Submission Rights: Upon submission, each participant warrants that he or she is the sole author and owner of the work, and that the work is wholly original and does not infringe on any copyright or any other rights of any third party of which the participant is aware. Participants retain title and full ownership in and to their application. Participants expressly reserve all intellectual property rights (e.g., copyright). However, each participant may be asked to grant to NIDA and others acting on behalf of NIDA, a royalty-free non-exclusive worldwide license to use, copy for use, and display publicly all parts of the application for the purposes of the Challenge. This license includes posting or linking to the application on the official NIDA website and making it available for use by the public.

Liability: By participating in this Challenge, participants agree to assume any and all risks and waive claims against the Federal Government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from their participation in the Challenge, whether the injury, death, damage, or loss arises through negligence or otherwise.

Indemnification: By participating in this Challenge, participants agree to indemnify the Federal Government against third party claims for damages arising from or related to Challenge activities.

Insurance: Based on the subject matter of the contest, the type of work that it will possibly require, as well as an analysis of the likelihood of any claims for death, bodily injury, or property damage, or loss potentially resulting from Challenge participation, participants are not required to obtain liability insurance or demonstrate financial responsibility in order to participate in this Challenge.

Privacy, Data Security, Ethics, and Compliance

Participants are required to identify and address privacy and security issues in their proposed projects, and describe specific solutions for meeting them. In addition to complying with appropriate policies, procedures, and protections for data that ensures all privacy requirements and institutional policies are met, use of data should not allow the identification of the individual from whom the data was collected. Participants are responsible for compliance with all applicable federal, state, local, and institutional laws, regulations, and policy. These may include, but are not limited to, Health Insurance Portability and Accountability Act (HIPAA), HHS Protection of Human Subjects regulations, and FDA regulations. The following links are intended as a starting point for addressing regulatory requirements, but should not be interpreted as a complete list of resources on these issues:

HIPAA

Main link: http://www.hhs.gov/ocr/privacy/index.html.

Summary of the HIPAA Privacy Rule: http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/index.html

Summary of the HIPAA Privacy Rule:

http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/index.html

Summary of the HIPAA Security Rule: http://www.hhs.gov/ocr/privacy/hipaa/understanding/srsummary.html

Human Subjects — HHS

Office for Human Research Protections: http://www.hhs.gov/ohrp/index.html

Protection of Human Subjects Regulations:

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

Policy & Guidance: http://www.hhs.gov/ohrp/policy/index.html

Institutional Review Boards & Assurances: http://www.hhs.gov/ohrp/assurances/index.html

Human Subjects — US Food and Drug Administration (FDA)

Clinical Trials: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm 

Office of Good Clinical Practice: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OfficeofScienceandHealthCoordination/ucm2018191

Consumer Protection — Federal Trade Commission (FTC)

Bureau of Consumer Protection:

http://business.ftc.gov/privacy-and-security