FAQ
Quick links about human research
Links are page specific. Linkage to the specific pages of the Investigator Manual work best with Internet Explorer or Chrome. If you are using Microsoft Edge you will have to scroll to the desired section of the manual until the issue is resolved. The page number for each topic is indicated in the URL of each question.
Getting Started
- 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?
Funding
- 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?
Clinical Research
- 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?
Recruitment
- What is an appropriate recruitment method?
- How do I get my studies posted on the Aggie Research Volunteers Recruitment Website?
Consent Information
- 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?
Review Process
- 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?
Ongoing Requirements
- 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