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
FDA
Information for Sponsor-Investigators Submitting IND's
FDA's Pre-IND Consultation
Program
Link to search
engine for FDA Guidance Documents
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FDA Draft
Guidance Regarding Clinical Holds (pdf format)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
| 
Graduate
Programs
