School of Medicine

Policies and Guidelines

Wayne State University and the WSU School of Medicine provide several levels of oversight for the conduct of biomedical research but ultimately the Principal Investigator is responsible for adherence to all applicable institutional, state, federal, and agency guidelines. This responsibility should not be undertaken lightly. The SOM Office of Research staff are available to provide assistance whenever a research-related question arises.

INSTITUTIONAL POLICIES and GUIDELINES

SOM Space Policy
WSU Fringe Benefits and Indirect Cost Rates
WSU Pre and Post Award Policies and Procedures
Policies and Procedures for Scientific Misconduct

FEDERAL POLICIES and GUIDELINES

OMB A-21 Regulations on Direct Charges
PHS Grants Policy Statement

National Science Foundation

General Policy Guidance
http://www.nsf.gov/bfa/cpo/gpm95/start.htm
NSF Grants Proposal Guide
NSF GC-1 General Conditions (4/01)

National Institutes of Health (DHHS/PHS)

NIH Grants Policy Statement (3/1/01)
PHS Grants Policy Statement (GPS)
OER Grants: Extramural Policy Notices
HHS Grant Regulations - Title 45 CFR
HHS Grants Administration Manual (GAM)
HHS Grants Policy Directives (GPDs)
HHS Other Grants Resources
Office of Laboratory Animal Welfare
Office for Human Research Protections
HHS Office of Research Integrity
Human Genome Project Intellectual Property Guidance
NIH Model Agreements from Office of Techonology Transfer

Regulatory Affairs and Compliance Links

FDA Guidance for Institutional Review Boards and Clinical Investigators
FDA Drug Approval Application Process
FDA Forms Download Site
FDA Form 1571 "Investigational New Drug Application" (pdf format)
FDA Form 1572 "Statement of Investigator" (pdf format)
Instructions for Completing FDA Forms 1571 and 1572
Link to search engine for Code of Federal Regulations (CFR)
FDA Modernization Act of 1997
FDA Guidance - Financial Disclosure by Clinical Investigators
FDA Overview of federal regulations for clinical investigators
FDA Draft Guidance Regarding Clinical Holds (pdf format)
FDA CBER Organizational Chart (pdf format)
FDA CDER Organizational Chart
FDA/ORA Bioresearch Monitoring Guidelines
Center for Drug Evaluation and Research (CDER) Regulatory Information
Submitting an Investigational New Drug (IND) Application for a biological product