Dr. Cheryl Peters, Evaluation Specialist

cpeters@anr.msu.edu

UNDERSTANDING THE IRB PROCESS

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?

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 #1

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 #2

Does the research involve intervention or interaction

with the individuals?

If yes, an IRB application is warranted.

IS IT RESEARCH? QUESTION #3

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).

3 QUESTIONS = 3 YES

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.

EXEMPT, BECAUSE….

Most Extension program evaluation is approved by the IRB under the exempt category & can waive collecting a signed informed consent document.

WAIVED 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/

INFORMED CONSENT

Exempt is still a type of IRB approval.Expedited and Full Board, VERY RARE.

IRB website: humanresearch.msu.edu

Form descriptions

Reference documents/ Forms

TYPES OF IRB APPROVAL

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

PI STATUS

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/requiredtraining.html

REQUIRED IRB TRAINING

Investigator LoginFaculty/Staff need Z-PID

ONLINE IRB APPLICATIONS ONLY

TitleReview category

ResourcesResearch sites

Project description and procedures (200 words)

WHAT YOU WILL NEED READY

Subject population characteristicsSubject risks

Subject privacy/confidentialityConflict of interest

TimelineConsent document (possibly)

Survey instrument (or questions)

WHAT YOU WILL NEED READY

Program Evaluation vs. Research.Intend to Publish Externally.Have your project stabilized and well-described before seeking application.Sometimes a call or email will help flesh out the “three questions”.Sometimes funders “want” IRB.

LAST THOUGHTS