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Emory University IRB P&Ps Revised May 24 2021Table of Contentsunder the auspices of Emory University. These P&Ps are made available to all Emory Universityinvestigators, staff, and the general public at the Emory IRB website: http://www.irb.emory.eduGoverning Laws, Regulations and Principles: The Emory HRPP is established pursuant to and inaccordance with the laws, regulations, and principles listed below regarding the protection ofHuman Subjects. Emory University will adhere to these laws, regulations, and principles withregard to Research conducted by or under its auspices:The Department of Health and Human Services (HHS) policy and regulations at 45 CFRPart 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 http://www.hhs.gov/ohrp/policy/common.htmlFood and Drug Administration (FDA) regulations at 21 CFR Parts 51 and 56 (collectivelyreferred to in this document as the “FDA Regulations,” found athttp://www.cfsan.fda.gov/ dms/reg-2.html;The principles (i.e., respect for persons, beneficence, and justice) set forth in the EthicalPrinciples and Guidelines for the Protection of Human Subjects of Research (collectivelyreferred to in this document as the “Belmont Report,” found elmont.htm;The Department of Veterans Affairs policies for Human Subjects Research protection,including the regulations at 38 CFR Part 16 and the VHA Handbook Section 1200.05(collectively referred to in this document as the “VA Regulations,” found athttp://www.access.gpo.gov/nara/cfr/waisidx 98/38cfr16 98.html on.asp?pub ID 3052 respectively) forResearch involving the Atlanta Veterans Administration Health Care System (AVAHCS)or Foundation for Atlanta Veterans Education and Research(FAVER);For projects conducted or supported by the DoD, 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 byall requirements of the applicable HHS, FDA, DOD and VA Regulations. In this regard, EmoryUniversity has charged the Emory IRB with carrying out all responsibilities of a duly constitutedInstitutional Review Board as set forth in these governing regulations and principles. EmoryUniversity agrees to provide the Emory IRB with meeting space and sufficient staff andresources to support its review, oversight, record-keeping and other duties.Provision of Resources: Emory University is committed to providing adequate staff, physicalspace, and resources to adequately maintain and operate the Emory HRPP, including the IRB.The IO is tasked with evaluating the needs of the Emory HRPP, including the IRB and the IRBOffice, and ensuring that they are provided with adequate resources, including staff, legalcounsel, meeting and office space, equipment and supplies (e.g., copiers, office supplies,computers, internet access, etc.) and financial resources for conducting IRB business such asPage 9 of 413

Emory University IRB P&Ps Revised May 24 2021Table of Contentscarrying out the HRPP education program, identifying and managing conflicts of interest,carrying out the HRPP quality improvement plan and community outreach activities. Theresources provided for the Emory HRPP shall be reviewed and evaluated during the university’sannual budget review process. Modifications to resources required to support IRB operationsshall be made as necessary.Applicable Regulations:45 CFR Part 46, including 45 CFR §§ 46.103(b)(1) -(2); 46.109; 46.111 & 46.11221 CFR Parts 50 and 56, including 21 CFR §§ 56.109 & 56.11238 CFR Part 16, including 38 CFR §§ 16.103(b)(1) – (2); 16.1-09; 16.111; 16.112 & VHA HandbookSection 1200.0532 CFR Part 219 and DOD Directive 3216.02.For defined terms, see specific regulatory references above for each term.Page 10 of 413

Emory University IRB P&Ps Revised May 24 2021Table of Contents2 PRINCIPLES GOVERNING EMORY HRPPPOLICY:The Emory HRPP (including the Emory IRB) is guided by the ethical principles set forth in theBelmont Report regarding Human Subjects Research. All institutional and non-institutionalResearch performance sites for Emory University will be obligated by Emory University toconform to ethical principles which are at least equivalent to those of Emory University (i.e., theBelmont Report principles) or as may be determined by the Secretary of HHS hereinafter the“HHS Secretary.”PROCEDURES:Principles Considered by the Emory IRB in Reviewing Research: It is the duty of the Emory IRBto review and make decisions on all protocols for all Human Subjects Research. The primaryresponsibility of the Emory IRB is the protection of Human Subjects from undue risk and fromdeprivation of personal rights and dignity. This protection is best assured by consideration ofthe three principles of the Belmont Report, which are the touchstone of ethical Research:Respect for Persons: That voluntary participation by the Human Subjects, indicated byfree and informed consent, is assured;Beneficence: That an appropriate balance exists between the potential benefits of theResearch to the Human Subject or to society and the risks assumed by the HumanSubject; andJustice: That there are fair procedures and outcomes in the selection of Researchsubjects.Implementation of Belmont Report Principles by the Emory IRB in its Review of Research –Respect for Persons:The Emory IRB shall implement this principle by striving to ensure voluntary informedconsent of Human Subjects through careful review of the recruitment and consentprocess and of the consent form or information sheet to be used with Human Subjects.The assurance of voluntary informed consent is one of the most important elements inany Research involving Human Subjects. Any person who is to be a Human Subject in astudy, whether the study is designed for their own direct benefit or for theadvancement of scientific knowledge in general, must understand as completely aspossible what is to be done and what the potential risks and benefits are. The personmust give their consent freely without pressure or inappropriate inducement.The Emory IRB shall extend the informed consent concept to those studies in which thesubjects are not able to give personal consent for themselves. In these instances, theconsent document is addressed to those who have been designated responsible for theHuman Subject’s wellbeing (e.g., parents of Children). The Emory IRB’s concern is toverify that the consent process and document are likely to assist these persons to makePage 11 of 413

Emory University IRB P&Ps Revised May 24 2021Table of Contentsan informed decision, which is in the best interest of the Human Subject.The Emory IRB shall consider the nature of the study population in determining thecapacity of that population for truly informed and voluntary participation in Research.At one extreme, there may be ample understanding and manifest freedom fromcoercion; at the other, there may be degrees of understanding and freedom that affectthe consent of potential subjects. The Emory IRB must exercise special care whenconsidering subjects whose ability to give free and informed consent may becompromised in any way and ensure that additional safeguards are completed asappropriate.Implementation of Belmont Principles by the Emory IRB in its Review of Research –BeneficenceThe Emory IRB shall implement this principle by examining the risk-benefit ratio of theResearch it is reviewing. The IRB is charged with deciding for any proposed activitywhich falls under its jurisdiction, whether, “[r]isks to subjects are reasonable in relationto anticipated benefits, if any, to subject and the importance of the knowledge that mayreasonably be expected to result.” [45 CFR Section 46.111(a)(2)].In assessing the risk-benefit relation, the Emory IRB may include consideration of thefollowing factors: (a) risks of injury or discomfort to the individual that can be physical;psychological and/or social; and (b) potential benefits to the individual, a group to whichthe individual belongs and/or to society. In reviewing Research protocols, the IRB mustcarefully assess the types and degrees of both risks and benefits for a given subjectpopulation, as well as the investigator’s communication of these risks and benefits inthe consent process and form.While the Emory IRB is not charged with reviewing the scientific design of Research perse, it must sometimes do so in order to assess the risk/benefit ratio. If a study’s designdoes not seem adequate to attain the stated aim of the study, then no benefit can beanticipated from conducting the study, and there is no justification for placing anyHuman Subject at risk, however, minimal. Thus, the design of the study must be soundand the nature and likelihood of all risks and benefits must be made clear in anyapplication to the IRB.Implementation of Belmont Principles by the Emory IRB in its Review of Research – JusticeThe Emory IRB shall implement this principle by ensuring that the Research involves afair selection of Human Subjects through a fair (a) sharing of Research risks and (b)sharing of Research benefits. Both the risks and potential benefits of Research shouldbe spread fairly among potential individual Research subjects and Research subjectgroups. Study design and selection of subjects should avoid bias for or against particularsocial, racial, sexual, or ethnic groups.Sharing Research Risks: The guiding principle in the ethical selection of Researchsubject groups is that any risks of the Research should fall upon the groups who mightbenefit from the Research. If the results of a risky protocol might benefit the generalPage 12 of 413

Emory University IRB P&Ps Revised May 24 2021Table of Contentspopulation, it would be unethical to focus subject recruitment on vulnerable ordisadvantaged groups (e.g., institutionalized people or Prisoners; or patients at freeclinics primarily patronized by people unable to afford other medical care) simplybecause they are easily accessible or can be persuaded to participate. An undue shareof Research risks also should not burden groups already burdened by other factors.Rather attempts should be made to include a fair sampling of the populations whomight benefit from the study. When Research involves persons whose autonomy iscompromised, it is expected that the Research bear some direct relationship to theconditions or circumstances of the Research subject population. In addition, groupsfully able to consider Research risks and informed consent should be asked to faceResearch risks before more Vulnerable Populations. For example, InvestigationalDrugs are usually tested in Adults before they are tested in Children. CertainInvestigational Drugs and procedures may be tested in healthy volunteers before beingtested in patients.Sharing Research Benefits: The Emory IRB should consider the desires of various groupsto be included in Research. As individuals, and through advocacy groups, many patientshave come to insist on having access to experimental treatments, as these experimentaltreatments may potentially provide the best medical care available. In addition,Researchers, ethicists and public officials have recognized that because many clinicaltrials focused primarily on white middle-class Research subject groups, the results ofsome trials were of questionable value to members of other social, racial, sexual andethnic groups. As a result, both the National Institutes of Health (NIH) and FDA nowrequire that study design include as broad a range of Research subjects as feasible andthe data be analyzed to uncover responses that differ between groups. Whereaswomen of child-bearing potential, Pregnant Women, and nursing women previouslywere routinely excluded from new drug trials, it is now required that whenever possiblethese women be asked to make their own choices regarding participation after beingfully informed of the risks of the Research.Ethical principles from other sources (e.g., International Conference on Harmonization) may alsobe applied to research covered by the HRPP, for example: To an individual protocol because its particular circumstances raise a type of ethicalissue that most other protocols do not When they are recognized by the federal or other funding source or the state or countrywhere the research will occur When they have been developed for specific areas or types of subjects (e.g., embryosand fetal tissue, illiterate subjects)In general, when Sponsor terms and conditions require the application of another set ofethical principles, specifically ICH-GCP, the Emory office reviewing the contract attempts toremove the requirement, and if the terms and conditions remain, that office will alert theIRB.Applicable Regulations:45 CFR § 46.111(a)(2)45 CFR § 56.111Page 13 of 413

Emory University IRB P&Ps Revised May 24 20213Table of ContentsINSTITUTIONAL AUTHORITYPOLICY:The President of Emory University has the power and authority to designate the individualwithin the University who may serve as the Institutional Official (IO) responsible for carrying outEmory University’s Human Research Protections Program (HRPP). The person designated asInstitutional Official must meet the qualifications set forth in these IRB Policies & Procedures(P&Ps). The President of Emory University has designated the Emory IRB as the body withinEmory University that has jurisdiction over all Human Subjects Research conducted under theauspices of Emory University.PROCEDURES:Appointment of the Institutional Official (IO): The President of Emory University shall appointthe IO in writing. As of the effective date of these P&Ps, the President of Emory University hasappointed the person named in Appendix 1 to serve as the IO. Appendix 1 shall be updated bythe IRB Director as necessary to reflect any changes in this appointment.Qualifications of the IO: In order to be eligible for appointment as the IO, an individual must bean employee of Emory University who holds a position within the University per which they hasthe legal authority to act and speak for Emory University as a whole, and per which they canensure that Emory IRB will effectively fulfill its Research oversight functions.Term of Appointment of the IO: The IO shall serve in this position until the earlier of the dateon which:The IO leaves Emory University;The IO no longer has the ability or capacity to fulfill the role of IO;The President of Emory University, at their discretion, requests the IO’s resignation andappoints a new IO; orUntil IO tenders a resignation from the position and the President appoints a new IO.The resignation shall be required at any time at which the IO does not meet thequalifications for holding this position.Designation of Emory IRB: The President of Emory University has designated the Emory IRB asthe body within Emory University that has jurisdiction over all Human Subjects Researchconducted under the auspices of Emory University, as described in the provision immediatelybelow entitled Human Subjects Research Subject to Emory IRB Authority.Human Subjects Research Subject to Emory IRB Authority: The Human Subjects Researchunder the auspices of Emory University that is subject to the authority of the Emory IRBincludes:Page 14 of 413

Emory University IRB P&Ps Revised May 24 2021Table of ContentsHuman Subjects Research conducted at Emory University;Human Subjects Research conducted by or under the direction of any employee oragent of Emory University in connection with their institutional responsibility;Human Subjects Research conducted by students of Emory University in connectionwith their institutional responsibilities;Human Subjects Research conducted by or under the direction of any employee oragent of Emory University using any property or facility of Emory University or involvingEmory University non-public information to identify or contact Human Subjects.Institutions In Addition to Emory University that Rely on the Emory University IRB:Per specific, written agreements with Emory University, other institutions may rely onthe Emory University IRB and are thereby subject to these P&Ps.The Emory IRB provides review for Human Subjects Research conducted at the AVAHCSunder the AVAHCS Memorandum of Understanding.Applicable Regulations:45 CFR Part 46, including 45 CFR §§ 46.103(b)(1)-(2); 46.109; 46.111; & 46.112.21 CFR Parts 50 and 56, including 21 CFR §§ 56.109; 56.111 & 56.112.38 CFR Part 16, including 38 CFR §§ 16.103(b)(1) – (2); 16.109; 16.111; & 16.112.Page 15 of 413

Emory University IRB P&Ps Revised May 24 2021Table of Contents4 FEDERALWIDE ASSURANCE (FWA)POLICY:Emory University holds a Federalwide Assurance (FWA) #5792, approved by the Office forHuman Research Protections (OHRP). The terms of the FWA apply whenever Emory becomesengaged in Human Subjects Research that is conducted or supported by any U.S. department oragency that has adopted the requirements set forth at 45 CFR Part 46 (the “Common Rule”)unless the Research is otherwise exempt from the Common Rule requirements or the federaldepartment or agency conducting or supporting the Research determines that the Researchshall be conducted under a separate assurance. All activities of the Emory IRB regarding anyHuman Subjects Research that is covered by the Common Rule, as set forth above, are governedby and subject to the terms and conditions of the FWA. With regard to Human SubjectsResearch that is not conducted or supported by any U.S. department or agency that hasadopted the Common Rule, Emory applies the standards and requirements of its internalHuman Research Protections Program.The Emory FWA and its terms are integral to the Emory HRPP. The terms of the FWA can befound on the OHRP website filasurt.htmPROCEDURES:Information Regarding the Emory FWA: Emory holds FWA 5792. Current information regardingthe Emory FWA can be found at the following OHRP website:http://ohrp.cit.nih.gov/searchContact Information at OHRP Regarding the FWA: Contact information for OHRP personnelresponsible for processing FWAs and answering related questions can be found at the followingOHRP t-us/index.html#staffEmory’s Execution of the FWA: The Emory University FWA, and any modifications oramendments thereto, shall be executed by the IO.Emory’s Agreement to Terms of FWA: Emory University, including the Emory IRB, is subject toand agrees to abide by the Terms of Assurance required by the OHRP. The Emory IRB agrees toprovide oversight to Human Subjects Research conducted or supported by a U.S. department oragency that has adopted the Common Rule that is carried out under its jurisdiction and it shallprovide this oversight in accordance with the terms and conditions of the Emory FWAEmory University-Related Components Covered by the Emory FWA: The components of EmoryUniversity that are covered by the Emory FWA are as follows: Emory University and EmoryHealthcare. The IO must grant approval to any additions or withdrawals of the componentsPage 16 of 413

Emory University IRB P&Ps Revised May 24 2021Table of Contentscovered by the Emory FWA.The IRB Director shall be responsible for filing any necessary documentation with the Office ofHuman Research Protections (OHRP) for the addition/withdrawal of a component from theEmory FWA.Other Institutions that Rely on the Emory FWA: Per agreement with Emory University, allinstitutions that rely on the Emory FWA are subject to the terms thereof and to these P&Ps.Emory FWA Renewal: The Emory FWA must be renewed every thirty-six months, even if nochanges have occurred, in order to maintain an active OHRP-approved FWA. The IRB Director isresponsible for ensuring that the Emory FWA is renewed in a timely fashion and is not permittedto expire. A copy of the complete current Emory FWA shall be kept in the IRB offices.Applicable Regulations:45 CFR §§ 46.I03 & .I07.56 CFR § 56.I07.38 CFR §§ 16.I03 & .I07.32 CFR § 219.103; DOD Directive 3216.2 E2.1.1Page 17 of 413

Emory University IRB P&Ps Revised May 24 2021Table of Contents5 ROLES AND RESPONSIBILITIES UNDER THE EMORY HRPP

emory university irb p&ps revised may 24 2021 . table of contents. page . 3. of . 413. 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 .