UNR Office of Human Research
Protection
Submit all applications to the UNR OHRP at 205 Ross Hall / 331,
(775) 327-2368
Policies and Procedures for Human Research Protection
August 28, 2006
1.2 Ethical Principles: The Belmont Report
3.1 Assurance of Compliance [45 CFR 46.103]
3.2 UNR Office of Human Research Protection (UNR OHRP)
4 UNR Institutional Review Boards (IRBs)
4.4 Roles and Responsibilities
4.4.3 Subcommittees of the IRB
4.6 Conduct of Quality Assurance/Quality Improvement Activities
for IRB Operation
5.2 Appointment of Members to the IRB
5.3 Use of Consultants (Outside Reviewers)
5.6 Training / Ongoing Education of Chair and IRB Members in
Regulations, Procedures
5.7 Liability Coverage for IRB Members
5.8 Review of IRB Member Performance
6.3 Records Retention Requirements
6.4 Written Procedures and Guidelines
7.1 Human
Subjects Research Determination
7.2.1 Categories of Research Permissible for Exemption
7.3.1 Schedule of IRB Meetings
7.3.3 New Protocol Applications
7.3.4 Pre-Meeting Distribution of Documents
7.3.5 Post-Meeting Distribution of Documents
7.3.6.1 IRB Member Conflicts of Interest
7.3.6.2 Investigator Conflicts of Interest
7.3.6.2.1 General
Conflict Management
7.3.6.2.2 Protocol-Specific
Conflict Management
7.3.7 Sponsored Research Contracts
7.3.8 Possible IRB Actions Taken by Vote
7.3.11 Review More Often Than Annually.
7.3.12 Independent Verification Regarding Material Changes.
7.4 Continuing Review of Active Protocols (Renewals)
7.4.1 Continuing Review Process
7.4.2 Expedited Review of Continuing Review
7.4.3 How is the Continuing Review Date Determined?
7.4.4 What Occurs if There is a Lapse in Continuing Review?
7.4.5 Studies that are Approved but Never Started
7.5 Modification of an Approved Protocol
7.6 Unanticipated Problems and Adverse Events
7.6.1.1 Unanticipated Problems
7.6.1.3 Relating Adverse Events to
Unanticipated Problems
7.6.2.1 Principal Investigator
Responsibilities
7.6.2.1.1 Internal
Adverse Events
7.6.2.1.2 External
Adverse Events
7.6.2.1.3 Other
Unanticipated Problems (not related to adverse events)
7.6.3 IRB
Review of Unanticipated Problems and Adverse Events
7.7 Expedited Review of Research
7.7.1 Categories
of Research Eligible for Expedited Review
7.8 Research
Involving an Investigational Drug or Device
7.8.1 Emergency
Treatment with an IND or IDE
7.8.2 Exception
from Informed Consent for Planned Emergency Research
7.8.3 Humanitarian
Use Device (HUD)
7.9 Further Review/Approval of IRB Actions by Others within the
Institution
7.10 Initiation of Research Projects
8 Criteria for IRB Approval of Research
8.2 Selection
of subjects is equitable.
8.5 Privacy
and Confidentiality
9.2 Elements of Informed Consent
9.3 Waiver of Informed Consent
9.4 Documentation of Informed Consent (Signed Consent)
9.5 Waiver of Documentation of Informed
Consent (Waiver of Signed Consent)
9.6 Review and Approval of the Informed Consent Form
9.7 Parental Permission and Assent
9.9 Consent and Language Barriers
10.1 Research Involving Children
10.1.3 Parental
Permission and Assent
10.1.3.3 Children Who are Wards
10.2 Research Involving Pregnant Women, Human Fetuses and
Neonates
10.2.2 Research
Involving Pregnant Women or Fetuses
10.2.3 Research
involving neonates
10.2.4 Research
Involving, After Delivery, the Placenta, the Dead Fetus or Fetal Material
10.2.5 Research
Not Otherwise Approvable
10.3 Research Involving Prisoners
10.3.5 Additional
Duties of the IRB
10.3.6 Waiver
for Epidemiology Research
10.4 Persons with Mental Disabilities or Persons with Impaired
Decision-Making Capacity
11 Complaints, Non-compliance, and Suspension or Termination of IRB Approval of Research
11.2.2 Review
of Allegations of Non-compliance
11.2.3 Review
of Findings of Non-compliance
11.3 Suspension
or Termination
12 Reporting to Regulatory Agencies and Institutional Officials
13 Investigator Responsibilities
13.3 Changes to Approved Research
13.4 Continuing Review after Protocol Approval
13.5 Required Reports to the IRB
13.5.2 Complaints,
Non-compliance and Protocol Deviations
13.6 Investigator-Required Record Keeping
13.7 Conflict of Interest – Investigators
13.8 Training / Ongoing Education of Principal Investigator and
Research Team
14 Health Insurance Portability and Accountability Act (HIPAA)
14.2 Effects of HIPAA on Research
15.1 Certificate of Confidentiality
15.3 UNR Students and Employees as Subjects
15.4 Psychology Department Subject Pool
15.5.2 Independent
Study, Theses and Dissertations
15.8 Research Involving Coded Private Information or Biological
Specimens