What is human subjects research?
For your project to qualify as human subjects research, it must meet the Code of Federal Regulations definitions of both research and human subject:
Research is a systematic investigation designed to develop or contribute to generalizable knowledge.
A human subject is a living individual about whom an investigator conducting research:
Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies or analyzes the information or biospecimens.
Obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens.
For more details (including other pertinent definitions) regarding what human subject research is, see the HRPP's Defining Human Subjects Research webpage.
May I start any research activities before I receive approval from the Brandeis University IRB?
No. You absolutely may not begin any research activities until you have received approval of the Brandeis University Institutional Review Board. This includes recruitment of subjects, data collection, data analysis (including anonymous data) and pilot studies where the investigator plans to use the pilot study data for future research projects.
Note: If you are collaborating with another institution that has received IRB approval, you still may not begin any research-related activities until you have received Brandeis University IRB approval.
What is the difference between anonymous and confidential data?
Anonymous data are recorded in such a way that no identifier of any kind exists which link a subject's research data to that subject. When data is recorded anonymously, not even the investigator can link the subject with the subject's research data.
Confidential data are recorded in such a way that identifiers of some kind do exist which link a subject's research data to that subject. When data are recorded confidentially, the investigator (and/or others) can (or could) identify the subjects, such as through a code and master list that links that code to the subject's identity. This applies even when the code and master list are stored in a secure location, such as encrypted files.
For more information, see the Anonymous vs. Confidential webpage.
Am I allowed to use deception in my human subjects research?
Yes. However, the use of deception must be justifiable — a complete explanation of why deception is required for your research must be included in your protocol. In addition, the use of deception requires additional precautions such as debriefing of the subjects once the participation of the subject or the research project is complete.
For more information regarding the use of deception, see the Deception in Research webpage.
Can my research be retroactively approved by the IRB?
No. Any subject recruitment, data collection, data analysis (including anonymous data) or pilot studies completed before Institutional Review Board approval may not be used for your project.
What should I do if my research involves rDNA, biological materials (e.g. infectious agents, allergens, blood, fluids, tissues or cell lines from humans or animals), or other potentially hazardous agents?
If your research involves any of these, it will require approval from the Institutional Biosafety Committee before you can submit it for Institutional Review Board review. For more information regarding the IBC and its procedures and processes, see the IBC website. Be sure to give yourself enough time for your application to go through both committees before your research will begin.
What should I do if my research involves animals?
If your research involves animals, it will require approval from the Institutional Animal Care and Use Committee. For more information regarding the IACUC and its procedures and processes, contact the IACUC office. Be sure to give yourself enough time for your application to go through both committees before your research will begin.
- About the HRPP: The Basics
- Student Researchers
- Working With Special Populations
- Special Topics
- Forms and Instructions
- Guidelines, Policies and Regulations
- Data Management and Protection
- Required Training
- Glossary of Terms
- Frequently Asked Questions
- Contact Us
Still Have Questions?
- Lara Kuhn, Director of Research Integrity and Compliance.
- Gail Goldman, Senior Research Integrity Administrator.
- Eric Taft, Research Integrity Administrator.
- Kevin Dardik, Research Integrity Administrator.
Human Research Protection Program
Bernstein-Marcus 2nd floor, MS 116
415 South Street
Waltham, MA 02453