Getting Through the IRB Process at ResU

1. Getting Through the IRB Process at ResU

2. Each Resurrection facility has its own IRB. ResU uses the Sts. Mary and Elizabeth Medical Center IRB.

3. The Sts Mary and Elizabeth Medical Center IRB meets once a quarter. IRB packets must be turned into the IRB Office at least 3 weeks prior to the next meeting.

4. The IRB Packet is made up of the following documents: • IRB Application for Expedited Review form • IRB Application for New Projects form • Study proposal and data collection forms • Informed consent forms • HIPAA Waiver form • Conflict of Interest Disclosure form • Certification of Human Subjects Protections Training (for each researcher)

5. IRB Application for Expedited Review form You can apply for expedited review if your study presents no more than minimal risk to subjects and if you are studying individual or group characteristics or behavior. Most studies at ResU fall into this category.

6. Advantages of an Expedited Review • You do not have to appear before the IRB Committee in person. • Your application is reviewed in 2 to 3 weeks.

7. Your study proposal and data collection instruments should follow the New Project Application. You should also include any permissions needed to use the data collection instruments.

8. Consent Forms You must insure that you provide certain protections for the people who participate in your study. • Subjects must have adequate information about the research. • The information must be presented to them in a way they can understand. • They have the right to refuse to participate, or to stop participating once they begin. • They must be protected from negative consequences from refusing to participate.

9. Consent Forms Consent forms must include the following information: • Participants must be informed that the data collected will be used for research purposes. • They must understand exactly which treatments or interventions will be as a part of the research study. • The goals of the study must be communicated. • Participants must be told the type of data that will be collected and how it will be collected. • Participants must be informed of the estimated time commitment involved in participation.

10. Consent Forms (cont.) • Sponsors or funders of the study must be disclosed. • Participants have a right to know how many people will be participating and how they were selected. • They must be informed of potential risks. • Potential benefits should be described. • Any compensation in the form of money or services must be explained. • Participants must be assured that their privacy will be protected.

11. Consent Forms(cont.) • Participants must be assured that their participation is strictly voluntary and that failure to volunteer will not result in any penalty or loss of benefits. • Participants must be told that they have the right to discontinue participation at any time without penalty. • Participants should be given contact information of the researchers.

12. Certification Each researcher involved in the study must complete the Human Subjects Protections Training given by NIH. This training can be accessed at: http://phrp.nihtraining.com/users/login.php Once you complete the training, make a copy of the certificate to attach to the IRB packet and another copy for your files (for the next research project!).

13. If your study will be conducted in a facility other than ResU or Sts Mary and Elizabeth, you must get permission from the IRBs of all facilities that will be involved. Each of the IRBs in Resurrection facilities meet at different times and on difference schedules.

14. RHC IRB Contacts