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Policies and Guidance

  Version Date
General Research Policies  
Qualifying "Engagement" in Human Subjects Research 02/02/2012
Investigator Responsibilities 04/30/2012
Policy for Approval 02/07/2012
Spectrum Health IRB - Jurisdiction and Authority 02/02/2012
Informed Consent and Legally Authorized Representatives for Research 02/06/2012
Spectrum Health Research Program Overview 02/2012
Human Subjects Research Protection Training Requirements 02/07/2012
COI - Research and Sponsored Programs 08/23/2012
OSP Conflict of Interest Reporting Management Procedures 08/23/2012
Research Conflict of Interest Committee Procedures  08/23/2012
Guidance  
Investigator Manual  04/22/2013
Case Report Guidance 09/09/2011
Humanitarian Use Device (HUD) FAQs 11/08/2013
Re-consenting Participants 08/01/2014
HIPAA & Research FAQs 06/04/2012
Personalized Medicine 12/03/2013
Protecting Patient Privacy in Research 03/30/2015
QI vs. Research Guidance 04/23/2012
Request for FCOI Information 08/24/2012
Recruitment Advertising 05/08/2014
Protocol Deviation Policy Guidance 10/19/2012
Consenting Limited English Proficiency Subjects 03/31/2014

Researcher Tools
Instructions for Encrypting Documents

Human Subjects Research
45 CFR 46 Human Subject Regulations (DHHS)
Good Clinical Practice in FDA – Regulated Clinical Trials
International Conference on Harmonization

Interpretation and Clarification of Regulations
Guidance Documents Listing
FDA Information Sheets for Investigators and IRBs - 1998 Update

Research Ethics
Belmont Report
The World Medical Association (WMA) – Declaration of Helsinki
Nuremberg Code

Government Web sites
DHHS Office for Human Research Protections (OHRP)
DHHS Office of Research Integrity
FDA Center for Drug Evaluation and Research (CDER)
FDA Center for Biologics Evaluation and Research (CBER)
FDA Center for Devices and Radiological Health (CDRH)
FDA: Laws, Regulations, Policies and Procedures for Drug Applications
National Cancer Institute (NCI)