Research Compliance:

1
Research Compliance

• An Overview of the Players and Issues Involved in
  Emorys Research Compliance Programs

2
Major Players in Emorys Research Compliance
Programs The Committees

• Institutional Review Board (IRB) Responsible
  for oversight of human subjects research,
  including HIPAA compliance.
• Institutional Animal Care and Use Committee
  (IACUC) Responsible for oversight of animal
  subjects research.
• Institutional Health Biosafety Committee
  (IHBC) Responsible for oversight of certain
  research involving recombinant DNA and involving
  certain hazardous agents.
• Radiation Safety Committee Responsible for
  oversight of certain research involving radiation
  and/or radioactive materials.
• Conflict of Interest (COI) Committee(s)
  Responsible for review/management of conflicts of
  interest that may affect research.

3
Major Players in Emory Research Compliance
Program Administrative Offices

• Office of Research Compliance (ORC) Monitors
  compliance activities and serves as resource for
  various units compliance operations. Director
  also serves as Privacy Officer under HIPAA.
• Office of Sponsored Programs (OSP) Responsible
  for pre-award activities regarding grants and
  contracts.
• Office of Grants and Contracts Accounting
  Responsible for post-award activities regarding
  grants and contracts.
• Environmental Health Safety Office (EHSO)
  Works with units on issues of laboratory safety,
  chemical and waste management, occupational
  health and safety issues, etc.
• School of Medicine Administration Has personnel
  responsible for COI issues, research integrity
  issues, etc.

4
Major Compliance Program Components

• Human Subjects Protections
• Animal Subject Protections
• Responsible Conduct of Research
• Confidentiality and Privacy
• Laboratory Health and Safety
• Fiscal Oversight of Studies

5
Component BreakdownHuman Subjects Protections

• Regulators and Regulations
• Office for Human Research Protections (OHRP),
  http//www.hhs.gov/ohrp/ 45 CFR Part 46
• Food and Drug Admin. (FDA), http//www.fda.gov/
  21 CFR Parts 50 56
• Chief Emory Contact Unit Emory IRB,
  http//www.emory.edu/IRB/

6
Key Points Human Subjects Protections

• Unless a specific regulatory exemption applies,
  the IRB must review and approve all research that
  involves human subjects before the research
  begins.
• The IRB is responsible for initial review and
  continuing oversight of human subjects research.
• Unanticipated problems involving risks to
  subjects or others or any serious or continuing
  noncompliance with the federal regulations or the
  Emory IRBs requirements or determinations must
  be reported to the IRB.

7
Component Breakdown Animal Subjects Protections

• Regulators and Regulations
• U.S. Dept. of Agriculture (USDA),
  http//www.aphis.usda.gov/subjects/animal_welfare/
  Animal Welfare Act regulations, 9 CFR Part
  2, Subpart C
• NIH Office of Laboratory Animal Welfare,
  http//grants.nih.gov/grants/olaw/olaw.htm
  Policy on Humane Care Use of Laboratory Animals
  at http//grants.nih.gov/grants/olaw/references/ph
  spol.htm and Guide for Care and Use of Laboratory
  Animals at http//www.nap.edu/readingroom/books/la
  brats/
• Assoc. for Assessment Accreditation of
  Laboratory Animal Care International (AAALAC),
  http//www.aaalac.org/programstatus/index.cfm
  Rules of Accreditation
• Chief Emory Contact Unit Emory IACUC,
  http//www.emory.edu/IACUC/

8
Key Points Animal Subjects Protections

• IACUC approval required before research using
  animals is initiated.
• IACUC performs initial and continuing review and
  approval.
• IACUC inspects areas in which animals are housed
  or certain animal procedures are performed on a
  semi-annual basis.

9
Component Breakdown Responsible Conduct of
Research

• Regulators Regulations
• HHS Office of Research Integrity (ORI),
  http//ori.dhhs.gov/ 42 CFR Part 93 (policies on
  research misconduct)
• National Science Foundation (NSF),
  http//www.nsf.gov/ 45 CFR Part 689 (policies on
  research misconduct)
• NIH Office of Extramural Research,
  http//grants1.nih.gov/grants/policy/coi/index.htm
  (policies on conflict of interest)
• Chief Emory Contact Unit Office of Research
  Compliance, http//www.orc.emory.edu/ and
  individual schools for COI questions.

10
Key Points Responsible Conduct of Research

• Prohibition of fraud, falsification and
  plagiarism.
• Ensuring data accuracy, completeness and
  integrity.
• Inquiry and investigation process handled by each
  school in connection with Office of Research
  Compliance.

11
Component Breakdown Confidentiality and Privacy

• Regulators Regulations
• HHS Office of Civil Rights HIPAA privacy rule
  enforcement -- http//www.hhs.gov/ocr/hipaa/ 45
  CFR Parts 160 164 (privacy rule)
• HHS Centers for Medicare and Medicaid Services
  (CMS) HIPAA security rule enforcement --
  http//www.cms.hhs.gov/SecurityStandard/ 45 CFR
  Parts 164, Subpart C (security rule).
• NIH -- Certificates of Confidentiality --
  http//grants1.nih.gov/grants/policy/coc/index.htm
  , 42 U.S.C. Section 2412(d).
• Chief Emory Contact Unit Office of Research
  Compliance, http//www.orc.emory.edu/
• Chief

12
Key Points Confidentiality Privacy

• HIPAA privacy and security regulations apply to
  Emorys Covered Components, i.e., EHC, EH, EC,
  CLH, SOM, SON, SOPH, Yerkes, Student Health,
  Psychological Counseling Centers.
• Privacy Rule focuses on Protected Health
  Information (PHI).
• Emory IRB serves as Institutional Privacy Board
  for all research that involves the use of PHI
  obtained from or used by persons in Emorys
  Covered Components.

13
Component Breakdown Laboratory Health and Safety

• Regulators and Regulations
• Occupational Health Safety Admin. (OSHA),
  http//www.osha.gov/ 29 CFR Part 1910.
• Environmental Protection Agency (EPA),
  http//www.epa.gov/ 40 CFR Parts 260-65.
• NIH Office of Biotechnology Activities (OBA),
  http//www4.od.nih.gov/oba/ NIH Guidelines for
  Recombinant DNA and Gene Transfer at
  http//www4.od.nih.gov/oba/rac/guidelines/guidelin
  es.html.
• Centers for Disease Control Prevention (CDC),
  http//www.cdc.gov/ 42 CFR Part 73 (select
  agents).
• State of Georgia Regulators including the
  Department of Natural Resources.
• Chief Emory Contact Unit Environmental Health
  Safety Office (EHSO), http//www.ehso.emory.edu/

14
Key Points Laboratory Health and Safety

• Requirements for review of certain types of
  research, e.g., IHBC must review research
  involving recombinant DNA and research involving
  Select Agents.
• Requirements for ensuring safety of lab workers,
  e.g., training requirements, personal protective
  equipment requirements.
• Requirements for use and disposal of certain
  materials, e.g., materials containing blood or
  body fluids radioactive materials certain
  chemical waste controlled substances.

15
Component Breakdown Fiscal Oversight of Studies

• Regulators Regulations Each funding agency
  has its own regulations and requirements. There
  are also overall requirements that may apply to
  federal or state funded research.
• Chief Emory Contact Units
• Pre-award Office of Sponsored Programs,
  http//www.osp.emory.edu/office/
• Post-award Office of Grants Contracts
  Accounting, http//www.ogca.emory.edu/office/

16
Key Points Fiscal Oversight of Studies

• Get familiar with the funding agencys
  requirements, including any reporting
  requirements.
• Have some mechanism in place for oversight of
  research taking place at other sites.
• Documentation is critical.

17
Asking Questions Reporting Compliance Concerns

• Compliance questions can be directed to
  individual units with compliance responsibility
  for area in question or to Office of Research
  Compliance.
• Concerns can be reported to departments, schools,
  Office of Research Compliance, or to Emory Trust
  Line _at_ 1-888-550-8850.
• Trust Line allows for anonymous reporting through
  hotline manned by independent company. See FAQ
  at http//emory.hr.emory.edu/iad.nsf/.

18
Contact Information for Compliance Office

• Emory University Office of Research Compliance
• Ste. 510, 1784 N. Decatur Rd.
• Atlanta, GA 30322
• Phone [phone]
• FAX [phone]
• Director Kris West, J.D.