ACH/ACHRI Policies and Procedures

ACH policies: via My ACH at http://webapps/vault/SearchPage.asp?Action=Search ACHRI policies: http://achri.archildrens.org/resources/policies.htm

Common Rule (U.S. Code of Federal Regulations Title 45 Part 46):

available via http://www.gpoaccess.gov/cfr/index.html Type in “45CFR46” (without the quotes) in the “Most Current Data” box and click on submit. After retrieval, scroll to bottom of page and click on the “txt” link under 45CFR46-- PART 46_PROTECTION OF HUMAN SUBJECTS

UAMS IRB

IRB main page: http://www.uams.edu/irb/IRB.asp

FDA Regulations

All Studies

Informed consents (all studies) : via GPO access at http://www.gpoaccess.gov/cfr/index.html Type in “21CFR50” (without the quotes) in the “Most Current Data” box and click on submit. After retrieval, scroll to bottom of page and click on the “txt” link under 21CFR50-- PART 50_PROTECTION OF HUMAN SUBJECTS

IRB (all studies) : via GPO access at http://www.gpoaccess.gov/cfr/index.html Type in “21CFR56” (without the quotes) in the “Most Current Data” box and click on submit. After retrieval, scroll to bottom of page and click on the “txt” link under 21CFR56-- PART 56_INSTITUTIONAL REVIEW BOARDS

Electronic Records and Electronic Signatures: via GPO access at http://www.gpoaccess.gov/cfr/index.html Type in “21CFR11” (without the quotes) in the “Most Current Data” box and click on submit. After retrieval, scroll to bottom of page and click on the “txt” link under 21CFR11-- PART 11_ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

Drug Studies

IND (Investigational New Drug Application) : via GPO access at http://www.gpoaccess.gov/cfr/index.html Type in “21CFR312” (without the quotes) in the “Most Current Data” box and click on submit. After retrieval, scroll to bottom of page and click on the “txt” link under 21CFR312-- PART 312_INVESTIGATIONAL NEW DRUG APPLICATION

Financial Disclosure : via GPO access at http://www.gpoaccess.gov/cfr/index.html Type in “21CFR54” (without the quotes) in the “Most Current Data” box and click on submit. After retrieval, scroll to bottom of page and click on the “txt” link under 21CFR54-- PART 54_FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS