Human Subjects Research and Scholarly Activity

1. Human Subjects Research and Scholarly Activity Ms. Denise Ball Associate Director, Office of the Institutional Review Board for Human Use

2. Human Subjects Research & the IRB • Institutional Review Board for Human Use (IRB) The committee that reviews all UAB research involving human subjects. The aim of the IRB review is to protect the rights and welfare of study participants. • The IRB review is based on the three ethical principles described in the Belmont Report http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm - April 1979

3. Belmont Report – Ethical Principles • Respect for Persons – autonomous agents, respect people with diminished autonomy or capacity for decision making. • Beneficence – Risk vs. Benefit - not all risks physical – risk to reputation, employability, financial standing, etc. • Justice – Risks and possible benefits of research to be equally shared by all that may benefit from the research.

4. Research • Research - a systematic investigation including research development, testing, and evaluation; designed to develop or contribute to generalizable knowledge. (45 CFR 46)

5. Human Subject • A living individual(s) about whom an investigator (whether professional or student) conducting research obtains: (1) data through intervention or interaction with the individual, or (2) identifiable private information. (45 CFR 46)

6. Definitions - • Intervention: Includes both physical procedures and manipulation of the subject or his environment for research purposes. • Interaction: Includes communication or interpersonal contact between investigator and subjects.

7. Definitions (continued) • Private Information - Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g. med record).

8. Human Subjects - examples Not only living persons, but also human tissue, blood samples, diagnostic/pathologic specimens, study of medical records, observation of public behavior, and all questionnaires. Not Human Subjects Designation • Cadaveric Materials, • Cell Lines

9. Former UCLA exec pleads guilty to body trafficking – October 17, 2008 • LOS ANGELES (AP) — The former chief of UCLA's cadaver program pleaded guilty Friday for his role in selling donated body parts to medical, drug and research companies in a scheme that netted up to $1 million, prosecutors said. • Henry Reid, 58, pleaded guilty in Los Angeles County Superior Court to one count of conspiracy to commit grand theft, with a special allegation that he damaged or destroyed more than $1 million worth of school property, which refers to the donated bodies.

10. IRB Application Types • No Humans – cadaveric/cell lines • Exemption – little or no risk, no identifiers • Expedited Review – Minimal Risk (the risk in daily living) • Full Review – more than minimal risk - vulnerable subject groups, investigational drugs, investigational devices

11. Not Human Subjects Designation • Cell lines, Cadavers, Use of data in which the participants cannot be linked to data – written agreement must be in place. • What is de-identified data? • What is anonymized data? • Is there a code/link? If so, who keeps the code, who has access, will the code be broken????

12. Not Human Subjects Designation • http://www.uab.edu/irb/forms/nhsr.doc • No Human Subjects Training Required • No Protocol Oversight Review by Department (protocol oversight review is for scientific integrity/validity) • Need signature of faculty advisor/mentor • No continuing review required • Student may be listed as Principal Investigator

13. Exemption Review • http://www.uab.edu/irb/forms/irb-exemption-review.doc • Training is required, initial and biennial continuing • Protocol Oversight Review by Department • Signature of Advisor • Address Informed Consent • Continuing Review/Final Report Required • Student Listed as Principal Investigator

14. Expedited & Full (convened) Review • http://www.uab.edu/irb/forms/hsp.doc - the Human Subjects Protocol • Training is required, initial and biennial continuing • Protocol Oversight Review by Department • Signature of Advisor • Address Informed Consent • Continuing Review/Final Report Required • Student Listed as Principal Investigator

15. Expedited & Full (convened) Review • Full reviews have deadline dates - http://main.uab.edu/show.asp?durki=60362 • Special Approvals – as applicable • Hospital, TKC, Children’s, Highlands, etc. • Off-campus locations • International locations – Ethics review locally for issues of local context • Radiation Safety, Pharmacy, Biosafety

16. Changes (Amendments) to Approved Protocols • If your advisor will add you to an existing, approved protocol – he/she must submit an amendment to that protocol. http://www.uab.edu/irb/forms/project-revision-amendment.doc • Amendment must clearly state the student’s name and role/duties associated with the protocol (data collection, data analysis, informed consent, etc.).

17. Changes (Amendments) to Approved Protocols (continued) • If the students’ work is for a dissertation ir thesis the name of the thesis should be included on the amendment form. • Student are required to have human subjects training. • The IRB may require that the student have a separate application based on the extent of the student’s work and independence.

18. Amendment Form - Example 1. Contact Information Principal Investigator's Name: Dr. Faculty Member BlazerID: facultymember E-mail:  facultymember@uab.edu Contact Person's Name:Ann Assistant BlazerID: aass E-mail: aass@uab.edu Telephone: 4-3789 Fax: 4-1301 Campus Address: Old Hillman Building 2. Protocol Identification Protocol Title:Faculty Member’s Protocol IRB Protocol Number: F100100100 Current Status of Project(check only one): Currently in Progress (Number of participants entered:100) Study has not yet begun (No participants entered) Closed to participant enrollment (remains active)— Number of participants on therapy/intervention: Number of participants in long-term follow-up only: Closed to participant enrollment (data analysis only)— Total number of participants enrolled:

19. Amendment Form - Example This submission changes the status of this study in the following manner(check all that apply): Protocol Revision Revised Consent Form Protocol Amendment Addendum (new) consent form Study Closed to participant entry Enrollment temporarily suspended by sponsor Study Closure Change in protocol personnel Other, (specify) 3. Reason for change Briefly describe, and explain the reason for, the change. If normal, healthy controls are included, describe in detail how this change will affect those participants. Include a copy of the protocol and any other documents affected by this change (e.g., consent form, questionnaire) with all the changes highlighted.I am requesting that Medical Student, John Doe be added to this protocol. Mr. Doe will be involved in data collection, data analysis (please be specific) as part of his MS-2 scholarly activity project. He has completed human subjects training. Note if you will be using data, obtaining samples, etc or if you plan to use the information/specimens for a dissertation, you will need to include the title of the dissertation here as well.

20. Amendment Form (continued) • Must be specific to each student’s work • Address applicable items for student’s work and put n/a if not applicable

21. Informed Consent • Informed consent is the cornerstone of research with people • Informed Consent Document with signatures • Verbal Consent with documentation waived – no signature • Waiver of Informed Consent • Minimal risk research • Waiver or alteration will not adversely affect the rights and welfare of participants • Research could not be practicably be carried out without waiver/alteration • Additional Information provided when appropriate • For more info – see 45 CFR 46.116

22. Informed Consent – Essex IRB Study • 578 individuals randomly selected to assess level of understanding of some commonly used terms in consent forms • Results: • A placebo is a small animal like an amoeba. • Double-blind means being blind in both eyes. • Serum is a drug. • An Institutional Review Board is a committee in a hospital that reviews your medical records to see whether or not you should be institutionalized.

23. Other examples of consent form out-takes... “The autopsy will have no benefit to you.” “This page left intestinally blank”

24. A note about expository writing.... • How to make a peanut butter and jelly sandwich

25. How to contact the IRB • irb@uab.edu • 470 Administration Building, 701 20th Street South • 205.934.3789 – phone • 205.934.1301 – Fax • http://main.uab.edu/show.asp?durki=30246 or www.uab.edu/irb • Questions?