80 FR 67773 - National Institutes of Health, National Institute on Drug Abuse (NIDA) Announcement of Requirements and Registration for “Addiction Research: There's an App for That” Challenge

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 212 (November 3, 2015)

Page Range		67773-67776
FR Document		2015-27939
The National Institute on Drug Abuse (NIDA), one of the components of the National Institutes of Health (NIH), announces the Challenge, ``Addiction Research: There's an App for that''. With this Challenge, NIDA aims to develop novel mobile applications (apps) for future addiction research explicitly created on Apple Inc.'s ResearchKit framework. ResearchKit is open-source software which makes it easy for researchers and developers to create apps for specific biomedical research questions by circumventing development of custom code. Contestants will create the solicited app for use by addiction researchers to engage mobile device users in future society-changing research.
Federal Register, Volume 80 Issue 212 (Tuesday, November 3, 2015)
[Federal Register Volume 80, Number 212 (Tuesday, November 3, 2015)]
[Notices]
[Pages 67773-67776]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-27939]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Institutes of Health, National Institute on Drug Abuse 
(NIDA) Announcement of Requirements and Registration for ``Addiction 
Research: There's an App for That'' Challenge

    Authority: 15 U.S.C. 3719.

SUMMARY: The National Institute on Drug Abuse (NIDA), one of the 
components of the National Institutes of Health (NIH), announces the 
Challenge, ``Addiction Research: There's an App for that''. With this 
Challenge, NIDA aims to develop novel mobile applications (apps) for 
future addiction research explicitly created on Apple Inc.'s 
ResearchKit framework. ResearchKit is open-source software which makes 
it easy for researchers and developers to create apps for specific 
biomedical research questions by circumventing development of custom 
code. Contestants will create the solicited app for use by addiction 
researchers to engage mobile device users in future society-changing 
research.

DATES: The Challenge begins November 3, 2015.
    Submission Period: November 3, 2015 to April 29, 2016, 11:59 p.m., 
ET.
    Judging Period: May 2, 2016 to July 29, 2016.
    Winners Announced: August 1, 2016.

FOR FURTHER INFORMATION CONTACT: Elena Koustova, Ph.D., MBA, Director, 
Office of Translational Initiatives and Program Innovations (OTIPI), 
NIDA Challenge Manager, National Institute on Drug Abuse (NIDA), 6001 
Executive Blvd. Room 4286, MSC 9555 Bethesda, MD 20892-9555 Phone: 
(301) 496-8768 Email: [email protected].

SUPPLEMENTARY INFORMATION:
    The Institute's Statutory Authority to Conduct the Challenge. NIDA 
is conducting this challenge under the America Creating Opportunities 
to Meaningfully Promote Excellence in Technology, Education, and 
Science (COMPETES) Reauthorization Act of 2010, 15 U.S.C. 3719. This 
Challenge is consistent with and advances the mission of NIDA as 
described in 42 U.S.C. 285o. The general purpose of NIDA is to conduct 
and support biomedical and behavioral research, health-services 
research, research training, and health-information dissemination with 
respect to the prevention of drug abuse and the treatment of drug 
abusers. App developed as a result of this Challenge will help NIDA to 
gain strides in behavioral addiction research. After winning apps are 
selected, NIDA may announce subsequent funding programs for a future 
research study with real human subjects to engage the widest possible 
community of participants--``citizen scientists.'' These future 
research studies will help researchers to better understand drug abuse 
and addiction.

Subject of Challenge

    Background: The problem of drug abuse affects almost every 
community and family and yet it remains an uncomfortable subject for 
discussion. Each year, substance abuse causes high rates of injuries 
and mortality among Americans and plays a role in many major social 
problems, such as drugged driving, violence, child abuse, stress, 
crime, and problems with employment. It harms unborn babies, destroys 
families, and contributes to homelessness. The societal burden caused 
by substance use disorders exceeds half a trillion dollars yearly. This 
cost to society is greater than other chronic conditions such as 
diabetes ($131.7 billion) and cancer ($171.6 billion). NIDA sponsors 
the majority of addiction-related scientific research in the world. 
NIDA-funded researchers seek to answer important scientific questions 
about the paths people take to avoid or to succumb to drug addiction, 
about the mechanisms and pathways involved in substance-use disorders, 
and about new tools and techniques for prevention and treatment.
    Because the problems stemming from drug abuse and addiction affect 
almost every community and family to some degree, NIDA issues this 
Challenge with the hope that Contestants will actively mobilize around 
the need to know more about the roots of drug abuse and addiction. 
Specifically, NIDA is seeking to engage communities to envision and to 
create an app which will help advance scientific research in areas of 
nicotine, opioids, cannabinoids (including marijuana), 
methamphetamines, and prescription drug use. The Institute is also 
interested in further understanding abstinence and wellness as it 
relates to drug addiction.
    The causes and consequences of addiction are multi-faceted, 
involving biological, behavioral, social, cultural, economic, and 
environmental factors. These factors likely interact, with no single 
factor exerting substantial independent influence on drug use and 
addiction risk. Unfortunately, most research addresses these factors 
separately because it is difficult to collect data on the large numbers 
of participants needed to understand the multi-factor relationships. 
However, this is changing. Mobile technology offers the capacity to 
recruit large numbers of participants, in diverse and distant places 
and to collect prospective data on a broad range of variables as these 
study participants go about their daily lives. This approach has 
already led to advances in addiction research. Mobile assessment has 
extended to geolocation and physiological monitoring, with promising 
results for predicting and detecting drug use in the field.
    As exciting as these findings have been, however, the scope of 
studies and the types and number of participants studied have been 
limited by researchers' access to mobile technology. The problem has 
been exacerbated by a gap in communication between addiction 
researchers and software and hardware developers. In addition, NIDA-
sponsored mobile tools and technologies are often afflicted by a lack 
of interoperability and by non-sustainability beyond the grant-funding 
period.
    Fortunately, those concerns can be successfully addressed by the 
inventive uses of customizable research platforms developed by the 
established informatics technology companies. The recently unveiled 
ResearchKit developed by Apple Inc. is the available platform designed 
specifically for

[[Page 67774]]

biomedical research (https://www.apple.com/researchkit/). NIDA's choice 
of ResearchKit as the platform does not reflect any endorsement of 
Apple Inc. and Apple's products in the Challenge; rather, it is a 
response to Apple's release of a set of tools specifically intended for 
use in health research.
    Challenge Goals: NIDA hopes this Challenge will help to promote the 
development of innovative research apps created on Apple's ResearchKit 
framework for future addiction studies. Research questions to be 
answered could include, but are not limited to: Would tracking 
lifestyle choices, behaviors, nutrition, stress, social participation, 
work, school, home, neighborhood, genetics, exposure to technology, 
etc. help to understand why some people manage to stay away from drug 
abuse and addiction? What contributes to the choice to abuse 
prescription drugs? How can we systematically collect the experience of 
patients recovering from addiction? Are there innovative approaches to 
recording patients' experiences of impact and burden of drug addiction 
over time? Can the benefits of reduced drug use be meaningfully 
detected? Can we reveal and collect the participant-identified disease 
impacts and the preferences for treatment impacts to identify 
meaningful, significant, perhaps, novel, and potential measures of 
benefit?
    It is critical to note that the apps developed as a result of this 
Challenge are to be explicitly created for future scientific research 
purposes, and not for self-help, education, or self-wellness monitoring 
like other apps already available on iTunes. The submissions must not 
contain any data about real people, and the Contestants must not use 
data from or about real people in the development or testing of the 
apps. However, the app should be designed such that it could be used in 
future clinical research studies with real human subjects.
    Major ethical and legal issues that have to be addressed at every 
step of the way should include privacy (especially in terms of the end-
user's experience as he or she interacts with the app) and 
confidentiality (the assurance that end-users' data will be seen and 
used only in the ways they want). Contestants are responsible for 
developing and coding the app so that its future use in a study with 
real human research subjects would be compliant with all applicable 
federal, state, local, and institutional laws, regulations, and 
policies. These include, but are not limited to, Substance Abuse 
Confidentiality Regulations at 42 CFR part 2, Health Information 
Portability and Accountability Act (HIPAA) protections, Department of 
Health and Human Services (HHS) Protection of Human Subjects 
regulations at 45 CFR part 46, and Food and Drug Administration (FDA) 
regulations.
    Rules for Participating in the Challenge. The Challenge is open to 
any Contestant 13 years of age or older. A Contestant may be (i) an 
entity or (ii) an individual or group of individuals (i.e., a team 
assembled with the purpose of participating in this Challenge), each of 
whom is a U.S. citizen or permanent resident of the United States. 
Individuals who are younger than 18 must have their parent or legal 
guardian complete the Parental Consent Form found at http://www.drugabuse.gov/sites/default/files/parentalconsentform.pdf.
    (1) To be eligible to win a prize under this Challenge, an 
individual or entity:
    a. Shall have registered to participate in the Challenge under the 
rules promulgated by NIDA as published in this Notice;
    b. Shall have complied with all the requirements set forth in this 
Notice;
    c. In the case of a private entity, shall be incorporated in and 
maintain a primary place of business in the United States, and in the 
case of an individual, whether participating singly or in a group, 
shall be a citizen or permanent resident of the United States. However, 
non-U.S. citizens and non-permanent residents can participate as a 
member of a team that otherwise satisfies the eligibility criteria. 
Non-U.S. citizens and non-permanent residents are not eligible to win a 
monetary prize (in whole or in part). Their participation as part of a 
winning team, if applicable, may be otherwise recognized when the 
results are announced.
    d. May not be a Federal entity;
    e. May not be a Federal employee acting within the scope of the 
employee's employment and further, in the case of HHS employees, may 
not work on their submission(s) during assigned duty hours;
    f. May not be an employee of the NIH, a judge of the challenge, or 
any other party involved with the design, production, execution, or 
distribution of the Challenge or the immediate family of such a party 
(i.e., spouse, parent, step-parent, child, or step-child).
    (2) Federal grantees may not use Federal funds to develop their 
Challenge submissions unless use of such funds is consistent with the 
purpose of their grant award and specifically requested to do so due to 
the Challenge design, and as announced in the Federal Register.
    (3) Federal contractors may not use Federal funds from a contract 
to develop their Challenge submissions or to fund efforts in support of 
their Challenge submission.
    (4) Submissions must not infringe upon any copyright or any other 
rights of any third party. Each Contestant warrants that he or she is 
the sole author and owner of the work and that the work is wholly 
original.
    (5) By participating in this Challenge, each Contestant (whether 
competing singly or in a group) and entity agrees to assume any and all 
risks and waive claims against the Federal government and its related 
entities (as defined in the COMPETES Act), 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 participation in this Challenge, whether the injury, 
death, damage, or loss arises through negligence or otherwise.
    (6) Based on the subject matter of the Challenge, the type of work 
that it will possibly require, as well as an analysis of the likelihood 
of any claims for death, bodily injury, property damage, or loss 
potentially resulting from Challenge participation, no Contestant 
(whether competing singly or in a group) or entity participating in the 
Challenge is required to obtain liability insurance or demonstrate 
financial responsibility in order to participate in this Challenge.
    (7) By participating in this Challenge, each Contestant (whether 
competing singly or in a group) and entity agrees to indemnify the 
Federal government against third party claims for damages arising from 
or related to Challenge activities.
    (8) A Contestant or entity shall not be deemed ineligible because 
the Contestant or entity used Federal facilities or consulted with 
Federal employees during the Challenge if the facilities and employees 
are made available to all individuals and entities participating in the 
Challenge on an equitable basis.
    (9) By participating in this Challenge, each Contestant (whether 
participating singly or in a group) and entity grants to the NIH/NIDA 
an irrevocable, paid-up, royalty-free nonexclusive, sublicensable 
worldwide license to post, link to, share, use and display publicly on 
the Web the submission, including the architectural design of the app 
and any other information necessary for a third-party to use, adapt, 
improve or otherwise modify the app. Each Contestant will retain all 
other intellectual property rights in their submissions, as applicable.

[[Page 67775]]

    (10) NIDA reserves the right, in its sole discretion, to (a) 
cancel, suspend, or modify the Challenge, (b) not award any prizes if 
no entries are deemed worthy, and (c) to disqualify from competition 
any submission that contains or uses data about real people or is 
deemed, in the judging panel's discretion, inappropriate, offensive, 
defamatory, or demeaning.
    (11) Each Contestant (whether participating singly or in a group) 
or entity agrees to follow all applicable federal, state, and local 
laws, regulations, and policies.
    (12) Each Contestant (whether participating singly or in a group) 
and entity participating in this Challenge must comply with all terms 
and conditions of these rules, and participation in this Challenge 
constitutes each such contestant's full and unconditional agreement to 
abide by these rules. Winning is contingent upon fulfilling all 
requirements herein.
    Registration Process for Contestants. To participate in this 
Challenge visit http://nida.ideascale.com, a NIDA Challenge platform 
provider. Alternatively, visit www.challenge.gov and search for 
``Addiction Research: There's an App for that'' and follow the 
instructions. NIDA encourages established addiction researchers to 
share the ideas via the Forum (http://nida.ideascale.com) and seek 
collaboration(s) with app developers and engineers to create the 
winning research apps.
    Submission Requirements. All submissions must be in English. The 
Contestants must not use HHS's logo or official seal or the logo of NIH 
or NIDA in the submissions, and must not claim federal government 
endorsement.
    Due to sensitivities surrounding addictions information, only 
fictitious data may be used for app development. The submission must 
not contain any data from or about real people, and the Contestant must 
not use data from or about real people in the development or testing of 
the app. However, the app should be designed such that it could be used 
in future potential clinical research studies with real human subjects. 
Entries that include data from or about real people will be 
disqualified.
    Each submission for this Challenge requires a complete ``Submission 
Package.'' The Submission Package includes:
    (1) A white paper describing the app built upon the proposed design 
of future scientific research studies. The white paper must describe a 
scientific research agenda and study design that could be undertaken 
using the developed app in future human subject research. Components of 
the white paper include, but are not limited to:

a. Research design or conceptual framework
b. Research agenda
c. Description of ResearchKit modules and add-apters incorporated and 
otherwise considered
d. Statement about compliance with substance abuse and other applicable 
laws and regulations
e. Data collection and management plan
f. Recruitment and retention advantages of the proposed approach

    The white paper must consist of a PDF file, not contain any 
information directly identifying the Contestants. The PDF document must 
be formatted to be no larger than 8.5'' by 11.0'', with at least 1 inch 
margins. The white paper must be no more than 12 pages long. Font size 
must be no smaller than 11 point Arial.
    (2) A video of the app prototype. A brief demo video (or its link 
to YouTube) must be no more than five (5) minutes and clearly 
demonstrate the app functionality. The Contestant must have permission 
to use all content in the video, including footage, music and images. 
The video must not contain any information or images directly 
identifying the Contestant.
    (3) App software. The working software must operate on a mobile 
device using Apple's ResearchKit framework. The Contestants must 
provide a way for the NIDA to test the app such as a weblink, 
installation file, or a shared test build. The submission may be 
disqualified if the software application fails to function as expressed 
in the prototype description submitted by the Contestant.
    Amount of the Prize; Award Approving Official. Up to three monetary 
prizes will be awarded: $50,000 for 1st Place, $30,000 for 2nd Place, 
and $20,000 for 3rd Place for a total prize award pool of up to 
$100,000. The names of the winners and the titles of their submissions 
will be posted on the NIDA Web site. The award approving official for 
this Challenge is the Director of the National Institute on Drug Abuse.
    Payment of the Prize. Prizes awarded under this Challenge will be 
paid by electronic funds transfer and may be subject to Federal income 
taxes. The NIH/NIDA will comply with the Internal Revenue Service 
withholding and reporting requirements, where applicable.
    Basis Upon Which the Winner Will Be Selected. The judging panel 
will make recommendations to the award approving official based upon 
the following 8 criteria. Each criterion will be scored with the 
maximum of 5 points.
    (1) Quality of the research agenda (0-5 points): How well is the 
research design or conceptual framework developed? Is it unique and 
clinically meaningful? Does the research agenda describe a logical, 
feasible plan and timeframe for addressing addiction knowledge gaps?
    (2) Proposed ResearchKit modules (0-5 points): How many existing 
features of the ResearchKit does the app use? How are the modules 
applicable for conducting future addiction research? Does the 
Contestant consider creating new modules?
    (3) Add-apters (0-5 points): Does the app utilize novel add-apters? 
How are the proposed add-apters applicable to the future research 
study?
    (4) Compliance with applicable legal policies. (0-5 points): 
Although the competition requires that the submission must not contain 
any research data about real individuals, and the Contestants must not 
use real data in the development of the app, the submission will be 
evaluated on whether the app design and research agenda would be 
compliant with all applicable federal, state, local, and institutional 
laws, regulations, and policies. These include, but are not limited to, 
Substance Abuse Confidentiality Regulations at 42 CFR part 2, HIPAA 
protections, HHS Protection of Human Subjects regulations at 45 CFR 
part 46, and FDA regulations. Would the app ensure compliance with 
consent requirements for future potential addiction studies? Would the 
app clearly explain study participation to the user? Would data 
management be safe and secure?
    (5) Study participant's engagement (0-5 points): How well would the 
app attract and retain human subject engagement? Does it assure the 
high level of human subject participation?
    (6) Durability of study participation (0-5 points): How reasonable 
is the plan for retaining human subjects and data collection over the 
duration of the future, proposed research study?
    (7) Clarity of the app context (0-5 points): Will the app provide a 
transparent, engaging user experience for both addiction researchers 
and human subjects? Would the future human subjects of research be able 
to easily track their overall progress during the research study? Would 
future human subjects of research know what information is being 
collected, why, and what will happen with their data?
    (8) Data quality for researchers (0-5 points): Is it easy for 
addiction researchers to monitor and manage the

[[Page 67776]]

overall progression of the research study? Is the data management plan 
appropriate? Are data clearly presented to the researcher?
    The evaluation process will begin by anonymizing and removing those 
that are not responsive to this Challenge or not in compliance with all 
rules of participation eligibility. Submissions that are responsive and 
in compliance will next undergo a review by federal employees with 
expertise in the relevant areas of science and executive scientific 
advisors. A panel of judges consisting of federal employees will then 
score responsive and compliant submissions entries in accordance with 
the judging criteria outlined above. Final recommendations will be 
determined by a vote of the judges based on score. Scores from each 
criterion will be weighted equally, but failure to meet a minimum 
standard for any one criterion might disqualify an application. The 
score for each submission will be the sum of the scores from each of 
the 5 voting judges, for a maximum of 200 points.

Additional Information

    What is ResearchKit? ResearchKit is an open-source software kit 
designed specifically for medical and health research; it simplifies 
the creation of iPhone apps that can help physicians and scientists 
gather data from willing participants. The framework allows researchers 
to circumvent the development of custom code for common tasks such as 
sharing, storage, and syncing of research data. It helps to create apps 
to recruit human subjects in research, present informed-consent 
materials, create surveys and tasks, and monitor sensors interoperable 
with smartphone technology. ResearchKit works seamlessly with Apple 
HealthKit, a suite of applications that can interact with the iPhone 
accelerometer, microphone, gyroscope, GPS sensors, and external 
hardware such as glucometers, inhalers, and other existing and newly 
developed sensors. These capabilities could help monitor a 
participant's gait, motor impairment, physical fitness, speech, and 
memory, to name just a few. Additional hardware extensions (add-apters) 
are frequently developed and available.
    It is important to note that the ResearchKit framework does not 
include a data management solution. The framework can be used with a 
data management solution only after IRB approval of the human health 
study with consideration of the provider's data privacy and security 
practices. Apple's ResearchKit debuted in March 2015 with five opt-in 
health research apps, now available for free public download. For more 
information about Apple's ResearchKit and the developed apps visit 
https://www.apple.com/researchkit/ and http://nida.ideascale.com.
    Features and modules currently accessible and compatible with 
Apple's ResearchKit: Apple's iPhones have a number of built-in sensors, 
including Touch ID, Barometer, Accelerometer, Gyroscope, Proximity 
Sensor, and Ambient Light Sensor. The Touch ID is a biometric 
technology that provides user identification through a finger scanner, 
the Barometer measures atmospheric pressure, the Accelerometer measure 
the tilting motion and orientation of the iPhone, and the Three-Axis 
Gyroscope enables 3-axis angular acceleration around the X, Y and Z 
axes, enabling precise calculation of yaw, pitch, and roll. The 
Proximity Sensor deactivates the display and touchscreen when the phone 
is brought near the face during a call and the Ambient Light Sensor 
adjusts the display brightness. All sensors are available for the 
iPhone 6 Plus, iPhone 6, iPhone 5S and iPhone 5. The only exceptions 
are the Barometer sensor, which is only available for the iPhone 6 
Plus, and iPhone 6, and the Touch ID sensor, which is only available 
for the iPhone 6 Plus, iPhone 6, and iPhone 5S.
    In addition to internal sensors, there are a number of add-apters 
which work with existing iPhones. The add-apters can measure pulse 
rate, breathing pattern, blood pressure, blood oxygen saturation, heart 
rate variability, galvanic skin response, and glucose concentration, 
and can even help detect ear infections and track inhaler medication 
use. Some add-adapters can be directly purchased through iTunes or 
third-party vendors; others must be purchased through a physician. 
Based on the type of adapter, prices can vary from $6 to $249.

    Dated: October 27, 2015.
Nora D. Volkow,
Director, National Institute on Drug Abuse, National Institutes of 
Health.
[FR Doc. 2015-27939 Filed 11-2-15; 8:45 am]
 BILLING CODE 4140-01-P
Document Created: 2018-03-01 11:32:33
Document Modified: 2018-03-01 11:32:33
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		The Challenge begins November 3, 2015.
Contact		Elena Koustova, Ph.D., MBA, Director, Office of Translational Initiatives and Program Innovations (OTIPI), NIDA Challenge Manager, National Institute on Drug Abuse (NIDA), 6001 Executive Blvd. Room 4286, MSC 9555 Bethesda, MD 20892-9555 Phone: (301) 496-8768 Email: [email protected]
FR Citation		80 FR 67773