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Your Roadmap to IRB Approval Applications Top 11 Tips for 20112011 IRB 101 – Your Roadmap to IRB Approval Applications Top 11 Tips for 20112011 IRB 101 – HUMAN SUBJECTS RESEARCH Boyd Herndon, JD, CIP Director of Research Compliance February 26, 2014 UNT Office of Research & Economic Development 1

1. Verify Your Project is “Research” with “Human Subjects” BEFORE You Start a UNT 1. Verify Your Project is “Research” with “Human 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 UNT Office of Research & Economic Development 2

What is “Generalizable Knowledge”? v YES: journal article, book chapter, academic conference presentation or What is “Generalizable Knowledge”? v YES: journal article, book chapter, academic conference presentation or poster, thesis, dissertation v NO: classroom assignment, internal program evaluation, UNT institutional research (note: with no external publication of results for each of these categories) v If questions, call IRB staff for assistance UNT Office of Research & Economic Development 3

Columbia Food Complaint Study - 2001 v Columbia professor of Organizational Behavior sent letters Columbia Food Complaint Study - 2001 v 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, 42 nd St. UNT Office of Research & Economic Development 4

Texas Department of Public Safety Criminal Convictions Database v STATE OF TEXAS VS. DARLIE Texas Department of Public Safety Criminal Convictions Database v STATE OF TEXAS VS. DARLIE ROUTIER CRIMINAL DISTRICT COURT #3 OF DALLAS CO COURT OFFENSE 09990015 (CAPITAL MURDER MULTIPLE) COURT OFFENSE LITERAL F 9639972 R 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 F 9639973 MJ FINAL PLEADING N (NOT GUILTY) COURT CONFINEMENT DEATH AGENCY RECEIVING CUSTODY TDCJ COURT PROVISION LITERAL DEATH SENTENCE COURT PROVISION 335 (DEATH SENTENCE) UNT Office of Research & Economic Development 5

2. If Study Requires Full Board Review (Less Than 5% Do), Plan Ahead for 2. If Study Requires Full Board Review (Less Than 5% Do), Plan Ahead for Monthly Meeting Schedule UNT INSTITUTIONAL REVIEW BOARD Patricia Kaminski, Ph. D. , IRB Chair, Psychology Amyn Amlani, Ph. D. , Speech and Hearing Sciences Kathleen Duffy, Community Member Rebecca Glover, Ph. D. , Educational Psychology Lisa Henry, Ph. D. , Anthropology Debbie Rohwer, Ph. D. , Music Education Richard Smith, Ph. D. , Behavior Analysis Chad Trulson, Ph. D. , Criminal Justice Mark Vosvick, Ph. D. , Psychology UNT Office of Research & Economic Development 6

3. Determine Which IRB Application to Complete v There are 2 IRB applications: a 3. Determine Which IRB Application to Complete v 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-andcompliance/use-of-humans-in-research v 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? UNT Office of Research & Economic Development 7

Which IRB Application? (continued) ♦ ♦ ♦ Will your study involve any sensitive topics 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 [email protected] edu If the answer to any of these questions is “yes, ” the Expedited/Full Board Application should be submitted to [email protected] edu UNT Office of Research & Economic Development 8

4. Who is the “Investigator”? v For those UNT theses or dissertations which require 4. Who is the “Investigator”? v 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 [email protected] 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 Office of Research & Economic Development 9

5. Submit IRB Training Certificates for All Investigators & Key Personnel v Submit a 5. Submit IRB Training Certificates for All Investigators & Key Personnel v 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 v NIH IRB Training Course: “Protecting Human Research Participants” http: //phrp. nihtraining. com/users/login. php OR v 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) UNT Office of Research & Economic Development 10

6. Draft Informed Consent Forms That Clearly Describe Study Activities and Potential Risks v 6. Draft Informed Consent Forms That Clearly Describe Study Activities and Potential Risks v Informed consent is a process that seeks to assure that research subjects voluntarily agree to participating in the study after receiving required disclosures v 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-ofhumans-in-research v Use lay language (with a goal of 8 th 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 UNT Office of Research & Economic Development 11

Scope of Informed Consent v Havasupai Tribe vs. Arizona State University ♦ ♦ $700, Scope of Informed Consent v Havasupai 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) UNT Office of Research & Economic Development 12

7. Do International Requirements Apply? v Office for Human Research Protections (OHRP) maintains compilation 7. Do International Requirements Apply? v 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/intlcompi lation/intlcompilation. html ♦Give special attention to local customs in drafting written informed consent documents or proposing alternative consent formats UNT Office of Research & Economic Development 13

8. Does Your Study Involve HIPAA? v DHHS regulations to implement HIPAA (the Health 8. Does Your Study Involve HIPAA? v DHHS regulations to implement HIPAA (the Health Insurance Portability & Accountability Act) restrict a researcher’s access to and use of PROTECTED HEALTH INFORMATION (PHI) v 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? v If yes, researcher must comply with the HIPAA Privacy Rule UNT Office of Research & Economic Development 14

Methods for Research with PHI v Obtain signed authorization from subjects v Use de-identified Methods for Research with PHI v Obtain signed authorization from subjects v Use de-identified PHI (all 18 identifiers removed) v Access “Limited Data Set” pursuant to Data Use Agreement v Obtain waiver of authorization from IRB or Privacy Board v Review PHI that is necessary to prepare a protocol (no data removal) v 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 UNT Office of Research & Economic Development 15

9. Attach All of These Items When Your Application is Submitted to untirb@unt. edu 9. Attach All of These Items When Your Application is Submitted to [email protected] 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 UNT Office of Research & Economic Development 16

10. Contact the IRB Staff for Help v The IRB Guide. Iines at http: 10. Contact the IRB Staff for Help v The IRB Guide. Iines at http: //research. unt. edu/faculty-resources/research-integrityand-compliance/use-of-humans-in-research contain the answers to the most commonly asked questions about the IRB approval process v For assistance beyond the IRB Guidelines, please contact the IRB staff at [email protected] edu or call Jordan Harmon, Research Compliance Analyst for Minimal Review studies, at 940 -5654258, or Shelia Bourns, Research Compliance Analyst for Expedited or Full Board Review studies, at 940 -565 -2018 v To request presentations about the IRB: Boyd Herndon, Director of Research Compliance, Boyd. [email protected] edu or 940 -565 -3941 UNT Office of Research & Economic Development 17