EMORY UNIVERSITY INSTITUTIONAL REVIEW BOARD …

1 EMORY UNIVERSITY INSTITUTIONAL REVIEW BOARD POLICIES AND PROCEDURES JANUARY 10, 2018 EMORY UNIVERSITY 1599 Clifton Road, 5th Floor - Atlanta, Georgia 30322 Tel: - Fax: - Email: - Web: An equal opportunity, affirmative action UNIVERSITY EMORY UNIVERSITY IRB P&Ps Revised 12/5/2017 Page 2 of 402 EMORY UNIVERSITY STANDARD POLICY FORMAT COVER SHEET POLICY: EMORY UNIVERSITY INSTITUTIONAL REVIEW BOARD (IRB) POLICIES AND PROCEDURES (P&PS) RESPONSIBLE OFFICIAL: INSTITUTIONAL OFFICIAL ADMINISTERING OFFICE: IRB OFFICE LAST REVISION: JANUARY 10, 2018 POLICY SECTIONS: SEE TABLE OF CONTENTS OVERVIEW: POLICIES APPLICABLE TO HUMAN SUBJECTS RESEARCH CONDUCTED UNDER THE AUSPICES OF EMORY UNIVERSITY . APPLICABILITY: UNIVERSITY -Wide POLICY DETAILS: See specific P&P Sections.

2 DEFINITIONS: Included within specific P&Ps and within P&Ps Glossary. RELATED LINKS: CONTACT INFORMATION: Subject Contact Phone Clarification of Policy IRB Director 404-712-0720 REVISION HISTORY: Initial draft January 25, 2007. Revised January 4, 2008, February 28, 2008, April 30, 2008, July 16, 2008, November 7, 2008, January 13, 2009, April 14, 2009, August 3, 2009, May 11, 2010, August 10, 2010, September 7, 2010, February 15, 2011, August 22, 2011, January 13, 2012, April 23, 2012, June 29, 2012, August 16, 2012, October 31, 2012, January 18, 2013, May 24, 2013, February 17, 2014, February 26, 2014, August 13, 2014, May 14, 2015, June 9, 2015, September 22, 2015, July 1, 2016, December 5, 2017 and January 10, 2018. EMORY UNIVERSITY IRB P&Ps Revised 12/5/2017 Page 3 of 402 TABLE OF CONTENTS 1 EMORY UNIVERSITY HUMAN RESEARCH PROTECTION PROGRAM & DEFINED TERMS 8 2 principles GOVERNING EMORY HRPP 11 3 INSTITUTIONAL AUTHORITY 14 4 FEDERALWIDE ASSURANCE (FWA) 16 5 ROLES AND RESPONSIBILITIES UNDER THE EMORY HRPP 18 6 NUMBER OF IRBS AND REGISTRATION 22 7 ROLES AND RESPONSIBILITIES FOR ENSURING ADEQUATE RESOURCES TO PROTECT HUMAN SUBJECTS 25 8 APPLICABILITY OF STATE LAW 26 9 EMORY UNIVERSITY IRB OFFICE 27 10 EMORY IRB P&PS 29 11 AUTHORITY AND RESPONSIBILITY OF THE EMORY IRB 32 12 JURISDICTION OF THE EMORY IRB 36 13 EMORY IRB RELATIONSHIPS WITH OTHER REGULATORY COMMITTEES 38 14 EMORY IRB COORDINATION WITH OTHER UNIVERSITY COMPLIANCE ENTITIES 41 15 EMORY IRB RELATIONSHIPS WITH OTHER INSTITUTIONS.

3 RELIANCE ARRANGEMENT FOR IRB REVIEW 43 16 LOCAL RESEARCH CONTEXT; RESEARCH CONDUCTED AT NON- EMORY SITES 48 17 HUMAN SUBJECTS RESEARCH AT THE ATLANTA VETERANS AFFAIRS MEDICAL CENTER (AVAMC)/ATLANTA RESEARCH AND EDUCATION FOUNDATION (AREF) 53 18 DEPARTMENT OF DEFENSE (DOD) SUPPORTED RESEARCH 61 19 EMORY IRB ADMINISTRATION AND OFFICIALS 67 20 SUBCOMMITTEES OF THE EMORY IRB 75 21 CONDUCT OF QUALITY ASSURANCE/QUALITY IMPROVEMENT ACTIVITIES FOR EMORY IRB OPERATIONS 77 22 IRB MEMBERSHIP 79 EMORY UNIVERSITY IRB P&Ps Revised 12/5/2017 Page 4 of 402 23 ORIENTATION AND EDUCATION FOR IRB CHAIRS, MEMBERS, AND STAFF 87 24 IRB MEMBER LIABILITY, INSURANCE AND INDEMNIFICATION 90 25 CONSULTANTS AND AD HOC REVIEWERS 91 26 CONFIDENTIALITY OBLIGATIONS FOR IRB OFFICIALS, MEMBERS, CONSULTANTS, STAFF, & GUESTS 93 27 DOCUMENTATION AND RECORD RETENTION 95 28 IRB PROTOCOL TRIAGE AND ASSIGNMENT OF REVIEW CATEGORY 100 29 DETERMINATIONS OF ENGAGEMENT IN HUMAN SUBJECTS RESEARCH OR CLINICAL INVESTIGATION 102 30 EXEMPT RESEARCH 106 31 EXPEDITED REVIEW 111 32 FULL COMMITTEE REVIEW 116 33 IRB MEETINGS 118 34 MINUTES OF AN IRB MEETING 123 35 CONFLICTS OF INTEREST INVESTIGATORS 126 36 CONFLICTS OF INTEREST ON THE PART OF IRB MEMBERS AND IRB STAFF 129 37 INDEPENDENCE OF EMORY IRB WITH RESPECT TO INSTITUTIONAL AND INVESTIGATOR INFLUENCE 132 38 POSSIBLE IRB ACTIONS ON HUMAN SUBJECTS RESEARCH PROTOCOLS 134 39 CONTINUING REVIEW 142 40 PROTOCOL MODIFICATIONS (AMENDMENTS)

4 147 41 CLOSURE OF PROTOCOLS 151 42 CRITERIA FOR EMORY IRB APPROVAL OF RESEARCH 152 43 INFORMED CONSENT 156 44 INFORMED CONSENT OF NON-ENGLISH SPEAKING SUBJECTS 162 45 LEGALLY AUTHORIZED REPRESENTATIVES AND SURROGATE CONSENT 165 46 WAIVER OF DOCUMENTATION OF INFORMED CONSENT 169 EMORY UNIVERSITY IRB P&Ps Revised 12/5/2017 Page 5 of 402 47 WAIVER OR ALTERATION OF INFORMED CONSENT FOR RESEARCH 171 48 WAIVERS OF, AND EXCEPTIONS FROM, INFORMED CONSENT FOR PLANNED EMERGENCY RESEARCH 175 49 CONSENT MONITORING 182 50 DATA AND SAFETY MONITORING PLANS 183 51 REVIEW OF RESEARCH PROTOCOLS INVOLVING VULNERABLE POPULATIONS 188 52 RESEARCH INVOLVING CHILDREN ADDITIONAL PROTECTIONS 191 53 RESEARCH INVOLVING WARDS OF THE STATE ADDITIONAL PROTECTIONS 199 54 RESEARCH INVOLVING PRISONERS ADDITIONAL PROTECTIONS 201 55 RESEARCH INVOLVING PREGNANT WOMEN, HUMAN FETUSES AND NEONATES ADDITIONAL PROTECTIONS 208 56 RESEARCH INVOLVING PERSONS WITH MENTAL DISABILITIES OR PERSONS WITH IMPAIRED DECISION-MAKING CAPACITY 213 57 REQUIREMENTS FOR RESEARCH INVOLVING HUMAN EMBRYONIC STEM CELLS, GERM CELLS.

5 STEM CELL-DERIVED TEST ARTICLES AND THE TRANSPLANTATION OF HUMAN FETAL TISSUE FOR THERAPEUTIC PURPOSES 216 58 COMPLAINTS 221 59 COMMUNICATION CHANNELS FOR HUMAN SUBJECTS ABOUT RESEARCH 222 60 REVIEW OF INSTANCES OF NON-COMPLIANCE FOR DETERMINATION OF SERIOUS OR CONTINUING NON-COMPLIANCE AND REPORTING 224 61 PROTOCOL OVERSIGHT AND PROCEDURES FOR HANDLING AUDITS AND VIOLATIONS 226 62 SUSPENSIONS AND TERMINATIONS OF PREVIOUSLY APPROVED RESEARCH 235 63 REPORTING TO GOVERNMENTAL REGULATORY AUTHORITIES, SPONSORS, AND INSTITUTIONAL PERSONNEL 239 64 USING FDA-REGULATED PRODUCTS 244 65 INVESTIGATIONAL MEDICAL DEVICES 246 66 EMERGENCY USE OF INVESTIGATIONAL MEDICAL DEVICES 254 67 TREATMENT USE ( COMPASSIONATE USE ) OF INVESTIGATIONAL DEVICES 258 EMORY UNIVERSITY IRB P&Ps Revised 12/5/2017 Page 6 of 402 68 HUMANITARIAN USE DEVICES: EXEMPTIONS & USES 262 69 INVESTIGATIONAL NEW DRUGS (OTHER THAN EXPANDED ACCESS) 269 70 INVESTIGATIONAL NEW DRUGS - EXPANDED ACCESS 275 71 SPONSOR-INVESTIGATOR DRUG SAFETY REPORTING OBLIGATIONS 290 72 INVESTIGATOR SAFETY INFORMATION REPORTING OBLIGATIONS TO IRB 295 73 REPORTING TO EMORY IRB OF PROTOCOL DEVIATIONS/PROTOCOL NON-COMPLIANCE; NON-COMPLIANCE WITH APPLICABLE LAWS, REGULATIONS, OR IRB POLICIES AND PROCEDURES.

6 AND REPORTS REQUIRED BY PROTOCOL OR CONTRACT 305 74 HIPAA AND OTHER APPLICABLE PRIVACY LAWS AND POLICIES 308 75 RESEARCH DATA AND/OR SPECIMEN REPOSITORIES CONTAINING PHI HIPAA REQUIREMENTS 318 76 CERTIFICATES OF CONFIDENTIALITY & INCLUDING RESEARCH INFORMATION IN THE MEDICAL RECORD 319 77 MANDATORY REPORTING TO LAW ENFORCEMENT AGENCIES 320 78 RECRUITMENT OF SUBJECTS 327 79 PAYMENT OF SUBJECTS 331 80 EMORY UNIVERSITY AND OTHER STUDENTS AS SUBJECTS - INCLUDING DEPARTMENT OF EDUCATION REQUIREMENTS 334 81 EMORY EMPLOYEES AS SUBJECTS 340 82 INVESTIGATOR QUALIFICATIONS 342 83 RESEARCH CONDUCTED BY STUDENTS AND TRAINEES 346 84 IRB REVIEW OF ORAL HISTORY PROJECTS 349 85 GENETIC STUDIES 351 86 COLLECTION, PROCESSING AND/OR BANKING OF HUMAN RESEARCH SUBJECTS SPECIMENS 354 87 RESEARCH INVOLVING CODED PRIVATE INFORMATION OR BIOLOGICAL SPECIMENS 359 88 DEPARTMENT OF ENERGY 362 89 DEPARTMENT OF JUSTICE 365 EMORY UNIVERSITY IRB P&Ps Revised 12/5/2017 Page 7 of 402 90 ENVIROMENTAL PROTECTION AGENCY 369 91 GLOSSARY 371 EMORY UNIVERSITY IRB P&Ps Revised 12/5/2017 Page 8 of 402 1 EMORY UNIVERSITY HUMAN RESEARCH PROTECTION PROGRAM & DEFINED TERMS POLICY: EMORY UNIVERSITY has established a Human Research Protection Program ( EMORY HRPP) to safeguard and promote the health and welfare of human research subjects by ensuring that their rights, safety and well-being are protected.

7 DEFINED TERMS: All defined terms used in this document are capitalized and in bold Italic typeface. Complete definitions of defined terms as well as any acronyms used herein, are set forth in the Glossary at the end of this document. PROCEDURES: Mission of EMORY UNIVERSITY HRPP: EMORY UNIVERSITY fosters a Research environment that promotes the respect for the rights and welfare of individuals recruited for, or participating in, Research conducted by or under the auspices of EMORY UNIVERSITY . EMORY UNIVERSITY is guided by applicable laws, regulations and principles in its REVIEW and conduct of Human Subjects Research. To fulfill this mission, EMORY UNIVERSITY has established a Human Research Protection Program. The mission of the EMORY HRPP is: To safeguard and promote the dignity and well-being of participants in research conducted at or by EMORY by assuring their rights, safety and welfare are protected; To provide timely and high quality REVIEW and monitoring of human subjects research; and To facilitate excellence in human subjects research by providing accurate guidance and education to EMORY investigators, IRB members, and research officials.

8 To ensure compliance with all regulatory and ethical obligations involved in Human Subjects Research conducted at or by EMORY . The HRPP is a multi-tiered program involving the administration of the UNIVERSITY , the INSTITUTIONAL Official, the INSTITUTIONAL REVIEW BOARD , other research administrative and compliance offices, investigators and research support staff. The HRPP includes mechanisms to: Establish a formal process to monitor, evaluate and continually improve the protection of human research participants. Dedicate resources sufficient to do so. Educate investigators and research staff about their ethical responsibility to protect research participants. When appropriate, intervene in research and/or respond directly to concerns of research participants. INSTITUTIONAL Authority: The EMORY HRPP operates under the authority of EMORY UNIVERSITY IRB Policies & Procedures.

9 , which govern the conduct and REVIEW of all human research conducted EMORY UNIVERSITY IRB P&Ps Revised 12/5/2017 Page 9 of 402 under the auspices of EMORY UNIVERSITY . These P&Ps are made available to all EMORY UNIVERSITY investigators, staff, and the general public at the EMORY IRB website: Governing Laws, Regulations and principles : The EMORY HRPP is established pursuant to and in accordance with the laws, regulations and principles listed below regarding the protection of Human Subjects. EMORY UNIVERSITY will adhere to these laws, regulations and principles with regard to Research conducted by or under its auspices: The Department of Health and Human Services (HHS) policy and regulations at 45 CFR Part 46, also known as the Federal Policy for the Protection of Human Subjects or the Common Rule (collectively referred to in this document as the HHS Regulations, found at ; Food and Drug Administration (FDA) regulations at 21 CFR Parts 51 and 56 (collectively referred to in this document as the FDA Regulations, found at ~.))

10 The principles ( , respect for persons, beneficence and justice) set forth in the Ethical principles and Guidelines for the Protection of Human Subjects of Research (collectively referred to in this document as the Belmont Report, found at ; The Department of Veterans Affairs policies for Human Subjects Research protection, including the regulations at 38 CFR Part 16 and the VHA Handbook Section (collectively referred to in this document as the VA Regulations, found at and respectively) for Research involving the Atlanta Veterans Administration Medical Center (AVAMC) or Atlanta Research & Education Foundation (AREF); For projects subject to a DOD Addendum, any DOD Requirements. All other applicable federal, state and local laws and regulations. Agreement to Abide by principles and Regulations: EMORY UNIVERSITY agrees to uphold the ethical principles of the Belmont Report and to abide by all requirements of the applicable HHS, FDA, DOD and VA Regulations.)