beijing, China
- March 2003
2
Objectives (1)
- Why?
- Who?
- Elements
3
Objectives (2)
- Process and Form
- Documentation and Waiver
- Research with Records and Specimens
4
Why Have Informed Consent?
- Show respect to human subjects (HS)
- Mandated by regulations
- Protect HS
- Insure that HS understand risk-benefit associated
with participation - Provide HS all information needed for decision
making about participation
5
Is It Just Signing the Form?
- No
- Involves
- Provide information
- Ensure understanding via question and
answer - Obtain voluntary agreement
6
Who Ensures Compliance With Regulations?
- FDA 21CFR 50
- OHRP 45 CFR 26
- Study Centers IRB
7
Basic Elements (1)
- Research, why, what, how long
- Risks or discomforts
- Potential benefits
- Aware of other alternatives
- Confidentiality protection
8
Basic Elements (2)
- If subjects at risk of physical harm
- Care if injured, whom to contact
- Contact for questions, problems
- Can withdraw without penalty
9
Additional Elements
- Additional where appropriate
- Possible unknown risks
- Involuntary termination
- Additional costs
- Consequences of withdrawal
- Inform of new findings
- Number of subjects
10
Consent Must Be
- Individual
- Voluntary
- Informed
- Effective
- Continuous
11
Subject Recruitment
- Recruitment ads, telephone scripts
- Often the first step in informed consent
- Must be reviewed by the IRB
12
Consent Process and Form
- Consent is a PROCESS in which
- investigator discloses all relevant information
- potential subject has opportunity to ask
questions - investigator answers questions
- repeat the above..
- The consent form is a permanent record of
- information conveyed
- subjects willingness to participate
13
Consent Process Must
- Give subject enough time to consider the decision
- Minimize possibility of coercion or undue
influence
45 CFR 46.116, 21 CFR 50.20
14
Consent Form Must
- Be understandable to subject or representative
- NOT
- waive subjects rights
- release investigator, sponsor, institution from
liability
45 CFR 46.116, 21 CFR 50.20
15
Documentation
- Use written form approved by IRB
- Form must be signed and dated by subject or
legally authorized representative - Give copy to subject/ representative
- Two types of forms permissible
45 CFR 46.117, 21 CFR 50.27
16
Criteria for Waiving or Altering Informed Consent
- No more than minimal risk to subjects
- Waiver will not adversely affect the rights and
welfare of subjects - Research could not practicably be done without
the waiver or alteration - When appropriate, subjects will be given
additional pertinent information after
participation
45 CFR 46.116(d), but not FDA
17
Criteria for Waiving Written Documentation of
Consent (45 CFR 46.117, 21 CFR 56.109)
- If consent form would be the only record linking
subjects to research, and the principal risk is
breach of confidentiality (HHS only) - If research has no more than minimal risk and
involves only procedures for which written
consent is not normally required outside research
(HHS and FDA)
18
Do Retrospective Medical Record Reviews Require
- ...IRB APPROVAL?
- Yes, if they are done for research
- ...INFORMED CONSENT of research subject?
- Not always, if the IRB agrees that waiver is
appropriate
19
Storage of Specimens for Future Research
- Why?
- Where?
- For how long?
- Who has access?
- With or without identifiers?
- Re-contact?
- What if clinically relevant information is found?
20
OHRP Website
- http//ohrp.osophs.dhhs.gov/
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