1. Human Subjects
Overview

2. Human Subjects Office - Mission
Create an atmosphere of respect for, and awareness of, the rights and welfare of human research participants
Continue to inform established researchers about the application of the federal regulations and ethical principles to their particular area of research in an effort to keep researchers current with evolving standards.
Educate students, faculty, and staff who conduct research about the ethical principles and federal regulations guiding research with humans.
Develop new approaches that better serve the overarching mission of the HRPP, such as state-of-the-art educational materials, more efficient methods for processing applications, tracking and monitoring research activities, and assessing the overall effectiveness of the HRPP

3. IU’s HRPP Nationally accredited Two campuses, one office
Six Institutional Review Boards (IRBs)
2 Social/Behavioral Boards
4 Biomedical Boards
IRB Executive Committee
Supported by the Office of Research Administration

4. Role & Authority of IRB: Protecting Human Subjects
Approve or disapprove research and require modifications
Conduct initial and continuing review at least annually (Except Exempt)
Must approve any changes in research before they can be implemented
Evaluate unanticipated problems and noncompliance
Suspend or terminate approval of research

5. Does it require IRB review?
Systematic investigation and designed to develop or contribute to generalizable knowledge
RESEARCH
Research about a living individual either through intervention/ interaction or identifiable private information
HUMAN SUBJECT
IRB Review
Does it require IRB review?
Questions to ask:
Is it research?
Does it involve human subjects?
Does the activity involve deceased individuals?
Is it subject to FDA regulations?
Is it a student project involving risk to human subjects?

6. Does it require IRB review?
Levels of IRB Review
No Review
Exempt
(Minimal Risk)
Expedited
Full Board
Type of Research
Non-human subjects research
Student projects
Observation of public behavior
Collection of existing data
Surveys
Prospective collection of data
Non-invasive or standard of care procedures
Focus groups
Most drug or device studies
Invasive procedures
Clinical trials
IRB Requirements
Registration only if necessary
Confirmation of exempt status
Undocumented informed consent
Prospective approval of any changes
Review by an IRB member
Written informed consent (unless waived)
Annual review
Review at a full IRB meeting
Minimal Risk: the risks of harm anticipated in the proposed research are not greater considering the probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological exams or tests

7. Does it require IRB review? Research with Existing Data
Example
Level of Review
Review of deidentified data or specimens
Investigators have no access to identifiable data
None – not human subjects research.
Retrospective chart review
Access to identifiable data
Data will be recorded in a deidentified manner
Exempt
Identifiable data will be recorded
Expedited
Prospective chart review

8. Does it require IRB review?
Student Projects
Class assignments
Generally not intended for publication and are not considered research
Projects which may be more than minimal risk AND involve a vulnerable population should be reviewed by the HSO
Application for Non-Research Student Projects
Thesis/Dissertation projects
Are considered research and should be submitted to the HSO as a new study
Faculty sponsor is required and have ultimate responsibility for ensuring the project is conducted appropriately

9. Does it require IRB review?
Examples
Example #1: You want to analyze existing, coded tissue samples from 10 patients collected before and after treatment with an investigative agent. Pre- and post- tissue samples are labeled only with a code to correspond the pre-treatment sample with the same patient’s post-treatment sample; code is not associated with or linked to subject. You want to look at the efficacy of a certain treatment in patients from which the tissue was previously collected by recording differences between the tissues.
 Systematic investigation
 Contributing to generalizable knowledge
 Interaction with living individuals and/or identifiable information
 IRB review NOT required

10. Does it require IRB review? Examples
Example #2: You want to evaluate the effectiveness of a surgical technique by analyzing data collected by a surgery registry and conducting telephone interviews with a sample of senior citizens. You would like to make a poster presentation of your findings at your next professional society meeting.
 Systematic investigation
 Contributing to generalizable knowledge
 Interaction with living individuals and/or identifiable information
 IRB review required – probably expedited

11. Does it require IRB review? Examples
Example #3: You want to evaluate whether an investigational device is more efficacious than an already approved device for treating a specific condition. You will be randomizing subjects to either of these devices and will be monitoring them with various procedures and blood draws.
 Systematic investigation
 Contributing to generalizable knowledge
 Interaction with living individuals and/or identifiable information
 IRB review required – full Board review

12. Does it require IRB review?
Failure to Obtain
What can happen if research is not reviewed and approved by the IRB?
The data collected may not be used for research purposes, i.e. the research can not be published or presented (more journals are checking)
The IRBs can impose or have imposed sanctions on investigators that conduct research without prospective IRB approval
IRBs must notify the federal government of any serious or continuing noncompliance

13. Submitting to the IRB Make all submissions to irb@iu.edu
Complete submission requirements
All investigators submit conflict of interest disclosures
All investigators complete CITI modules
Required documents submitted
Incomplete submissions will be returned to you with a list of requirements to be completed, weekly follow-up from staff

14. IRB Review Process Complete submission Pre-review:
Each department assigned to HSO team
Completeness and understandability
Review (depending on level of review)
Provisions/concerns addressed (if necessary)
Approval documents sent

15. Ongoing Review
Continuing review: required annually for non-exempt studies
Amendments: all changes must be prospectively approved prior to implementation
Including Co-Investigators (key personnel)
Research personnel updates (non-key) do not require approval; notification only
Reporting

16. Ongoing Review: Reporting
Unanticipated Problems
Noncompliance
What to Report
Any event meeting the definitions listed on the Prompt Reporting Form
ALL noncompliance
When to Report
Within 5 business days of discovery
How to Report
Prompt Reporting Form
Noncompliance Form
IRB Determinations
Unanticipated problem involves risk to subjects or others (UPIRTSO)
Serious noncompliance,
Continuing noncompliance, OR
Serious & continuing noncompliance
Possible IRB Actions
No action
Restrict research activities
Conduct audit
Require remediation, mentoring, education
Require changes to protocol, informed consent process/documents, monitoring
Withdrawal, notification, or reconsenting of subjects
Suspend or terminate research

17. Principal Investigator Responsibilities
Eligibility
Must meet eligibility criteria
Complete submission requirements
Responsibilities
Management and completion of project
Hiring and assigning employees and resources
Ensuring appropriate training of study staff
Ensuring integrity and security of data
Ensuring consent process
Adherence to protocols and policies (federal, state, insitutional)

18. Additional Investigator Responsibilities
Good Clinical Practices
A standard by which clinical trials are designed, performed, monitored, audited, recorded, analyzed, and reported so that there is public assurance that the data are credible, and that the rights, integrity, and confidentiality of subjects are protected.
Auditing
Provided by Clinical Research Compliance Office
Directed and scheduled
General audit process: notification, to site visit, to audit report, response to findings, and then IRB Review (also see IU SOPs for Research Involving Human Subjects)
Responsibilities related to external audits

19. Additional Investigator Responsibilities FDA-Regulated Studies
Additional oversight: FDA
Oversight of clinical research (IND/IDEs, etc.)
Safety reporting
Accuracy of submissions
Patient enrollment
Informed consent
Records retention post approval
Financial disclosures
Inspection rights

20. Additional Investigator Responsibilities FDA-Regulated Studies
Investigational drugs (IND) and devices (IDE)
Provide IRB with IND/IDE number
Devices: provide information regarding significant Risk/nonsignificant for IRB determination
If the investigator holds IND/IDE:
Meet with individuals within the Office of Research Administration to discuss the responsibilities prior to study approval

21. Additional Investigator Responsibilities FDA-Regulated Studies
IND Enforcement Actions
Illegal Clinical Trial
Synthes, Inc. and four top executives charged with conducting clinical device trials without FDA authorization
Label of bone cement contained a warning against the use being studied
All 4 executives were sentenced prison time
Sentencing exceeded the sentencing guidelines

22. CTSI-supported Indiana Biobank
Goal: Create a research resource by linking a subject’s blood sample to their medical record
Subjects consent to broad research use
Consent allows researchers to use past, present and future data in the medical record
Over 14,000 pediatric and adult subjects already consented and available for research studies
Studies collecting samples can partner with the Indiana Biobank to expand this research resource
Investigators consenting subjects and collecting a blood sample for the Indiana Biobank receive samples from the Indiana Biobank at reduced rates
To participate, contact Dr. Tatiana Foroud

23. Contact the HSO Submit via email to iuirb@iupui.edu
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