Forms/Instructions/Guidelines/ Other Materials | Last Updated | Description/Comments |
| Application forms |
| Application for HUD Review |
March 2004 |
Request for approval of a Humanitarian Use Device protocol |
| Application for New Protocol Review |
January 2008 |
Application for full, expedited and exempt protocol submissions |
| Consent forms |
| Consent Form Template and Guidelines |
December 2005 |
Consent form template, guidelines and requirements |
| Consenting Tips |
December 2006 |
AHC IRB consenting help sheet |
| HIPAA forms, instructions & guidelines |
| HIPAA Authorization |
April 2003 |
Advocate HIPAA Authorization form for research |
| HIPAA Authorization, Arabic |
HIPAA Authorization translation into Arabic |
| HIPAA Authorization, Polish |
HIPAA Authorization translation into Polish |
| HIPAA Authorization, Russian |
HIPAA Authorization translation into Russian |
| HIPAA Authorization, Spanish |
HIPAA Authorization translation into Spanish |
| HIPAA Waiver |
Advocate HIPAA Waiver request form for research |
| HIPAA Waiver Instructions |
October 2006 |
Information Sheet HIPAA Waiver instructions |
| Other forms |
| Adverse Event Report |
June 2005 |
All local and non-local adverse events on active protocols have to be submitted with this completed form |
| Amendment Report |
June 2002 |
All amendments to active protocols, consents, and other protocol-related documents have to be submitted with this completed form |
| Continuing Review Report |
June 2002 |
Continuing review should be submitted at least 3 weeks before the study approval expiration date |
| Deviation/Violation Report |
June 2002 |
All deviation/violations on active protocols have to be submitted with the completed form |
| AHC IRB policies & guidelines |
| Advertising & Recruiting Research Subjects |
October 2006 |
Information Sheeet on OHRP and FDA policy and guidelines on advertising and recruiting study subjects |
| Application & Protocol Status Terminology |
October 2006 |
Information Sheet on the AHC IRB application and protocol status terminology |
| HIPAA & PHI Overview |
October 2006 |
Information Sheet on federal HIPAA and PHI requirements |
| Policies & Procedures |
June 2001 |
AHC IRB Policies & Procedures (74 pages) |
| QA/QI & Research |
October 2006 |
Information Sheet on determining whether a project is human subject research or a Quality Assurance (QA), or Quality Improvement (QI) activity |
| Term "Experiment(al)" in Human Subject Research |
October 2006 |
Information Sheet on avoiding the use of the term "experiment(al)" in human subject research |
| Other documents |
| AHC IRB Brochure |
October 2006 |
Summary information on the AHC IRB |
| AHC IRB Meeting Schedule-2008 |
January 2008 |
2008 IRB meeting schedule and submisson deadlines |
| NCI Central IRB Process |
October 2003 |
NCI Central IRB initiative and process |