1. Joey Casanova, Education Coordinator Human Subject Research Office

3.  Respect: individuals must be autonomous in their decisions of whether to participate in research (making informed decisions)  Beneficence: securing well-being of participants by reducing risks  Justice: considerations appropriate to avoid injustices that arise from social, racial, sexual, and cultural biases

4.  The mission of the OHRP is to monitor and promote compliance with regulations set forth from the Department of Health and Human Services (DHHS) that relate to the ethical standards of research involving human subjects (45 CFR 46).  Any research involving a drug, a biologic, or a medical device is subject to Food & Drug Administration (FDA) regulation (21 CFR 50, 56, respectively).

5. UM Policies & Procedures State and Local Laws Federal Regulations

7.  HHS: A living individual about whom an investigator… conducting research obtains 1. Data through intervention or interaction with the individual, or 2. Identifiable private information  FDA: Recipient of test article or control

8.  HHS: A systematic investigation designed to develop or contribute to generalizeable knowledge  FDA: Clinical Investigations of FDA Regulated Products – any experiment in which a drug, biologic or significant risk device is administered or dispensed to or used involving one or more human subjects

9. Human Subjects Research

10. Exempt Low Expedited Minimal Full Higher *Level of risk helps determine route of review

11.  DHHS 45 CFR 46.102(i) & FDA 21 CFR 56:  The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during routine physical or psychological exams or tests  OHRP Guidance:  Minimal risk is relative to the daily life of a normal, healthy person. The risk threshold cannot increase because the person is sick and faces greater risk due to illness

12.  Six categories defined by 45 CFR 46  Research must fall into one or more of the categories to be exempt  IRB has the responsibility to determine exemption, PI cannot make determination  May still require consent or other safeguards  How is data being collected?  Is there a code that links data to subjects (easily identifiable)?

13. (1) Educational research (2-3) Tests, surveys, interviews or public observation (4) Research on existing public or anonymous data or specimens (5) Federal demonstration projects (6) Taste and food evaluation

14.  Expedited does not mean quicker  Rigor of review is the same, number of reviewers different  Review carried out by IRB chair or by one or more experienced reviewers  Reviewers may approve or modify, but may not disapprove

15. An IRB may use the expedited review procedure to review either of the following:  Some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk  Minor changes in previously approved research during the period (of one year or less) for which approval is authorized

16. (1) Clinical studies: IND/IDE not required (2) Blood sample collection (routine methods – small amounts) (3) Prospective collection of biological samples – noninvasive means (4) Data collected through noninvasive means (routinely practiced in clinical settings) (5) Materials (data, documents, specimens) have been collected or will be collected for non- research purposes (6) Collection of voice, video or digital data for research purposes (7) Individual or group behavior, surveys, interviews, oral histories

17. This is not correct. The IRB must consider the risk of criminal/civil liability, financial risk, employment risk, risk of stigmatization, risk to insurability, and risk of embarrassment in addition to physical risk when deciding if risk is truly minimal.

18.  A full quorum is assembled (at least half of the members plus one, includes nonscientist)  All members participate in discussion and make comments (plenary review)  Decision is rendered by a majority of the assembled quorum  No member with a conflict of interest participates in the decision  Numerical vote is taken and recorded

19.  Minimized risks (not eliminated)  Reasonable risk/benefit assessment  Equitable subject selection  Informed consent process  Informed consent documentation  Data monitored for safety  Confidentiality/privacy maintained  Vulnerable populations protected

21.  Unless waived by the IRB, the investigator must obtain the legally effective informed consent of the subject or the subject’s legally authorized representative  Must provide the subject sufficient opportunity to consider participation and minimize undue influence  Information must be in language understandable to the subject  May not include exculpatory language

22.  Consent is a Process in which:  You disclose relevant information  The potential subject has the opportunity to ask questions  You answer questions  The consent form is a permanent record of…  The information you conveyed  The fact that the process occurred  The subject’s willingness to participate

23.  Research acknowledgement  Purpose of the study  Description of procedures  Description of potential risks  Description of potential benefits  Alternatives  Confidentiality  Compensation for Injury  Who will answer questions  Participation is voluntary

24.  The fact there may be unforeseeable risks  Involuntary termination of participation  Additional research costs  Consequences of subject withdrawal  Significant new finding will be reported to subject  Approximate number of subjects  Payments/Reimbursement

26.  Applies to children 7 through 17 years of age.  Failure to object is not assent  IRB determines whether and how it is documented  Assent is required except:  when child not capable: age, maturity, or psychological state;  Research presents direct benefit; important to the child’s well-being, and available only in context of research

27.  Assent can be waived if:  Research involves no more than minimal risk  Waiver will not adversely affect the rights and welfare  Research could not be practicably carried out without the waiver  Whenever appropriate the participants will be provided with additional pertinent information

28. http://hsro.miami.edu

29. Electronic PROtocol Submission & Tracking system  Assists the HSRO in supporting and managing all biomedical and social behavioral research  Access via standard internet browser  Internet Explorer (PC Users)  Safari (Apple Users)  Captures information capture as required by federal regulations, state laws, and institutional policies

30.  Full Re-deployment of the electronic workflow will be completed in February 2008  Study teams will continue to complete protocol forms in eProst  All members of the Protocol Team need to Submit their Conflict of Interest disclosures individually  Principal Investigator will then be able to Submit Protocol  Study will now be traveling through the workflow

31.  Accessible anywhere you have internet access  Faster turnaround time for submissions to the HSRO  Easier tracking of studies through review process  Incorporated audit trail  Improved interaction between study teams and Institutional Review Board staff  Back-ups performed regularly by both the HSRO and Med-IT  IRB-approved and watermarked documents available online

32. No new studies are being reviewed at WIRB Many existing studies currently at WIRB are being reacquired at continuing review WIRB submissions will still need to be printed for submission to the HSRO and subsequently WIRB Only WIRB forms required for continuing report or amendment ◦ Investigators asked to update smart form for amendments when necessary

33.  eProst User Guide available at http://hsro.miami.edu http://hsro.miami.edu  Up-to-date information relayed via eProst and HSRO eNews

64. Pre-Submission Originating Department Review Changes Required by Originating Department Ancillary Committee Review Changes Required by Ancillary Reviewer Pre-Board Review Disapproved Withdrawn

65. Pre-Board ReviewRegulatory Review Awaiting Meeting Assignment IRB Meeting Assigned Changes Required by Regulatory Staff Expedited Review in Progress Approved Deferred to Full Board Exempt Review in Process Approved Deferred to Full Board Changes Required by Pre-Board Staff Protocol at WIRB Ancillary Committee Review

66. IRB Meeting Assigned Meeting Complete: Post- Board Review Approved Deferred to Chair Board Disapproval Deferred to Full Board

67. Average time for completion of review process/IRB determination = 4-6 weeks Study cannot begin until PI has received approval notification from the IRB. Submission arrives At HSRO Post-Board Review (Determination Letter) IRB Regulatory Specialist (Exempt & Expedited Review) IRB Regulatory Analyst (Full Board Review) IRB Full Board IRB Chair/Designee (Exempt/Expedited)

68.  Educational Initiatives  Marisabel Davalos, M.S.Ed., C.I.P. Assistant Director for Educational Initiatives mdavalos@med.miami.edu 305-243-9769 mdavalos@med.miami.edu  Joey Casanova Education Coordinator jcasanova@med.miami.edu 305-243-3476 jcasanova@med.miami.edu  HSRO IT Group  Stella Uyeno Sr. Systems Administrator suyeno@med.miami.edu 305-243-3196 suyeno@med.miami.edu  Leandro Guzman Software Specialist II lguzman3@med.miami.edu 305-243-8554 lguzman3@med.miami.edu  Regulatory Guidance/ Participant Complaints  Amanda Coltes-Rojas, M.P.H., C.I.P. Associate Director for Regulatory Affairs and Educational Initiatives acoltes@med.miami.edu 305-243-6494 acoltes@med.miami.edu  eProst Help Desk  Daniel Auguste IRB Senior Staff Assistant dauguste@med.miami.edu 305-243-9662 dauguste@med.miami.edu  eProst General Technical Assistance Via email: eprost@med.miami.edu 305-243-3195eprost@med.miami.edu