HRPP Investigator Manual
Frequently Asked Questions
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Getting Started
- What is human research?
Page 5
- Who may be a principal investigator for human research?
Page 5
- What training do researchers need to conduct human research?
Page 6
- What financial interests do researchers need to disclose to conduct human research?
Page 8
- What other approvals are required before initiating human research?
Page 8
- How do I submit new human research to the IRB?
Page 9
- When can investigators submit research to an external IRB?
Page 10
- How do I write an investigator protocol?
Page 10
- How do I create consent or assent documents?
Page 11
- Should I obtain a certificate of confidentiality for my research?
Page 24
- What is community based participatory research?
Page 28
Funding
Research with Children
Research with Genetic Information
Student/Classroom Research Projects
Clinical Research
Recruitment
Consent Information
- How do I obtain informed consent from participants?
Page 20
- Do research participants have to sign a consent document?
Page 21
- How do I document consent or assent?
Page 21
- How do I obtain a waiver of alteration of informed consent?
- When is it permissible to use the short form written consent process?
Page 19
- Is a certificate of translation required for a consent document written in another language?
Page 25
- Tips for writing consent forms
Protected Health Information
- How can I use or disclose Protected Health Information (PHI) for research and comply with the privacy rule?
Page 32
- How do I de-identify Protected Health Information (PHI) under the privacy rule?
Page 20
- How do I obtain an authorization for research uses and disclosures of PHI?
Page 32
- Is a waiver of HIPAA authorization appropriate for my research?
Page 32
- What is a limited data set and data use agreement?
Page 32
Review Process
Ongoing Requirements
- What are my obligations as an Investigator in order to conduct human research?
Page 14
- What new information Items need to be promptly reported to the IRB?
Page 15
- How do I submit a modification (amendment)?
Page 18
- How do I submit a continuing review?
Page 19
- How do I close out a study?
Page 19
- How long do I keep records?
Page 20
Federal Agency Specific Requirements
- Additional requirements for DHHS-Regulated Research
Page 33
- Additional requirements for FDA-Regulated Research
Page 35
- Additional requirements for Clinical Trials (ICH-GCP)
Page 41
- Additional requirements for Department of Defense (DOD) Research
Page 49
- Additional requirements for Department of Energy (DOE) Research
Page 51
- Additional requirements for Department of Justice (DOJ) Research
Page 53
- Additional requirements for DOJ research conducted in the Federal Bureau of Prisons
Page 53
- Additional requirements for DOJ research funded by the National Institute of Justice
Page 55
- Additional requirements for Department of Education (ED) Research
Page 56
- Additional requirements for Environmental Protection Agency (EPA) Research
Page 57