Tulane University HRPO Uptown Workshop Social/Behavioral Research

1. WELCOME to the TULANE UNIVERSITY HUMAN RESEARCH PROTECTION OFFICE WORKSHOP for SOCIAL/BEHAVIORAL RESEARCH(March 2, 2010) Tulane University HRPO Uptown Workshop Social/Behavioral Research

2. TULANE UNIVERSITY INSTITUTIONAL REVIEW BOARDS:Tulane University has established 2 Institutional Review Boards (IRBs):1 for Biomedical Research and 1 for Social/Behavioral ResearchThe Social/Behavioral IRB typically reviews research involving the social sciences, such as sociology, psychology, social work, political science, and history. Typical methodologies include: direct observation, interviews, questionnaires, focus groups, and surveys. Tulane University HRPO Uptown Workshop Social/Behavioral Research

3. WHAT IS SUBJECT TO IRB REVIEW AND APPROVAL:In accordance with Federal Regulations, all Social/Behavioral Research involving human subjects conducted at or in affiliation with Tulane University must be reviewed and approved by the Social/Behavioral IRB prior to initiating the study. Tulane University HRPO Uptown Workshop Social/Behavioral Research

4. ETHICAL PRINCIPALS GUIDING THE IRB:In 1974, the National Research Act established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission published the Belmont Report, which sets forth the basic ethical principals that guide the conduct of research with human subjects. The IRB is guided by the 3 principles established:Respect for Persons:Investigators are required to seek voluntary informed consent from potential subjectsBeneficence:Requires that researchers maximize the potential benefits to the subjects and minimize the risk of harmJustice:Subjects are selected fairly and the risks and benefits of research are distributed equitably Tulane University HRPO Uptown Workshop Social/Behavioral Research

5. REGULATIONS GUIDING THE IRB:The IRB reviews research in accordance with the Health and Human Subjects (HHS) regulations published in the Code of Federal Regulations (45 CFR 46, or “The Common Rule”).In the review of research projects, the Criteria for Approval are as follows:-Risks are minimized by the use of sound research design-Risks to subjects are reasonable in relation to anticipated benefits-Selection of subjects is fair and equitable-Participation is voluntary and informed consent will be sought from each subject (or the subject’s legally authorized representative)-Informed consent will be appropriately documented-When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects-There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data Tulane University HRPO Uptown Workshop Social/Behavioral Research

6. 3 TYPES OF IRB REVIEWS: EXEMPT REVIEW EXPEDITED REVIEW FULL BOARD REVIEW Tulane University HRPO Uptown Workshop Social/Behavioral Research

7. EXEMPT RESEARCH:Certain categories of research can be exempt from Federal Regulations (Exempt does not mean exempt from IRB review)In order to qualify for an Exemption, the research must fall entirely under one or more of the 6 Categories of Exemption AND cannot place the subjects at a greater than minimal risk.In accordance with Tulane HRPO Policy, any international research does not qualify for exemption.In accordance with Federal Regulations, if the research involves prisoners, it does not qualify for exemption. Tulane University HRPO Uptown Workshop Social/Behavioral Research

8. EXEMPT RESEARCH:Some common examples of Exempt Research are the following:-Observational Studies-Simple Surveys (not collecting any identifying information)-Research using published or secondary data that has been de-identifiedIf you are planning to conduct a research project and think it falls under the Exempt Categories, we urge you to email a short summary of the project to irbmain@tulane.edu for a definitive answer before you apply. Tulane University HRPO Uptown Workshop Social/Behavioral Research

9. EXPEDITED RESEARCH:Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB.A list if 7 categories has been established in the Federal Register and in order to qualify for an Expedited review, all research activities must only involve procedures listed in one or more of these categories and present subjects with a no more than minimal risk. Tulane University HRPO Uptown Workshop Social/Behavioral Research

10. EXPEDITED RESEARCH:What is MINIMAL RISK?Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves that those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Tulane University HRPO Uptown Workshop Social/Behavioral Research

11. FULL BOARD REVIEW:-If the research study proposed does not meet the criteria for Exempt or Expedited review, then it must be submitted for full review at a convened meeting of the Social/Behavioral IRB-The studies reviewed by the IRB are typically studies that represent a greater than minimal risk or involve a vulnerable populationNOTE: ALTHOUGH A PRINCIPAL INVESTIGATOR MAY APPLY FOR A SPECIFIC TYPE OF REVIEW, THE TULANE UNIVERSITY IRB RESERVES THE RIGHT TO REQUIRE A MORE STRINGENT REVIEW OF ANY STUDY AS DEEMED APPROPRIATE. Tulane University HRPO Uptown Workshop Social/Behavioral Research

12. Tulane University HRPO Uptown WorkshopSocial/Behavioral Research • 2010 SOCIAL/BEHAVIORAL IRB MEETING DATES AND DEADLINES • EXEMPT AND EXPEDITED SUBMISSIONS ARE TAKEN ON AN ONGOING BASIS

13. INFORMED CONSENT:Informed Consent is one of the basic ethical obligations for researchers.The purpose of a Consent Form is to provide a written source of information about the research project and a place to document that the subject’s consent was given before subject enrollment.NOTE: IN SOME CIRCUMSTANCES, THE INFORMED CONSENT PROCESS AND/OR THE DOCUMENTATION OF INFORMED CONSENT CAN BE WAIVED. MORE INFORMATION CAN BE FOUND ON THE TULANE HRPO WEBSITE.NOTE: WE HAVE CREATED A SOCIAL/BEHAVIORAL INFORMED CONSENT TEMPLATE FOR YOUR USE AND URGE YOU TO USE IT, AS IT CONTAINS ALL THE REQUIRED ELEMENTS OF A PROPER INFORMED CONSENT DOCUMENT. THE TEMPLATE CAN BE FOUND ON THE TULANE HRPO WEBSITE. Tulane University HRPO Uptown Workshop Social/Behavioral Research

14. INVESTIGATOR RESPONSIBILITES:Responsibilities of the Primary Investigator while conducting research include:-Following the IRB approved protocol and using only the IRB approved documents including the Informed Consent Document, Advertisements, etc. -Submitting a Continuing Review/Progress Report before the expiration date to the HRPONOTE: A CONTINUING REVIEW/PROGRESS REPORT MUST BE SUBMITTED IN ENOUGH TIME PRIOR TO THE EXPIRATION DATE TO ALLOW FOR A MEANGINGFUL AND SUBSTANTIVE REVIEW. 60 AND 30 DAY NOTICES ARE SENT OUT VIA IRBNET.-Submitting any Unanticipated Problems and Protocol Violations to the HRPO-Submitting a Study Closure when all research activity is final Tulane University HRPO Uptown Workshop Social/Behavioral Research

15. TULANE UNIVERSITY HRPO STANDARD OPERATING PROCEDURES:(SOPs)The SOPs for our office are available along with many other resources on our website: http://tulane.edu/asvpr/irb/index.cfmThe SOPs are to assist Investigators and other Research Staff with Tulane University requirements as well as Federal requirements. Tulane University HRPO Uptown Workshop Social/Behavioral Research

16. SUBMISSION TO THE TULANE HRPO:-CITI Training-Initial Submission Checklist-Secondary Submission Checklist-Electronic Submission via IRBNet(IRBNet Video: New Project Submission and IRBNet Users Guide) Tulane University HRPO Uptown Workshop Social/Behavioral Research