Getting to and through the IRB

Transcription

1 Getting to and through the IRB Mary R. Lynn Assistant Director, Operations, Office of Human Research Ethics Co-Chair, Public Health-Nursing IRB University of North Carolina at Chapel Hill

2 Why are studies reviewed? Protection of human subjects History Linked to Federal funding but here all studies are treated the same It is the right thing to do

3 Which studies are reviewed by IRB? Those studies classified as human subjects research (HSR).

4 Which studies are HSR? Human Subjects --- a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information Research --- a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

5 Is my study HSR? If you will be interacting (directly or indirectly) with a living human being (or their data) for any activity related to research (which includes those aspects some call preparatory to research ) you need to either submit an application to the IRB for approval before the interaction or clarify with the IRB in advance if an IRB application is required.

6 Are all studies that have contact with humans HSR? No, many are Not Human Subjects Research Some examples include many (but not all) secondary analyses of existing data, QI projects, and class projects that are not thesis/project research, among others. The IRB makes determination not the researcher (or for students not the advisor). The online application will screen for NHSR for all studies. If it is NHSR the application will be very short.

7 How to succeed Follow the directions Inconsistencies across various parts of the application is one of the biggest issues in having the opportunity to address concerns after the IRB has reviewed it.

8 And where are the directions? irb.unc.edu One website for all of the campus IRBs (one entry place as well)

9 What will you find there? Application Regulatory documents and other information for researchers Deadlines & meeting dates (Only matter if you have a full board study which few students have) Lots of additional information

10 Where do you start? Start with the online application answer any and all questions you are offered. It is a smart application and should tailor what is asked to the kind of study you are proposing Ask your advisor for help with the application Your consent form will be templated as you complete the application. Once the application is done fill out the individualized aspects of the template. Call us if you still have questions: Can make an appointment with an IRB Coordinator if have more questions.

11 It all starts with selecting School of Nursing as your department

12 Anything Else? Complete the required IRB education at Be sure to print a copy of your certificate you get at the end of the program for safekeeping in case the automatic transfer of your completion record does not work right away. The training database will verify that you have done the required education when you submit your application Be sure your advisor and your advisory committee members who are actively involved in designing your study have also done the required education

13 Do students have additional requirements? Students must have their materials reviewed and co-signed (by certifying when the application is routed) by their faculty advisor who is assuming responsibility with/for the student

14 Speaking of proposals All relevant proposals (1 copy) if one exists must be submitted with the IRB application. This applies to all researchers, whether students or faculty.

15 Types of Review Exempt Expedited Are reviewed by IRB staff/chairs and do not go to the full committee Convened Committee ( Full Board )

16 Are all applications handled in the same time frame? No Exempt and expedited - submit ANYTIME (there are no deadlines that apply), expect feedback in 3-5 days Full board* submit at least 2 weeks before a scheduled meeting (check deadlines), expect feedback within 3 days after the meeting * These are rare for SON students or faculty

17 Feedback? Indeed Rare is the application that makes it through the first time with no issues to be resolved The purpose of the feedback is either to get clarification or the submission has not exactly conformed to the requirements (remember, follow the directions!)

18 What do I do with the feedback? Whine and moan All interactions are online but you can, of course, call with any questions about the feedback Address the issues and resubmit what is asked for in the feedback you receive

19 Within a few days of the resubmission... You will usually receive an approval memo which includes information related to the IRB and it s ongoing role with you and your research study

20 With your approval you ll also have access to... Stamped consent forms and approved flyers, recruitment materials, etc. You must copy or print out the stamped consent forms and use them for the period of time between your approval and the renewal of the study. Other materials that have been approved for use in the study are found online but you can use that copy or one you have already if it is the same

21 Once it s approved, I m on easy street? Usually.. but Exempt studies that remain unchanged will not have any ongoing interaction with the IRB. The only time an exempt study comes back to the IRB is, generally, when a change is made that alters the risk for subjects. All other studies that make any change in the approved application must submit a modification for the change to be approved before it can be implemented

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23 Submitting a modification will allow you access to your application to alter it in line with the proposed changes.

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25 Anything else? Modification any change in the study requires IRB review and approval before being implemented Continuing renewal At least annually Substantive Has specific requirements and is accessed online

26 How will I know when to renew? Your approval (or renewal) will include the date for renewal. The IRB will notify you at least two months in advance of the renewal date and again 30 and 7 days before the expiration date. But it is ultimately your responsibility to have the study renewed on time --- make a note of the renewal date and plan ahead for it.

27 And after I submit the renewal? If it s full board it is reviewed by the whole committee at the next meeting, after which you ll receive feedback changes may be needed so be sure to plan time before your approval expires If it s expedited, you should hear about the renewal in a few days after it is submitted

28 How long must studies stay active? The general rule is as long as there are human subjects to protect. Once a study is in data analysis only and there is no chance you will re-contact the subjects, it is possible that you can close the study.

29 If I close it, can it be reopened? Not really need to submit a new application

30 What about student s studies? Students should close their studies online before they graduate. If they do not do so the faculty advisor will be responsible for the closure. Exempt studies are never really opened since the IRB doesn t maintain contact with those projects. However, an to the IRB when the study has ended helps the IRB with record keeping.

31 Miscellaneous questions Must I submit an IRB application for secondary analysis of another researcher s data? Yes, even if that researcher s IRB approval is current but in submitting the application you will likely be screened to a very short application to complete. There are some exceptions related to identifiablility of the data.

32 If I am doing a secondary analysis and the researcher s IRB approval is not current, does that protocol have to be reopened? No, your online application will be sufficient.

33 I have not received any feedback from the IRB or I have not received my approval memo or I did not get my renewal notice. Check with the IRB to make sure all your contact information (surface mail and addresses) is correct

34 Important contact information Webpage: ohre.unc.edu or irb.unc.edu Phone: Mailing address: CB# 7097, UNC- Chapel Hill, Chapel Hill, NC Location: Building 52 (Trailer near the entrance to the ACC off Mason Farm Road)