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Frequently Asked Questions Common Concerns
On This Page:
Fiscal Year 2005
Fiscal Year 2004
Fiscal Year 2003
Fiscal Year 2002
Fiscal Year 2005
Types of Human Subjects Concerns in Order of Prevalence:
HS Section 30% |
Inadequate/Incomplete |
Missing - Checked "No" |
Inadequate Use/Justification of an Exemption |
Not All Populations Protected |
Missing - Checked "Yes" |
|
Risks 24% |
Physical |
Psychological |
Missing/Inadequate Referral Plan |
Legal/Employability/Reputation |
Other |
Participant Burden |
|
Informed Consent 15% |
Inadequately Addressed |
Inadequate Disclosure |
Assent Needed |
Not Addressed |
Inadequate Permission |
Inadequate Assent |
Permission Needed |
Inadequate Justification for a Waiver |
|
Confidentiality 10% |
Inadequately Addressed |
Not Addressed |
Reporting Requirements |
|
DSM Plan 8% |
Missing |
Inadequately Addressed |
Inadequate/Inappropriate Monitoring |
Missing/Inadequate AE Reporting Plan |
DSMB Needed |
|
Recruitment 7% |
Coercion |
Undue Influence |
Inadequately Addressed |
Inappropriate Setting |
Inclusion/Exclusion Criteria |
Compensation Inadequately Addressed |
Not Addressed |
|
Other 5% |
Clarify Research Procedures |
Incidental Findings |
Subpart D Not Addressed |
Equivalent Protections |
Inequitable Compensation |
Informing Subjects of Results |
Subpart B Not Addressed |
Subpart C Not Addressed |
Compensation Described as Benefit |
FDA Approval for Intervention |
Randomization |
Sample Size |
Screening Process |
Subpart D Inadequate Protections for Population |
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Total applications with human subjects concerns 506 |
Fiscal Year 2004
Types of Human Subjects Concerns in Order of Prevalence:
Human Subjects Section 28%
Inadequate
Missing
Inadequate Justification for an Exemption
Not all Populations Protected
Risks to Subjects 22%
Physical Risks
Psychological Risks
Legal Risks
Risks to Employability
Informed Consent 16%
Inadequate Informed Consent
Inadequate Disclosure
Parental Permission/Child Assent
Inadequate Justification for a Waiver (or “Passive” Consent)
Informed Consent Not Addressed
Data and Safety Monitoring 11%
Missing DSM Plan
Inadequate Monitoring Described
Inadequate Information Provided
DSMB Needed
Missing/Inadequate Adverse Event Reporting Process
Confidentiality 12%
Confidentiality Inadequately Addressed
Confidentiality Not Addressed
Reporting Requirements Not Addressed
Protection of Identifiable Data
Inappropriate Access to Records
Recruitment 7%
Recruitment Inadequately Addressed
Coercion
Undue Influence
Inappropriate Inclusion/Exclusion
Secondary Subjects
Other 4%
Informing Subjects of Results
Inadequate Protections for Prisoners
Inadequate Protections for Children
Conflict of Interest
Equitable Treatment
Protocol Internally Inconsistent
574 Total Applications with Human Subjects Concerns
Fiscal Year 2003
Types of Human Subjects Concerns in Order of Prevalence: Human Subjects Section 24%
Inadequate
Missing
Inadequate Justification for an Exemption
Risks to Subjects 20%
Physical Risks
Psychological Risks
Risks to Employability
Legal Risks
Informed Consent 15%
Inadequate Informed Consent
Parental Permission/Child Assent
Inadequate Disclosure
Inadequate Justification for a Waiver (or “Passive” Consent)
Informed Consent Not Addressed
Data and Safety Monitoring 13%
Missing DSM Plan
Inadequate DSM Plan
Missing/Inadequate Adverse Event Reporting Process
DSM Board Needed
Confidentiality 11%
Inadequate Protections of Confidentiality
Confidentiality Inadequately Addressed
Limits of Confidentiality
Identifiability of Data/Access to Medical Records
Confidentiality Not Addressed
Recruitment 10%
Coercion or Undue Influence
Inappropriate Inclusion/Exclusion Criteria
Recruitment Inadequately Addressed
Inappropriate Compensation
Other 7%
Missing/Inadequate Referral Plan
Inadequate Protections for Prisoners
Inadequate Protections for Children
Informing Subjects of Results
Questions about Repositories
Conflict of Interest
758 Total Applications with Human Subjects Concerns
Fiscal Year 2002
Types of Human Subjects Concerns in Order of Prevalence:
Human Subjects Section 25%
Inadequate
Missing
Inadequate Justification for an Exemption
Informed Consent 20%
Inadequate Informed Consent
Parental Permission/Child Assent
Risks to Subjects 19%
Physical Risks
Psychological Risks
Data and Safety Monitoring 15%
Missing DSM Plan
Inadequate DSM Plan
Confidentiality 10%
Other 8%
Inadequate Protections for Children
Inadequate Protections for Prisoners
Inadequate Protections for Pregnant Women, Human Fetuses and Neonates
Conflict of Interest
Recruitment 3%
Coercion or Undue Influence
702 Total Applications with Human Subjects Concerns
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