Question

Of the following factors, which one does not influence the capacity to consent?
A. Age
B. Cognitive (mental) impairment
C. Illness
D. Financial factors

Answer 1

Explanation:

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INFORMATION SHEET

Informed Consent

Draft Guidance for IRBs, Clinical Investigators, and Sponsors

JULY 2014

Draft

Not for implementation. Contains non-binding recommendations.

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Docket Number:

FDA-2006-D-0031

Issued by:

Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice

Center for Drug Evaluation and Research

Center for Devices and Radiological Health

Center for Biologics Evaluation and Research

This guidance document is being distributed for comment purposes only. 1

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TABLE OF CONTENTS

I. INTRODUCTION

II. SUMMARY OF THE CONSENT PROCESS

III. FDA INFORMED CONSENT REQUIREMENTS AND DISCUSSION

A. General Requirements for Informed Consent

1. Exceptions to Informed Consent

2. Coercion and Undue Influence

3. Language Understandable to the Subject or the Representative

4. Exculpatory Language

B. Basic Elements of Informed Consent

1. Description of Clinical Investigation

2. Risks and Discomforts

3 Benefits

4. Alternative Procedures or Treatments

5. Confidentiality

6. Compensation and Medical Treatments in Event of Injury

7. Contacts

8. Voluntary Participation

Answer 2

Financial factor is the factor does not influence the capacity to consent.

• The ability of a person to understand and explain the nature and effects of decisions relating to them, their property, and their way of life, including a decision to accept or refuse services, is referred to as the capacity to consent.
• Age, mental health, emotional stability, physical health, and degree of cognitive impairment are some of the variables that affect consent capacity.
• Three key processes are thought to have an impact on a person's capacity to consent:

1. comprehension (ability to understand and retain information).
2. decision-making (the capacity to evaluate information and make decisions)
3. communication ( capacity to communicate the decision made).

Answer is D. Financial factors

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