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South Texas Aging Registry & Repository (STARR)

BIOBANK DESCRIPTION AND PURPOSE:

The South Texas Aging Registry and Repository (STARR), led by Nicolas Musi, MD and Sara E. Espinoza, MD, MSc, is a database and specimen resource of adults from the South Texas community who are interested in volunteering for research studies on aging or who have already participated in research and are willing to allow the materials collected to be used in future research. This will facilitate the inclusion of older adults in clinical research studies and help to accelerate and enhance the quality of research relating to them. A major goal of the STARR is to provide generalizable knowledge about factors that contribute to healthy aging. The registry consists of subjects age 18 and older with illnesses and medical conditions as well as those who have no health problems. De-identified repository data and samples are available to qualified investigators for future studies related to aging. In addition, participants/research volunteers who agree to be re-contacted will be matched with future IRB-approved studies which they are likely to qualify for based upon information provided by each STARR participant at the time of enrollment and which is gathered using provided samples.

Biobanked materials. This repository banks data and specimens collected prospectively or are existing from ongoing or closed research studies. The data is stored centrally by being entered into a limited access, password-protected database on the secure REDCap Project server at UTHSCSA. Specimens are stored centrally in freezers that are managed by the STARR leadership and personnel and located on the UTHSCSA campus or the VA. The inventory includes data and specimens from human subjects from multiple racial and ethnic groups.

Data types:

  • Data from questionnaires including gender, age, ethnicity, education, income, medical history, smoking history, prescription and over-the-counter medications
  • Anthropometric measures including pulse, blood pressure, height, weight
  • Performance-based frailty measures including grip strength and walking speed
  • Results from blood chemistry tests including hemoglobin A1c (HbA1c) measure, lipids, liver and kidney function
  • Data gathered from any new genomic or proteomic research performed on the samples

Specimen types:

  • Blood samples – plasma, serum, WBC
  • Biopsy tissue – fat, skin
  • DNA
  • RNA

CONTRIBUTING DATA AND SAMPLES TO THE BIOBANK

Samples and data from open or closed IRB approved studies that are consented for sharing can be contributed by the study Principal Investigator to the STARR. Review and approval of the contribution will be conducted by the STARR and Pepper Center leadership. Contributing investigators must agree to the following policies:

  • Contributing investigators will maintain access to the materials contributed; however, any costs related to their own retrieval of data and/or samples from the STARR will be the responsibility of the contributing investigator.
  • Any requests from non-STARR investigators for contributed materials will require the approval of the contributing investigator. As future specimen and data use should be consistent with the uses described in the original donor consent form, it will be the responsibility of the contributing investigator to make those uses explicit.
  • For studies that are prospectively collecting data and/or samples that will be contributed to the STARR, separate signed consent of each participant whose research records and/or specimens will be transferred to the repository is required. The Principal Investigator of the contributing study will be responsible for insuring that only STARR study personnel who are approved by the OCR will consent patients to the STARR.

REQUESTS FOR REGISTRY INFORMATION AND BIOBANKED MATERIALS

No study using STARR material shall initiate by STARR investigators or outside investigators without prior approval. All requests for material or information from the STARR will be handled by the STARR and Pepper Center leadership and the relevant contributing investigator(s) (sample/data owners). Requests must be submitted to the STARR coordinator using the Recipient Investigator Agreement form found here. Approval for sharing of materials is based on scientific merit, research impact, and sample availability.

Requests for data and specimens:
The recipient investigator must have appropriate approvals or Non-Human/Non-Research determination as required, Material Transfer Agreements, and a signed Recipient Investigator Agreement Form in place before any release of sample or data will be made. The following policies must be adhered to by recipient investigators:

  • Recipient-investigators who are not part of the repository staff will receive de-identified samples and data, and will not be provided access to the identities of donor-subjects or to information through which the identities of donor-subjects may readily be ascertained without evidence that a waiver of consent and written authorization was approved by the IRB. Recipients will agree not to attempt to re-identify subjects. Recipient-investigators who are part of the repository staff may obtain materials as long as they are re-coded in a manner that will render the obtained materials permanently de-identified.
  • Samples and data will not be transferred to other persons not under the direct supervision of the requesting investigator except as stipulated in the Recipient Investigator Agreement.
  • New uses of the shared samples and data other than those described in the currently approved research project require submission of a new request for samples and/or data to the STARR biobank.
  • The researcher/institution using the samples assumes responsibility for all risks associated with the receipt, handling, storage, and use of samples.
  • Cost incurred for distribution of data or specimens will be the responsibility of the recipient investigator.
  • When the approved requesting investigator’s research project is complete, unused samples or remaining sample material will either be returned to the STARR at the requesting investigator’s expense, or discarded in compliance with all applicable statutes and regulations as directed by the STARR at the time of material distribution from the biobank.
  • Publications resulting from research supported by NIH grants must comply with the NIH Public Access Policy. Publications resulting from the use of materials from the STARR shall acknowledge the resource in the appropriate section of the publication using the following phrase:
    • “Samples and/or data from the South Texas Aging Registry and Repository, which receives support from the Barshop Institute at the University of Texas Health Science Center San Antonio, were used in this study. We thank contributors who collected samples used in this study, as well as the large community of participants whose involvement and sharing made this work possible.”
  • The STARR and Pepper Center leadership will negotiate with each recipient investigator regarding sharing of newly discovered data (genotypes, biomarkers, laboratory results) for inclusion in the STARR database upon completion of the research project and publication of the main results.

Requests to recruit from the STARR Registry:
Participants/research volunteers who agree to be re-contacted will be matched with future studies which they are likely to qualify for based upon information provided by each STARR participant at the time of enrollment and which is gathered using provided samples. Requests for access to eligible participants in order to recruit into a new study will be reviewed by the STARR and Pepper Center leadership and the relevant contributing investigator(s) (sample/data owners). Subsequent to IRB approval of the new study, the STARR participants deemed eligible for an approved new prospective study will be notified of their eligibility via mail by STARR study staff. The IRB-approved mailer provided by the PI of the prospective study will include contact information for the new study. Cost of re-contacting the eligible participants will be covered by the PI of the new study as negotiated with the STARR leadership prior to initiation.