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IRB Basics IRB Basics andand

Tips for Navigating Tips for Navigating the IRB Review Processthe IRB Review Process

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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

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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)

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

A baseline standard of ethics for researchers

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

http://ohsr.od.nih.gov/guidelines/belmont.html

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2 Ethical convictions◦ Acknowledge autonomy◦ Protect those with diminished

autonomy

Voluntary participation Possess adequate information

◦ Informed consent

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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?

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◦ 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

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Fairness in distribution◦ Inclusion ◦ Exclusion

Are subjects included because of:◦ Ease of availability?◦ A compromised position?

Consider issues of:◦ Gender◦ Age◦ Ethnicity◦ SES

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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◦ http://www.cdc.gov/tuskegee/timeline.htm

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Guatemala STD experiments (1940s)◦ U.S. government researchers infected hundreds,

1/3 received no treatment – Apology in 2010◦ http://www.msnbc.msn.com/id/39456324/ns/health-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”)

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Creation of National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Belmont Report (1979)

Established Institutional Review Boards

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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

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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.

◦ http://www.news.vcu.edu/news/VCU_officials_work_around_the_clock_to_reinstate_research

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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

◦ http://web.tamu-commerce.edu/academics/graduateSchool/faculty/humanSubjectsIRB/default.aspx

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

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Seven important questions to askSeven important questions to ask

Three types of reviewThree types of review

Tips for getting it rightTips for getting it right

Common errors to avoidCommon errors to avoid

TimelinesTimelines

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Are you dealing with human beings?◦ Living individual◦ Obtain data through:

Intervention Interaction Previously collected private information

(secondary data)

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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

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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

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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)

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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

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Are you collecting sensitive information?

Are subjects at risk of:◦ Criminal or civil liability?◦ Damage to financial standing?◦ Employability?◦ Reputation?

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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

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

Big QuestionBig Question: What steps will you take to safeguard confidentiality?

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Publish in written or oral forms◦ WWW site◦ News releases◦ Journal article◦ Public Forum

Provide program accountability◦ Used solely within system◦ Program improvements

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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

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Exempt - (Administrative)

Expedited

Full

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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 evaluation5. Taste testing

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Exempt from continuing IRB review, Exempt from continuing IRB review, NOT Exempt from initial reviewNOT Exempt from initial review

IRB decides whether exemptIRB decides whether exempt

You must inform IRB if anything You must inform IRB if anything changes that might affect exempt changes that might affect exempt

statusstatus

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1. Moderate exercise programs2. Recording of data using non-

invasive procedures3. Research on individual or group

behavior: involves no manipulation and is not stressful

4. Subjects can be identified5. Voice recordings

No more than minimal risk:◦“Risk that is not above that of daily life”

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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

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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

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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

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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.

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Typos, grammatical Typos, grammatical errors, and punctuation errors, and punctuation mistakes mistakes

in informed consent formsand research site lettersin informed consent formsand research site letters

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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

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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

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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

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Exempt Review ApprovalExempt Review Approval◦ 7 to 14 Days

Expedited ReviewExpedited Review◦ 7 to 14 Days

Full ReviewFull 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

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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

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Keep all materials for 3 years from project Termination date. Store in a locked file. Include:

1. Copies of recruitment pieces2. Participant surveys3. Data compilation sheets4. Results of study5. Reports generated from results

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Acknowledgments:◦ Purdue University IRB◦ Emory University IRB◦ Indiana University IRB tutorial

http://www.indiana.edu/~rcr/files/hspt-nbm.pdf

◦ OHRP http://www.hhs.gov/ohrp/