submitting irb applications (or “do i have to do an irb?”) linda a. detman, ph.d. research...
TRANSCRIPT
1
Submitting IRB Applications (or “Do I have to do an IRB?”)
Linda A. Detman, Ph.D.Research Associate
Lawton & Rhea Chiles Center for Healthy Mothers and BabiesFlorida Perinatal Quality Collaborative
2
Have you completed training in the protection of human subjects?
3
Have you completed training on HIPAA?
Health Insurance Portability and Accountability Act of 1996
Access training module at https://learn.health.usf.edu
4
Have you ever submitted an IRB application?
5
Agenda
• Overview of research and when you need IRB review
• Types of IRB reviews• Tips for submitting your IRB application• Resources• Questions
6
What is Research?
Per Federal regulations research is defined as the systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge
7
What is Systematic Investigation?
An activity that involves a:• Prospective research plan which incorporates• Data collection and• Data analysis to answer a research question
8
What is Generalizable Knowledge?
• Definition for IRB purposes: Contributing to generalizable knowledge means:– (1) conclusions are drawn from particular
instances, and– (2) the information from the investigation is to be
disseminated.• To be considered research, the generalizable
knowledge must be drawn from the results of a systematic investigation of human subjects.
9
What is a Human Subject?
Per Federal regulations (45CFR46.102(f)), a human subject is defined as:– A living individual about whom an investigator
(whether professional or student) conducting research obtains:• Data through intervention or interaction with the
individual, or• Identifiable private information
10
So when do I need to submit an IRB?
• You are conducting research (systematic investigation to develop or contribute to generalizable knowledge), and
• You are interacting with human subjects to collect data or obtain identifiable private information about living individuals
11
Types of IRB Reviews• Exempt– Does not mean no IRB review required
• Expedited– Does not mean fast
• Full Board– Reviewed by fully convened Board
12
Exempt Studies
• Must be minimal to virtually no risk• Cannot involve pregnant women, human
fetuses, or prisoners– Anonymous surveys– Existing data (documents, records, pathological or
diagnostic specimens) recorded in de-identified fashion
– Research comparing standard practice methods in an educational setting (commonly used in elementary, secondary, or post-secondary schools)
13
Expedited StudiesMust be minimal risk—no greater risk than what is experienced in everyday life
• Surveys with identifiable information
• Analysis of data collected (or to be collected) for non-research purposes
• Research involving noninvasive clinical procedures
• Video or audio recordings
• Focus groups
14
Full Board StudiesGreater than minimal risk; involves sensitive information or is invasive• Pharmaceutical and medical treatment studies
• Studies involving prisoners or data on prisoners or other vulnerable populations (children, pregnant women)
• Information that could place participants at risk of civil or criminal liability or cause harms (stigma, ostracism, excommunication, etc.)
15
Not Human Subject Research
• Research using data or specimens from decedents
• De-identified secondary data analysis
• Non-private information such as available or disclosed in a public forum or that is directory information
16
Questions or Comments?
17
IRB Application Tips
• Write your protocol first– Everything in it can be cut and pasted into your
application– No such thing as TMI
• Provide consistent information in all submitted documents
• Upload documents in the proper places
18
Informed Consent
• Use the USF informed consent templates
• Consider waiver of documentation of informed consent
• Provide adequate description of how you will carry out informed consent process
19
Final Tips• If you are collaborating with external agencies or
organization:– Draft a letter of support for them – Additional approvals may be necessary (e.g., public school
systems, DOH, other universities)
• All study data must be retained for 5 years
• Last item in eIRB application: Describe your plan for ensuring the integrity of the data you collect, including how often you plan to monitor the data
20
The eIRB System• Smart form system—as you answer questions, the forms
will customize to assure only applicable questions appear
• Answering all questions ensures a smoother review-- questions marked * are required
• Click ‘continue’ to move through the application
• Remember to formally submit to the IRB by clicking ‘Submit Study’ under ‘My Activities’ on the left side of the system workspace
21
Principal Investigator• Ultimately shoulders the responsibility for the
conduct of the study, including the actions or inactions of the study team, support staff, etc.
• Is responsible for conducting research in the same ethical manner and with the same respect for the privacy and confidentiality of research subjects, no matter what type of IRB review
22
Remember…• The review of your IRB application requires
careful collaboration with multiple parties—build in time when planning your study
• Not all studies are approved on first submission—allow at least 30-45 days to ensure adequate time for review
23
Training is Available!
• USF Student Researcher Workshop– Tuesday, September 1, 6:30 – 9 p.m.
• eIRB System Training– Friday, October 9, 9 – 10 a.m.– Email [email protected] to sign-up (include course
name in email)
24
Resources• Division of Research Integrity and Compliance
http://www.research.usf.edu/dric/ -- click on ARC Portal
• Applications for Research Compliance (ARC) system– Tip sheets– Informed consent templates– Guidelines and procedure manual– Training videos– Sandbox
