3.0 Regulatory Management and Research Risks

3.1 Office of Research Integrity Assurance

Universities, as partners in the national research enterprise, are required by federal regulations to establish specific research committees to ensure the ethical and safe conduct of research and certain other scholarly activities.  The Institutional Animal Care and Use Committee, the three Institutional Review Boards, and the Institutional Biosafety Committee have been established to oversee activities involving, respectively, vertebrate animal subjects, human research subjects, and recombinant DNA (rDNA).  These federally mandated faculty committees are administered and supported by the Office of Research Integrity Assurance, which reports to the Vice President for Research.  Procedures for obtaining committee approval can be found at www.researchintegrity.gatech.edu.​

3.1.1 Institutional Review Board (IRB)

Additional Resources: 

Policy No: RESEARCH 3.1.1
Type of Policy: Administrative
Effective Date: September 2013    
Last Revised: September 2013

Policy Owner: GTRC-ORIA
Policy Contact: Barbara Henry, Executive Director, barbara.henry@gtrc.gatech.edu

1. Reason for Policy

Georgia Tech subscribes to the basic ethical principles that underlie the conduct of biomedical and behavioral research involving human subjects as set forth in the Belmont Report, the timeless statement of ethical principles and guidelines for the protection of human subjects published in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

2. Policy Statement

The three Georgia Tech Institutional Review Boards are charged with protecting the rights and welfare of human subjects participating in research projects conducted by Georgia Tech faculty, staff, or students.  These include the Central IRB, the Joint Georgia State University-Georgia Tech IRB for the Advanced Brain Imaging Center, and the Classified IRB. The IRBs have the responsibility and authority to review, approve, disapprove, or require changes in research activities involving human subjects.  All proposed research activities involving human subjects, regardless of source of funding or study location, must be reviewed and approved by the appropriate Georgia Tech Institutional Review Board (IRB) prior to initiation of research. The IRBs hold regularly scheduled meetings to review research protocols involving human subjects.

Georgia Tech’s Federalwide Assurance is approved by the Department of Health and Human Services, and the Institutional Review Boards are registered with the Department of Health and Human Services, Office for Human Research Protections.

Committee members are appointed by the Vice President for Research, who also serves as the Institutional Official for matters related to human subjects.  Membership is structured in accordance with federal requirements set forth in Title 45 Code of Federal Regulations Part 46, “Federal Policy for the Protection of Human Subjects” including Subparts A, B, C, and D, and in Title 21 Code of Federal Regulations, Parts 50, 56, 312, and 812.

3. Scope

This policy applies to all Georgia Tech Faculty, Staff, and Students.

4. Enforcement

To report suspected instances of noncompliance with this policy, please visit Georgia Tech’s EthicsPoint, a secure and confidential reporting system, at: https://secure.ethicspoint.com/domain/en/report_custom.asp?clientid=7508

5. Related Information

Resource Link
IRB Policies and Procedures http://researchintegrity.gatech.edu/about-irb/irb-policies-and-procedures/
Belmont Report http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html

6. Policy History

Revision Date Author Description
12-30-2013 GTRC-ORIA Rev 1.0

3.1.2 Institutional Animal Care & Use Committee (IACUC)

Additional Resources: 

Policy No: RESEARCH 3.1.2
Type of Policy: Administrative
Effective Date: September 2013    
Last Revised: September 2013

Policy Owner: GTRC-ORIA
Policy Contact: Mary Beran, Associate Director, mary.beran@gtrc.gatech.edu

1. Reason for Policy

The Georgia Institute of Technology is committed to ensuring that vertebrate animals used in research and teaching activities receive humane care and treatment.

2. Policy Statement

The Institutional Animal Care and Use Committee (IACUC) is charged with reviewing all proposed use of vertebrate animals, regardless of where the work is performed and source of funding, if any. The IACUC has the responsibility and authority to review, approve, disapprove, or require changes in research activities involving vertebrate animals.  This committee regularly inspects and monitors the animal care and use facilities and program at the Institute to ensure that all components are in compliance with regulations outlined in the federal Animal Welfare Act, the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, and with the Eighth Edition of the Guide for the Care and Use of Laboratory Animals.  

The animal facilities are registered with the U.S. Department of Agriculture and undergo frequent, unannounced inspections by that agency.  Georgia Tech’s Animal Welfare Assurance is approved by the Department of Health and Human Services. Committee membership is structured in accordance with federal requirements; members are appointed by the Vice President for Research, who also serves as the Institutional Official for matters related to vertebrate animal subjects.   

The IACUC has set forth procedures for reporting, without fear of reprisal, concerns about the humane use and treatment of vertebrate animals used in research and teaching activities at Georgia Tech.   The IACUC meets monthly to review research protocols which propose the use of vertebrate animal subjects; committee approval must be obtained prior to initiation of proposed activities.

3. Scope

This policy applies to all Georgia Tech Faculty, Staff, and Students.

4. Enforcement

To report suspected instances of noncompliance with this policy, please visit Georgia Tech’s EthicsPoint, a secure and confidential reporting system, at: https://secure.ethicspoint.com/domain/en/report_custom.asp?clientid=7508

5. Related Information

Resource Link
IACUC Policies and Procedures http://researchintegrity.gatech.edu/about-iacuc/policies-procedures/

6. Policy History

Revision Date Author Description
12-30-2013 GTRC-ORIA Rev 1.0

3.1.3 Institutional Biosafety Committee (IBC)

Additional Resources: 

Policy No: RESEARCH 3.1.3
Type of Policy: Administrative
Effective Date: September 2013    
Last Revised: September 2013

Policy Owner: GTRC-ORIA
Policy Contact: Mary Beran, Associate Director, mary.beran@gtrc.gatech.edu

1. Policy Statement

The Institutional Biosafety Committee (IBC) is responsible for reviewing all registrations for research, teaching, and training that involve the use of recombinant DNA by Georgia Tech faculty, staff or students and ensuring that the proposed activities comply with the federal “NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules” and all other applicable regulations.  All scholarly activities involving recombinant DNA, regardless of source of funding, must be reviewed by the IBC.  The Committee has the responsibility and authority to review, approve, disapprove, or require changes in research, teaching, and training activities involving recombinant DNA materials.

Georgia Tech’s Institutional Biosafety Committee is registered with the National Institutes of Health’s Office of Biotechnology Activities (OBA).  IBC works closely with Georgia Tech’s Biosafety Officer in the Office of Environmental Health and Safety.  Committee membership is structured in accordance with federal requirements.  Members are appointed by the Executive Vice President for Research, who is also the Institutional Official for matters related to the Biosafety Committee.  The IBC holds meetings as needed to review registrations.

2. Scope

This policy applies to all Georgia Tech Faculty, Staff, and Students.

3. Enforcement

To report suspected instances of noncompliance with this policy, please visit Georgia Tech’s EthicsPoint, a secure and confidential reporting system, at: https://secure.ethicspoint.com/domain/en/report_custom.asp?clientid=7508

4. Related Information

Resource Link
IBC Guidance http://researchintegrity.gatech.edu/about-ibc/ibc-guidance-for-faculty-planning-to-work-with-rdna/

5. Policy History

Revision Date Author Description
12-30-2013 GTRC-ORIA Rev 1.0

3.1.4 Export Control

Additional Resources: 

Policy No: RESEARCH 3.1.4
Type of Policy: Administrative
Effective Date: September 2013    
Last Revised: September 2013

Policy Owner: GTRC-ORIA
Policy Contact: Mary Beran, Associate Director, mary.beran@gtrc.gatech.edu

1. Reason for Policy

Research is a global endeavor, and international experiences and opportunities are vital in preparing Georgia Tech’s students to become leaders who meet the challenges of the future. It is sometimes challenging to conduct these programs in compliance with complex laws and regulations that change frequently.  The Office of Research Integrity Assurance (ORIA), in coordination with the Office of Legal Affairs (OLA) and the Research Security Department (RSD), assists faculty members with the review of research proposals and awards and when appropriate prepares Technology Control Plans (TCP) to protect export controlled technology.

2. Policy Statement

It is the policy of the Georgia Institute of Technology (GIT) to fully comply with all applicable federal statutes, executive orders, regulations, and contractual requirements for the safeguarding of export controlled technical information in its possession. This includes full and total compliance with export controls and transfer of controlled technology. Under no circumstances shall employees or other persons acting on behalf of GIT engage in activities in contravention of U.S. export control laws. In general, export controlled Information means activities, items, and information related to the design, development, engineering, manufacture, production, assembly, testing, repair, maintenance, operation, modification, demilitarization, destruction, processing, or use of items with a capacity for military application utility.  Export controlled information does not include basic marketing information on function or purpose; general system descriptions; or information concerning general scientific, mathematical, or engineering principles commonly taught in schools, colleges and universities or information in the public domain.

The export of equipment and information including technical data, software and hardware is controlled by federal regulations such as the Export Administration Regulations (EAR) and the International Traffic in Arms Regulations (ITAR). Information such as brochures, proposals, site visits and technical discussions are deemed "technical data." Exporting information or talking to a foreign sponsor (either in the U.S. or abroad) about certain types of technical data which may have a possible military application requires a State Department export license, which may take up to three months to obtain. Exporting information or a commodity which does not have significant military application usually requires obtaining one or more of the following: an assurance which precludes reexport; supporting documentation; or a Commerce Department export license. Export of some items to certain countries and some types of subcontracts with those countries are prohibited altogether. For more information: http://www.export.gatech.edu/

3. Scope

This policy applies to all Georgia Tech Faculty, Staff, and Students.

4. Enforcement

To report suspected instances of noncompliance with this policy, please visit Georgia Tech’s EthicsPoint, a secure and confidential reporting system, at: https://secure.ethicspoint.com/domain/en/report_custom.asp?clientid=7508

5. Related Information

Resource Link
Export Control Form & Procedures http://researchintegrity.gatech.edu/about-export/forms-and-procedures/

6. Policy History

Revision Date Author Description
12-30-2013 GTRC-ORIA Rev 1.0

3.2 Conflict of Interest

Additional Resources: 

It is the policy of the Georgia Institute of Technology that all Financial Conflicts of Interests (FCOI) will be managed, reduced, or eliminated in accordance with Federal Regulations, State law, and Institute Policy.  In order to ensure timely management and reporting of FCOIs, every Employee of the Institute, including all who participate in outside professional activities and/or sponsored research must complete an annual disclosure using the online Conflict of Interest system (eCOI), which is available at https://ecoi.research.gatech.edu. In answering the eCOI questions, if an Employee has indicated an actual or potential conflict, the system will notify the COI Office for review.  Employees must update their disclosures on an ongoing basis when circumstances change.  This includes receiving prior approval before engaging in any outside professional activity.

3.3 Responsible Conduct of Research

3.6 Environmental Health and Safety

The Environmental Health and Safety (EHS) Office at Georgia Tech develops programs and provides oversight, consultation, training and other specialized services to assist the Institute community in meeting its public health, safety, environmental protection, and compliance responsibilities.

http://www.ehs.gatech.edu/

3.6.1 Office of Radiological Safety

The Office of Radiological Safety (ORS) manages all aspects of the use of radioactive material (RAM) and radiation generating devices at Georgia Tech.

http://www.ors.gatech.edu/

3.7 Related Georgia Tech Policies and Procedures

Administration and Finance
http://af.gatech.edu/
Grants & Contracts Accounting
http://grants.gatech.edu/
Office of Legal Affairs
http://www.legalaffairs.gatech.edu/
OIT
http://www.oit.gatech.edu/