Human Subjects SOPs

SOPs on this page supersede all previous policies, procedures, and guidance documents.

1. ORIA and IRB administration

1.1.   General

1.1.1.    Definitions

1.1.2.    Training

1.1.3.    Conflicts of Interest – In Development

1.1.4     Communication

1.2.   Discipline/ Study Type Specific Policies

1.2.1.      Histories and Journalism

1.2.2.      Drug and device studies

1.2.3.      Existing Data

1.2.4.      Biobanking and specimen/data repositories

1.3.   Special Research Circumstances

1.3.2.      International Research

1.3.3.      Research in Schools – In Development

1.3.4.      Certificate of Confidentiality and Privacy Certificates

1.3.5.      Classroom projects

1.3.6       Collaborative Research

1.3.7.      Research conducted on GMU campus by outside entities

1.3.8.      Deception

1.3.9        Department of Defense research

1.4.   Special Populations and Sensitive Topics

1.4.1.      Research Involving Children – In Development

1.4.2.      Research Involving Fetuses, Pregnant Women, in vitro fertilization and dead fetuses, fetal material, and placentas – In Development

1.4.3.      Research involving prisoners – In Development

1.4.4.      Research involving other vulnerable population – In Development

1.4.5.      College Students as Research Participants

1.4.6.      Research involving sensitive topics (including illegal behavior) – In Development

1.5.   Non-compliance and complaints

1.5.1.      Noncompliance and deviations

1.5.2.      Research participant complaints

1.5.3.      Suspension/termination of IRB review

1.6.   IRB administrative procedures

1.6.1.      Full Board meeting

1.6.2.      IRB minute taking and storage of minutes

2.  Protocol submission and review

2.1.   General

2.1.1.      Types of RDIA/IRB decisions

2.1.2.     Study intake and triage

2.1.3.      Verification of no material changes from other sources

2.1.4      Reliance agreements

2.2.   Informed Consent

2.2.1.      Informed consent, assent, parental permission, and documentation

2.2.2.      Waivers of informed consent and waivers of documentation of informed consent

2.3.   Participant Recruitment

2.3.1.      Recruitment

2.3.2.      Providing incentives to participants

2.4.   Application Submission Procedures

2.4.1.      Submitting a human subjects research project for review

2.5.   Review Procedures

2.5.1.      Full Board Review

2.5.2.     Expedited and Exempt Review

2.5.3.      Non-human subjects research review procedures

2.6.   Post Review Procedures

2.6.1.      Continuing Review

2.6.2.     Project Completion/Project Close-Out

2.6.3.      Appeals of an IRB Decision

2.6.4.      Modifications/Amendments

2.6.5.      Unanticipated Problem/Adverse Event Reporting

2.6.6.      Post-Approval Monitoring and Education Visits

 

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