This section is for researchers considering writing and submitting a SBER (social, behavioral, educational research) project. SBER studies represent a broad scope of complexity. SBER researchers have a wide range of experience. You may have been through an IRB review process before, but even though the applicable regulations for human subject protection are the same, the processes used to apply them are different for each IRB.
Examples of SBER studies:
- Evaluation Studies
- Survey Validation (whether or not FDA regulated)
- Interventions or Surveys in Afterschool Programs
- Focus Groups
- Secondary Use of Data
Purpose of this Section:
We could call this section “the guidance for simple studies”, but some simple studies aren’t really simple.* It is the objective of this part of our website to provide guidance, give clarification and help streamline your submission process.
Where to Start:
We will help you through the threshold questions to evaluate if what you are doing:
- Meets the definition of research involving human subjects and, if so;
Assist in determining if your human subjects research requires IRB review, or if it qualifies for an exemption from the IRB review requirement.
We will further help you through several human subjects aspects of study design and consideration to assist you through the IRB review requirements.
Our objective is to successfully navigate you through the review process as quickly as possible, by helping to assure that your submisison is complete and ready for review.
* ASIDE: IRB administrators have one of those instant jokes. Someone will say, “but it’s just a simple study” and everyone will laugh. Simple studies are often the ones with the most problems, generally through omission. With the materials provided here we hope that your simple study will be the one to disprove the rule.