Atlanta VAMC Clinical Studies Center

Atlanta VAMC Clinical Studies Center

WELCOME TO THE ATLANTA VA HEALTH CARE SYSTEM This presentation will provide you with the Atlanta VA Health Care System policies and stepby-step procedures for conducting human subjects research. The Atlanta VA Human Research Protection Program has the infrastructure for conducting research that ensures consistency in quality and performance which is in accordance with federal regulations and institutional policies. 01/01/2020 1 Atlanta VA Health Care System (AVAHCS) Research webpages: http://www.atlanta.va.gov/ATLANTA/services/research/about.asp http://www.atlanta.va.gov/services/research/investigators.asp http://www.atlanta.va.gov/services/research/Conducting_Human_Research.asp Research staff must be knowledgeable about the guidance documents, tools, policies, and procedures located on the AVAHCS research websites. 01/01/2020 2 Investigators Responsibilities Principal Investigator Definition: An individual who conducts a research study and under whose immediate direction

the investigation occurs. When a team of individuals conducts a study, the responsible leader of the team is the Principal Investigator (PI). The Atlanta VA Research & Development (R&D) Committee is responsible for ensuring that: Investigators are qualified to conduct the study The PI is trained and knowledgeable about the disease or condition described in the protocol The investigator has completed required VA training 01/01/2020 3 Investigators Responsibilities Ensure the safety and welfare of study participants.

Comply with VA policies and procedures and federal regulations for conducting human subjects research. Is solely responsible for the conduct of the study. Has sufficient, qualified, and trained study staff to conduct the study. Ensure that all study team members complete research credentialing and training before engaging in research activities. Document any delegated responsibilities to study staff in the research Scope of Practice. Supervise, oversee and communicate with study members on an ongoing basis about all aspects of the study.

01/01/2020 4 Investigators Responsibilities Ensure that study members are knowledgeable about the protocol and follow study activities accurately. Obtain Institutional Review Board (IRB), VA Sub-Committees on Research Safety (SRS) and VA Radiation Safety (if applicable), ISSO/PO (Information System Security Officer/Privacy Officer) and R&D Committee approval prior to initiating any study activities. This will be represented in a FINAL letter of approval from the Associate Chief of Staff for Research (ACOS/R). Delegate in writing who will be obtaining consent (i.e. in IRB submission, VA Scope of Practice, Delegation of Authority Log)

When required by the IRB, obtain informed consent & HIPAA Authorization from each participant prior to starting any study activities or delegates this responsibility to qualified research staff. Adhere to the research protocol procedures. Maintain adequate and accurate documentation for each participant. 01/01/2020 5 Investigators Responsibilities Document each research encounter in the subject's medical record or paper chart per AVAHCS policy. Comply with protocol reporting obligations to the IRB of record and R&D Committee regarding study changes, annual progress, unanticipated problems, risks to the subject or other individuals, reportable events and conflict of interest. Keep research regulatory documents organized in a study binder and/or on a secured AVAHCS research drive and keep study records locked in a secured area (secured = behind TWO locks). Keep all data collected for the research study at the VA (unless offsite authorization has been obtained). Prepare for internal and external audits as required. Follow study records retention guidelines.

Check VA email. Many important communications are sent via VA email. 01/01/2020 6 Research Staff Responsibilities Research Coordinator Definition: The person who assists the Principal Investigator (PI) in the conduct of the study and may handle administrative responsibilities. In addition, acts as a liaison between the study participants, PI, sponsor, IRB, and R&D Committee. The Research Staff Responsibilities policy is located at AVAHCS Conducting Human Research website: http://www.atlanta.va.gov/services/research/Conducting_Human_Research.asp 01/01/2020 7 Research Staff Responsibilities Complete required research training and credentialing prior to engaging in study activities.

Be listed in IRB as research staff for each and every research project you are engaged in. Conduct study in accordance with federal regulations and institutional policies. Follow the Privacy Rules regarding privacy and use of Protected Health Information (PHI). Coordinate day-to-day study protocol activities as delegated by the PI. Assist with IRB and R&D regulatory issues as required. Ensure the safety and welfare of the study participants.

If appropriate, provide an in-service to hospital staff impacted by the research study. 01/01/2020 8 Research Staff Responsibilities Recruit and screen potential study participants according to the protocol criteria. When delegated, obtain informed consent and HIPAA Authorization from each subject prior to starting any study activities. Promptly report any Reportable Events (REs) and Unanticipated Problems (UPs) to the PI, study sponsor, and the IRB as described in Reportable Event Policy. Maintain adequate and accurate source documents for each study participant and records observations during the study. Document research activities as required by VA policies.

01/01/2020 9 Research Staff Responsibilities Keep accurate records of screened and enrolled subjects AND maintain an organized filing system for all regulatory documentation and other study records. Maintain ongoing communication with the PI about study activities. Obtain research education on an ongoing basis. Regularly attend research meetings. Regularly read all research policies and procedures located on the Atlanta VA research websites to stay informed of policy and procedure changes.

Keep accurate records of the receipt, dispensation, and return of all study drugs and/ or devices. Attend the sponsor investigator meetings, communicate study activities to the sponsor and be available for the study sponsor monitoring visits. 01/01/2020 10 Preparing for a Research Study The Clinical Studies Center (CSC) Medical Director is available for assistance and guidance with protocol design and review. Georgia Clinical & Translational Science Alliance (CTSA) for a Studio Consultation at http://www.actsi.org/discovery/studio-consultation.html is a resource for Emory faculty. A Studio Consultation will assist researchers in any of the following areas:

1. Hypothesis Generation 2. Study Design 3. Implementation 4. Analysis and Interpretation 5. Translation 6. Manuscript Development 01/01/2020 11 Preparing for a Research Study Prepare Case Report Forms (CRF) for study data collection. Start a Study Binder (available at CSC) to keep paper copies of all regulatory documents and prepare any study tools (source documents templates, tracking tools, etc). Define study reimbursement procedures in advance.

Define and disclose the recruitment plan and how the study data will be secured, used, disclosed and/or transferred in the protocol. Obtain access to the VA research secured server (authorized by the Director of Research Operations) to save all electronic study data. In order to use the electronic Emory IRB system (eIRB), staff must obtain an account by following instructions at: www.irb.emory.edu http://www.irb.emory.edu/eirb/faq.html#faq1 01/01/2020 12 Preparing for a Research Study Procedures for Industry-Sponsored Clinical Trials

Obtain the final research protocol from the study sponsor for review and feasibility. Receive the CRFs, Study Binder, and supplies from the study sponsor. After IRB and all relevant subcommittee approvals are obtained, proceed with R&D Committee submission for review and approval. Schedule the sponsors site visit and include the Research Pharmacist and the CSC Manager for this visit. For contracting issues, contact the Foundation for Atlanta Veterans Education and Research, Inc. (FAVER) Contracts/Grants

Administrator. 01/01/2020 13 Preparing for a Research Study For IndustrySponsored Clinical Trials If the research study involves drugs: Review Management of Investigational Drugs Procedure and complete VA Form 10-9012. Documents are available at: http://www.atlanta.va.gov/services/research/Conducting_Human_Research.asp Provide a copy of the Protocol and Investigational Brochure to the Research Pharmacist for review and approval. Scheduling a meeting with the pharmacist is recommended.

Complete a FDA 1572 form (Investigators Agreement), if applicable. 01/01/2020 14 Approval Process Objectives Principal Investigators Responsibilities To outline approval processes for the Institutional Review Board (IRB) and the AVAHCSs Research Committees. Obtain approval for:

The original research protocol submission (IRB and VA approval needed) Continuing review (if applicable) Amendments to the original protocol A final letter of approval must be obtained from the AVAHCSs Associate Chief of Staff/Research (ACOS/R) prior to starting any research activities (this includes screening). 01/01/2020 15 Approval Process Research protocols at the Atlanta VA must be submitted to the one of the following IRBs for review and approval: Emory IRB

VA Central IRB National Cancer Institute CIRB IRBs specifically designated by ORD All Of Us (AOU) IRB Emory IRB Submissions are completed online through the Emory eIRB system; Log on to www.irb.emory.edu for submission guidelines and information. Use Emory University username & password VA Central IRB uses a different process so contact the AVAHCSs Research Office for those submissions All projects must also be submitted to the AVAHCSs online system called the Electronic Request to Review Research Proposal (eRRRP) at https://vaww.gateway.research.va.gov/errrp. Use FAVER username & password Is Intranet only. Must log in using a VA computer or via VPN

01/01/2020 16 Approval Process Subcommittees: Subcommittee on Research Safety (SRS): All human research protocols that process bloodborne pathogens and/or any body fluids/specimens at a AVAHCS research laboratory must be approved by the AVAHCS Sub-Committee on Research Safety. This does not apply to projects that ship specimens to an outside lab or projects that deliver specimens to the AVAHCS central lab (on the second floor) for processing. SRS submission is completed online as part of the eRRRP submission process. Radiation Safety Committee (RSC): Human research protocols performed at the VA involving radiation and radioactive materials must be approved by the AVAHCS Subcommittee on Radiation Safety Committee. VA Radiation approval forms are available on the AVAHCS research website. 01/01/2020

17 Approval Process Definitions: ACOS/R: Dr. Michael Hart, Associate Chief of Staff for Research at Atlanta VAMC eIRB: Emory University IRB electronic submission link https://eresearch.emory.edu/emory eRRRP: VA electronic Research Review Proposal. It is intranet only and must be accessed from a VA computer. Use FAVER username and password https://vaww.gateway.research.va.gov/errrp/modules/srs/data_clinical_research.cfm?id=758E 6B84-1C23-CF3F-5E9EAE9B3B4B4774 FAVER: Foundation for Atlanta Veterans Education and Research, Inc.

HIPAA: Health Insurance Portability and Accountability Act 01/01/2020 18 Approval Process Definitions (continued): ICF: Informed consent form IRB Liaison: Daniel Roysden, VA employee who works at Emory IRB and manages all AVAHCS Emory IRB submissions ISSO: AVAHCS Information System Security Officer (ISSO). They review every research project via the eRRRP submission

PO: AVAHCS Privacy Officer (PO). They review every research project via the eRRRP submission R&D: AVAHCS Research & Development Committee (R&D). They review every research project via the eRRRP submission SIO: AVAHCS Science Information Office SRS: Subcommittee for Research Safety at Atlanta VAHCS. 01/01/2020 19 Approval Process Start here for projects submitted to Emory IRB. Start at Step 6 if using CIRB, NCI IRB, or other IRB. Step 1: eRRRP: PI/Study team complete PO/ISSO section and PI submits.

Submitting project will send notification to PO, ISSO and IRB liaison. eIRB: PI/Study team completes eIRB smartform and PI submits. Contract/budget: PI contacts appropriate office (FAVER, Emory, VA). Sponsor: Approves ICF and HIPAA documents before eIRB and eRRRP submission (if applicable). Step 2: eRRRP: PO & ISSO perform pre-review. Study team will receive logged comments in eRPPP if items need to be addressed by PI. 01/01/2020 20 Approval Process Step 3: eRRRP: eRRRP notifies IRB liaison, Daniel Roysden, that PO/ISO pre-reviews are done. IRB Liaison: Reviews eIRB and eRRRP submissions for completeness. PI will receive logged comments in eIRB if items need to be addressed before submission can move forward. Some project information in eRRRP is automatically transferred from PO/ISO section to the R&D section after PO/ISSO sign-off. PI/study team may begin R&D section after PO/ISSO sign-off but not before. 01/01/2020 21

Approval Process Step 4: IRB Liaison: Assigns project to IRB Committee for review once all comments/concerns have been reconciled. eIRB sends an email to PI indicating the project has been scheduled for IRB Committee review. Step 5: IRB approval obtained: IRB liaison sends approval letter to PI and stamps consent and HIPAA documents. 01/01/2020 22 Approval Process Start here for CIRB or other projects that are approved by IRB other than Emory IRB Step 6: eRRRP: SRS- 1) PI/study team complete SRS forms (if applicable) & PI submits 2) SRS approval obtained and AVAHCS SIO will upload approval letter in eRRRP R&D- PI/study team: 1) complete R&D section and forms 2) upload all IRB approved and stamped documents

3) respond to all comments 4) PI submits for R&D Committee review 01/01/2020 23 Approval Process Step 7: Pharmacy review: research pharmacist reviews pharmacy forms that have been uploaded into eRRRP. Project assigned to AVAHCS R&D Committee. Step 8: R&D: approval obtained. PO/ISSO: approval obtained. AVAMC Science Information Office reviews study team training certificates for completion and verifies staff are VA research credentialed. 01/01/2020 24 Approval Process Step 9: All approvals are in place.

ACOS/R letter received by PI. Budget and contract finalized. Research may commence Study activities (including screening) may not start until the ACOS/R notification of approval letter has been obtained. 01/01/2020 25 ACOS Letter 01/01/2020 26 Emory eIRB Submission Checklist

eIRB Initial Submission (requires the Department Chairs Approval) Upload Lay Summary Upload Full Protocol Upload Investigators Brochure, if applicable Upload the VA Informed Consent Form (ICF) into eIRB. Use the VA Informed Consent Form Template located on the Atlanta VA research website. Upload the VA HIPAA Authorization Form into eIRB if using a stand alone HIPAA form. It is located on the Atlanta VA research website. Oncology protocols must include documentation of approval from Winship Cancer Center Review Committee. Upload recruitment materials & any letters, or other information given to the subject. Waiver forms if applicable HIPAA Worksheet Application for Waiver of Authorization VA Collaborative Research Worksheet (CRW) 01/01/2020

27 Approval Process The Investigator is required to keep a paper or electronic copy of the FINAL, APPROVED submission packet for his/her files (both eIRB and eRRRP). 01/01/2020 28 AVAHCS Radiation Safety Committee All projects that involve radiation must have AVAHCS Radiation Safety Committee approval. AVAHCS Radiation Safety guidance and forms are located on the AVAHCS Conducting Human Research website in the Informed Consent section. All consent forms must have radiation safety language approved by AVAHCS Radiation Safety Committee.

See Radiation Risks Language and Instructions for ICFs on research website. As soon as possible and before IRB and R&D submission, send the following documents to Kevin Allen at [email protected]: ICF that includes AVAHCS suggested radiation safety language Protocol Completed Radiation Safety Form for Proposals located on the AVAHCS research website 1. 2. 3. Study team will receive Radiation Safety Committee approval letter. Upload approval letter in eRRRP and in Emory IRB in miscellaneous section if using Emory IRB. If using Emory IRB, state that the research project will obtain AVAHCS Radiation Safety Committee

01/01/2020 approval. The AVAHCS does not use Emory Universitys Radiation Safety Committee. 29 Approval Process Protocol Modifications The IRB must approve any changes made to the originally approved research study. These are called modifications or amendments. A modification includes: protocol changes, adding or changing a procedure, consent form revisions, request for recruitment, etc. For Emory IRB approved studies, submit modification in eIRB. Once approved, study team must ensure that the approval is forwarded to the SIO at the AVAHCS.

For the VA CIRB, NCI or other IRBs processes, please consult the AVAHCS Science Information Office (SIO) . To make staff changes, complete and submit the AVAHCS Staff Change form and email to [email protected] No amendment is needed. 01/01/2020 30 Approval Process The amendment must also be approved by the full R&D Committee for: Protocol Modifications a change in the risk/benefit ratio a change in the PI the creation or amendment to a data repository

Modifications involving Privacy, Information System Security, BioSafety and/or Radiation will be routed by the SIO for appropriate committee review and approval PRIOR to review and approval from the R&D Committee. Examples can be changes in x-ray or radiographic procedures, or blood/tissue collections: that are not collected in the clinical setting and/or that have not previously been approved 01/01/2020 31 Approval Process IRB Continuing Review

Many projects require the IRB to conduct a Continuing Reviews (CR). Check your IRB approval letter or with Daniel Roysden to confirm if CR is required. CR is conducted at intervals based on the degree of the risks. CR requests should be submitted to the IRB at least 30 working days in advance, if applicable. Tip: set reminder in outlook calendar. For Emory approved projects, log on to www.irb.emory.edu for instructions. Ensure that the VA IRB liaison has forwarded a copy of the continuing review approval and any updated corresponding forms to the SIO. It is the PI/Study Staffs ultimate responsibility to keep up with Continuing

Review by not letting the study lapse. Lapses = required reporting to the Office of Research Oversight (ORO). 01/01/2020 32 Approval Process IRB Continuing Review As a result of the Revised Common Rule, some projects may not require CR. That may include: Research eligible for expedited review. Research reviewed by the IRB in accordance with the limited IRB review.

Research that has progressed to the point that it involves only one or both of the following: Data analysis, including analysis of identifiable private information or identifiable bio-specimens Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care Must have notification from IRB if CR not required 01/01/2020 33 Recruitment of Research Subjects Recruitment policies and guidance are located on the research website: http://www.atlanta.va.gov/services/research/Conducting_Human_Research.asp These policies must be followed when recruiting potential research subjects at the AVAHCS

Recruitment Policy In Person Recruitment Policy Recruitment Letter Policy and sample letters Recruitment Flyer Policy and sample flyer Recruitment policies for Non-VA research projects 01/01/2020 34 Recruitment of Research Subjects Making initial contact with potential subjects in person or by an IRB approved recruitment letter is permitted. This must be done prior to initiating any telephone contact, unless there is written documentation that the subject is willing to be contacted by telephone about the type of study in question (i.e. registry). Cold Calling is not allowed at the Atlanta VA. Cold Calling is making contact by telephone when the potential subject is not expecting contact.

You are permitted to call a potential subject after a 1 week waiting period if the subject received an IRB approved recruitment letter stating if we havent heard from you in 1 week, someone from the research team may call you. 01/01/2020 35 Recruitment of Research Subjects Any initial contact by letter or telephone must list/mention the AVAHCS Research Compliance Officers (RCO) phone number - (404) 321-6111 ext. 206964 - so the potential subject can verify that the study constitutes VA research. It is important to reinforce with all potential subjects that participation is voluntary and the decision not to participate will not affect their healthcare now or in the future.

When the Clinician or Provider is also the Principal Investigator, the Clinician/Investigator must use safeguards to reduce or eliminate coercion. 01/01/2020 36 Recruitment of Research Subjects Recruitment Letters Get permission in writing from Clinician, Provider, or Section Chief to recruit his/her patients if possible Provide equal opportunity to opt-in or opt-out Confidentiality: Do not use any language relating to substance abuse, HIV, sickle cell anemia, mental health, military sexual trauma, PTSD, or STDs, etc. Must be on official VA letterhead

Reference the referring Clinician/Provider by name and/or have him/her sign recruitment letter if applicable Provide AVAHCS Research Compliance Officer contact name and telephone number 01/01/2020 37 The Informed Consent Process Objectives Outline policies and procedures regarding the Informed Consent Process. Describe the policies and procedures for the review and documentation of the VA Research Consent Form to ensure that research subjects are consented properly. Comply with federal guidelines and the Atlanta VA policies and procedures regarding the consenting process.

01/01/2020 38 The Informed Consent Process VA Consent Templates, VA HIPAA Authorization Form, and the VA Revocation Letter are located at: http://www.atlanta.va.gov/services/research/Conducting_Human_Research.asp General Guidelines on Writing a Consent: http://www.irb.emory.edu/forms/consent_toolkit/guidance.html 01/01/2020 39 The Informed Consent Process Informed Consent is a persons voluntary agreement, based upon adequate knowledge and understanding, to participate in research, including an investigational medical procedure. No informed consent process, whether written or verbal, may include exculpatory language through which the subject or the representative is made to waiver, or appear to waive, legal rights or releases or appear to release the investigator, the sponsor, the institution or its agents from liability or negligence. Informed Consent Form (ICF) is a study document that provides a summary of the human research (including its purpose, the research procedures and schedule, potential risks and benefits, alternatives to participation, and other required elements) and explains the rights of a participant in research. It

must be approved by the IRB and signed and dated by the subject prior to enrollment in a research protocol. 01/01/2020 40 The Informed Consent Process Informed Consent Process entails ongoing dialogues between subjects and researchers to help subjects make educated decisions about whether to begin or continue participation in a research study. Researchers know that a written document alone will not ensure that individuals fully understand what participation in research means. Therefore, before, during, and after an individual participates in research, the study team discusses the purpose, procedures, risks and potential benefits, and rights of participants with that individual. If an individual decides to participate, the team will continue to update that person on any new information that may affect study participation. This process allows subjects the opportunity to ask questions and raise concerns prior to, as well as during, the course of the study. Thus, informed consent is an ongoing, interactive process, rather than a one-time session to obtain signature. 01/01/2020 41 The Informed Consent Process Procedures:

Obtain informed consent and HIPAA prior to initiating any study activity. Conduct consent process in a private room. Use the most currently IRB approved versions of the VA Informed Consent Form (ICF) and HIPAA documents. See slides 49 and 50. Discuss all elements of the consent and answer all questions before the subject decides whether or not to volunteer for the study. Allow subjects sufficient time to read the ICF so they can consider whether or not they wish to take part in the study. Rushing through the consent process increases the likelihood of an ill-informed and/or coerced decision.

If necessary, provide or mail a copy of the ICF to the potential study participant prior to a scheduled discussion. 01/01/2020 42 The Informed Consent Process Procedures (continued): If there is any question about a potential subjects decision-making capacity and there is no documentation in the medical record that the individual lacks decision-making capacity and the individual has not been ruled incompetent by a court of law, the investigator must consult with a qualified practitioner (can be on the research team) about the individuals decision-making capacity before consenting. Please read The Informed Consent Process policy located on the Atlanta VA research website for further details. 01/01/2020 43

The Informed Consent Process Procedures (continued): A Legally Authorized Representative (LAR) may sign the Informed Consent on behalf of a subject. Individuals that may serve as LARs are (in this order): Health Care Agent ( Durable Power Of Attorney for healthcare) Legal guardian Next-of-kin (relative) 18 years of age or older in the following order 1- spouse, 2- child, 3- parent, 4- sibling, 5- grandparent, 6- grandchild Close friend A Personal Representative may sign the HIPAA on behalf of a subject. A Personal Representative is a person with legal authority to make decisions on behalf of the subject Individuals that may serve as a personal representative include: 1. The subjects Health Care Power of Attorney (POA) 2. Court Appointed Legal Guardian Important: LARs may be qualified to sign ICF but are not always qualified to sign the HIPAA 01/01/2020

44 The Informed Consent Process Procedures (continued): ICF signature page: Subject (or legally authorized representative) must print his/her name, sign, and enter the date. Study staff is not permitted to complete any fields in the subjects signature box. For some projects, the person obtaining consent must print his/her name, sign, and enter the date. If using the standalone HIPAA VA form 10-0493: Staff are allowed to complete the header on each page. All subjects (or POA or legal guardian) sign and date page 4. Page 5 is signed ONLY if applicable (when optional data or biological specimens are being placed in a repository). Do not complete or enter information on page 5 if it is not applicable. It may be removed if not being used. 01/01/2020 45

The Informed Consent Process Procedures (continued): The original signed and dated ICF must be kept with the investigators study files. In some cases this may be an electronic copy Provide a copy of the consent form to the study subject Provide a signed copy of the consent form to the Research Pharmacist if the study involves investigational drugs Document the consent process in the Computerized Patient Record System(CPRS) or shadow/paper chart. If this is a re-consent, this must be documented as well. Please read The Informed Consent Process policy located on the Atlanta VA research

website for further details. 01/01/2020 46 AVAHCS Templates Template options: 1. VA Informed Consent Form template pre-2018 Common Rule (version 7/19/2018) Use this template if your existing project is not transitioning to 2018 Common Rule Must continue to use with VA Form 10-0493 standalone HIPPA VA Informed Consent Form & HIPAA template combined 2018 Common Rule (version 1/21/2019) May be used for new submissions

Must not be used if: 2. 3. 4. 5. 6. Project includes optional tissue or data banking Project includes the possibility that a Legally Authorized Representative will be signing ICF VA Informed Consent Form Standalone 2018 Common Rule (version 1/21/2019) Use for new submissions that have optional tissue or data banking or

Use for new projects that include the possibility that a Legally Authorized Representative will be signing ICF VA Form 10-0493 Standalone HIPAA (version Sept 2015). This form must be used if using standalone ICF Use the National Cancer Institute template for oncology studies Use the CIRB template for VA CIRB studies 01/01/2020 47 The Informed Consent Process ICF writing tips that promote readability: Use as few words with three or more syllables as possible

Break all compound sentences into separate short sentences Use simple, declarative statements where possible Change all passive voice sentences to active voice Proofread for spelling, typographical, and grammatical errors Avoid imbedding lists in phrases, instead breakdown into bullets or into a numbered list Use tables to present information such as visits, procedures and compensation Avoid using technical terms. If you must use them, explain what they mean in lay language Restrict descriptions of procedures to those things the subjects will actually experience 01/01/2020 48 The Informed Consent Process For Emory IRB approved studies, the most up-to-date and approved ICF, HIPAA, and Revocation Letter are located under the documents tab in eIRB. It is VERY important to verify that you are using the latest IRB approved versions! 01/01/2020 49 The Informed Consent Process Go here to find approved ICF, HIPAA, and Revocation Letter

01/01/2020 50 The Informed Consent Process The IRB and the VA Research Compliance Officer (RCO) have the authority to observe the consenting interview. The AVAHCS Research Compliance Office periodically audits consent and HIPAA documents. They verify the following: Correct version of IRB approved ICF was used

IRB approval date is present on upper right hand corner Subject printed, signed and dated ICF by himself Correct version of IRB approved HIPAA form was signed and dated VA Form 10-0483 HIPAA document was used if stand-alone HIPAA required Consent process was documented in CPRS if subject received research procedures or interventions that are either used in or may impact their medical care Please see the Informed Consent Document Audit Tool located on the AVAHCS research website for more information. 01/01/2020 51 The Informed Consent Process You Tube Informed Consent Video https://www.youtube.com/watch?v=Vb7e_0Mw4ps 01/01/2020 52

The Informed Consent Process Procedures For Alternative Informed Consent The IRB will determine in which circumstances informed consent may be obtained in an alternative manner. The IRB may waive the requirement for the consent process (or written documentation) if the research presents no more than minimal risk to study participants. When this waiver is in effect, the IRB may require that the PI provides a written statement regarding the research to the study subjects. 01/01/2020

53 The Informed Consent Process Provide a copy of the Notice of Privacy Practices (NOPP) form to any non-veteran who will be taking part in a AVAHCS research study. Review the Notice of Privacy Practices (NOPP) policy on the research website. https://www.atlanta.va.gov/Docs/The_Notice_of_Privacy_Practice_Procedure_for_Non-Veteran_Research_Participants.pdf If the protocol is amended, the IRB may require that study participants are re-consented. Any changes made to the consent, (even after initial IRB approval) must be (re) submitted to the IRB for review and approval, and then, forwarded to the R&D Committee for their approval or acknowledgement. 01/01/2020

54 Posting the Clinical Trial ICF An IRB approved informed consent form must be posted if it meets all requirements below: The project is subject to the 2018 Common Rule Requirements (new projects approved in 2019 or those that have transitioned to the 2018 Common Rule). If the research is a clinical trial If no waiver of informed consent has been obtained 01/01/2020 55 Posting of Clinical Trial ICF Procedures: Post one copy of an IRB approved informed consent form used to enroll subjects. Only one needs to be posted for the entire study, including multisite studies. Post no later than 60 days after the last study visit by any subject For multi-site studies, it applies when all sites have closed subject recruitment Personal information should be redacted (i.e. remove PI & staff names and phone numbers) Post on https://clinicaltrials.gov or http://Regulations.gov

ORD is responsible for posting the ICF for ORD funded projects The awardee is responsible for posting the ICF for clinical trials funded by a federal agency or department other than VA The VA investigator is responsible for ensuring that the ICF has been posted 01/01/2020 56 HIPAA & Research HIPAA = Health Insurance Portability and Accountability Act Purpose is to ensure that Patient Health Information (PHI) is safe and secured from individuals and entities that are not authorized to use or transfer PHI. HIPAA regulates how researchers are able to use and access PHI.

Research activities are not considered to be part of normal healthcare operations and therefore a HIPAA waiver and/or signed HIPAA authorization is required. 01/01/2020 57 HIPAA & Research The Privacy Rule permits a covered entity (i.e. medical center) to use and disclose PHI for research purposes, without an individuals authorization, provided the medical center obtains either: Documentation that an alteration or waiver has been approved by the IRB The researcher states the use and disclosure of PHI is solely to prepare a research protocol The researcher describes how PHI is necessary to conduct the research 01/01/2020 58 HIPAA & Research HIPAA & Research

HIPAA (Alteration) Waiver Worksheet It is a required document and must be completed at time of initial submission It is found on the AVAHCS research website Describes: The use or disclosure of PHI involves no more than a minimal risk to the privacy of individuals That the research could not practicably be conducted without the waiver or alteration That the research could not practicably be conducted without access to and use of the protected health information. 01/01/2020 59 HIPAA & Research HIPAA & Research Types of HIPAA waivers Full/Complete: A complete HIPAA waiver allows an investigator to use and disclose PHI for a particular research trial or activity without obtaining written authorization from the participants. Partial: A partial HIPAA waiver permits the use of PHI for recruitment purposes only, to allow identification and, as appropriate, contact of potential participants to determine their interest in study participation.

HIPAA worksheets and forms are submitted to the IRB and R&DC and approved by AVAHCS Privacy Office. The HIPAA authorization form must be signed by subject, durable power of attorney (DOA), or legal guardian. Only LARs that are the DOA or legal guardian are qualified to sign the HIPAA on behalf of the participant. The protocol, ICF, IRB, and eRRRP must be consistent with the HIPAA authorization. 01/01/2020 60 HIPAA & Research Core Elements of the HIPAA Authorization:

Description of the PHI to be used and disclosed (VA health records, demographics photographs, audio recordings, etc.) Specific information about the persons or groups authorized to use or disclose PHI (PI, research team, etc.) To whom the PHI is used or disclosed to (FDA, Sponsor, Emory, etc.) Description of purpose for use or disclosure Expiration date End of research study None (data repository or registry) Patient rights: to revoke authorization at any time Signature of subject or legal representative Authorization section for placing data or specimens in a repository or future use projects. 01/01/2020 61 18 HIPAA Identifiers 1.Names 2.All

geographical subdivisions smaller than a state, except the initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000 3.All elements of dates except year and all ages over 89 4.Phone numbers 5.Fax numbers 6.Electronic mail addresses 7.Social Security numbers 8.Medical record numbers 9.Health plan beneficiary numbers 10. Account numbers 11. Certificate/license numbers 12. Vehicle identifiers and serial numbers, including license plate numbers 13. Device identifiers and serial numbers 14. Web Universal Resource Locators (URLs); 15. Internet Protocol (IP) address numbers 16. Biometric identifiers, including finger and voice prints 17.

Full face photographic images and any comparable images 18. Any other unique identifying number, characteristic, or code (note this does not mean the unique code assigned by the investigator to code the data) 01/01/2020 62 HIPAA & Research Preparatory to Research Data repositories (including VA medical records) may be used (i.e., accessed) by VA investigators for activities that are preparatory to VA research without the requirement to obtain either a HIPAA authorization from the subject or a waiver of HIPAA authorization by an IRB or Privacy Board. This includes use of PHI for the preparation of a research protocol prior to submission to the IRB(s). Preparatory to Research activity is the only instance of access for research purposes allowed in VHA without a written HIPAA authorization signed by the individual, a waiver of HIPAA authorization by an IRB or Privacy Board, or approval by the IRB(s). This access is granted only to VHA researchers. http://vaww.vhadataportal.med.va.gov/DataAccess/PreparatorytoResearchAccess.aspx 01/01/2020 63

HIPAA & Research Preparatory to Research The PI must document in his/her research files: 1. The access to PHI is only to prepare a protocol; 2. No PHI will be removed from the covered entity (i.e., VHA); and 3. The PHI accessed is necessary for preparation of the research proposed. Only aggregate data may be recorded and may be used only for background information, to justify the research, or to show that there are adequate numbers of potential subjects No recording of Individually Identifiable Health Information No recruiting from the data Pilot studies are not considered to be activities preparatory to research The preparatory to research activities end once the protocol has been submitted to the IRB and R&D Committee. http://vaww.vhadataportal.med.va.gov/DataAccess/PreparatorytoResearchAccess.aspx 01/01/2020 64 Data Repository Research Data Repository is a data repository created from data obtained either to conduct a research protocol(s) or gathered in the course of conducting a research protocol and is maintained after the completion of the research protocol.

Establishment of Data Repositories need IRB and R&D approval Require Standard Operating Procedures (SOPs) Require annual review by IRB and R&D Releasing data from the repository requires IRB & R&D approval Data Repository policies and tools are located on the AVAHCS research website. 01/01/2020 65 Scanning Forms into CPRS Objectives: Outline scanning procedures for: VA form 10-9012. The Investigational Drug Information Record from VA form 10-0483. The Notice of Privacy Practices Acknowledgement form.

Procedures: Provide a good quality copy of documents with the subjects full name and social security number on the bottom of the first page of the document. Scanning signed ICF, HIPAA, and Revocation Letter is optional. 01/01/2020 66 Scanning Forms into CPRS Procedures: Complete the Scanning Research Request form for research documents. This form is located on the AVAHCS research website.

Place documents in privacy envelope and drop them in the designated mailbox at the Clinical Studies Center (Room 11c119). These may include: ICF, HIPAA, Accounting of Disclosure Form, Notice of Privacy Practices Acknowledgement VA form 10-0483 , and VA form 10-9012. Documents are picked-up weekly by medical records. Medical Records scanning staff will shred the paper copy. THEREFORE DO NOT SUBMIT THE ORIGINAL FOR SCANNING. The original documents should be kept by the PI and/or designee. 01/01/2020 67 Scanning the Investigational Drug Information Record Objectives: Responsibilities:

Outline procedures for scanning the Investigational Drug Information Record VA Form 10-9012 in CPRS. It provides additional protection for subjects who are participating in research studies involving drugs. The PI or designee is responsible for ensuring that the VA form 109012 is completed and scanned into CPRS when investigational drug is dispensed to the study subject. 01/01/2020 68 Scanning the Investigational Drug Information Record Procedures:

Provide a good quality copy of VA Form 10-9012 with the subjects full name and social security number on the first page of the document. Complete a Research Documents Scanning Request Form available at the AVAHCS research website. Deliver scanning requests to the designated mailbox located at the Clinical Studies Center, Room 11C119. The medical record scanning team will shred the consent copy after scanning. The PI and Pharmacy must keep a copy of VA Form 10-9012 filed in the study binder. 01/01/2020 69

Documentation Requirements Investigators and research staff are responsible for promptly documenting research subject encounters in the Computerized Patient Record System (CPRS) or a paper research record. A CPRS consent note and progress note(s) is required for all research subjects (Veterans or non-Veterans) who receive research procedures or interventions as inpatients or outpatients at VA medical facilities that are either used in or may impact the medical care of the research subject A research consent template must be used. See Research Note Titles & Templates policy on AVAHCS research website. If a non-veteran is using a hospital service as part of the research study, then a CPRS record must be created so research encounters/visits may be documented and orders for procedures or tests may be entered in CPRS. Documentation of the research encounter in a paper record is required if a CPRS note has not been created. Sample templates are available on the AVAHCS research website. The consent process must be documented by the research staff member who obtained the research consent. Please contact the CSC Manager for situations when this is not feasible. 01/01/2020 70 Documentation Requirements CPRS: Visit Location:

ALWAYS select ATL Research-Study or other ATL ResearchClinic Historical Visit: ALWAYS select Historical Visit 01/01/2020 71 Documentation Requirements Please refer to the following guidance on the Atlanta VA website for further details: Research Note Titles & Templates Research Progress Note Template for Paper Charts

Research Consent Note Template for Paper Charts Research Documentation Requirements Entering Research Progress Notes in CPRS Non-Veterans: Refer to Notice of Privacy Practices for Non-Veterans (NOPP) policy located on the Atlanta VA research website. Contact the CSC for further details and instructions on enrolling a non-Veteran in research. 01/01/2020 72 Documentation Requirements

CPRS access and training will be provided to staff. Request CPRS username and password from [email protected] . He will enter a IT request and will notify you when your account has been activated. To schedule training, email [email protected] 01/01/2020 73 Certificates of Confidentiality Certificates of Confidentiality (CoC) add a layer of privacy protection for participants enrolled in sensitive research projects. A CoC primarily protects against compulsory legal demands, such as court orders and subpoenas, for identifying information or identifying characteristics of a research participant. All NIH funded projects are granted CoC status automatically. Generally, a human subjects research project that collects personally identifiable,

sensitive information and that has been approved by an IRB is eligible to apply for a CoC. For example, research on HIV, AIDS, STDs, studies that collect information about sexual attitudes, preferences, or practices, studies on alcohol, drugs, or other addictive products, and studies about illegal conduct. 01/01/2020 74 Certificates of Confidentiality If a project has a CoC, the ICF must include the mandatory CoC language described in the AVAHCS ICF template. Information is available here: https://www.research.va.gov/services/csrd/confidentiality.cfm#Q1 http://www.irb.emory.edu/forms/coc.html 01/01/2020 75 Research Clinics A Research Clinic is a virtual non-billable location created in CPRS to:

Document research encounters and distinguish research versus standard of care visits. Order investigational drugs and tests/procedures that are above and beyond standard of care. Avoid billing research participants for research procedures. Comply with documentation requirements of the informed consent process and research encounters. A protocol-specific Research Clinic location is needed when a research study impacts a hospital service by performing tests and/or procedures solely required for the study. For example: laboratory, radiology, Pulmonary Function Laboratory, Nuclear Medicine, etc.

The Clinical Studies Center handles and oversees the clinic setup process. 01/01/2020 76 Regulatory Documents The Principal Investigator and/or designee is responsible for keeping complete and accurate regulatory documents for the study. Collect, organize, and maintain all documents in a regulatory binder or electronically on a AVAHCS research drive. If it isnt written down, it never happened. At the end of the study, store the study binder with other research records. NEVER DESTROY ANY STUDY DOCUMENTS.

The Procedure For Completing Accounting of Disclosure Form For Research may be found on the Atlanta VA research website. Please refer to Regulatory Documents Policy located on the Atlanta VA research website. This includes the Regulatory Document Checklist. 01/01/2020 77 Regulatory Documents Checklist Protocol and any amended protocols IRB & R&D approval documentation

Copies of the eIRB initial submission Continuing review approval documentation Copies of the eRRRP submission Reportable Events (SAEs, UPs, SPs, RIIs) Approval letter from ACOS for Research Recruitment materials

Approved Informed Consent Form and HIPAA IRB, R&D, and Sponsors Correspondence Documents Protocol Termination form Modifications forms with supporting documents 01/01/2020 78 Regulatory Documents Checklist

Investigators Brochure Enrollment log Final signed 1572 and amended FDA 1572s Monitoring visits reports Principal Investigators CV Research Training Certification

Copy of randomization codes Signature and Delegated Investigational article log and copies of drug/device shipment/retrieval Lab Certification Accounting of Disclosure Form** Responsibilities Log Abstracts or manuscripts with study results

01/01/2020 79 Source Documents Source Documents are any forms, records or documents where study data is first recorded. Information captured in source documents includes clinical findings, observations, and other study activities and is used to complete the Case Report Forms (CRFs). Source documents must be attributable, legible, contemporaneous, accurate, complete, & verifiable. Principal Investigators and/or designee are responsible for maintaining complete and accurate Source Documents. Source Documents are important because they: Promote data consistency and ensures that information required for transcription to CRFs is captured. Verify the subjects participation in the study as well as data integrity. Are Good Clinical Practice and are FDA required.

Corrections should be initialed/dated by the person making the correction. Do not make corrections on behalf of a study subject. The study subject must make his own corrections. No whiteout or other means of concealing errors should be used on any research document. Please refer to the Source Documents policy on the Atlanta VA website. 01/01/2020 80 Accounting of Disclosures VHA Privacy Office requires that an Accounting of Disclosure form be maintained for each and every disclosure of information from a research study to a non-VA entity. The form (or spreadsheet) must be accurately completed for all research projects and sent to the

Privacy Office and Medical Records department. The Accounting of Disclosures form must be available for review by the AVAHCS Privacy Office at any point in time. It should be filed in each projects Regulatory Binder. A separate Accounting of Disclosure Form is required for each research study. For more information: http://www.atlanta.va.gov/Docs/ACCOUNTING_OF_DISCLOSURES_FORM_FOR_RESEARCH_3-15-2012.xlsx https://www.atlanta.va.gov/Docs/PROCEDURE_FOR_COMPLETING_THE_ACCOUNTING_OF_DISCLOSURE_FORM_FOR_RESEARCH.pdf 01/01/2020 81 Accounting of Disclosures Form 01/01/2020

82 Data Management and Security VA research data and information must be saved on a secured AVAHCS research server. Contact the Director of Research Operations for access. Secure paper study files in a locked cabinet and in a locked office at the VA. Never leave PHI unattended. All VA sensitive research information needs to be used and stored within the VA unless approvals by Privacy and Information Systems Security Offices are given. A data transfer agreement (DTA) is required if VA sensitive data is transmitted or removed outside the VA unless the HIPAA covers the transfer. PHI and/or identifying information should not be included in the CRFs unless special authorization for a limited data set has been granted.

Social security numbers should not be recorded in the CRFs. Only use a study ID to identify study participants. 01/01/2020 83 Data Management and Security You need to know: WHAT YOUR PROTOCOL STATES IN TERMS OF DATA MANAGEMENT & SECURITY. WHAT YOUR IRB AND ERRRP APPLICATIONS STATE. WHAT YOUR RESEARCH DATA INVENTORY FORM STATES.

WHAT YOUR IRB AND R&D APPROVALS STATE. WHERE YOUR RESEARCH DATA IS STORED. These documents will tell you if you are permitted to disclose data and how. 01/01/2020 84 Data Management and Security

Contact the Information Systems Security Officer (ISSO) for information about data transfer agreements and other security issues You must have permission from the ISSO if any data is going off-site Laptops and flash drives must be encrypted by the VA if used for transporting data outside the VA Know where your data is located and where it is going. This must be stated in the protocol, ICF, and HIPAA forms Study subjects need to be informed how their PHI is used, accessed, and/or disclosed. Report any Research Security Information Incidents within one hour to the ACOS/R, PO and ISSO Complete TMS courses annually and be knowledgeable about: VHA Privacy and Information Security Awareness and Rules of Behavior VHA Privacy and HIPAA Training Data Management Policy is located on the AVAHCS research website 01/01/2020 85 Authority to Transport

Study team members will need to obtain Authority to Transport (AUT) if they are physically transporting outside of the VA any of the following: Paper research files containing PHI and/or Specimen/samples that are labeled with code+date+other element of PHI An AUT is not required if specimen contains only study ID and a date Complete a New Request in the LEAF system by following the instructions located on the AVAHCS research website: https://www.atlanta.va.gov/Docs/LEAF_AUT_Instructions_Document.docx Renew annually in LEAF system

01/01/2020 86 Management of Investigational Drugs An investigational drug is a medication for which an Investigational New Drug (IND) application has been filed with the Food and Drug Administration (FDA) . At the VA, an investigational drug is also defined as an approved drug that is being studied for an unapproved or approved use in a controlled, randomized, or blinded clinical trial. The Principal Investigator (PI) is responsible for complying with VA policy regarding storage and dispensing of investigational drugs. The Clinical Research Pharmacist , Dr. Mehran Salles, is responsible for assessing the investigational drug feasibility prior to protocol approval. E-mail: [email protected]

Provide a completed Investigational Drug Information Record VA Form 10-9012 for the drugs used in the clinical trial. Staff working with studies involving drugs are required to take additional training regarding the pharmacy procedures. Training is provided by the Research Pharmacist or CSC Manager. 01/01/2020 87 Management of Investigational Drugs Investigational Drug Policies and Forms are located on the Atlanta VA website: Investigators Instructions for Placing Orders in CPRS for Investigational Drugs Research Coordinators Instructions for Placing Orders in CPRS for Investigational Drugs Management of Investigational Drugs Procedures Procedures for Scanning the Investigational Drug Information Record VA Form 10-9012 01/01/2020 88

Management of Investigational Devices An Investigational device is a device, including a transitional device, that is the object of an investigation. Generally, these devices are not approved by the FDA, or are being tested or studied for indications not previously approved by the FDA. The Principal Investigator (PI) is responsible for controlling, securing, accounting for, and using Investigational Devices properly. The PI or research staff will record receipt of the device on an Investigational Device Log throughout the study to maintain an accurate inventory and utilization record. Refer to the Management of Investigational Devices Procedures policy on the Atlanta VA website for detailed instruction. Contact the CSC Manager for further guidance.

01/01/2020 89 Flagging Medical Records The R&D Committee determines if posting a Patient Record Flags: Category II warning in CPRS is required for VA patients participating in a research study. In addition, study teams may choose to post a Research Flag because it lends additional protection to patients that are participating in research studies by informing the subjects healthcare providers of their research participation. Procedures to Post, Remove & Edit Research Flags in CPRS can be found on the Atlanta VA research website. 01/01/2020 90

Research Subject Reimbursement The terms and conditions of reimbursement for research participants should be disclosed in the research proposal. In the Informed Consent Form, specify the reimbursement amount, payment form (cash, check, etc.), when, and how it will be done. The investigator must ensure that reimbursements are appropriate, prorated, and do not constitute or appear as undue pressure and/or coercion to the subject. The investigator may delegate to a research team member the responsibility of handling reimbursements for study participants. Reimbursement procedures depend on where the funds are managed (VA, Emory, FAVER).

Maintain clear documentation of any subject reimbursement. Refer to Research Participants Reimbursement Procedures located on the Atlanta VA research website. 01/01/2020 91 Reportable Events VA Investigators must report unanticipated and research related: Local research deaths Local Serious Adverse Events (SAE) Serious Problems (SP) The PI and research team must be knowledgeable about the Reportable Event policies for both the AVAHCS and the IRB of Record.

Unanticipated/unexpected refer to an event/problem in human research that is new or greater than previously known in terms of nature, severity, or frequency, given the procedures described in protocol documents and the characteristics of the study population. A related adverse event, death, or problem is one that may reasonably be regarded as caused by, or probably caused by, the research. 01/01/2020 92 Reportable Events A Serious Adverse Event (SAE) is an untoward occurrence in human research that results in death, a life-threatening experience, inpatient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, congenital anomaly, or birth defect, or that requires medical, surgical, behavioral, social, or other intervention to prevent such an outcome.

Serious Problem (SP) is a problem in human research or research information security that may reasonably be regarded as: (1) Presenting a genuine risk of substantive harm, to the safety, rights, or welfare of human research subjects, research personnel, or others, including their rights to privacy and confidentiality of identifiable private information; or (2) Substantively compromising a facilitys HRPP or research information security program. (VHA Handbook 1058.014t) 01/01/2020 93 Reportable Events Deaths that are unanticipated and related to the research conducted in local VA studies must be orally and immediately reported to the IRB of record followed by a written report within 5 business days. Other Unanticipated and Research Related Reportable Events (SAEs and SPs) should be reported to the IRB of record within 5 business days of learning of the event.

In addition to reporting the event to the IRB of record, an email must be sent to [email protected] This will alert the AVAHCS Research Office that a Reportable Event has occurred. Include the following information: PIs name IRB number IRB name Study title Summary of the event. 01/01/2020 94 Reportable Events The Reportable Event Policy, the Reportable Event Flowchart, and other forms and instructions are located on the AVAHCS research website. IRB of record reportable event guidance links: i. National Cancer Institute (NCI): https://www.ncicirb.org/institutions/institution-quickguides/managing-study/completing -up-and-or-scn ii. Emory IRB: http://www.irb.emory.edu/forms/reportable.html

iii. VA Central IRB: https://www.research.va.gov/programs/pride/cirb/forms/119.doc iv. All of Us: Report per AoU IRB SOP 0312. 01/01/2020 95 Reportable Events Continuing Review: The PI may be required to submit a summary of all local reportable events at Continuing Review to the IRB of Record. If using Emory IRB, submit the Atlanta VA Periodic Reportable Event Summary posted on the AVAHCS research website. The PI is also responsible for tracking any events that did not meet the reporting threshold and documenting why this event did not need to be reported within that time frame. Keep this information with the study records. 01/01/2020 96 Reportable Events Protocol Deviations (PD) Definition A departure from the IRB-approved protocol. Deviations may represent minor departures and/or noncompliance.

Report PDs to the IRB of record if there has been a substantive deviation from the protocol that could or did adversely affect at least one of the following: The rights, welfare, or safety of subjects; The subjects willingness to continue participation; or The scientific integrity of research data Protocol Deviation and Noncompliance Policy is located on the AVAHCS research website. 01/01/2020 97 Reportable Events Non-compliance: Definition: Failure to comply with any of the regulations and policies of the IRB and/or VA and failure to follow the determinations of the IRB and R&D Committee. Noncompliance may be minor or sporadic, or it may be serious and/or continuing. Noncompliance can be on the part of researchers, staff, other employees, and of the IRB. Consult the IRB or the VA Research Compliance Officer (RCO) for questions about what to report and how.

Reportable Research Incidents: Incidents, events or problems that involve the unauthorized use, disclosure, transmission, removal, theft, loss, or destruction of VA research-related protected health information (PHI), individually identifiable private information, or confidential information as defined by the HIPAA Privacy Rule, the Common Rule, the Privacy Act or 38 U.S.C. must be reported within 1 hour as described in the AVAHCS policy entitled: Research Information Incidents. This policy can be found on the AVAHCS research website. 01/01/2020 98 Monitoring & Audit Visits All study monitors and/or external auditors need to check-in at the Clinical Studies Center (CSC) and provide a copy of the Entrance Briefing Form to the CSC Administrative Assistant. Note: No entity other than those listed on the consent and HIPAA form may have access to any documents with Protected Health Information. All forms and instructions are found on the AVAHCS research website:

Procedure for External Monitoring Visits VHA Privacy Policy Training Instructions for Monitors (if applicable) Monitoring Visit Report Entrance Briefing Form Monitoring Visit Report Exit Briefing Form 01/01/2020 99 Monitoring & Audit Visits Monitors Access to CPRS: The Atlanta VA Employee Driver Method: The Atlanta VA Health Care System study team member is present while monitor reviews CPRS and/ or paper records. The monitor only has access to research subjects information associated with the research project, and is supervised by the study team throughout the visit. If accessing CPRS, the AVAHCS study team member logs in, opens the appropriate screens in CPRS, and is present during the review of CPRS. Monitors are not allowed unsupervised access to CPRS. The Atlanta VA Employee Driver Method is the preferred method for Monitors to view CPRS. 01/01/2020

100 Monitoring & Audit Visits The monitor is responsible for conveying any potential or actual serious findings to the PI and the Research Compliance Officer (RCO). Findings that require an exit interview include, but are not limited to: Any suspicions or concerns that non-compliance may exist. Serious non-compliance with the study protocol, Emory Institutional Review Board (IRB) requirements, or applicable regulations and policies such as: Failure to consent subjects prior to initiating study activities Enrolling subjects who do not meet study inclusion criteria Failure to report serious or unexpected adverse events The research office is required to report to the VA Office of Research Oversight (ORO) all findings of serious non-compliance through the Medical Center Director.

Contact Information: Research Compliance Officer Rodney Thompson Phone: (404)321-6111 ext. 206964 Fax: at: (404) 417-2927 01/01/2020 101 Study Close Out Procedures A study is "closed" when: Study is closed to enrollment and all subjects have completed study participation Data collection is completed. No additional PHI is being collected Collection of specimens has ceased The sponsor terminates the study and completes a study close out visit Data analysis of PHI is complete The PI is responsible for following the Procedures for Closing Human Research Studies policy on the AVAHCS Research website

For Emory IRB studies, close out the study by selecting the Create Close-Out button in My Activities section in eIRB and complete as directed Close out the study with the R&D Office by emailing the SIO: A copy of the IRB Close Out approval letter An end of study summary abstract 01/01/2020 102 Research Records Retention & Storage Guidance for Long Term and Short Term Storage of Research Records is located on the Atlanta VA research website Research records are the responsibility and property of the VA Medical Center Submit all research records of closed studies to the Clinical Studies Center for storage

Contact the CSC to obtain boxes and receive instructions to prepare records for storage Submit a completed Research Records Storage Request by email to the CSC Administrative Assistant. The request form is available on the AVAHCS research website. Also refer to the Research Record Retention & Storage Policy. 01/01/2020 103 Staff Credentialing & Training Requirements In order to be engaged in research at the AVAHCS, Investigator and Co-Investigators must either have a VA appointment or without compensation appointment (WOC). All MDs, RNs, LPNs, LCSWs, and other licensed personnel must complete VetPro credentialing prior to engaging with research subjects.

CITI certification must be updated every three years on your anniversary date. There is no grace period. Further information may be found at: https://www.atlanta.va.gov/services/research/Research_Credentialing.asp 01/01/2020 104 Staff Credentialing & Training Requirements Additional training is required if: Performing phlebotomy, inserting IVs, or processing specimens. Contact the CSC Manager to arrange training. Transporting hazardous materials. The packaging and shipping training in CITI named Packaging and Shipping of Class 6.2 Agents must be completed every two years. 01/01/2020

105 Research Related Web Sites AVAHCS Website: http://www.atlanta.va.gov/ATLANTA/services/research/about.asp AVAHCS Website for Investigators: forms and policies: http://www.atlanta.va.gov/services/research/investigators.asp AVAHCS Website for Conducting Human Research: http://www.atlanta.va.gov/services/research/Conducting_Human_Research.asp AVAHCS Website for Research Credentialing and Training: https://www.atlanta.va.gov/services/research/Research_Credentialing.asp AVAHCS Website for the Data Analytics Core: https://www.atlanta.va.gov/services/research/Data_Analytics_Core.asp 01/01/2020 106 Research Related Web Sites Foundation for Atlanta Veterans Education and Research, Inc. (FAVER) https://faver.foundation.org Emory IRB Web Page: www.irb.emory.edu Collaborative IRB Training Initiative (CITI): www.citiprogram.org Office of Human Research Protection (OHRP): www.hhs.gov/ohrp/ Office of Research Oversight (ORO) vaww1.va.gov/oro/ Public Responsibility in Medical Research: www.primr.org

National Institute of Health (NIH): www.nih.gov Food and Drug Administration (FDA): www.fda.gov 45 CFR 50 Protection of Human Subjects: www.gpoaccess.gov/cfr/index.htm 01/01/2020 107 Research Related Web Sites Research Professional Organizations: Society of Clinical Research Associates (SOCRA): www.socra.org Association of Clinical Research Professionals (ACRP): www.acrpnet.org Public Responsibilities in Medicine and Research (PRIM&R):www.primr.org VINCI: VA Informatics and Computing Infrastructure http://vaww.vinci.med.va.gov/vincicentral/ DART: Data Access Request Tracker http://vaww.vhadataportal.med.va.gov/DataAccess/DARTRequestProcess.aspx 01/01/2020 108 Research Agreements with Collaborators

The Principal Investigator (PI) or designee is responsible for contacting the FAVER Contracts/Grants Administrator and informing him/her of his/her interest in participating in an industry-sponsored clinical trial. The PI is required to provide FAVER with a completed Assessment of Clinical Impact Form located on the Atlanta VA website, outlining the obligations of the study for the Atlanta VA Medical Center and a copy of the study protocol. Instructions can be found on the Atlanta VA website. The FAVER Contracts/Grants Administrator is responsible for the legal review and final negotiation of agreements, including the budget. All research projects administered by FAVER must have a signed agreement between the Collaborator and FAVER. VA Research & Development (R&D) Committee approval may be sought simultaneously while establishing the FAVER contract. As a general rule, no research funds should be expended until IRB and R&D (ACOS/R) approvals

have been obtained. However, reasonable and usual preliminary costs for project planning prior to approval are allowable according to VA policy. For FAVER administered studies, PIs must have a signed agreement before studies are initiated (= enrollment of first study subject). 01/01/2020 109 Clinical Studies Center The Clinical Studies Center (CSC) is a controlled and professional research center designed to promote and facilitate clinical research for human subjects at the AVAHCS. The CSC is designed to conduct outpatient research studies and is located on the 11th floor at the AVAHCS. The Clinical Studies Center consists of the following: Administrative offices: Medical Director, CSC Manager, and Administrative Assistant Two Workstations: for research coordinators and study monitors Five exam rooms: equipped with exam tables, vital signs monitoring machine, X-ray view box, phlebotomy chairs, ophthalmoscope/otoscope, and computer access

01/01/2020 110 Clinical Studies Center On site record storage for studies which have been closed A laboratory to prepare research specimens for shipping or storage. This includes: Bio-Safety cabinet -80C freezer Refrigerator

Centrifuge Refrigerated centrifuge Dry ice 01/01/2020 111 Clinical Studies Center To reserve an exam or interview room at the CSC, email the CSC Room Request Form to the CSC Administrative Assistant or CSC Manager with the following information : Room type (exam/interview/monitor station) Requestors name Study Name Date, time, and length of time needed Please do NOT enter subject name, initials, or any identifiers (study ID only)

People using the CSC rooms are responsible for greeting participants in a timely manner and notifying the CSC of appointment cancellations. The Clinical Studies Center Operating Guidelines are located on the AVAHCS website. 01/01/2020 112 Clinical Studies Center Staff Lawrence Phillips, MD is the Clinical Studies Center Medical Director. He is a Professor of Medicine and Associate Professor of Physiology, appointed to the Division of Endocrinology. In the past, he served as the Director of Endocrinology and Program Director of the Emory University GCRC. He served on the Editorial Boards for the journals Diabetes and Endocrinology, and as a member of the NIDDK- B NIH Study Section that reviews grants. He is experienced in training Junior Faculty members and Fellows who have gone on to pursue an academic career in clinical investigations. Dr. Phillips is experienced in peer-review standards for research quality as exemplified by the awarding of extramural research support, and is personally involved in clinical investigations on a daily basis. Dr. Phillips currently directs the AVAHCS Clinical Studies Center Investigator Mentoring Program. He interacts, mentors, and trains VA junior investigators at multiple levels.

01/01/2020 113 VA Contact Information Associate Chief of Staff, Research Services Michael Hart, MD (404) 728-7772 [email protected] Director, Research Operations Antonio Laracuente, MBA (404) 728-7643 [email protected] Research & Development Program Coordinator Kallie Medbery [email protected] Ext. 206177 Research Compliance Officer (RCO) Rodney Thompson Ext. 206964 Fax (404) 417-2927 [email protected] Research Compliance Auditor

Lorrie Graham Ext. 207279 [email protected] Research Pharmacist Mehran Salles, Pharm D Ext. 4214, Pager (404) 596-8692 Fax (404) 417-1809 [email protected] 114 CSC Contact Information Medical Director, Clinical Studies Center Lawrence Phillips, MD Ext. 207608 [email protected] HRPP Quality Manager Jennifer Whelan Ext. 203452 [email protected] Manager, Clinical Studies Center Jane Guidot, RN, CCRC Ext. 206933

[email protected] CSC Administrative Assistant, Clinical Studies Center David Worley Ext. 204934 Fax (404) 417-2991 [email protected] 115 IRB Contact Information Emory IRB Office Location: 1599 Clifton Road 5th floor, Room 213 Atlanta, GA 30322 IRB Director: Rebecca Rousselle [email protected] (404) 712-9750 IRB Office Numbers: Phone: (404) 712-0720

Toll free: 1-877-503-9797 Fax: (404) 727-1358 AVAHCS/IRB Liaison Daniel Roysden, PhD, ThM [email protected] (404) 712-9749 or ext. 202512 IRB Department Email: [email protected] 01/01/2020 116 FAVER Contact Information Main Office Phone Number: (404) 728-7643 Fax (404) 728-4847 Chief Operating Officer-FAVER Leslie Hughes Ext. 202535 [email protected]

https://faver.foundation/ Human Resources Manager Ellen Schneider Ext. 207271 [email protected] 01/01/2020 117

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