Policies & Guidance

Explore our Living Repository for Human Subject Research Policies and Guidance 

General Topics

• Human Subjects in Research–ISU Policy
• IRB Basics – a general overview of the IRB review process
• PI Eligibility
• Requirements for Obtaining Letters of Cooperation/Approval 
• State Law Regarding Research Involving Humans

Is IRB Approval Required?

• Decision Tree 1:  Does Your Project Require IRB Approval?  
• Decision Tree 2:  Research Use of Secondary Data  
• Guidance for Oral History Projects  
• Student Projects Involving Human Participants  

Exempt Research

• Exempt Research
• Modifications to Exempt Research
• Informed Consent for Exempt Studies
• Exempt Review Wizard
• Wizard Eligible Exemptions
• Wizard Verification Form Template

Recruitment and Informed Consent

• Participant Recruitment
• Mass Email Policies and Procedures – ISU policies relevant to recruiting research participants using mass/group email 
• Research Participant Payment Process – ISU Controller’s Department 
• Consent Process
• Elements of Informed Consent
• Informed Consent Templates 
• Retention of Informed Consent Records
• Waivers or Alterations of Consent

Privacy and Confidentiality

• TipSheet — Preventing Reidentification in Study Results
• TipSheet — Privacy During Recruitment, Informed Consent, and Data Collection
• Working Remotely with Human Subjects Research: Privacy and Confidentiality Considerations 
• IRB Guidance for Certificates of Confidentiality
• Cloud Storage Change Procedures
• Data Security — Iowa State Information Technology Security Policies & Guidance
  • Data Classification
  • Minimum Security Standards
  • ISU ITS Approved Vendors and Software
• Reporting Responsibility – ISU policy on reporting suspected violations of policies, regulations, and laws 

Special Topics

• Mechanical Turk (MTurk)
• Research Involving Deception
• AAPOR Guidance for IRBs and Survey Researchers
• Asking About Gender & Sexuality Guide

Vulnerable Populations

• Vulnerable Populations — Children
• Background Checks for Researchers Conducting Research with Children – Office of Risk Management
• Youth on Campus – Office of Risk Management – policies and procedures related to working with children 
• Vulnerable Populations — Prisoners
• Vulnerable Populations — Subordinates 

Data Stewardship

• ISU Research Data Portal – Iowa State resources related to research data 
• ISU Research Data policy  

Post-Approval Considerations

• Modifications
• Continuing Review
• Participant Enrollment and Accrual
• Policy on IRB Review of Noncompliance
• Reporting Adverse Events and Unanticipated Problems 
• Study Closure 

Clinical Trials

• ClinicalTrials.gov Registration & Results Reporting
• Good Clinical Practice (GCP) Training
• Guidance on Research Involving FDA-Regulated Investigational Articles
• Special Requirements for Clinical Trials

International Research

Approval from the researcher’s IRB is the minimum requirement for all international research involving human participants. Many countries also have their own regulations governing this type of research. In addition, some countries require national or local registration or both. Information about some of these requirements can be accessed via the link below. 

• OHRP International Program – a compilation of international laws and regulations relating to human subjects research 
• Global Privacy Law and Data Protection Authority (DPA) Directory – global privacy laws compiled by the International Association of Privacy Professionals 
• GDPR:  Compliance with the European Union General Data Protection Regulation – Iowa State GDPR policy 
• GDPR Notice Template

Federal Regulations and Agency Requirements

• The Belmont Report – Ethical Principles and Guidelines for the Protection of Human Subjects of Research
• 45 CFR 46 – Protection of Human Subjects (The Common Rule)
• Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects
• The Nuremberg Code – Directives for Human Experimentation
• Centers for Disease Control and Prevention:  Human Participant Protection in CDC Research
• Food and Drug Administration Regulations on the Protection of Human Subjects:
  • 21 CFR 50 – Protection of Human Subjects
  • 21 CFR 56 – Institutional Review Boards
  • 21 CFR 812 – Investigational Medical Device Requirements
  • 21 CFR 312 – Investigational Drug Requirements
• National Institutes of Health:  NIH Inclusion Across the Lifespan Policy Information
• National Institutes of Health:  Protection of Human Subjects
• National Institutes of Health:  Certificates of Confidentiality
• National Science Foundation:  Human Subjects Protection Information
• National Institute of Standards and Technology:  Additional Requirements for Research involving the National Institute of Standards and Technology
• U.S. Department of Defense: Instruction 3216.02
• U.S. Department of Education:  Protection of Human Subjects in Research
• U.S. Department of Energy:  Additional Requirements for Research Involving the Department of Energy
• U.S. Department of Justice, National Institute of Justice: Human Subjects and Privacy Protection; NIJ Privacy Certificates
• U.S. Environmental Protection Agency:  Additional Requirements for Research Involving the Environmental Protection Agency
• U.S. Department of Veterans Affairs:  Human Subjects Research Policies and Guidance