Credentialing for Research Staff Engaged in Human Research

Credentialing for Research Staff Engaged in Human Research Projects at the Atlanta VAMC 1

VHA’s obligation: • to preserve public trust in the integrity and quality of research carried out by its investigators and other research staff. • careful stewardship of public funds that support research programs. 2

• Appropriate mechanisms must be in place to ensure that all persons within the VHA research program are qualified and meet all VA credentialing requirements. AVAMC Research Credentialed 3

• • Are you engaged in VA Research? You are engaged in VA research if performing research duties at the AVAMC You are engaged in VA research if you are funded by a VA project You are engaged in VA research if you are participating in a project that has a VA approved off-site waiver You are engaged in VA research if performing research specific duties that are not part of normal clinical duties during your tour of duty (i. e. ICU nurse implementing research survey) • You are engaged in VA research if listed in e. IRB or e. RRRP as VA research staff 4

Who is not considered to be engaged in VA Research? • You are not engaged in VA research if performing normal clinical duties during your normal tour of duty: – Oncology nurse hanging investigational study drug – Phlebotomist – Research pharmacist – ECG technician 5

Purpose of Credentialing To detail the duties and responsibilities via Research Scope of Practice – For research staff with direct contact with patients – For research staff with indirect contact with patients – For research staff who have access to Protected Health Information (PHI) 6

Types of Personnel Engaged in Research • Principal Investigator • Personnel with direct contact are those who: – – perform procedures interviews telephone calls to research subjects clinical interventions with patients during the conduct of a research project • Personnel with indirect contact are those who: – do not interact directly with patients – manage and/or collect study data and/or PHI (i. e. retrospective chart review) – handle human specimens for research purposes 7

All research personnel who are part of the AVAMC research team engaged in the conduct of research using human subjects must be credentialed by AVAMC Research Service, regardless of type of appointment or sources of compensation (Emory, VA, AREF, or WOC) 8

Credentialing must occur prior to beginning any research duties and/or contact with patients. 9

Research Scope of Practice (SOP) • The documentation of duties requested by personnel with direct or indirect research human subject contact • It is granted by the PI 10

Scope of Practice • PI must complete a Research Scope of Practice outlining the specific researchrelated duties that will be delegated to research personnel. • PIs and Co-I must also complete a SOP • The Research SOP does not replace the AVAMC credentialing process for physicians or other clinical staff. 11

• • Scope of Practice Reviewed at least annually Updated as needed Signed by research staff member, PI, and ACOS for Research SOP is appropriate as it relates to education, experience, and training 12

Scope of Practice • Do NOT perform any duties or practice beyond what is allowed in the SOP • For example: If your SOP does not list that you are permitted to obtain consent, then you are not permitted to do so 13

AVAMC Research Training Coordinator is Nakela Jackson Forms and courses are dependent upon: • Research duties • Direct human contact? • Indirect human contact? • Handle biological specimens? • Are you licensed personnel? 14

Start here! New staff begins the credentialing process by registering on the AREF website http: //www. atlaref. org/ 15

All VA Research Personnel Engaged in Human Subjects research will take at a minimum: TMS • VA Privacy & Information Security Awareness and Rules of Behavior course • Infection Control: Bloodborne Pathogens & Tuberculosis • Privacy and HIPAA – if direct contact CITI • VA Human Research modules • Biosafety for personnel performing phlebotomy or handling biological specimens (annually) 16

Vet. Pro • Is the program AVAMC uses to credential VHA health care providers who have a professional license. • AVAMC Human Resources is responsible for this process. • Pertains only to “licensed” personnel. – MD, RN, NP, PA, LPN, LCSW, and others 17

Vet. Pro • Need to be Vetpro’d: – if you are a licensed staff member who engages with subjects at the AVAMC – before engaging directly with subjects – if your project has a VA off-site waiver and staff members are seeing study subjects at that site • Do not need to be Vetpro’d – if Emory staff are seeing VA patients only at Emory 18

Human Studies Orientation (HSO) • This course reviews PI responsibilities, research staff responsibilities, and all VAMC policies and procedures that pertain to human studies research. • Direct contact? – Must take HSO • VA PI and VA Co-I? – Must take HSO even if only indirect contact 19

Initial Submissions and Amendments List location where research staff will be engaged in research: • At VA • At Emory • At both VA and Emory 20

Q & A: • Question # 1: A researcher hires a study coordinator who will be performing a chart review at the AVAMC. He will not be directly engaged with research subjects. Does this person need to be research credentialed? – Answer: YES. He will indicate in the AREF registration that he will have indirect contact with human subjects. AVAMC Research Training Coordinator will inform him which courses and forms need to be completed for indirect contact, including completion of a SOP. 21

• Question # 2: A researcher recently hired a RN. She has completed her VA research credentialing but she has not completed the Vet. Pro credentialing process. Is she allowed to see research patients yet? – Answer: NO. She must complete the Vet. Pro credentialing process prior to engaging with research patients. 22

• Question # 2 (continued) Can the research RN perform research duties that don’t involve direct contact? – Answer: YES. She is allowed to perform administrative duties that don’t involve PHI (work on e. IRB research submission, e. RRRP, etc. ). However, her first SOP will need to reflect this and should not list any duties that describe direct contact with patients. Once Vetpro’d, then the SOP needs to be updated to reflect direct contact with patients. – Exception: RNs who are paid by the VA are not allowed to engage in ANY activities until Vet. Pro’d. 23

• Question # 3: Emory University study staff are doing data analysis for an AVAMC project. They do not have direct contact with patients. Do they need to be VA research credentialed? – Answer: It depends upon: • The location of the data analysis – if the data analysis is occurring at the AVAMC, then they need to be AVAMC research credentialed • What does the HIPAA state? – If the data analysis is occurring at Emory, and the HIPAA states that data will be disclosed to Emory Researchers, then they do not need to be VA research credentialed – If the data analysis is occurring at Emory, and the HIPAA does not state that data will be disclosed to Emory Researchers, then they need to be VA research credentialed • If there is no access to PHI and the data is completely de-identified, they do not need to be VA research credentialed • Are they listed as VA research staff in e. IRB or e. RRRP? – If yes, they need to be VA research credentialed 24

• Question # 4: Does everyone working in AVAMC research (direct and/or indirect contact) need to have a SOP? – Answer: YES. It needs to be updated annually and updated if changes in scope of practice occur. 25