The Submission Process for the Purdue Institutional Review Board

1
The Submission Process for the Purdue
Institutional Review Board

• Purdue University
• Cooperative Extension Service
• Spring 2002

2
Introduction

• IRB History
• Why Extension is now being asked to comply
• Deciding if you need IRB Approval
• The three forms of IRB approval
• The process you will use
• Management of your effort once approval is
  received

3
Historical Perspectives on Human Subjects Research

• 1946 Nuremberg Doctors Trial
• 1960s Thalidomide Tragedy
• 1932/72 Tuskegee Syphilis Study

4
National Research Act

• Department of Health, Education and Welfare
• Established the Institutional Review Boards
• Belmont Report

5
Belmont Report

• Respect for persons
• Beneficence
• Justice

6
The Belmont Report Basic Ethical Principles and
Their Application Video
7
Respect for Persons

• 2 Ethical convictions
• Acknowledge autonomy
• Protect those with diminished autonomy
• Voluntary participation
• Possess adequate information
• Consent forms

8
Beneficence

• Keeping individuals from harm
• Is the person embarrassed?
• Does the person feel coerced to answer?
• What are the repercussions if they decline to
  participate?

9
Do Not Harm!

• Would the answer jeopardize
• The participants job
• Financial standing
• Ability to get insurance
• Would they suffer any stigma if word got out
• Maximize benefits and minimize harms

10
Justice

• Fairness in distribution
• Inclusion
• Exclusion
• Are subjects included because of
• Ease of availability
• A compromised position
• Consider issues of
• Gender
• Age
• Ethnicity

11
Law Changes in 1996

• Initially investigator determined need for IRB
  review
• New federal regulations for exempt research
• Now all research must go to IRB even to receive
  an exempt approval

12
The Environment has Changed

• Universities are being audited for compliance
• Extension systems included
• New leadership at Purdue
• Compliance is a priority
• All university staff and resources will comply

13
Question 1 Are You Using Human Subjects?

• Are you dealing with human subjects?
• Living individual
• Obtains data through
• Intervention
• Interaction
• Private information

14
Question 2 What is the Purpose of the
Information?

• Are you doing research or evaluation?
• Research is
• Systematic investigation
• Contribute to generalizable knowledge
• Published outside of system
• Impact statements
• Conference presentations or posters
• Journal article

15
Research or Evaluation?

• Evaluation is
• Used for planning
• To improve the quality of the program
• To assess the value of the program
• Not intended to be replicated
• Not generalized beyond the program site

16
Question 3- Who are Your Participants?

• Will you be working with vulnerable audiences?
• Pregnant women
• Prisoners
• Youth under 18
• Elderly or nursing home residents
• Other institutionalized individuals

17
Children

• Tests to see what they have learned are exempt
• Surveys, interviews, or observations of behavior
  of children are subject to review
• All efforts in a school will require letters from
  the school

18
Question 4 - Are theParticipants at Risk?

• Are you collecting sensitive information?
• Are subjects at risk of
• Criminal or civil liability
• Damage to financial standing
• Employability
• Reputation

19
Question 5- Is Your Effort Voluntary and
Anonymous?

• Participation is totally voluntary
• No identifying information is included
• Social Security Numbers
• Names, addresses for follow -ups
• Data is reported in way to assure anonymity

20
Procedures That IRB May Question

• Pre post tests
• Demographic information
• Names and addresses
• Social security numbers
• Follow-up contacts
• Video or audio taping

21
Question 6 What is the Funding Source?

• Information collected for work funded by
• Grants
• Contracts
• Collaborative efforts with other agencies
• Requires proper completion of transmittal slip
• Copy of grant proposal

22
Purdue UniversityGrant Transmittal Slip
27 Will human subjects be used in this project
Yes No If yes, has approval been obtained
from the University Human Subjects Committee?
In Review No Yes,
Approval _________ Date Approved__________ If
yes, List the title of the Protocol, Note If
the title has changed, please notify the
committee.
23
Question 7 Has This Effort been Previously
Approved?

• Has effort received approval by specialists?
• Check it out
• http//
• Letter giving permission to use
• Must follow protocol exactly
• Notify the PI of any changes, mishaps
• Report number of participants

24
Question 8- How Will You Use the Information?

• Publish in written or oral forms
• WWW site
• News releases
• Journal article
• Public Forum
• Provide program accountability
• Used solely within Extension system
• Program improvements

25
Types of Reviews

• Exempt - (Administrative)
• Expedited
• Full

26
Exempt Reviews

• Research in normal educational settings
• Research using educational tests
• Surveys or interviews with adults
• Taste testing

27
Exempt Reviews, cont.

• Form HS-96/4
• Director as Principal Investigator
• Educators and others involved in the effort?
• What is your project?
• How will you recruit your subjects?
• Who are they, and how many are there?
• Ways you will assure the effort is voluntary?
• Ways you will assure anonymity?
• What will you do with the results?

28
Expedited Reviews

• Moderate exercise programs
• Most psychology-like experiments
• Surveys or interviews with minors
• Subjects can be identified
• Voice recordings
• Risk that is not above that of daily life

29
Expedited Reviews

• Completed HS-3
• Application narrative
• Consent forms
• All supporting materials
• Evaluation instruments
• Original copy

30
Full Reviews

• Research that involves more than minimal risk
• Any research that involves vulnerable groups
• Get application package in early

31
Timelines

• Exempt Review Approval
• 7 to 10 Days
• Expedited Review
• 7 to 10 Days
• Full Review
• To IRB by 2nd Tuesday
• Committee meets the last Tuesday
• Plan to attend the IRB meeting

32
Consent Forms

• Expedited or Full Reviews
• Follow Purdue template
• www.purdue.edu/Research/ORA/humans/
• humans-main.shtml
• What to include

33
Extension Process for County Educators

• Complete appropriate form and attach all
  supporting documents
• Give to CED
• CED will review, initial, and forward to Program
  Leaders

34
Extension Process for County Educators

• Program Leaders will review data-gathering
  instruments
• Help you with needed revisions
• Forward to Directors Office
• Director's Office will review, sign and send to
  IRB
• Upon IRB notice, Director will notify educator,
  Program Leader

35
Approval

• Good for 1 year from date of IRB approval
• Send notification near expiration date, asking
  for status
• If effort is ongoing, renewal of effort can be
  requested

36
Record Keeping

• Keep all materials for 3 years from project
• Termination date. Store in a locked file.
• Include
• Copies of recruitment pieces
• Participant surveys
• Data compilation sheets
• Results of study
• Reports generated from results

37
IRB Audits

• Possible Audits by
• Internal by Purdue Extension
• 2. The Purdue IRB
• 3. External by the Federal Office of Human
  Protections Research (OHRP)