Study Materials - (14)zip

We developed these materials based on the presentations and exercises used in our on-line and classroom training classes. The .zip file includes all the self-paced materials. Be sure to read the Study Overview document.

Study Materials - (14)zip

The statewide program of study frameworks have been updated (September 2022) and are posted below. The updated documents include newly developed CTE innovative courses, Technology Applications courses, and a comprehensive list of industry-based certifications from the TEA-approved list that are aligned to each program of study. PowerPoint versions of the documents are available to edit and can be downloaded through a zip file at the bottom of the page.

A covered entity may provide access to decedents' records for research purposes if the covered entity receives from the researcher: Representations that the decedents' PHI is necessary for the research and is being sought solely for research on the PHI of decedents (not, for example, living relatives of decedents); and, upon request of the covered entity, documentation of the deaths of the study subjects. No Authorization or alteration or waiver of Authorization by an IRB or Privacy Board is needed for use or disclosure of PHI for research only on the PHI of deceased persons, if these conditions are met.

Q: May a single Authorization permit a covered entity to use or disclose PHI for multiple activities of a specific research study, including the collection and storage of tissues for only that study? Does the option for using a single Authorization differ if a research study also collects and stores PHI as part of a central repository for future research?

A: A single Authorization may cover uses and disclosures of PHI for multiple activities of a specific research study, including the collection and storage of tissues for that study. In addition, where two different research studies are involved, such as where a research study collects information for the study itself, and collects and stores PHI in a central repository for future research, the Privacy Rule generally would permit them to be combined into a single, compound Authorization form. However, a compound Authorization is not allowed where the provision of research-related treatment, payment, or eligibility for benefits is conditioned on only one of the Authorizations, and not the other. See section 164.508(b)(3)(iii) of the Privacy Rule. For example, a covered entity that conducts an interventional clinical trial that also involves collecting tissues and associated PHI for storage in a central repository for future research would not be permitted to obtain a compound Authorization for both research purposes if research-related treatment is conditioned upon signing the Authorization for the clinical trial. Any compound Authorization must clearly specify the different research studies covered by the Authorization so the individual is adequately informed.

A: A covered entity is permitted to use or disclose PHI to identify or locate the whereabouts of a research participant during the study as long as the use or disclosure is not limited in the individual's Authorization (or grandfathered prior permission, if relevant) or waiver or alteration of Authorization. In addition, such use or disclosure is permissible if, for example, it is necessary for treatment of the individual or for a permissible public health purpose.

A: Yes. HHS has stated, "...some express legal permissions and informed consents have not been study-specific and sometimes authorize the use or disclosure of information for future unspecified research. Furthermore, some IRB-approved waivers of informed consent have been for future unspecified research. Therefore, the final Rule at [section] 164.532 permits covered entities to rely on an express legal permission, informed consent, or IRB-approved waiver of informed consent for future unspecified research, provided the legal permission, informed consent or IRB-approved waiver was obtained prior to the compliance date." (See 67 Federal Register 53226, August 14, 2002.)

A single copy of these materials may be reprinted for noncommercial personal use only. "Mayo," "Mayo Clinic," "MayoClinic.org," "Mayo Clinic Healthy Living," and the triple-shield Mayo Clinic logo are trademarks of Mayo Foundation for Medical Education and Research.

This Funding Opportunity Announcement (FOA) invites an application from the Program Director/Principal Investigator (PD/PI) of the current Data Coordinating Center (DCC) for The Environmental Determinants of Diabetes in the Young (TEDDY) study, an ongoing epidemiological study. This DCC has been involved in study design and data and biosample acquisition and management since the inception of the TEDDY Consortium. This FOA provides support for the TEDDY DCC to continue to follow TEDDY children, allowing collaborators to conduct further studies in the measurement and analysis of immune markers using samples from TEDDY subjects.

This Funding Opportunity Announcement (FOA) invites an application from the Program Director/Principal Investigator (PD/PI) of the current Data Coordinating Center (DCC) for The Environmental Determinants of Diabetes in the Young (TEDDY) study, an ongoing epidemiological study. This DCC has been involved in study design and data and biosample acquisition and management since the inception of the TEDDY Consortium.

Type 1 diabetes is a serious and burdensome chronic disease that usually affects children and young adults. The rate of type 1 diabetes incidence is rising worldwide, especially in the very young. These findings suggest that environmental triggers are responsible for increased and accelerated rates of disease in genetically susceptible individuals. The goal of the TEDDY study is to identify environmental triggers of type 1 diabetes - dietary, infectious, or other factors that predispose to or protect against type 1 diabetes in children at high genetic risk - and to analyze the interaction of environmental and genetic factors contributing to development of the disease.

In this opportunity, NIDDK also intends to fund TEDDY to establish collaborative partnerships for the next stage in the analysis of serum, plasma and PBMCs, specifically to assist in its analysis of the immune system in its study subjects for development of islet autoimmunity and T1D using new research technologies.

TEDDY collects serum and plasma and PBMCs every 3 months till 4 years of age 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48 months of age; subsequent visits are every 6 months for autoantibody negative subjects and 3 months for autoantibody positive subjects. Over 500,000 serum plasma, 700,000 plasma samples and 70,000 PBMCs have been collected from TEDDY subjects. These specimens provide a unique opportunity for scientists to test novel hypotheses. TEDDY is encouraging partnerships to assist in its analysis of the immune system in its study subjects for development of islet autoimmunity and T1D using new research technologies. It is therefore imperative that immune profiling is performed combining cellular with humoral analyses of the stored PBMCs, serum and plasma samples. Significant progress has been made in measuring immune status and small populations of cells. Novel methods such as CyTOF and microengraving provide single-cell multi-parameter measurements. Highly advanced processing of information can identify processes and signatures that correspond to disease. Thus, technologies that could be applied to TEDDY samples could include large-throughput multiparameter protein and gene profiling of global immune cells and of antigen-specific T and B cells at the single cell level. These technologies are operational and are rapidly expanding the range of parameters that can be measured. Humoral assays that guide selection of samples and interpretation of PBMC results are also available but may also be expanded into novel approaches. The specific questions that could be addressed by the use of immunological assays included for example:

1. Developing the research design and study protocol, including definition of objectives and approaches, sample size and power calculations, and establishing procedures for participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, and publication of results.

3. Designating Protocol Chairs. The Program Directors/Principal Investigators (for studies involving multiple protocols) shall designate a single Protocol Chairperson (if the Program Director/Principal Investigator does not assume this role) for each protocol to be carried out by the study group. The Protocol Chairperson shall function as the scientific coordinator for the protocol and shall assume responsibility for obtaining approval to implement the protocol from the Steering Committee and for developing and monitoring the protocol. Significant modifications to approved protocols must be approved by the Steering Committee.

4. Implementing collection of data specified by the study protocol. For a multi-center study, each awardee/site is required to ensure that data will be submitted expeditiously to the Data Coordinating Center. Additionally, individual investigators/sites must demonstrate the ability to implement the strategy specifically designed for their individual study population.

5. Establishing procedures for data quality and completeness. Awardees are responsible for ensuring accurate and timely assessment of the progress of each study, including development of procedures to ensure that data collection and management are: (1) adequate for quality control and analysis; (2) for clinical trials, as simple as appropriate in order to facilitate cooperation/referral of study participants by physicians to avoid unnecessary expense; and (3) sufficiently staffed across the participating institutions. For research involving multiple sites, a plan for analysis of pooled data will be developed by the Steering Committee. 041b061a72