UNDERSTANDING THE IRB PROCESS Dr. Cheryl Peters, Evaluation Specialist firstname.lastname@example.org IS IT RESEARCH? Does our Extension project require IRB review? 3 Questions IS IT RESEARCH? MSUE IRB differentiates between program evaluation (with intent to inform or improve program implementation), quality assurance or quality improvement (is the program implemented as intended and with fidelity) and research. IS IT RESEARCH? QUESTION #1 Is the activity a systematic investigation designed to develop or contribute to generalizable knowledge? If yes, the activity is defined as research. Next question to consider: IS IT RESEARCH? QUESTION #1 • • • • Generalizable knowledge? Contributes to theoretical framework Primary beneficiaries are other researchers/filed practitioners Publications, presentations intended for professional purpose Results intended for replication IS IT RESEARCH? QUESTION #2 Does the research involve obtaining information about living individuals? If yes, the research involves human subjects. Next question to consider: IS IT RESEARCH? QUESTION #2 • • • • Living individuals? A human subject Data through investigation or interaction with the individual Identifiable private information De-identified data may not require IRB review IS IT RESEARCH? QUESTION #3 Does the research involve intervention or interaction with the individuals? If yes, an IRB application is warranted. 3 QUESTIONS = 3 YES If yes, an IRB application is warranted. Most Extension program evaluations fall under the category of exempt because the evaluation plan involves research conducted in established or commonly accepted educational settings, involving normal education practices (use of surveys, interviews, observations, or tests). EXEMPT, BECAUSE…. Presents minimal risk. Often the consent document would be the only record linking the subject and the research. Note: Keeping your Extension survey voluntary and confidential can support the allowance of waived consent. WAIVED CONSENT Most Extension program evaluation is approved by the IRB under the exempt category & can waive collecting a signed informed consent document. INFORMED CONSENT All Extension program evaluations should include the elements of voluntary involvement, confidentiality, and notifying participants regarding the intent of the research or evaluation. The consent process should be informative and empowering. Templates of consent forms are available on the MSU IRB website. http://www.humanresearch.msu.edu/ TYPES OF IRB APPROVAL Exempt is still a type of IRB approval. Expedited and Full Board, VERY RARE. IRB website: humanresearch.msu.edu Form descriptions Reference documents/ Forms PI STATUS Updated March 2012 • • • If Masters degree – no longer require special permission If do not currently hold a Master’s or higher-level degree, special permission still required for PI status before beginning work on a grant or project If Ph.D. research, must apply through Faculty Advisor REQUIRED IRB TRAINING Individuals listed on an IRB proposal as PI, or staff assisting in the collection of data, are required to have IRB training. The IRB training is online and has a test. Once you complete the training, it is good for 2 years. Instructions and links for the required IRB training are here: http://www.humanresearch.msu.edu/require dtraining.html ONLINE IRB APPLICATIONS ONLY Investigator Login Faculty/Staff need Z-PID WHAT YOU WILL NEED READY Title Review category Resources Research sites Project description and procedures (200 words) WHAT YOU WILL NEED READY Subject population characteristics Subject risks Subject privacy/confidentiality Conflict of interest Timeline Consent document (possibly) Survey instrument (or questions) LAST THOUGHTS Program Evaluation vs. Research. Intend to Publish Externally. Have your project stabilized and welldescribed before seeking application. Sometimes a call or email will help flesh out the “three questions”. Sometimes funders “want” IRB.