As announced earlier this month by the Office of Sponsored Programs, NIH had released the updated Grants Policy Guidance (GPG) on March 31, 2015 to replace interim guidance as well as incorporate the new Uniform Guidance requirements.  Here is a link to the 3/31/15 NIH Grants Policy Statement.

We in the OPRC wanted to highlight a few items from the GPG that are of interest to areas in research compliance. If you have questions or want more information, please contact us at complaince@umbc.edu.

2.3.12 Protecting Sensitive Data and Information Used in Research

NIH fund recipients are required to protect sensitive and confidential data and take all reasonable and appropriate actions to prevent the inadvertent disclosure, release or loss of sensitive personal information. NIH advises that personally identifiable, sensitive, and confidential information about research participants not be housed on portable electronic devices. If such devices must be used (such as laptops, CDs, disc drives, flash drives), they should be encrypted to safeguard data and information.

Personally identifiable information should be restricted via password protection and other means. Research data should be transmitted only when the security of the recipient’s systems is known and is satisfactory to the transmitter.  For more information, go to the ORPC page on UMBC’s security requirements for protecting sensitive research data.

4.1.1 Animal Welfare Requirements

The PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy) requires that an approved Animal Welfare Assurance be on file with the Office of Laboratory Animal Welfare (OLAW) at the time of award for all recipient organizations receiving PHS support for research or related activities using live vertebrate animals. The use of vertebrate animals required in the Research Plan of the application. If the involvement of animals is indefinite at the time of application, applicants should provide an explanation and indicate when it is anticipated that animals will be used. Verification of IACUC approval may be filed at any time before award in accord with Just-in-Time procedures. IACUC approval must have been granted within three years of the budget period start date to be valid; however, IACUCs may determine that continuing review on a more frequent basis is appropriate. For more information, go to the ORPC page on the UMBC IACUC’s protocol submission procedures.

4.1.10 Financial Conflict of Interest

NIH requires recipients and investigators (except Phase I SBIR/STTR applicants and recipients) to comply with the requirements of 42 CFR 50, Subpart F, “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought.” These regulations are designed to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be free from bias by any conflicting financial interest of an Investigator.  For more information, go to the ORPC page on how to report and manage potential financial conflicts of interest.

4.1.15 Human Subjects Protections

The HHS regulations for the protection of human subjects provide the framework to safeguard the rights and welfare of individuals who participate as subjects in research activities supported or conducted by the NIH or other HHS components. HHS regulations stipulate that the recipient organization, whether domestic or foreign, bears ultimate responsibility for safeguarding the rights and welfare of human subjects. In accepting an award that supports human subjects research, a recipient institution assumes responsibility for all research conducted under the award, including protection of human subjects at all participating and consortium sites, and for ensuring that an FWA and certification of IRB review and approval exists for each site before human subjects research may begin. Verification of IRB approval may be filed at any time before award in accord with Just-in-Time procedures. Certification of IRB review and approval must be provided before research activities with human subjects begin. For more information, go to the ORPC page on the UMBC IRB’s protocol submission procedures.

4.1.26 Research Involving Recombinant or Synthetic Nucleic Acid Molecules

The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) apply to all research projects (NIH-funded and non-NIH-funded) that involve recombinant or synthetic nucleic acid molecules and are conducted at or sponsored by an organization that receives NIH support for recombinant or synthetic nucleic acid molecule research.  Each organization that conducts research involving recombinant or synthetic nucleic acid molecules, including contractors under grants, must have policies and procedures to ensure compliance with the NIH Guidelines and must establish a standing IBC. The IBC is required to review each proposed project for recombinant or synthetic nucleic acid molecule experiments to ensure that the procedures, project, personnel, and facilities are adequate and in compliance with the NIH Guidelines. For more information, go to the ORPC page on the UMBC IBC’s submission procedures.

 4.1.27 Research Misconduct

The PHS Policy on Research Misconduct specifies recipient responsibilities to have written policies and procedures for addressing allegations of research misconduct, to file an Assurance of Compliance with the HHS Office of Research Integrity, and take all reasonable and practical steps to foster research integrity. Research misconduct is defined as the fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. The ORPC plays a role in the assurance process.  Education is a key component of the “steps to foster research integrity). For more information on what’s required to conduct research responsibly, go to the ORPC page on Responsible Conduct of Research.