Institutional Review Board (IRB) at SMU. Dr. Maribeth Kuenzi, Chair Ms. Shannon Lunt, SMU Director of Research Compliance

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1 Institutional Review Board (IRB) at SMU Dr. Maribeth Kuenzi, Chair Ms. Shannon Lunt, SMU Director of Research Compliance

2 Permission granted 11/24/14

3 What does the IRB review? Research involving human subjects Rights, welfare, and wellbeing of human subject participants Risk associated with participation Federal Regulation Compliance

4 What is human subject research? Human subject - living person used or studied as part of research project Research Systematic study or investigation Methods: Surveys Questionnaires Cognitive experiments Analysis of existing data Evaluation of educational programs Observation of individuals or groups Contributes to general knowledge base

5 Does all human subject research YES and NO. need IRB approval? YES, all human subject research has to be submitted for review. NO, if the research is GENERALIZABLE KNOWLEDGE: Classroom exercises solely to fulfill course requirement Shared (i.e. presented) only within the SMU community Not published Oral history (single person) solely for documenting historical events Service or course evaluation Analyses of existing data or biological specimens (with no identifiers) The decision is made by the IRB, not the researcher.

6 Types of IRB Reviews Full Board Expedited More than minimal risk to subjects and/or vulnerable populations Examples: interventions involving emotional or physical distress, sensitive data, power over subjects Minimal risk to subjects Examples: surveys that do not involve protected populations or place subjects at high risk for legal, emotional, or physical harm/distress Exempt No risk to subjects Examples: research with deidentified data, anonymous surveys, program evaluation * Defined by federal regulation 45 CR 46

7 The 4-Step IRB Process Preparation Application Modifications Outcome

8 Step 1: Preparation What type of research will you conduct? ce/irb Contact Shannon Lunt (Director of Research Compliance; DRC) Download your application (probably will be expedited) ce/irb/forms Include additional documents (see next slide)

9 IRB Application Forms/Documents Forms Protocol Application Exempt Expedited/Full Board Documents Informed Consent Parental Consent and/or Assent Site Permission Letters Recruitment Material All documents human subject participants will touch, see, sign, read or be read to them

10 Preparation (cont.) Complete your Citi Training All key researchers MUST complete the training in the ethical use of human participants in research before the IRB application is approved Takes 3-4 hours Do not have to take all at one time

11 Step 2: Application Complete IRB application The application must be signed by principal investigator (PI) OR sent from the of the PI completed IRB application package for initial review to: Receive submission acknowledgement from with assigned study ID number Wait for feedback of initial review from DRC

12 Step 3: Modifications If necessary, receive notification from DRC of modifications that need to be made prior to IRB submission As needed, revise-and-submit any modifications, comments to modifications and/or documents to the DRC **This step cycles until the entire package** is ready for IRB submission.

13 Step 4: Outcome When application package is ready, DRC submits it to the IRB Receive outcome letter Approved (final IRB approval) Approval pending modifications (minor additions/changes required prior to approval) Tabled (study needs extensive work and will not be reviewed until major changes/additions have been made by researcher)

14 When are IRB reviews? For full board application packages, amendments, and continuing reviews: Monthly, first Wednesday at 8:00 am For exempt and expedited new application packages, amendments, and continuing reviews: As needed, throughout the month

15 Summary IRB reviews and approves all human subject research to ensure Federal Regulation Compliance prior to researchers beginning their study. Plan ahead!