KUMC Policies |
Revised |
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PDF |
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SOP
1.0 HSC Authority and Institutional Commitment |
June 2007 |
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SOP
2.0 Initial Review Procedures |
June 2007 | |
SOP
3.0 HSC Relation to Other KUMC Committees |
June 2007 |
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SOP
4.0 Privacy and Confidentiality |
December 2006 | |
SOP
5.0 Reviews of Ongoing Research |
June 2007 | |
SOP
6.0 Continuing Review Procedures |
June 2007 | |
SOP 7.0 Informed Consent Requirements |
December 2006 | |
SOP
8.0 Selection and Recruitment of Subjects |
December 2006 | |
SOP
9.0 Vulnerable Populations |
June 2007 | |
SOP
10.0 Research with Human Biologic Material |
December 2006 |
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SOP
11.0 FDA-Regulated Research |
September 2007 | |
SOP
12.0 Social and Behavioral Research |
December 2006 | |
SOP
13.0 Collaborative Research |
December 2006 | |
SOP
14.0 Investigator Responsibilities |
June 2007 |
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SOP
15.0 Education and Training in Human Research
Protections |
December 2006 | |
SOP 17.0 Institutional Responsibilities | June 2007 |  |
Research
Records Retention Policy |
January 2008 |
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Policy
on Research with Coded or De-identified Data/Specimens |
11/01/2004 |
Federal Regulations and Guidelines |
DHHS
Protection of Human Subjects (The Common Rule) 45 CFR 46 |
| FDA
Regulations on Protection of Human Subjects 21 CFR 50 |
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| FDA
Regulations on Institutional Review Boards 21 CFR 56 |
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| FDA
Regulations on Investigational New Drugs 21 CFR 312 |
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| FDA
Regulations on Investigational Device Exemptions 21 CFR 812 |
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| FDA
Regulations on Financial Disclosure by Clinical Investigators
21 CFR 54 |
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| Federal
Wide Assurance |
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| OHRP
Guidebook |
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| FDA
Instruction Sheets |
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| OHRP International Compilation of Human Subject Research Protections | ||
KUMC Wichita | Research Institute | Research Advisory Council
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The University of Kansas Medical Center