Demystifying the IRB

Transcription

1 Demystifying the IRB Mariette Marsh, MPA, CIP Assistant Director Human Subjects Protection Program Ms. Marsh is the Assistant Director for Education and Outreach at the Human Subjects Protection Program. She brings with her over 12 years of human research review experience. She will provide guidance for investigators surrounding the review and approval process, electronic submissions, and helpful hints related to different types of clinical research. Proposed changes to the rules and regulations will be discussed time permitting. There will be plenty of opportunity to answer questions. Thursday, March 1, 2012 Noon to 1 PM 1609 N. Warren Ave., BRL Rm. C114 (Lunch provided please rsvp) For More Information and to RSVP, contact: paulette@aemrc.arizona.edu

2 Human Subject Protection Program New Investigators Mariette Marsh, MPA, CIP Assistant Director, HSPP (Direct) or (Main)

3 Role of the IRB Oversight of projects involving human research includes a review that ensures: The ethical conduct of research Compliance with Federal, State, local, and Institutional regulations and guidance. Provision for the protection of the rights, safety and welfare of human subjects involved in research at The University of Arizona and affiliated entities. 2

4 Founding Principles Three principles of The Belmont Report are key to protecting human subjects in either funded or unfunded research Respect: informed, voluntary consent of subjects Beneficence: assessment of risk/benefit to the subjects Justice: fairness in subject selection 3

5 Is it Research? Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Is the activity an investigation? (Investigation: A searching inquiry for ascertaining facts; detailed or careful examination.) Is the investigation systematic? (Systematic: Having or involving a system, method, or plan.) Is the systematic investigation designed to develop or contribute to knowledge? (Designed: evaluate whether the activities taking place will develop or contribute to knowledge. Develop: to elaborate or expand in detail. Contribute: to be an important factor in; help to cause. Knowledge: truths, facts, information.) Is the knowledge generalizable? (Generalizable: Publication does not automatically mean universal applicability.) 4

6 Definition of Human Subjects Human Subject means a living individual about whom an investigator conducting research (whether a professional or a student) obtains Data through intervention or interaction with the individual OR Identifiable private information 5

7 What may not be human research? Quality improvement activities Case Studies and Oral Histories Program evaluations Secondary analysis of existing data not collected specifically for the proposed project AND not identifiable 6

8 If the project is not Human Subjects Research Complete the FORM: Human Research Determination. If it is determined that the project is not human research, obtain all required signatures, and submit to HSPP for review. Unit reviewers may require additional documentation prior to making a determination If the PI is a graduate student, a copy of the form may be requested by the Graduate College. 7

9 Classifications Based on Risk Exempt (low or no risk) Receives an administrative review Expedited (minimal risk) Subject to Federal Regulations Reviewed by the Committee Chair/Co-Chair or designee Full Committee (greater than minimal risk) Subject to Federal Regulations Requires review by Committee at a convened meeting. 8

10 IRB Committees IRB 1 IRB 2 IRB 3 IRB 4 General Biomedical COM-Tucson General Biological Social and Behavioral COM-Phx SAVAHCS Oncology 9

11 Review Process Application Submission: Classification of project Approval Letter Issued Research Begins Include Current Project Approval Form, Protocol, All Recruitment Materials, Consent Form(s), and questions or surveys Exempt, Expedited or Full Review Revisions Requested Review and Approval Revisions Accepted Investigator makes all Revisions Continuing Review Required (if not exempt) Research Continues or Concludes 10

12 First Things First IRB Approval comes BEFORE: Recruitment Consent Enrollment Changes are Implemented There is no retroactive approval, and data may be lost if permission is not obtained prior to collection. 11

13 Materials Required for Submission Completed application CITI training is required for everyone involved with human research Is good for 4 years Copies of recruitment materials must be IRB approved prior to use (e.g. flyers, handouts, s, scripts) Types of Consents may include: Subject Consent, Parental Permission, Minor Assent, Subject Disclosure Grants, protocols, surveys, questionnaires, data abstraction sheets, etc. 12

14 Common Pitfalls Submitted too late to provide adequate time for review The most current template(s) were not used Lack of a thorough, clear description of the research goal Insufficient detail about the study procedures Incomplete answers to all questions (If not applicable, state why) The question asked is not the question answered Not all materials that a subject may see, hear, or be asked are submitted 13

15 Continuing Review Projects that are non-exempt must be re-approved by the IRB each year before the expiration date. Paperwork must be submitted to the HSPP 45 days in advance of expiration of project. Notices are sent 60 days in advance of expiration to address on file. If the project is not approved by the expiration date, the project will be administratively closed and a new application will be required. Investigators must complete the continuing review before new human research will be approved. 14

16 Special Populations Identified in regulations as vulnerable: Children Pregnant Women Prisoners Cognitively Impaired Other populations may include: Low socio-economic Migrants Native American Students 15

17 Stay Connected Visit our website to get the newest forms and updates Sign up for the HSPP Listserv to get the latest information and updates- it s easy: Mariette Marsh, MPA, CIP Assistant Director, HSPP marshm@ .arizona.edu (Direct) or (Main) 16

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