Human Research Protection Program

Your project qualifies as human subject research if it meets the Office of Human Research Protection's definitions for both research and human subjects:

• Research: A systematic investigation designed to develop or contribute to generalizable knowledge.
• Human subject: 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, analyzes or generates identifiable private information or identifiable biospecimens.

For details (including other pertinent definitions) regarding what human subject research is, see the HRPP's Defining Human Subjects Research webpage.

Your project requires IRB approval if it meets both of the following conditions:

1. It is being conducted under the auspices of Brandeis University.

2. It meets the Federal Regulations definitions of both research and human subjects:

   • Research: A systematic investigation designed to develop or contribute to generalizable knowledge.
   • Human subject: 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, analyzes or generates identifiable private information or identifiable biospecimens.

For details (including other pertinent definitions) regarding what human subject research is, see the Defining Human Subjects Research webpage.

Yes. All human subject research conducted at Brandeis University or by Brandeis University representatives (faculty, staff, postdoctoral fellows or students) must be reviewed by the Brandeis University Institutional Review Board. 

Yes. All human subject research conducted at Brandeis University or by Brandeis University representatives (faculty, staff, postdoctoral fellows or students) must be reviewed by the Brandeis University Institutional Review Board. 

Generally speaking, class assignments (excepting dissertations and master's or honors theses) will not meet the definition of human subject research. If the data collected will not be shared outside of class, Institutional Review Board review is not necessary.

Note that this data may at no time be presented or published outside of the class and that IRB approval is never retroactive. If a student hopes to present his/her findings in, for example, a poster session, s/he will need to have IRB approval before beginning the research project. 

Yes. It is generally assumed that theses and dissertations will meet the Federal Regulations definition of research ("a systematic investigation designed to develop or contribute to generalizable knowledge") and, as such, will require Institutional Review Board approval. 

Yes. A survey is an example of an intervention or interaction. 

It may, if your research involves an intervention or interaction with the subjects. For help in determining whether your project is human subjects research requiring IRB review, see the HRPP's IRB Review Determination Tree (pdf). If still in doubt, contact the IRB administrator for help. 

It may, if the identities of the human subjects can be ascertained in the data, documents, records or pathological specimens you receive (regardless of whether you record the data in such a way that the identities of the subjects can not be ascertained).

If the data you receive has been stripped of all identifying information prior to your receiving it and you have no way of re-identifying the information, it does not qualify as human subject research and does not require IRB approval.

For help in determining whether your project is human subjects research requiring IRB review, see the HRPP's IRB Review Determination Tree (pdf). If still in doubt, contact the IRB administrator for help.

Generally speaking, when an investigator engages in human subject research, Institutional Review Board approval is required from that investigator's institution, regardless of where the research takes place. However, if the investigator is collaborating with a colleague from another institution, either IRB may, in certain situations, cede review and approval to the collaborating institution. In this case, an institutional authorization agreement may be arranged to establish one IRB as the designated IRB of record. 

Yes. When an investigator engages in human subject research, Institutional Review Board approval is required from that investigator's institution, regardless of where the research takes place. Note that your research may require IRB approval from the IRB (or its local equivalent) used by the international site in addition to Brandeis University's IRB approval. For details on conducting international research, see the HRPP's International Research webpage. 

No. Investigators may not make the determination that their own research is exempt — only a qualified HRPP staff member can make the determination that research is exempt from IRB review. Investigators engaged in human subjects research that qualifies for exempt status must complete an initial research protocol (as well as a modification request, when appropriate, and a termination and final report at the conclusion of their research). For an explanation of exempt categories, see the HRPP’s Research Review Categories webpage.