November 23rd, 2016
Frequently Asked Questions
How often can participants use the program?
The Computer-Tailored Intervention (CTI) is available every 30 days. A common requirement is to complete the CTI three times over a 6 month period. The Personal Activity Center is available at any time after the first CTI session is completed. Each time users return to the CTI they receive tailored feedback on how they are doing, what change strategies they are using well, which they may be underutilizing, and what steps they can take to continue progressing.
How are desktop, mobile, and coaching versions different?
Each interaction with our program is linked and re-tailored based on previous sessions. Coached feedback uses a bulleted format of discussion points. Mobile sessions have the same questions and feedback formatted for touch and/or a smaller screen. Users and coaches can mix and match any of the formats across multiple or even a single session.
Is the LifeStyle Management Suite only available online?
No. The LifeStyle Suite is available online, in a coaching version, or in a print version.
Why do you use just one theory (i.e., the TTM)?
We don’t just use one theory. The TTM integrates over 12 leading theories of behavior, matching processes from various theories to the appropriate stage of change to achieve the best results for each individual. And while the TTM is the core foundation of our work, we incorporate other models of change and communication, and principles of persuasion.
Do you recommend the use of incentives?
We support the use of incentive plans that reward participation rather than outcomes. Connecting insurance premiums to participation is a successful model.
Are the options within the LifeStyle Suite configurable?
Yes, clients can opt to offer one LifeStyle Management Program, any combination of programs, or the entire suite. The Health Risk Intervention is also a feature that can be turned off or integrated with a client’s existing HRA.
Conflict of Interest Policy Related to Research
August 20th, 2012
Part I: Introduction
This policy is in response to Financial Conflict of Interest (FCOI) Regulation 42 CFR Part 50 Subpart F (grants and cooperative agreements) and 45 CFR Part 94 (contracts). The regulation pertains specifically to responsibility of applicants for promoting objectivity in research for which Public Health Service (NIH, AHRQ, HRSA, CDC, IHS, SAMHSA, ATSDR) funding is sought. This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest.
Pro-Change Behaviors Systems, Inc. (Pro-Change) has the responsibility to identify, manage, reduce, or eliminate any conflicts of interest (COI) that may exist between the financial interest(s) of an individual as related to research conducted at or by Pro-Change. Failure to adhere to this policy may jeopardize current and future funding, and impact personal and institutional reputations. Thus, Pro-Change requires that individuals disclose any relevant financial interests. While full and accurate disclosure is required, Pro-Change recognizes that many potential conflicts of interest are not actual conflicts of interest, or may be acceptable with proper oversight and monitoring. A FCOI exists when Pro-Change, through procedures outlined below, determines that an individual’s financial interests could affect the design, conduct, or reporting of research.
The purpose of this policy is to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest. To address FCOI, Pro-Change has established a process by which Investigators disclose potential conflicts and are evaluated on a case-by-case basis. This policy describes procedures for disclosure, review, and oversight when necessary.
Part II: Definitions
Investigator: The project director or Principle Investigator and any other person regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the NIH, or proposed for such funding, which may include collaborators or consultants.
Significant Financial Interest (SFI): A financial interest consisting of one the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities. As pertains to Pro-Change, a SFI exists:
- If the value of any remuneration received from an entity in the 12 months preceding the disclosure, when aggregated, exceeds $5,000
- When the Investigator (or Investigator’s spouse or dependent children) holds any equity interest (e.g. stock, stock option, or other ownership interests) in an entity
- When income is received as related to intellectual property rights and interests (e.g. patents, copyrights)
- Note: Investigators must also disclose any reimbursed or sponsored travel (paid on behalf of Investigator and not reimbursed to the Investigator, such that the monetary value may not be able to be determined). (This refers to things like “business vacations” – e.g. 5 day all expenses paid trips to Hawaii to discuss “research” with an outside entity, and paid for by the outside entity.)
- Salary or other remuneration paid by Pro-Change to the Investigator if the Investigator is employed or otherwise appointed by Pro-Change
- Intellectual Property Rights assigned to Pro-Change and agreements to share in royalties related to such rights
- Any ownership interest in Pro-Change held by the Investigator
- Mutual funds and retirement accounts
- Income from seminars, lectures, or teaching engagements sponsored by a federal, state, local government agency, an institution of higher learning, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher learning
- Income from service on advisory committees or review panels for a federal, state, local government agency, an institution of higher learning, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher learning
Example of SFI/FCOI: Pro-Change has an intervention that is currently in Phase II clinical trial. Over the course of the trial, Company X has become interested in the intervention and is pursuing a contract to license it. Investigator Z owns more than $5,000 of stock in Company X. Although Investigator Z’s ownership of Company X’s stock is entirely unrelated to the research and the contract, it could still be construed by outsiders as a FCOI and therefore must be disclosed.
Part III: Investigator Training
FCOI training is required per NIH. Each Investigator must complete training prior to engaging in research related to any NIH-funded grant and at least every four years after that.
In the circumstances below, training must be done within 7 business days:
- Institutional FCOI policies change in a manner that affects Investigator requirements
- An Investigator is new to the institution
- An institution finds an Investigator to be noncompliant with the institutions FCOI policy or management plan
FCOI training includes thorough review of Pro-Change’s policy, as well as thorough review of the NIH slides “What NIH Grantees Need to Know About the 2011 Revised Financial Conflict of Interest Regulation” (available online by clicking the link, or here: P:Conflict of InterestInvestigator Training). Upon completion of training, Investigators must sign the FCOI Training Certificate.
Part III: Disclosure, Review, and Monitoring
- An annual disclosure form for each federally funded project is required from:
- Pro-Change employees responsible for the design, conduct, and reporting of PHS funded research
- Investigators and other individuals identified on PHS funded grants and responsible for the design, conduct, or reporting of research
- Investigators and other individuals identified on IRB applications and responsible for the design, conduct, or reporting of research
- Individuals required to provide an annual reporting form must disclose any SFI greater than $5,000 (for themselves, spouse, or dependent children). See Part II for definitions of SFI.
- Individuals will be informed by Pro-Change’s COI officer of the need to complete the annual disclosure form on August 1. Completed disclosure forms are due back September 1.
- Individuals are responsible for maintaining a current accurate disclosure form. If a new relationship or change in a current relationship could be perceived as a FCOI, individuals must update their disclosure form to reflect such conflicts within 30 days.
- Investigators are required to disclose all SFI/FCOI at time of application for PHS funds (i.e. complete a disclosure form for proposed research)
After disclosure forms are returned to Pro-Change’s COI officer, they will be reviewed to determine whether or not an overlap with research and external interests might exist. Individuals will be notified if a COI exists such that it could directly and significantly affect the design, conduct, and reporting of NIH funded research. Individuals will then work with the COI team to mitigate the conflict (by managing, reducing, or eliminating it). Pro-Change’s IRB will be called upon as needed.
Acceptable strategies for managing, reducing, or eliminating FCOIs include:
- Disclosure of FCOI when publishing or presenting research findings: Investigators will disclose relationships with [business entity] to all journals where this research will be published and in all public presentations of this research
NOTE: If applicable, the Investigator will request an addendum to all previously published presentations of research
- Disclosure of FCOI to potential human subjects: Any FCOIs will be disclosed to all potential research participants in the consent process
- NOTE: The IRB will decide whether the possibility of bias is sufficient to justify disclosure of FCOI to potential human subjects
- Changes to informed consent documents: Any FCOIs will be clearly and simply stated in the consent documents
- NOTE: The IRB will decide whether the possibility of bias is sufficient to justify disclosure of FCOI in the informed consent process
- Oversight and monitoring of research and decisions by a DSMB or non-conflicted member of the research team: Name person(s), clearly state responsibilities and decision making powers, provide documentation of agreement
- Severance of relationships that create actual or potential FCOIs
Part IV: Reporting to NIH
NIH will be notified within 30 days if bias is found with the design, conduct, or reporting of research and will include a Mitigation Report outlining the management plan. Initial, annual (ongoing), and revised FCOI reports will be submitted to NIH (via eRA Commons):
- Prior to expenditure of funds
- Within 60 days of identification for an Investigator who is new to the project
- Within 60 days for new, or newly identified, FCOIs for existing Investigators
- At least annually (in conjunction with annual progress reports or at the time of an extension)
- Following a retrospective review to update a previously submitted report
NIH will be notified within 30 days if an Investigator fails to comply with this policy or if the FCOI management plan appears to have biased the design, conduct, or reporting of research.
Compliance with Pro-Change’s FCOI policy for PHS research is a condition of employment with Pro-Change. See employee handbook for more information.
Per NIH, within 120 days of Pro-Change determining noncompliance, Pro-Change will complete a retrospective review of the Investigator’s activities and the NIH-funded research project to determine if there was bias in the design, conduct, or reporting of research. Pro-Change is required to document the retrospective review.
Part V: Maintenance of Records
All FCOI records (disclosures, management plans, retrospective reviews) will be held for three years after the final report is submitted to NIH.
Part VI: External Agencies and Sub-Awards
Before grant application is made, all collaborators/subcontractors must:
- Provide Pro-Change with documentation of their institution’s COI policy and written intent to abide by that policy, and disclosure of any COIs, or
- Sign a disclosure of any FCOIs and a statement that they will abide by Pro-Change’s COI policy
Part VII: Public Accessibility
Pro-Change’s FCOI policy will be publicly available on prochange.com by August 24, 2012.
In the event that FCOIs are identified, information regarding the COI and the Investigator will also be publicly available on prochange.com. Publicly available information will be:
- Updated annually
- Updated within 60 days of newly identified FCOIs
- Remain available for 3 years from the most recent update.
Information to be made publically available is to include, but is not limited to:
- Investigators name
- Investigators title and role with respect to the research project
- Name of the entity in which the SFI is held
- Nature of the SFI
- Approximate dollar value of SFI (or a statement that the interest of one whose values cannot be readily determined)
January 24th, 2012
Pro-Change is a proud recipient of multiple SBIR grants and has received a Tibbets Award recognizing our achievements in this area. With both public and private funding, we have developed a suite of behavior change products in the areas of health and disease prevention.
We are seeking partner companies to help us market and distribute these programs. Rather than marketing our programs directly, we align ourselves with leaders in various market segments who distribute our evidence-based, tailored behavior change solutions. Often the joint effort to bring maximally effective, population-based programs to large audiences involves a licensing agreement for a partner to provide our LifeStyle Management Programs for a specified number of eligible users. All programs can be branded provided that the Pro-Change copyright is maintained. Small increases in the licensing fee occur as the audience expands beyond the negotiated initial size. Standard annual upgrades to the suite are included at no charge. As new programs are added, the licensing fee increases for the customers who choose to distribute them. We do not have and exclusive relationship with any partners and are not precluded from partnering with new organizations.
Pro-Change also accepts funding for research and development of new programs in areas of interest to our partners. In other instances, we create opportunities by inviting partners to act as commercialization partners or subcontractors for our Small Business Innovative Research proposals.
Senior staff at Pro-Change can also provide consultation on a variety of topics, including how to include behavior change messages in marketing campaigns or communications.
Please see our products page for a list of our behavior change programs and contact us if you are interested in a partnership or just learning more about our programs.
For more information on NIH’s Pipeline to Partnerships, please see the P2P web site.
December 14th, 2007
The Pro-Change strategies that help people adopt healthier lifestyles can also help employees adopt new ways of working. We offer programs to increase readiness and lower employee stress as organizations ask their employees to adopt new policies, execute continuous quality improvement strategies, work in teams, and participate in ongoing learning.
Organizational change initiatives fail about 75% of the time. The number one reason is employee resistance to change produced by action imposed on people who are not prepared to act. Pro-Change can reduce this resistance with programs tailored to the needs of each employee.