Confidentiality
Ensuring the security and integrity of research data is of the utmost importance to maintain participant confidentiality and data quality. Some general policies regarding confidentiality of research data are as follows:
- All data must be kept confidential. No data or information regarding subject participation will be shared or accessible with anyone who is not listed as a co-investigator on the IRB-approved protocol or involved in activities related to CTSI Core services.
- All data should be de-identified. Subject names or other identifying information should not be included on data forms.
- The study protocol will be followed as written, without exception. Deviations will be reported to the IRB and/or the department or organization for which HANDS Core services are being accessed through at the time of deviation.
- If collecting data off-site, data will remain with study staff at all times. Data should be transported in a locked case and not left in cars or unattended in public areas.
- To ensure security of data, all data will be stored in locked cabinets. No disposal of data containing PHI or other identifying information will be permitted.
- The use of the computer’s lock function under the Start button will be utilized by all HANDS Core personnel when leaving work areas to ensure that unauthorized individuals do not have access to data and passwords will not be shared among HANDS Core personnel.
As a CTSI core, we are required to provide the name and department of investigators making use of the core and a list of publications resulting from core use. This information will be provided confidentially through biannual reporting.
Partial or Waived Payments
The HANDS core expects payment for services rendered. An IU account number or a purchase order number (PO#) should be provided at the beginning of the service. A full payment is expected if services are delivered regardless of whether or not it represents the results expected by the investigator. Payment details will be specified within the contract agreement and will be determined prior to the beginning of HANDS core services. Partial payments or waiver of payments would require discussion with the HANDS Director and Financial Services Manager as part of the Neurosciences Administration prior to service delivery.
Prioritization of Work
Work is generally completed on a first come first served basis. Minor rearrangements may be made if a minor shift in schedule can make better use of the HANDS Core services. The HANDS Core Director reserves the right to break up larger service requests if it will expedite availability of the HANDS Core Director and key personnel in regards to service delivery in an effort to minimize delays for Core consumers. Ongoing communication with consumers of HANDS Core services will facilitate processes and scheduling.
Publication and Authorship
We ask that the HANDS in Autism® Center be acknowledged in all publications resulting from data and/or delivery of HANDS Core services, and that a copy of the publication be provided to the HANDS Core Director to enable accurate reporting of HANDS in Autism® research and partnership activities in annual reports and semiannual meetings with the HANDS advisory board. Inclusion of HANDS personnel as authors in publications is expected only when we provide collaboration on study design and /or analysis and interpretation of the data and study findings. If substantial intellectual contributions are required in regards to the study design, data analysis, interpretation, discussion, and/or manuscript writing, co-authorship should be granted to the involved Core personnel.
Consultations pertaining to:
- Autism spectrum disorder (ASD), developmental or intellectual disabilities (DD/ID), and other neurodevelopmental disabilities
- Applied Behavior Analysis (ABA) and special education
- Behavioral and educational assessment and intervention
- Implementation science and practice in the community
- Caregiver, teacher and provider training
- Program evaluation and gap analyses
Development and use of behavioral and educational measures to assess:
- Sample profiles
- Impact of intervention at the level of individuals, families, service providers and other stakeholders
- Impact of interventions at the community and/or state level
- Change in knowledge about disabilities and evidence-based practices
- Application of knowledge related to evidence-based practices
- Implementation of evidence-based practices in educational, medical and other community practice settings
- Analyses of needs and gaps related to services (quantitative and qualitative)
Are you working with participants at risk for ASD, newly diagnosed, and/or with ongoing needs related to their ASD, we can provide a full set of options of resources, training, support to your participants, families and providers who take part in you study. It is often challenging to find the right information AND in the right format to share with your participants, whether they are individuals with ASD across lifespan, their families, or providers. We can help you locate and/or provide accommodations to make the information accessible to your participants.
As we use the measures in our studies, we can collaborate on a range of materials by providing access to our databases and analysis.
