Basic Information and Frequently Asked Questions

Transcription

1 1 Sheppard Pratt Institutional Review Board Basic Information and Frequently Asked Questions The Sheppard Pratt Institutional Review Board (Sheppard Pratt IRB) has purview over all research activities in the programs of the Sheppard Pratt Health System and all programs and agencies that are within the Sheppard and Enoch Pratt Foundation. Any research activity proposed to be performed at any of these programs must first be approved by the Sheppard Pratt IRB. The Sheppard Pratt IRB committee meets on a regular basis, the third Wednesday of each month, to review research applications. All materials to be reviewed at the monthly meeting must be submitted on IRBNet by 5:00 p.m. on the second Wednesday of the month. A research application may be accepted from any qualified researcher. However, for principal investigators who are not Sheppard Pratt employees, additional requirements apply as noted elsewhere on the website. The Sheppard Pratt IRB is registered with the Department of Health and Human Services and the IRB registration number is The IRB also has a federalwide assurance (FWA), FWA All principal investigators and Sheppard Pratt co-investigators are required to have documented completion of a course in human subjects research protection. One such course that is available free of charge may be found at the following web address: Contacts for the Sheppard Pratt IRB (Please contact via .) o Administrative Contact: Lynn Flanigan, lflanigan@sheppardpratt.org (office) (fax) o Chair: Dr. Faith Dickerson, fdickerson@sheppardpratt.org (Contact via preferred.) o Vice Chair: Gayle Hurt, ghurt@sheppardpratt.org

2 2 Frequently Asked Questions 1. How do I submit a proposal to the Sheppard Pratt IRB? All proposals must be submitted via IRBNet. To submit forms on IRBNet, you must be individually registered on IRBNet. To access the IRBNet website, go to 2. How can I receive more training on IRBNet? Below is a link to training resources which include short, helpful videos. You will need to use the following log-on to access these trainings. User Name = sheppardpratt Password = training 3. What forms and resources are available? You may access forms and resources via the Library in IRBNet. To view the Library, log in to IRBNet and click on the Library button on the left side. 4. I am a non-sheppard Pratt researcher. When I submit a study to IRBNet, what research institution s name should I use? For purposes of your application to the Sheppard Pratt IRB, the research institution will appear as the Sheppard and Enoch Pratt Foundation. Do not list your home institution. 5. I am not sure if my project is a research study that requires review by the Sheppard Pratt IRB. What should I do? Contact Lynn Flanigan at lflanigan@sheppardpratt.org. Sometimes it is not clear if a project is an evaluation study which may not need to be reviewed by the IRB or if it is a research study which does need IRB review. This determination can be made by discussion about the proposed study with Lynn Flanigan. 6. When I am submitting a project to IRBNet for the first time, with whom do I need to share the project and who needs to sign the project in IRBNet? The project must be signed by the PI. For outside researchers, the project must also be shared with and signed by the Sheppard Pratt co-investigator and the Sheppard Pratt site director or designee. 7. How do I submit a modification, renewal report, or other official document about a study which has already been submitted? You must submit a new package within the same IRB project. To do so, go to the initial project, click on Project History then Create New package. Please also refer to the Library in IRBNet for forms and additional resources.

3 3 8. How do I attach an education certificate such as a completion of a human subjects protection course? Certificates should be attached to the individual s profile on IRBNet. To do so, go to User profile for the individual on the top bar of the IRBNet screen and then go to the bottom of screen in the section entitled Training and Credentials. 9. My protocol has been reviewed by the IRB of another institution. Do I still need to have the study reviewed by the Sheppard Pratt IRB in order to perform the study at a Sheppard Pratt site? Yes, all studies at Sheppard Pratt must be reviewed by the Sheppard Pratt IRB even if the study has been approved by another IRB, except under special circumstances. 10. I am not an employee, student, or volunteer at Sheppard Pratt or at a Sheppard Pratt affiliated agency. Can I apply to do a research study at a Sheppard Pratt site? Yes, you may apply. However, a Sheppard Pratt co-investigator is required. As an outside researcher at the time of application, you must sign a research agreement and submit a letter to the IRB from the outside researcher, co-signed by both the site director or designee of the Sheppard Pratt site where the research is to take place and by the Sheppard Pratt coinvestigator. Refer to the Library on IRBNet for a sample Required Co-signed Letter for Outside Researchers. If you are unsure of your status, you may contact Lynn Flanigan at lflanigan@sheppardpratt.org or How long does it take for a Sheppard Pratt IRB review? What if I need to start my study before then? Once the final protocol and all of the necessary materials are received by the Sheppard Pratt IRB, the initial review process can usually be completed in less than one month. If modifications are required additional review may take longer. The IRB meets on the third Wednesday of the month. Materials must be submitted by 5:00pm ET on the second Wednesday of the month to be reviewed that month. Investigators are prohibited from starting a study before it receives approval by the Sheppard Pratt IRB. 12. Is it necessary for research that takes place at Sheppard Pratt affiliates (e.g. psychiatric rehabilitation programs) to be reviewed by the Sheppard Pratt IRB? Yes. The Sheppard Pratt IRB has purview over research conducted at all Sheppard Pratt Health System sites and sites affiliated with the Sheppard and Enoch Pratt Foundation. This includes the psychiatric rehabilitation programs and school programs that are affiliated with Sheppard Pratt. 13. In what format should I submit my protocol document(s)? This information is covered in the resources available in the Library in IRBNet.

4 14. If my protocol has been reviewed by another IRB, can I submit the existing protocol or does Sheppard Pratt have a required format for the protocol? Sheppard Pratt does not necessarily require a specific format for the protocol. However, the protocol should include any specific information, procedures, or risks that apply to participants at Sheppard Pratt sites. Refer to the Library on IRBNet for Protocol Content Requirements and additional resources. 15. In what format should I submit my informed consent document(s)? The information is covered in the Requirements and Policies document available in the Library in IRBNet. 16. If my protocol has been reviewed by another IRB, can I submit the existing approved consent form or does SP require that I have a second separate consent form? Sheppard Pratt does not necessarily require a separate consent form. However, the consent form should include any specific information that applies to participants from Sheppard Pratt sites. At a minimum, this typically includes the following: Reference to the Sheppard sites generally found in a procedures section. For example, a consent that includes the statement, The research will be conducted at the following locations: Location X, Location Y, and Location Z, should include the Sheppard Pratt location(s) in the list. For multisite studies or studies that would require additional travel or coordination of care for participants from Sheppard Pratt sites, any special procedures or risks that apply to participants from the Sheppard Pratt sites. The Sheppard Pratt IRB contact information generally found in a rights section. For example, If you have questions regarding your rights as a research participant, you may contact Dr. Faith Dickerson of the Sheppard Pratt IRB at For multi-site studies you may need to direct the statement to participants from Sheppard Pratt. For example, If you are a participant from Sheppard Pratt and have questions regarding your rights as a research participant, you may contact Dr. Faith Dickerson of the Sheppard Pratt IRB at I would like to review medical records at Sheppard Pratt for a research project. Do I still need to obtain IRB approval? Yes. Studies based on record reviews do require IRB approval. 18. How do I know when my study is due for continuing review? The approval letter will indicate the approval/expiration date. In addition, IRBNet will send reminder s at 45 and 60 days prior to expiration. It is the investigators responsibility to submit materials for continuing review in a timely manner. 19. What is HIPAA and how does it apply to research studies? HIPAA refers to privacy laws that have been enacted by the federal government for clinical practice and which also pertain to research studies. Under the terms of the HIPAA regulations, persons participating in a research study must be informed about the privacy of 4

5 the health information that is being collected in the study. A parallel act (FERPA) applies to school settings. Refer to the Library in IRBNet for the Privacy Waiver application form, if needed, and additional guidance on consent language and privacy requirements. 20. Who can I talk to at Sheppard Pratt about the IRB process and about my study? Your first step is to talk with the IRB administrative contact, Lynn Flanigan at If you need further assistance, you may contact the IRB chair, Dr. Faith Dickerson at fdickerson@sheppardpratt.org. 5