Quick links about human research
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- What is human research?
- Who may be a principal investigator for human research?
- What training do researchers need to conduct human research?
- What financial interests do researchers need to disclose to conduct human research?
- What other approvals are required before initiating human research?
- How do I submit new human research to the IRB?
- When can investigators submit research to an external IRB?
- How do I write an investigator protocol?
- What is community based participatory research?
- How do I create consent or assent documents?
- Should I obtain a certificate of confidentiality for my research?
- Does my funded project qualify for a “Delayed Onset Determination”?
- Is the primary awardee of federal funds always “engaged” when the project includes human research?
Research with Children
- When is written parental permission required for research with minors?
- What else do I need to know when conducting research with minors in an educational setting?
Research with Genetic Information
- How do I conduct research using genetic information?
- How do I obtain institutional certification for submission of genomic data to an NIH-designated data repository?
Student/Classroom Research Projects
- Do I need IRB review for Texas A&M classroom-based research projects conducted by students?
- Do I need IRB review for Texas A&M classroom-based research projects conducted by faculty?
- Do I need a FDA IND for research with approved drugs, biologics, or dietary supplements?
- Do I need a FDA IDE for use of an investigational or approved device in humans?
- When should I register my research with Clinical Trials.gov?
- How do I obtain informed consent from participants?
- Do research participants have to sign a consent document?
- How do I document consent or assent?
- How do I obtain a waiver of alteration of informed consent?
- When is it permissible to use the short form written consent process?
- Is a certificate of translation required for a consent document written in another language?
- 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?
- How do I de-identify Protected Health Information (PHI) under the privacy rule?
- How do I obtain an authorization for research uses and disclosures of PHI?
- Is a waiver of HIPAA authorization appropriate for my research?
- What is a limited data set and data use agreement?
- What are the different regulatory classifications that research activities may fall under?
- What are the decisions the IRB can make when reviewing proposed research?
- How does the IRB decide whether to approve human research?
- What will happen after IRB review?
- What are my obligations as an Investigator in order to conduct human research?
- What new information Items need to be promptly reported to the IRB?
- How do I submit a modification (amendment)?
- How do I submit a continuing review?
- How do I close out a study?
- How long do I keep records?
Federal Agency Specific Requirements
- Additional requirements for DHHS-Regulated Research
- Additional requirements for FDA-Regulated Research
- Additional requirements for Clinical Trials (ICH-GCP)
- Additional requirements for Department of Defense (DOD) Research
- Additional requirements for Department of Energy (DOE) Research
- Additional requirements for Department of Justice (DOJ) Research
- Additional requirements for DOJ research conducted in the Federal Bureau of Prisons
- Additional requirements for DOJ research funded by the National Institute of Justice
- Additional requirements for Department of Education (ED) Research
- Additional requirements for Environmental Protection Agency (EPA) Research