3.0 Regulatory Management and Research Risks

3.0 Regulatory Management and Research Risks s1polics Wed, 04/20/2016 - 15:24

3.1 Office of Research Integrity Assurance

3.1 Office of Research Integrity Assurance s1polics Wed, 04/20/2016 - 15:31

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)

3.1.1 Institutional Review Board (IRB)
Type of Policy
Administrative
s1polics Wed, 04/20/2016 - 15:35
Policy No
RESEARCH 3.1.1
Effective Date:
Last Revised:
Policy Owner
Georgia Tech Research Corp. (GTRC)
Contact Name
Kelly Winn
Contact Title
Director, HRPP and Regulatory Affairs
Contact Email
kelly.winn@oria.gatech.edu
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.

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.

Scope

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

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

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

3.1.2 Institutional Animal Care & Use Committee (IACUC)

3.1.2 Institutional Animal Care & Use Committee (IACUC)
Type of Policy
Administrative
s1polics Wed, 04/20/2016 - 15:41
Policy No
RESEARCH 3.1.2
Effective Date:
Last Revised:
Policy Owner
Georgia Tech Research Corp. (GTRC)
Contact Name
Mary Beran
Contact Title
Associate Director
Contact Email
mary.beran@gtrc.gatech.edu
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.

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.

Scope

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

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

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

3.1.3 Institutional Biosafety Committee (IBC)

3.1.3 Institutional Biosafety Committee (IBC)
Type of Policy
Administrative
s1polics Wed, 04/20/2016 - 15:49
Policy No
RESEARCH 3.1.3
Effective Date:
Last Revised:
Policy Owner
Georgia Tech Research Corp. (GTRC)
Contact Name
Mary Beran
Contact Title
Associate Director
Contact Email
mary.beran@gtrc.gatech.edu
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.

Scope

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

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

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

3.2 Office of the General Counsel

3.2 Office of the General Counsel kcross8 Fri, 07/16/2021 - 10:35

3.2.1 Export Control

3.2.1 Export Control
Type of Policy
Administrative
s1polics Wed, 04/20/2016 - 15:54
Policy No
RESEARCH 3.1.4
Effective Date:
Last Revised:
Review Date:
Policy Owner
The Office of the General Counsel
Contact Name
Office of the General Counsel
Contact Email
export@gatech.edu
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 the General Counsel, in coordination with 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.

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: https://ethicsfirst.gatech.edu/exportandtrade.

Scope

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

 

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

Policy History
Revision Date Author Description
07/15/2021 OGC/GTRC Updated owner
12-30-2013 GTRC-ORIA Rev 1.0

3.2.2 Conflict of Interest

3.2.2 Conflict of Interest s1polics Wed, 04/20/2016 - 15:55

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 athttps://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.

 

3.6 Organizational Conflict of Interest Policy

3.6 Organizational Conflict of Interest Policy kcross8 Thu, 09/23/2021 - 15:35
Effective Date:
Review Date:
Contact Name
Office of the Executive Vice President for Research
Contact Names
Gail Spatt
Contact Title
Director of Research Operations
Contact Email
spatt@gatech.edu
Reason for Policy

Organizational conflict of interest (OCI) assessment is a requirement of many government and some industry sponsors that fund Georgia Institute of Technology (Georgia Tech) research. The purpose of OCI assessment is to ensure objectivity in federal contracting. As a contractor, it is Georgia Tech’s intent to detect, avoid, and mitigate any OCI issues in its dealings with sponsors. The Organizational Conflict of Interest Policy provides consistency across such assessments and assurance to those sponsors who require that such a policy be in place before contracting with Georgia Tech.

Policy Statement

An organizational conflict of interest may occur when a federal contractor has an Unfair Competitive Advantage over other potential contractors or is unable to avoid Impaired Objectivity, or the appearance of Impaired Objectivity, in the course of the contracted work. (See section 4 below for detailed definitions of Unfair Competitive Advantage and Impaired Objectivity.) In order to comply with the Federal Acquisition Regulation (FAR) Subpart 9.5 – Organizational and Consultant Conflicts of Interest, researchers or their designates submit all research proposals via the eRouting system, where they answer questions about the programmatic requirement of an OCI assessment. Proposals that may contain an OCI requirement, as well as proposals for which the researcher would like a review, move to a member of the OCI Review Committee for a more detailed analysis. Georgia Tech is committed to recognizing, avoiding and mitigating potential organizational conflicts of interest, both real and perceived, wherever possible.

OCI review results are retained by the OCI committee and communicated via the eRouting system for institutional documentation.

Scope

This policy applies to all employees conducting sponsored research at Georgia Tech.

Policy Terms
Unfair Competitive Advantage Competing for work after having had access to source selection relevant information (from the sponsor or competitor’s private data) not available to all competitors or having defined the ground rules of the competition.
Impaired Objectivity Evaluating one’s own products, or similar products from competitors, on behalf of the government, in which judgment could be impaired or guidance provided to the government could be biased.
Procedures
OCI Evaluation
Submission The initial step for submission of any proposal at Georgia Tech is an entry into the eRouting system. This system contains a series of initial screening questions for OCI. Learn more here.
Review The screening questions in eRouting trigger an evaluation by the OCI Review Committee of all proposals that indicate a potential OCI or the potential appearance of an OCI. The committee’s review process typically includes, at a minimum: assessment of all relevant proposal paperwork and a search of other projects currently or recently underway for the sponsor by Georgia Tech researchers. Reviews generally take place as quickly as possible in the order in which the proposals were received, though the committee will place a greater priority on those proposals with a pending sponsor deadline. The review will be initiated within five business days of the committee’s receipt of the request, but the time frame for completion of the review will depend on its complexity.
Responsibilities

Faculty and Staff
Faculty and staff submitting proposals, conducting research, and supporting research operations are expected to consider the potential of organizational conflict of interest (OCI). They are to bring any concerns about possible OCI or the appearance of OCI to the attention of the Office of the Executive Vice President (EVPR), or the Georgia Tech Research Institute (GTRI), as well as to the contracting officer for the sponsor engagement. Faculty and staff should review information regarding submission timelines here. During execution of the project, researchers are to be vigilant about any developments which may introduce OCI. They must bring these to the attention of the above contracting officer so that these new developments can be disclosed, and potential mitigations considered.

Contracting Officers
When a proposal requires OCI review, the assigned contracting officer in the Georgia Tech Research Corporation or the Georgia Tech Applied Research Corporation ensures that the OCI Review Committee has evaluated the proposal and provided a recommendation. Based on that recommendation, the contracting officer is responsible for completing the necessary paperwork and certifying Georgia Tech’s compliance as required. The contracting officer is responsible for disclosing to the sponsor any OCI that emerges in the course of the work and for addressing any required mitigation actions with their counterparts in the sponsoring organization.

Office of the Executive Vice President for Research (EVPR)
The EVPR’s office is responsible for ensuring the accurate and thorough assessment of potential OCI on any given project, to the best of Georgia Tech’s ability. The Executive Vice President for Research directly appoints 1-2 members of the OCI Review Committee and delegates appointment of GTRI representatives to the director of GTRI. Other groups or offices may be asked to participate in this process at the direction of the EVPR.

Director of the Georgia Tech Research Institute (GTRI)
GTRI is designated as a University Affiliated Research Center (UARC) by the Department of Defense. A UARC is required to operate in the public interest and conduct its business in a manner befitting its special relationship with the government. To maintain the government’s trust in the integrity of the work, the GTRI Director has established a specially trained team that closely evaluates all proposals going out of GTRI. This team maintains OCI support throughout the life cycle of each GTRI project and supports the EVPR on other projects as required.

Georgia Tech Organizational Conflict of Interest (OCI) Review Committee
The OCI Review Committee works with researchers to evaluate the potential for OCI in sponsored projects, and then to plan and document avoidance or mitigation strategies if necessary and appropriate. The OCI committee also provides contracting officers in the Georgia Tech Research Corporation and the Georgia Tech Applied Research Corporation with advice on how to complete required OCI review certification or disclosure documents in sponsored proposals. Finally, the OCI review committee is available as a consulting body if researchers have questions around OCI or suspect that circumstances within their project may have altered their original analysis of real or perceived OCI.

Enforcement

The Georgia Tech OCI committee works diligently to ensure that noncompliance does not become an issue in the course of the award. Anyone involved in research who becomes aware of such an occurrence should immediately contact the EVPR office for correction according to the sponsor’s guidelines. Failure to disclose potential OCI issues to sponsors can cause awards to be rescinded or terminated or result in restrictions on future contracting. Actual OCI or the appearance of OCI can also be a cause for protests from competitors, creating program delays, loss of funding, and strained relations with government and industry partners. Deliberate violation of this policy constitutes research misconduct.

Policy History
Revision Date Author Description
09/2021 Office of the Executive Vice President for Research New Policy

3.7 Environmental Health and Safety

3.7 Environmental Health and Safety s1polics Wed, 04/20/2016 - 16:05

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/

3.7.1 Office of Radiological Safety

3.7.1 Office of Radiological Safety s1polics Wed, 04/20/2016 - 16:06

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/