Policies and Guidelines

The Investigator Manual (HRP-103) is the resource for investigators who need information regarding IRB policies and the responsibilities of investigators.  

Click here to access the Investigator Manual

Standard Operating Procedures

To Access Standard Operating Procedures for the IRB:

1. Go to CATS-IRB
2. Log in with your Penn State Access Account Username and Password
3. Click on "IRB" (below the CATS logo in the upper left-hand side of page)
4. Click on "Library" (left margin)

5. You will now be within the "Standard Operating Procedures" tab

Guidelines

• IRB Guideline I - Parental Consent and Child Assent 
• IRB Guideline II - International Research Involving Human Participants 
• IRB Guideline V - Research Using Penn State Students as Participants 
• IRB Guideline X - Guidelines for Computer- and Internet-Based Research Involving Human Participants 

• IRB Guideline XI - Research Involving Audio, Video or Digital Recordings of Research Participants 

FERPA and HIPAA Information

• FERPA Information

• HIPAA Information

Penn State Policies

• AD22 - Health Insurance Portability and Accountability Act (HIPAA) 
• AD51 - Use of Outdoor Areas for Expressive Activities 
• AD56 - Use of Group Communication Tools to Communicate University Business to Employees and Students 
• RPG03 - Payments to Human Participants in Research 
• RP03 - The Use of Human Participants in Research 
• RP06 - Disclosure and Management of Significant Financial Interests 

• RP07 - HIPAA and Research at Penn State 

Federal Policies

• APA Ethical Principles of Psychologists and Code of Conduct 
• Code of Federal Regulations - Title 45 CFR Part 46 
• Code of Federal Regulations - Title 21 CFR Part 50 
• Code of Federal Regulations - Title 21 CFR Part 56 
• Code of Federal Regulations - Title 21 CFR Part 312 
• Code of Federal Regulations - Title 21 CFR Part 600 
• Code of Federal Regulations - Title 21 CFR Part 812 
• Declaration of Helsinki 
• FDA Guidance for IRBs and Clinical Investigators 
• NIH - Certificates of Confidentiality Kiosk 
• NIH FAQs Regarding Human Participant Research 
• NIH Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials 
• NIH Policy - Required Education in the Protection of Human Research Participants 
• NIH Policy for Data and Safety Monitoring 
• Office for Human Research Protections (OHRP) - Policy Guidance 
• OHRP 2016 International Compilation of Human Research Standards 
• OHRP IRB Guidebook 
• The Belmont Report 
• The Nuremberg Code