FAQs - Additional Information and What is Considered Human Subjects Research
Where can I read more on the regulations governing human subject research?
What happens when a non-research activity becomes research?What questions should you ask yourself about what is research?
Where can I read more on the regulations governing human subject research?
You can find a lot of information governing human subject research at the following sites:
- 45 CFR 46:
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html - NIH:
http://www.nih.gov/ - Office of Human Research Protections:
http://www.hhs.gov/ohrp/ - FDA Title 2 I, Part 50:
http://www.access.gpo.gov/nara/cfr/waisidx_00/21cfr50_00.html - FDA Title 21, Part 56:
http://www.access.gpo.gov/nara/cfr/waisidx_00/21cfr56_00.html - FDA Information Sheets:
http://www.fda.gov/oc/ohrt/irbs/
What happens when a non-research activity becomes research?
Research using data collected for non-research purposes requires IRB to determine if the research:
- Is exempt because it already exists, and the sources are publicly available or the information is recorded by the investigator in such a manner that participants cannot be identified, directly or through identifiers linked to the participants;
- May be reviewed using the expedited procedure if risks are minimal;
- Requires full IRB review if data are identifiable and risks cannot be minimized
What questions should you ask yourself about what is research?
Is the activity a routine operation in the setting?
If yes, then it probably isn't research.Do the data gatherers normally have regular and routine contact with the data or the subjects?
If yes, then it probably isn't research.Does the activity require additional procedures?
If no, then it probably isn't research.Does the activity alter the timing or frequency of standard procedures?
If no, then it probably isn't research.Is the responsible agency sponsoring the activity?
If yes, then it probably isn't research.Is the goal of the activity to test a hypothesis or answer a research question?
If yes, then it probably is research.
Is there anything else I should know?
All communication concerning IRB submissions should be submitted directly to the ORS office, and not to individual committee members or to other University of Texas officials. Per federal regulations, 45 CFR 46.112 and 21 CFR 56.112, officials may not approve the research if it has not been approved by an IRB. These regulations prevent University of Texas officials such as the ORS Director, the Institutional Official, and the Vice President of Research from overruling a decision by the IRB.