Preamble - Overviews - Applications - Modifications - Approach, Recruitment, and Informed Consent - Reviewer Resources - Staff Resources - UWise
Miscellaneous old informational materials

Special Topics
E-mail, the Web, and Research International IRBs - OHRP FAQs - Performance sites engaged in research - Retention Requirements - web-based recruitment -

Overviews
• The Human Subjects Manual, with a somewhat analytic table of contents that allows one to jump directly to a desired section.
• Clinical Trials Handbook

Applications and the application process

• Application forms
• 310 form
• Application numbers and what they used to mean:
  a note of purely historical interest

Modifications and the modification process

• Modification form
• Modifications: how and why

Approach, Recruitment and Informed Consent
Informed consent is not a matter of signing a piece of paper. The whole process of approaching and recruiting potential subjects is an integral part of informing them about the study; the actual consent form is simply a formal documentation (in general, mandated by Federal regulations) of the completion of the consent process. This is why it is inaccurate to call the consent form an "informed consent", and unnecessarily verbose to call it an "informed consent form". This is also why it is very important that the information presented during approach and recruitment be clear, accurate and consistent.
• approach and recruitment using the web
• Confidentiality Agreements and research use of information in private records without consent
• Consent form issues
• Investigator signature requirements
• Retention requirements
  
• Tips on Consent Forms from OHRP
see the two entries under "Consent Forms for Research"
• Who should be listed as an investigator on a consent form?
• HIPAA: Authorization, Waiver of Authorization, and general overview

Resources for reviewers:
An inchoate page for reviewers of applications reviewed as involving "behavioral research"; currently this is limited to pointers to special regulatory requirements for research involving children or prisoners, and a planned section on UWise tips and pointers.

Resources for staff:
An inchoate page of resources for staff supporting the behavioral review committees, currently including a gradually increasing autotext archive, and a pointer to a source for IRB registration numbers.

Special Topics

• E-mail, the Web and Research
• International IRBs
• International Research Regulations
  84 countries, 900 laws: one pdf document
• OHRP FAQs
• Performance Sites
  A site where research is performed.
  Department of Health and Human Services (HHS) regulations at 45 CFR 46.103(a) require that each institution "engaged" in human subjects research provide OPRR with a satisfactory Assurance to comply with the regulations, unless the research is exempt under 45 CFR 46.101(b).
• Retention requirements
  These can vary depending on the funding agency, relevant law, and other considerations. The General Records Retention Schedule for the UW lists University of Washington requirements, which vary according to type of document (e.g., the requirements for Certificates of exemption differ from those for consent forms, which in turn differ from those for human subjects applictions).
• web-based recruitment: although, in general, the issues are the same as for all forms of recruitment, certain features of the web may affect the way the material is publish ed.

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