Policies and Guidance

General Topics

• IRB Basics – a general overview of the IRB review process (UPDATED: 1.21.2019)
• IRB Guidance for Certificates of Confidentiality (NEW:  9.6.2022)
• Is IRB Approval Required?
  • Guidance for Oral History Projects (NEW:  7.20.2020)
• Mechanical Turk (MTurk) (NEW:  6.2.2020)
• Participant Recruitment (UPDATED: 9.20.2022)
• PI Eligibility (NEW:  8.16.2022)
• Research Involving Deception
• Requirements for Obtaining Letters of Cooperation/Approval (UPDATED: 5.2.2023)
• State Law Regarding Research Involving Humans
• Student Projects Involving Human Participants (UPDATED: 12.4.2018)
• Vulnerable Populations — Children (NEW:  5.2.2023)
• Vulnerable Populations — Prisoners (UPDATED:  9.8.2022)
• Vulnerable Populations — Subordinates (NEW:  9.6.2022)
• Working Remotely with Human Subjects Research: Privacy and Confidentiality Considerations (UPDATED: 10.20.2020)

Special Situations

• Cloud Storage Change Procedures (NEW: 1.19.2021)

Exempt Research

• Information about Exempt Research  (UPDATED: 1.19.2021)
• Modifications to Exempt Research  (UPDATED: 3.21.2023)
• Informed Consent for Exempt Studies (NEW:  2.2.2021)

Informed Consent

• Consent Process
• Elements of Informed Consent (UPDATED: 1.21.2019)
• Informed Consent Templates (UPDATED: 12.18.2018)
• Retention of Signed Consent Forms (UPDATED: 1.21.2019)
• Waivers or Alterations of Consent (UPDATED: 1.21.2019)

Post-Approval Considerations

• Continuing Review  (UPDATED: 2.19.2019)
• Policy on IRB Review of Noncompliance (UPDATED: 12.21.2021)
• Participant Enrollment and Accrual (UPDATED: 9.5.2017)
• Reporting Adverse Events and Unanticipated Problems (UPDATED: 4.7.2020)
• Study Closure (UPDATED: 8.16.2022)

Guidance for Survey Researchers

• AAPOR Guidance for IRBs and Survey Researchers
• Asking About Gender & Sexuality Guide

Clinical Trials

• ClinicalTrials.gov Registration & Results Reporting (UPDATED: 11.21.2023)
• Good Clinical Practice (GCP) Training
• Guidance on Research Involving FDA-Regulated Investigational Articles (UPDATED: 1.21.2019)
• Special Requirements for Clinical Trials (UPDATED: 11.21.2023)

International Research

Approval from the researcher’s IRB is the minimal 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 links listed below; this section will be updated as new information is obtained.

• International Compilation of Human Research Protections, OHRP’s listing of the laws, regulations and guidelines that govern human subjects research in many countries around the world
• India – Ethical Guidelines for Biomedical Research
• India – Ethical Guidelines for Social Science Research in Health
• Kenya – Procedures and Guidelines for Research Authorization
• Uganda – National Guidelines for Research Involving Humans
• Uganda – Research Registration and Clearance

Other Relevant ISU Policies and Procedures

• PI Eligibility Guidelines
• GDPR:  Compliance with the European Union General Data Protection Regulation – research that collects data about persons located in the European Union is subject to GDPR requirements
• GDPR Notice Template (NEW:  6.19.2020)
• Research Participant Payment Process
• Data Security
  • Data Classification
  • Minimum Security Standards
  • ISU ITS Approved Vendors and Software
• Background Checks for Researchers Conducting Research with Children – background checks are conducted by the Office of Risk Management
• Mass Email Policies and Procedures – includes policies relevant to recruiting research participants at ISU using mass/group email

University Policies

• Human Subjects in Research

Federal 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 Science Foundation:  Human Subjects Protection Information
• National Institute of Standards and Technology:  Additional Requirements for Research involving the National Institute of Standards and Technology (NEW:  12.17.2019)
• 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 (UPDATED:  6.2.2020)
• 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 (NEW: 12.17.2019)
• U.S. Department of Veterans Affairs:  Human Research

2018 Common Rule Changes–Summary Documents

• Changes to Continuing Review Requirements — Summary
• Changes to Exempt Research — Summary
• Changes to Informed Consent — Summary
• Changes to Research Definition — Summary
• Clinical Trials — Summary