1 IRB Basics and Tips for Navigating the IRB Review Process

2  What is the “Common Rule”?  Ethical Principles  A Brief History  Navigating the Review Process ◦ Three forms of IRB review ◦ The review process ◦ Tips for success

3  Federal Policy for the Protection of Human Subjects  Codified in Department of Health and Human Services Title 45 (public welfare) CFR 46 (protection of human subjects)   A baseline standard of ethics for researchers

4  Foundational document for ethics of human subjects research in U.S. 

5  2 Ethical convictions ◦ Acknowledge autonomy ◦ Protect those with diminished autonomy  Voluntary participation  Possess adequate information ◦ Informed consent

6  Keeping individuals from harm ◦ Is the person embarrassed? ◦ Does the person feel unsafe? ◦ Does the person feel coerced to participate? ◦ What are the repercussions if they decline to participate?

7 ◦ Would the answer jeopardize  The participant’s job?  Financial standing?  Ability to get insurance? ◦ Would they suffer any stigma if word got out?  Maximize benefits and minimize harms  What’s the benefit to participants? ◦ Not only benefit to you or the profession ◦ Harm includes wasting their time on poorly designed study, questionnaire, or interview

8  Fairness in distribution ◦ Inclusion ◦ Exclusion  Are subjects included because of: ◦ Ease of availability? ◦ A compromised position?  Consider issues of: ◦ Gender ◦ Age ◦ Ethnicity ◦ SES

9  1946 Nuremberg Doctors’ Trial ◦ Nuremberg Code (1948) ◦ “The voluntary consent of the human subject is absolutely essential”  1932/72 Tuskegee Syphilis Study ◦ Inadequate informed consent ◦ Subjects monitored 40 years treatment withheld ◦ President Clinton apologized 1997 ◦

10  Guatemala STD experiments (1940s) ◦ U.S. government researchers infected hundreds, 1/3 received no treatment – Apology in 2010 ◦ sexual_health/t/us-apologizes-guatemala-std-experiments/ sexual_health/t/us-apologizes-guatemala-std-experiments/  Milgram’s “obedience to authority” studies at Yale and Harvard (1960s) ◦ Deception: subjects believed they were inflicting harm  Stanford Prison Experiment (Zimbardo-1972) ◦ 2-week simulation of prison life ended after 6 days due to negative effects on “prisoners” and “guards”)

11  Creation of National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research  Belmont Report (1979)  Established Institutional Review Boards

12  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 ◦ IRB decides

13  Universities are being audited for compliance  Virginia Commonwealth University (2000) ◦ Complaint to federal officials that VCU genetics study asked invasive questions about family history. ◦ Result: Office of Human Research Protection (OHRP) temporarily suspended all human subjects research at VCU. ◦ reinstate_research reinstate_research

14  At Texas A&M University-Commerce ◦ Compliance is a priority ◦ All university faculty, staff, and students expected to uphold the highest standards of research conduct ◦ and adhere to all federal, state, and local regulations involving research ◦ commerce.edu/academics/graduateSchool/faculty/humanSubje ctsIRB/default.aspx commerce.edu/academics/graduateSchool/faculty/humanSubje ctsIRB/default.aspx

15 How do we work as a team to protect human subjects? to protect human subjects?

16  Seven important questions to ask  Three types of review  Tips for getting it right  Common errors to avoid  Timelines

17  Are you dealing with human beings? ◦ Living individual ◦ Obtain data through:  Intervention  Interaction  Previously collected private information (secondary data)

18  Are you doing research or evaluation?  Research is: ◦ “Systematic investigation” ◦ “Contribute to generalizable knowledge” ◦ Published outside of system ◦ Impact statements  Conference presentations or poster sessions  Journal article

19  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

20  Will you be working with vulnerable audiences? ◦ Pregnant women ◦ Prisoners ◦ Children and adolescents under 18 ◦ Elderly or nursing home residents ◦ Other institutionalized individuals  (e.g., juvenile detention, residential substance abuse treatment center)

21  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 superintendent of ISD and from school

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

23  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  Anonymity vs. Confidentiality

24  Pre – post tests  Demographic information  Names and addresses  Social security numbers  Follow-up contacts  Video or audio taping  Big Question  Big Question: What steps will you take to safeguard confidentiality?

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

26  Information collected for work funded by ◦ External Grants  File Limited Protocol for Extramural Grant Development to get started ◦ Collaborative efforts with other agencies  Reviewed by A&M-Commerce IRB as well as other agency IRB

27  Exempt - (Administrative)  Expedited  Full

28 1. Instructional strategies in normal educational settings 2. Educational tests, observation of public behavior 3. Study of existing data, publicly available, or no identifying info 4. Program evaluation 5. Taste testing

29 Exempt from continuing IRB review, NOT Exempt from initial review IRB decides whether exempt You must inform IRB if anything changes that might affect exempt status

30 1. Moderate exercise programs 2. Recording of data using non- invasive procedures 3. Research on individual or group behavior: involves no manipulation and is not stressful 4. Subjects can be identified 5. Voice recordings No more than minimal risk: ◦ “Risk that is not above that of daily life”

31  Research that involves more than minimal risk  Any research that involves vulnerable groups  Survey research that involves sensitive questions or likely to be stressful for subject  Any research that doesn’t fit exempt or expedited categories

32  Start early, allow plenty of time for revisions  Get someone else to read it through to check for consistency and comprehension  Students: work closely with faculty advisor – ahead of time – for guidance

 Provide a description of the study purpose, with rationale for such a study, and reference to the literature  Focus on mechanics rather than theory. IRB is mostly interested in data collection and protection of human subjects  Use the 40-item checklist before you submit your protocol for review 33

34  Provide copies of informed consent and assent forms.  Be sure: ◦ Language is correct for intended target audience (beware of acronyms and jargon) ◦ Description of study is consistent with that in protocol  Ask someone not familiar with your study to read it through

35  Language used in consent form inappropriate or complex  Consent forms don’t include required, correct contact info  Consent forms don’t include all necessary areas  Avoid use of first person: ◦ “I am...”, “I agree...”  Use third person language.

36 Typos, grammatical errors, and punctuation mistakes in informed consent forms and research site letters in informed consent forms and research site letters

37  Sample size and characteristics unclear or inconsistent  Data collection activities unclear  Recruitment strategies not explained  Who is PI, who is Faculty Advisor, who is co- PI?  Site permission letter missing

38  College of Education and Human Services ◦ Each Department has HSPC  College of Business & Entrepreneurship  College of Humanities, Social Sciences & Arts  College of Science, Engineering & Agriculture Each has college-wide HSPC

39  Your protocol logged in and screened before it goes to IRB chair ◦ Evaluated against 40-item checklist  One week to submit your revisions  When revisions complete, then protocol forwarded to IRB Chair

40  Exempt Review Approval ◦ 7 to 14 Days  Expedited Review ◦ 7 to 14 Days  Full Review  Full Review – Monthly full board meetings ◦ Schedule posted on Grad School website ◦ Plan to attend the IRB meeting ◦ Advisor strongly encouraged to attend ◦ If incarcerated population, a rep may be required to attend as advocate

41  Good for 1 year from date of IRB approval  Before expiration date, submit Renewal/Continuance request  Renewal/continuation good for 1 year  Submit an Amendment if making changes in your study after approval

42  Keep all materials for 3 years from project  Termination date. Store in a locked file.  Include: 1. Copies of recruitment pieces 2. Participant surveys 3. Data compilation sheets 4. Results of study 5. Reports generated from results

43  Acknowledgments: ◦ Purdue University IRB ◦ Emory University IRB ◦ Indiana University IRB tutorial  ◦ OHRP