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Duke Employee and Student Resources | Grants | Human Subjects Research

Science Literature Research, Search Engines and Dictionaries

Here is a collection of web links and documents that may be particularly useful to members of RAI Labs, but may be useful to others as well:

Human Subjects Research

IRB | HHS OHRP | Federal Relations | CRSO | SOM | CITI | Radiology SBR

Radiation Safety Division | OESO | DCTI | DIAL (SQUID)

Duke University's IRB (Institutional Review Board)

The IRB works to ensure the protection of human research subjects by conducting scientific and ethical review of research studies while providing leadership and education for the research community.

• IRB Main Page (irb.duhs.duke.edu/)
• IRB Staff Contact Information (http://irb.duhs.duke.edu/modules/irb_staff/index.php?id=1)
• IRB Staff Departmental Assignments (http://irb.duhs.duke.edu/modules/irb_staff/index.php?id=2)
• IRB Policies and Procedures (irb.duhs.duke.edu/modules/irb_pols/index.php?id=3)
  • Research that Does Not Involve Human Subjects Research Using Coded Specimens or Coded Identifiable Private Information
• Policy (pdf)
• Data Use Agreements (DUA) (see attachments 2 & 3) (doc):
• Assurances from Personnel (see Attachment 1) (doc):
• Research Databases and Specimen Repositories
  • Policy (pdf)
• Use of Existing Data or Specimens in Retrospective Research
  • Policy (pdf)
• Waiver of Documentation of Consent/ Authorization
  • Policy (pdf)
• Quality Improvement Activities or Public Health Surveillance vs. Research
  • Policy (pdf)
• Determining if Research is Subject to or Exempt from the privacy Rule (HIPAA)
  • Policy (pdf)
    
• IRB Forms & Standard Language (irb.duhs.duke.edu/modules/irb_forms/index.php?id=1 )
  • Includes:
    • DUHS PI Agreement
    • Standard Language
    • Submission Forms
      • Research Summary Instructions
      • Amendment
    • Consent Form Templates and Tools
    • Reporting to the IRB
    • Checklists
    • Primary Reviewer Checklists
    • Waiver Requests
    • Checklists for IRB Reviewers
    • Pathology Review Form
    • Durham Regional and Duke Raleigh Hospital Site Specific Forms
• eIRB (https://eirb.mc.duke.edu/eirb/)
• eIRB Forms (https://eirb.mc.duke.edu/eirb/Rooms/DisplayPages/LayoutInitial?Container=
  com.webridge.entity.Entity%5BOID%5B2374ADAB42020F4DA3F44AD283EC1EDF%5D%5D)

United States Department of Health and Human Services (HHS)

Office for Human Research Protections (OHRP)

The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and behavioral research.

• HHS OHRP Main Page (hhs.gov/ohrp)
• Pertinent Human Subjects Research Questions Explained
  • How does HHS OHRP define "research"? (see pg. 2 of pdf)
  • How does HHS OHRP define "human subject"? (see pg. 2 of pdf)
  • How does HHS OHRP define "coded"? (see pg. 2 of pdf)
  • How does HHS OHRP define "obtaining identifiable private information"? (see pg. 3 of pdf)
  • Who should determine whether human subjects are involved in research? (see pg 4 of pdf)
  • What is the difference between "Research not Involving Human Subjects" and "Exempt Human Subjects Research" (see pgs 5-6 of pdf)
  • How do the HIPAA Privacy Rule and 45 CFR 46 differ in their definitions of identifying information? (see pg 7 of pdf)
• HHS OHRP Policy Guidance organized by topic (hhs.gov/ohrp/policy/index.html)
  • HHS OHRP Guidance on Coded Private Information (www.hhs.gov/ohrp/policy/index.html#coded)
    • Guidance of Research Involving Coded Private Information of Biological Specimens (http://www.hhs.gov/ohrp/policy/index.html#biol)
      • Guidance on Coded Private Information
  • HHS OHRP Common Rule Guidance (hhs.gov/ohrp/policy/index.html#common)
    • Federal Policy ("Common Rule") (hhs.gov/ohrp/policy/common.html)
    • Code of Federal Regulations (CFR) Title 45 Part 46 (45 CFR 46) (hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm)
      • 45 CFR 46.101 "Exemptions"    (hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.101)
    • 45 CFR 46 FAQs (hhs.gov/ohrp/45CFRpt46faq.htm
      • Nuremberg Code (hhs.gov/ohrp/references/nurcode.htm)
      • Belmont Report "Ethical Principles and Guidelines for the Protection of Human Subjects of Research " April 18, 1979 (hhs.gov/ohrp/humansubjects/guidance/belmont.htm)
  • HHS OHRP Human Subjects Guidance (hhs.gov/ohrp/policy/index.html#human)
• Basic Protections for Human Subjects (hhs.gov/ohrp/humansubjects/guidance/basics.htm)
• Human Subjects Regulations Decision Charts (hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm)

Duke University's Federal Relations Office

The Federal Relations Office represents Duke University in Washington, D.C. on legislative and regulatory matters of interest to Duke. The issues range from funding for scientific research and student aid to technology transfer and intellectual property law.

• Federal Relations Office Main Page (duke.edu/federalrelations)

Clinical Research Support Office (CRSO)

The CRSO participates in the development of institutional policies regarding clinical research, provides training and education to study teams and the clinical research community at Duke, and reviews and approves charge assignment grids.

• CRSO Main Page (crso.som.duke.edu)
• CRSO Training (crso.som.duke.edu/modules/crso_resrch/index.php?id=1)
• CRSO Site-Based Research (SBR) Units(crso.som.duke.edu/modules/crso_sbrg/index.php?id=62)
  • CRSO Radiology Site-Based Research Unit (crso.som.duke.edu/modules/crso_sbrg/index.php?id=12

Duke University School of Medicine (SOM)

Duke University SOM is a center for medical education, clinical care and biomedical research.

• Duke SOM Main Page (medschool.duke.edu)
• Duke SOM Research Support Services (medschool.duke.edu/modules/rs_services/index.php?id=1)
• Duke SOM Compliance Office (medschool.duke.edu/modules/som_compliance/index.php?id=1)
• Duke SOM Human Subjects Protection (HSP) Certification 
  • Human Subjects Protections (HSP) Certification at SOM Research Services
    (medschool.duke.edu/modules/rs_services/index.php?id=41)
• Human Subjects Protections (HSP) Certification at SOM Research
  (medschool.duke.edu/modules/som_research/index.php?id=10)
• Duke SOM Research Overview
  (medschool.duke.edu/modules/som_research/index.php?id=4)
• Duke SOM Basic Science Research Home Page
  (basicscience.medschool.duke.edu/modules/bsci_adept/index.php?id=1)

Collaborative Institution Training Initiative (CITI)

The CITI Program is a subscription service providing human subjects Protection (HSP) certification and research ethics education to all members of the research community. To participate fully, learners must be affiliated with a CITI participating organization.

• CITI Main Page (https://www.citiprogram.org/Default.asp?)
• Opening/Accessing a Duke Medicine-affiliated CITI account
  (medschool.duke.edu/wysiwyg/downloads/CITI_Access_Instructions_revised_12.29.2008.pdf)

Radiology Site-Based Research (SBR) Unit

The Radiology SBR serves as the organizational home for site-based research in Radiology.

• Radiology SBR Main Page (radiology.duke.edu/modules/dept_rad_research/index.php?id=26)
  • SBR Request Forms
    (http://radiology.duke.edu/modules/dept_rad_research/index.php?id=33)
    • Radiology SBR Request for Study Consideration "Statement of Intent" Form (doc)
• Clinical Research Support Office (CRSO) (http://crso.som.duke.edu/modules/flash_articles/)
  • CRSO Site-Based Research Units (http://crso.som.duke.edu/modules/crso_sbrg/index.php?id=62)
  • Radiology CRSO SBR Quick Link (http://crso.som.duke.edu/modules/crso_sbrg/index.php?id=12

Duke Radiation Safety Division

The Radiation Safety division provides guidance and oversight to users of radiation producing devices and radioactive material on campus, in the Medical Center, in the Medical School, at the accelerator facilities, and at Duke University affiliated medical facilities.

• OESO Radiation Safety Division Main Page (www.safety.duke.edu/RadSafety)
• Radiation Safety Main Page (www.safety.duke.edu/radsafety/main.asp)
• Radiation Safety Risk Statements (www.safety.duke.edu/radsafety/consents/default.asp)

Duke University & Duke Medicine Occupational & Environmental Safety Office (OESO)

OESO promotes a safe environment for the Duke Community.

• OESO Main Page (www.safety.duke.edu)
• OESO Radiation Safety Division Main Page (www.safety.duke.edu/RadSafety)

Duke University's School of Medicine Computed Tomography (DCTI) Institute

DCTI conducts CT research and CT education, and accepts applications for using CT resources at Duke.

• DCTI Institute Main Page (cti.radiology.duke.edu)
• DCTI Institute Proposal Submission (cti.radiology.duke.edu/modules/cti_prpsl/index.php?id=1)
• DCTI Application Form (cti.radiology.duke.edu/wysiwyg/downloads/DCTI_Application_Form.pdf)

Duke Image Analysis Lab (DIAL) - Scalable Query Utility & Image Database (SQUID)

DIAL provides imaging support in research studies and clinical trials to various agencies with SQUID.

• DIAL Main Page (dial.mc.duke.edu)
• SQUID (dial.mc.duke.edu/SQUID.php)

Back to Lab Manger Resource Main Page

Duke Employee and Student Resources | Grants | Human Subjects Research

Science Literature Research, Search Engines and Dictionaries

Lab Manager Resource Pages created by Karen Leanza Wilson, Lab Manager for RAI Labs, 2009-2010