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Responsible Conduct of Research

General Responsible Conduct Links

Responsible Conduct of Research Brochure (PDF for printing)
UNC-Chapel Hill Ethics Policy: "Policies and Procedures on Ethics in Research"

Responsible Conduct by Specific Subject

Does your research or university service involve:

Animals?
Human Subjects?
Use of Protected Health Information (PHI)?
Recombinant DNA?
Chemicals and Other Hazardous Materials?
Radioactive Materials?
Shipment of Hazardous Materials?
Biological Safety Cabinets?
Generation of Hazardous Waste?
X-rays or Lasers?
Activities Subject to U.S. Export Control Laws and Regulations?
Inventions, Patents, Materials Transfer, or Other Intelletual Property Issues?
Outside Activities that May Pose Conflicts of Interest?
Closing or Moving a Laboratory?
A Sabbatical or Extended Absence?

Does your research involve Animals?

Then you need to:

Complete online Institutional Animal Care and Use Committee (IACUC) orientation
Obtain approval from IACUC before beginning any project using live vertebrate animals
Submit medical history registration form for all animal handlers and caretakers
Order research animals, arrange facilities, or talk with a veterinarian about veterinary or technical services at the Division of Laboratory Animal Medicine (DLAM)
Report any concerns regarding the use of animals to IACUC or the Research Compliance Coordinator

Does your research involve Human Subjects?

(This section is currently under construction.)

Then you need to:

Obtain Institutional Review Board (IRB) approval prior to beginning research or contacting potential human subjects (this includes all research, funded or unfunded, faculty or student)
Review the Office of Human Research Ethics (OHRE) Guide to the IRB Process (future link here)
Submit protocol for review to the IRB associated with your home department or school and obtain approval or exempt determination, using required forms and procedures (future link here)
Prior to IRB approval, satisfy the Human Subjects Protection Required Education (future link here) including the online research ethics course, necessary for all human subjects investigators and project staff.

Does your research or service activity involve the use of Protected Health Information (PHI)?

Then you need to:

Complete the Online Health Insurance Portability and Accountability Act (HIPAA) training module
Implement measures to keep individual patients' health information securely confidential

Do you conduct research involving Recombinant DNA?

Then you need to:

Review "Responsibilities of Researchers Using Recombinant DNA/Human Gene Transfer Experiments" (PDF) to determine whether your experiment is exempt or requires approval
Register your experiment with the Institutional Biosafety Committee (IBC) of the Office of Environment, Health and Safety and obtain approval before initiating your research

Do you work with Chemicals and Other Hazardous Materials?

Then you need to:

Review the Office of Environment, Health and Safety (EHS) Laboratory Safety Manual
Develop a Laboratory Safety Plan (LSP) addressing hazards and precautions in your specific laboratory
Ensure training of laboratory personnel in LSP procedures and appropriate use of Material Safety Data Sheets

Do you work with Radioactive Materials?

Then you need to:

First obtain a radioactive materials license from the Office of Environment, Health, and Safety (EHS). To do so, you need to:
Complete and submit a Laboratory Safety Plan (specifically include Schedule C) to EHS
Complete training requirements with either the Radiation Safety Orientation Class (classroom) or the radiation safety review course
Complete pre-licensing consultation with Radiation Safety Office to get approval from the Radiation Safety Committee
Get approval before purchasing radioactive materials

Does your research require Shipment of Hazardous Materials to or from campus?

Then you need to:

Before shipping, determine whether materials are deemed hazardous (PDF)
Ensure required training for all staff involved in shipping and/or receiving hazardous materials
Become familiar with license requirements for international shipment of infectious agents and toxins

Do you use Biological Safety Cabinets?

Then you need to:

Get your cabinets reviewed and approved by the Health and Safety Office at time of purchase, installation, whenever they are moved, prior to use, and periodically thereafter

Does your research Generate Hazardous Waste in the laboratory?

Then you need to:

Do you work with X-ray machines or operate Lasers?

Then you need to:

Get approval from Radiation Safety Office before acquiring equipment
Develop written safety plan and safe operating procedures

Do you conduct research or training activities that are subject to U.S. Export Control Laws and Regulations (involving foreign nationals in the U.S. or the transfer of controlled technology to foreign nationals in the U.S. or overseas)?

Then you need to:

Review the Office of Sponsored Research (OSR) website for policy and guidance on export controls
Consult with OSR to determine whether your research is impacted by the controls or requirements contained within the export regulations
If required, sign certification on the handling of export-controlled information (PDF)
Re-evaluate in cooperation with OSR before changing the scope or adding new staff to the project to assess whether such changes alter the initial determination
Make export determinations far enough in advance to obtain a license, should one be required

Has your research produced an invention? Do you need a material transfer agreement? Do you have questions about invention disclosures, patents or copyrights, invention marketing and commercialization, confidentiality agreements or other agreements involving intellectual property issues?

Then you need to:

Contact the Office of Technology Development (OTD)
Submit a report of invention form or materials transfer agreement online
Discuss the potential patentability of your invention with OTD before disclosing it to others
Submit a report of invention to your collaborators or non-government sponsors, if required by your research contract or a material transfer agreement.

Do you have conflicts of interest, i.e., financial relationships, time commitments, and other interests that may compete with your University responsibilities?

Then you need to:

Review the University's "Policy on Conflicts of Interest and Commitment" online
Complete the annual evaluation form for possible conflict of interest or commitment (PDF)

Are you closing or moving a laboratory?

Then you need to:

Remove all materials, including chemicals and biologicals
Clean and decontaminate laboratory and storage areas
Contact Office of Environment, Health, and Safety (EHS) at least 60 days prior to vacating (PDF)
Contact Institutional Animal Care and Use committee (IACUC) to terminate any animal use protocol or amend protocol to name new principal investigator

Are you going to be on sabbatical or absent for more than 30 days?

Then you need to:

Appoint someone familiar with procedures to provide laboratory oversight in your absence
Empower a co-investigator to make necessary decisions on animal use protocols

Research at Carolina

Research at Carolina Offices

Responsible Conduct of Research

General Responsible Conduct Links

Responsible Conduct by Specific Subject

Does your research or university service involve:

Does your research involve Animals?

Then you need to:

See also:

Does your research involve Human Subjects?

(This section is currently under construction.)

Then you need to:

See also:

Does your research or service activity involve the use of Protected Health Information (PHI)?

Then you need to:

See also:

Do you conduct research involving Recombinant DNA?

Then you need to:

See also:

Do you work with Chemicals and Other Hazardous Materials?

Then you need to:

See also:

Do you work with Radioactive Materials?

Then you need to:

See also:

Does your research require Shipment of Hazardous Materials to or from campus?

Then you need to:

See also:

Do you use Biological Safety Cabinets?

Then you need to:

See also:

Does your research Generate Hazardous Waste in the laboratory?

Then you need to:

See also:

Do you work with X-ray machines or operate Lasers?

Then you need to:

See also:

Do you conduct research or training activities that are subject to U.S. Export Control Laws and Regulations (involving foreign nationals in the U.S. or the transfer of controlled technology to foreign nationals in the U.S. or overseas)?

Then you need to:

See also:

Has your research produced an invention? Do you need a material transfer agreement? Do you have questions about invention disclosures, patents or copyrights, invention marketing and commercialization, confidentiality agreements or other agreements involving intellectual property issues?

Then you need to:

See also:

Do you have conflicts of interest, i.e., financial relationships, time commitments, and other interests that may compete with your University responsibilities?

Then you need to:

See also:

Are you closing or moving a laboratory?

Then you need to:

See also:

Are you going to be on sabbatical or absent for more than 30 days?

Then you need to: