All persons wishing to use data from the ADRC Clinical Research Database must adhere to the policy for data use as outlined below.

1. Researchers wishing to obtain data from the ADRC Clinical Research Database must complete a Data Use Proposal to be submitted to the ADRC Data Use Committee. This proposal must, at a minimum:
   1. identify the characteristics and numbers of participants within each group for which data is desired
   2. identify all variables which are being requested (variables that are requested must directly pertain to the research questions that the investigator wishes to address)
   3. identify research questions and hypotheses that will be addressed with the data requested
   4. identify proposed statistical methods, including power given the requested sample, and
   5. identify the time period of the proposed research
   
   This proposal will be reviewed for its appropriateness, scientific integrity, and feasibility by the Data Use Committee.

2. Following the approval of the proposal by the Data Use Committee, the researcher will complete a Data Use Agreement form, whereby the researcher will:
   1. agree to adhere to the terms of this Policy
   2. agree not to share or give any of the content of the data provided from the ADRC with third parties
   3. agree to use the data provided only for the purposes as outlined in the Data Use Proposal
   4. agree to adhere to all policies of the UAB Institutional Review Board (IRB) for Human Subjects research
   5. agree to provide the ADRC Data Use Committee with interim progress reports and a final report on a schedule to be determined by the Data Use Committee
   6. agree to give appropriate publication credit to ADRC investigators on any papers, posters, abstracts or other dissemination of findings resulting from the provided data, and
   7. agree to adhere to all NIH policies regarding open access for publications resulting from NIH-funded research.

3. Researchers must complete an IRB Human Subjects Protocol application for the proposed research. Data will not be given to investigators until written proof of IRB approval is provided to the ADRC Data Use Committee.

4. Upon satisfactory completion of the prior steps, data from the ADRC Clinical database will be provided to the researcher. This data will not contain personal identifiers as defined by HIPAA regulations. This data will most typically be provided in electronic format either as .csv files or as an Excel spreadsheet. Researchers will be responsible for translation of this data into formatting for subsequent data analysis.

5. Researchers will be responsible for maintaining electronic data security and ensuring privacy for all the data provided. As mentioned above, data will not contain personal identifiers. Researchers should abide by policies for electronic data security as outlined by the UAB IRB.

6. At a time designated by the Data Use Committee and following completion of the proposed research, the researcher must return data files and/or destroy data files. This will not include files and/or output that is generated in the process of the approved data analysis, which the researcher may retain for future reference.

7. If during the process of the proposed data analysis the researcher needs to use an alternate statistical method, this is allowable as long as the overarching research question remains constant. If the researcher requires further data as a result of preliminary findings or review of findings, this can be obtained from the database with written approval by the Data Use Committee and after filing an IRB amendment. If the researcher wishes to change the fundamental research question being addressed with the data, this will require a re-review by the Data Use Committee and by the IRB.

8. Provision of ADRC data to researchers will not be considered to grant any proprietary rights over that data to the researcher. Thus, if another interested party requests data for similar purposes, the ADRC Data Use Committee will have the prerogative to provide that data to another researcher.

9. Any violation of the data use policies, terms of the Data Use Agreement, and/or terms of the IRB Human Subjects Protocol by the researcher will be followed by revocation of the permission for the researcher to use ADRC data and voluntary surrendering of ADRC data along with all files and output related to data analysis of the ADRC data.

10. The ADRC Data Use Committee reserves all rights to alter the terms of the Data Use Agreements if deemed necessary. Such alteration of Data Use Agreement terms will be provided to researchers through written notification and requiring signing of a revised Data Use Agreement.