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Boyd Herndon, JD, CIP Director of Research Compliance

February 26, 2014

Your Roadmap to IRB Approval Roadmap to IRB Approval Applications - Top 11 Tips for 2011

20112011IRB 101 – HUMAN SUBJECTS RESEARCH

1. Verify Your Project is “Research” with “Human 1. Verify Your Project is “Research” with “Human Subjects” BEFORE You Start a UNT IRB Application Subjects” BEFORE You Start a UNT IRB Application

♦ RESEARCH: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge

♦ HUMAN SUBJECT: a living individual about whom an investigator (whether professional or student) conducting research obtains: (a) data through intervention or interaction with the individual; or (b) identifiable private information

» Intervention: physical procedures or manipulations of the subject or the subject’s environment

» Interaction: communication or interpersonal contact between investigator and subject

» Private information must be individually identifiable (i.e., the identity of the subject is known or may readily be ascertained) in order for obtaining private information to constitute human subjects research

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What is “Generalizable Knowledge”?What is “Generalizable Knowledge”?

YES: journal article, book chapter, academic conference presentation or poster, thesis, dissertation

NO: classroom assignment, internal program evaluation, UNT institutional research (note: with no external publication of results for each of these categories)

If questions, call IRB staff for assistanceUNT Office of Research & Economic Development 3

Columbia Food Complaint Study - 2001Columbia Food Complaint Study - 2001

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Columbia professor of Organizational Behavior sent letters to 240 New York City restaurants complaining about food poisoning for journal article regarding how restaurants respond to such complaints

Chez Josephine, 42nd St.

Texas Department of Public Safety Criminal Texas Department of Public Safety Criminal Convictions DatabaseConvictions Database

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STATE OF TEXAS VS. DARLIE ROUTIER

CRIMINAL DISTRICT COURT #3 OF DALLAS CO COURT OFFENSE 09990015 (CAPITAL MURDER MULTIPLE) COURT OFFENSE LITERAL F9639972R CITATION 19.03(A)(7) LEVEL AND DEGREE OFFENSE FX (FELONY - CAPITAL FELONY) COURT DISPOSITION 310 (CONVICTED) COURT DISPOSITION DATE 02/04/1997 DATE OF SENTENCE/STATUS 02/04/1997 CAUSE NUMBER F9639973MJ FINAL PLEADING N (NOT GUILTY) COURT CONFINEMENT DEATH AGENCY RECEIVING CUSTODY TDCJ COURT PROVISION LITERAL DEATH SENTENCE COURT PROVISION 335 (DEATH SENTENCE)

2. If Study Requires Full Board Review (Less Than 5% 2. If Study Requires Full Board Review (Less Than 5% Do), Plan Ahead for Monthly Meeting Schedule Do), Plan Ahead for Monthly Meeting Schedule

UNT INSTITUTIONAL REVIEW BOARDPatricia Kaminski, Ph.D., IRB Chair, Psychology Amyn Amlani, Ph.D., Speech and Hearing SciencesKathleen Duffy, Community Member Rebecca Glover, Ph.D., Educational PsychologyLisa Henry, Ph.D., AnthropologyDebbie Rohwer, Ph.D., Music EducationRichard Smith, Ph.D., Behavior AnalysisChad Trulson, Ph.D., Criminal JusticeMark Vosvick, Ph.D., Psychology

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3. 3. Determine Which IRB Application to CompleteDetermine Which IRB Application to Complete There are 2 IRB applications: a Minimal Review Application and an

Expedited or Full Board Review Application♦ Both applications are available on the IRB’s main page at:

http://research.unt.edu/faculty-resources/research-integrity-and-compliance/use-of-humans-in-research\

Answering 6 questions will determine which application you should fill out based on the risks presented by your study:

♦ Will your research study involve any vulnerable populations such as children, prisoners, pregnant women or mentally disabled persons?

♦ Could public disclosure of any identifiable data you collect place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability or reputation?

♦ Will your study involve data collection procedures other than surveys, educational tests, interviews, or observation of public behavior?

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Which IRB Application? (continued)Which IRB Application? (continued)♦ Will your study involve any sensitive topics such as:

• Abortion• Criminal History• Sexual Activity• Sexually Transmitted Diseases• Prior Mental Health Diagnosis • Victims of Violence

♦ Will your study involve audio-recording or video-recording the participants?♦ Will your study involve obtaining or using individually identifiable information

from health care plans, health care clearinghouses, or health care providers?

If the answer to all of these questions is “no,” the Minimal Review Application should be submitted to untirb@unt.edu

If the answer to any of these questions is “yes,” the Expedited/Full Board Application should be submitted to untirb@unt.edu

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4. 4. Who is the “Investigator”?Who is the “Investigator”?

For those UNT theses or dissertations which require IRB review, the graduate student is the “Student Investigator” and the faculty member is the “Supervising Investigator” ♦ IRB application is transmitted to untirb@unt.edu from the

faculty member’s email account ♦ IRB Chair and IRB staff communicate with both regarding

approval questions ♦ Office for Human Research Protections (OHRP) & UNT IRB

may audit study records for up to 3 years following end of research; informed consent forms and copies of summary study records must be retained at UNT

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5. Submit IRB Training Certificates for All 5. Submit IRB Training Certificates for All Investigators & Key PersonnelInvestigators & Key Personnel Submit a completion certificate for either the NIH or

CITI IRB training course for the Student Investigator, the Supervising Investigator and all “key personnel” responsible for the design, conduct, and reporting of the study

NIH IRB Training Course: “Protecting Human Research Participants” http://phrp.nihtraining.com/users/login.php OR

CITI IRB Training Course: “Social & Behavioral Human Subjects Research” https://www.citiprogram.org/default.asp?language=english (CITI= Collaborative Institutional Training Initiative, University of Miami)

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6. 6. Draft Informed Consent Forms That Clearly Draft Informed Consent Forms That Clearly Describe Study Activities and Potential Risks Describe Study Activities and Potential Risks Informed consent is a process that seeks to assure that

research subjects voluntarily agree to participating in the study after receiving required disclosures

Obtain and document informed consent (from subject or from parent or guardian if subject is under 18) and assent (from subjects 7-17) in accordance with federal regulations and as approved by the IRB; use templates for adult or minor subjects on UNT IRB website (see templates on IRB main page at http://research.unt.edu/faculty-resources/research-integrity-and-compliance/use-of-humans-in-research

Use lay language (with a goal of 8th grade reading level for general population studies); clearly explain what participants will be asked to do and what risks (if any) are involved in those activities

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Scope of Informed ConsentScope of Informed ConsentHavasupai Tribe vs. Arizona State University

♦ $700,000 settlement to tribe members in 2010♦ Blood samples/DNA obtained for diabetes study

also used to study mental illness & geographic origin of tribe (in conflict with Havasupai legends)

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77. Do International Requirements Apply?. Do International Requirements Apply?

Office for Human Research Protections (OHRP) maintains compilation of international research requirements

♦See OHRP website for country chart at: http://www.hhs.gov/ohrp/international/intlcompilation/intlcompilation.html♦Give special attention to local customs in drafting written informed consent documents or proposing alternative consent formats

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8. Does Your Study Involve HIPAA?8. Does Your Study Involve HIPAA? DHHS regulations to implement HIPAA (the Health Insurance

Portability & Accountability Act) restrict a researcher’s access to and use of PROTECTED HEALTH INFORMATION (PHI)

Will the proposed research involve: ♦any information that relates to the provision of health care to an individual; the past, present, or future physical or mental health or condition of an individual; or the past, present, or future payment for the provision of health care to an individual; ♦that will be obtained from a health care plan, a health care clearinghouse, or a health care provider that transmits any health care information in electronic form in connection with a health care transaction; and ♦such information identifies the individual or could reasonably be used to identify the individual?

If yes, researcher must comply with the HIPAA Privacy Rule

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Methods for Research with PHIMethods for Research with PHI Obtain signed authorization from subjects Use de-identified PHI (all 18 identifiers removed) Access “Limited Data Set” pursuant to Data Use

Agreement Obtain waiver of authorization from IRB or Privacy

Board Review PHI that is necessary to prepare a protocol

(no data removal) Limit study to PHI of deceased individuals

For details, see NIH’s “Protecting Personal Information in Research: Understanding the HIPAA Privacy Rule http://privacyruleandresearch.nih.gov/pr_02.asp

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9. Attach All of These Items When Your9. Attach All of These Items When YourApplication is Submitted to untirb@unt.eduApplication is Submitted to untirb@unt.edu

♦ Copies of all NIH or CITI IRB training completion certificates not previously submitted to the IRB Office

♦ A copy of all recruitment materials (flyers, emails, advertisements, script of classroom announcements)

♦ A copy of approval letters from each data collection site (other than UNT); example: school district approval

♦ A copy of all informed consent forms/notices you plan to use (unsigned; no contact with subjects before IRB approval)

♦ A copy of all data collection instruments, intervention protocols, and interview scripts

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10. Contact the IRB Staff for Help10. Contact the IRB Staff for Help The IRB GuideIines at

http://research.unt.edu/faculty-resources/research-integrity-and-compliance/use-of-humans-in-research contain the answers to the most commonly asked questions about the IRB approval process

For assistance beyond the IRB Guidelines, please contact the IRB staff at untirb@unt.edu or call Jordan Harmon, Research Compliance Analyst for Minimal Review studies, at 940-565-4258, or Shelia Bourns, Research Compliance Analyst for Expedited or Full Board Review studies, at 940-565-2018

To request presentations about the IRB: Boyd Herndon, Director of Research Compliance, Boyd.Herndon@unt.edu or 940-565-3941

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