GUIDELINES & PROCEDURES
Below are links to guidelines and procedures utilized by the Office for Research & Economic Development.
GENERAL
PRE-AWARD
- Appropriate Use of Voluntary Uncommitted Cost Share
- Budget Procedures for Grants and Contracts
- Colleges and Universities Rate Agreement
- Guidelines for Classification of Sponsored Projects
- Guidelines for Defining Teaching, Research, and Service
- Minimum Allowable PI Effort
- On/Off Campus Facilities & Administrative (F & A) Rates Application
POST-AWARD
- Extra Compensation/Supplemental Pay Policy
- Financial Stewardship
- Graduate Assistance in Areas of National Need (GAANN)
- How to Prevent and Resolve Deficit Budget Balances
- Participant Support Costs
- Procedure to Allocate Indirect Costs (IDC) to Divisions
- Travel Charges to Sponsored Projects – Tips & Pointers
- Tuition, Stipends, and Other Student Payments
RESEARCH COMPLIANCE
ANIMAL SUBJECTS (IACUC) – need uploaded to box
- AVMA Guide to Euthanasia
- SOP for Animal Carcass Use as Food for Living Animals (Approved April 2006)
- SOP for Satellite Facility
- SOP on Satellite Animal Facilities
- SOP for the Use of Non-Pharmaceutical Grade Substances in the UA Animal Care and Use Program
- SOP on Reporting the Unexpected Death of a Vertebrate Animal
EXPORT CONTROL
U.S. Department of State
- Office of Defense Control-Country Policies and Embargoes
- International Traffic in Arms Regulations (ITAR)
U.S. Department of Commerce
U.S. Department of Treasury
- Office of Foreign Assets Control (OFAC)
- Defense Threat Reduction Agency (DTRA)
- Code of Federal Regulations
- The Federal Register (FR)
- Military Control Technologies List
- The Wassenaar Arrangement
- Deemed Exports
HUMAN SUBJECT RESEARCH (IRB)
- Allegations and Findings of Noncompliance
- Appropriate and Equitable Selection of Subjects
- Authority and Independence of the IRB in Protecting Human Research Participants
- Closure of Approved Protocols
- Conflict of Interest for IRB Members, Chairs, and Consultants
- Conformity of Investigational or Unlicensed Test Articles (Devices) to Federal Regulations
- Conformity of Investigational or Unlicensed Test Articles (Drugs, Biologics) to Federal Regulations
- Continuing Review of Approved IRB Protocols
- Creation, Revision, Review, and Dissemination of Policies for Human Research Protection Program
- Data and Safety Monitoring in Proposed Research
- Department of Defense Regulations for Human Subjects Research
- Department of Energy Regulations for Human Subjects Research
- Documentation of IRB Discussions and Decisions (IRB Minutes)
- Educational Opportunities for the Community
- Emergency Use of a Test Article
- Environmental Protection Agency Requirements for Human Subjects Research
- Expedited Review
- Faculty Use of Students as Research Participants or Paid or Unpaid Assistants in their Research
- Federalwide Assurance (FWA) for Protection of Human Subjects
- Full Board Review of Protocols
- General Responsibilities of Investigators Guidelines
- Human Research Determination
- Human Research Participant Protection Plan
- Identifying and Minimizing Risks to Human Research Participants
- Improving Qualifications and Expertise of IRB Members, Investigators, and Office for Research Staff
- Institutional Commitment to Protection of Human Subjects by the IRB
- Investigator and Staff Response to Participants’ Questions, Complaints, and Concerns
- Investigator Assessment of Participant Comprehension
- Investigator Input into the HRPP/IRB Review Process
- Investigator Responsibility for Informed Consent Process and Documentation
- IRB and Investigator Responsibilities for Applications Involving Declared or Undeclared Investigator Conflicts of Interest
- IRB Record Keeping and Management
- Mandatory Reporting Laws Affecting Research Conducted in Alabama
- Modifying Approved IRB Protocols
- Monitoring of Previously Approved Research for Cause: Suspension and Termination
- Obtaining Additional Expertise or Expert Consultation for IRB Reviews
- Participant and Community Questions, Suggestions, Complaints, and Concerns about Research Studies
- Protection of Children in Research
- Protection of Human Research Participants’ Privacy and Confidentiality
- Protection of Pregnant Women, Fetuses, and Neonates
- Protection of the Cognitively Impaired
- Qualifications and Responsibilities of Investigators
- Reportable Events: Protocol Deviations, Unanticipated Problems, and Adverse Events
- Research Involving Prisoners
- Research Involving the Internet
- Research Using a Limited Data Set
- Research Using a Restricted Access Data Set
- Research Using Publicly Available Data-sets
- Research Utilizing Records, Chart Reviews, and Case Studies/Reports
- Review and Oversight of Research Conducted at Multiple Sites
- Review for Exemption
- Routine Post-Approval Monitoring of Protocols (PAM)
- Sponsored Projects Agreements for Human Subjects Research and Human Research Protections
- Student Research Pools
- Student Researchers at UA
- Subject Recruitment and Compensation
- University Expectations for Persons Involved with HRPP
- Waivers, Alterations, and Exceptions to Informed Consent or its Written Documentation
RESPONSIBLE CONDUCT OF RESEARCH
CONFLICT OF INTEREST
- PUBLIC HEALTH SERVICE REGULATIONS – Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50. Subpart F) Responsible Prospective Contractors (45 C.F.R. Part 94)
- NSF Guidance for Financial Conflict of Interest
- FDA Guidance – Financial Disclosure by Clinical Investigators