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Dec 12 -- The Office of the Assistant Secretary for Health, Office of Research Integrity (ORI) invites comments to OMB by March 6, 2023 regarding the proposed Data Management Standard Operating Procedures Survey (DMSOP). [Comments are due 30 days after submission to OMB on February 3, 2023.] Information from respondents to the survey will be used to develop a Data Management Standard Operating Procedures toolkit that will be disseminated to researchers, research administrators, and research institutions to implement. In addition, other products will be developed to disseminate survey results and findings to include, social media posts, YouTube video, webinar, and summary report for the research community.
 
Under the authority of Sec. 301 of the Public Health Service Act, 42 U.S.C. § 241, as delegated to the Director of ORI, and in response to growing interest in developing effective approaches for data management and resources, ORI, during FY 2021, awarded a two-year cooperative agreement to the University of Maryland (hereafter referred to as “Awardee Institution” in this document). The broad goals of the awarded cooperative agreement are to:

• Support development of effective approaches and resources for data management that help enhance the integrity and reliability of data generated with PHS funds;
• Ensure data acquired using PHS funds are available for subsequent use by the research community; and
• Ensure data are available for examination should there be an issue related to the integrity, authenticity, reproducibility, and/or reliability of the research.
 
The awardee institution’s project to address the goals of the awarded cooperative agreement, include doing the following:

(1) Conduct a thorough review of data management practices by researchers, research institutions, and research administrators, and develop a data management standard operating procedure (DMSOP) practice survey;
(2) Conduct research on responsible data management and stewardship approaches and practices among American Statistical Association (ASA) and American Society for Cell Biology (ASCB) stakeholders; and,
(3) Based on the results of that research, develop a DMSOP toolkit and other products that will be disseminated to researchers, research institutions, and research administrators for implementation.
  
ORI can use the information to identify data management practices by PHS-funded researchers, research institutions, and research administrators in each of the following essential areas: data provenance, record keeping, organization of data, storage of data, reporting of research data and results, sharing and access, institutional policies, and data management standard operating procedures. In addition, the information will assist in the development of a comprehensive and effective data management toolkit. The collected information and the resulting data management product (i.e., DMSOP toolkit) will allow researchers to assess their data management practices and follow data management standards. Use of the toolkit is expected to help ensure on-going improvement of data management practices and address potential data quality problems, such as, data loss, inconsistent data, and faulty findings.

The overall scope of this project is to investigate the practice of a broad array of data management, data processing, and data analysis standard operations. A 53-item Data Management Standard Operating Procedures (DMSOP) survey was developed and will be administered to a random sample of U.S. biostatisticians from the American Statistical Association (ASA) and bio-science researchers from the American Society for Cell Biology (ASCB). The purpose of the project is to: 1) conduct research on responsible data management and stewardship approaches and practices among biostatisticians and bio-science researchers; and 2) based on the results of this research, develop a toolkit related to the DMSOP survey that can be implemented by researchers, research institutions, and research administrators. Several products will be developed to disseminate survey results and findings, including a DMSOP toolkit, social media posts, YouTube video, webinar, and summary report for the Public Health Service-funded research community.

The DMSOP survey will include 53 questions or items to respond to. The respondents will be a random sample of biostatisticians from the ASA registered list and/or bio-science researchers from the ASCB registered list. The ASA and ASCB will work with the Awardee Institution (the University of Maryland (UMD)) to identify potential respondents from their registered members lists. The eligible potential respondents will be those who self-identify themselves as having specialization in (1) data management, (2) data processing, and/or (3) data analysis. A procedure using Statistical Analysis System (SAS) software will be used to randomly select 1200 members from the two lists. After selection by the random procedure, an email invitation will be sent to the first batch of 300 members, introducing the purpose of the survey, asking if they agree to participate in the survey, and if they agree, asking them to read the informed consent form. Based on the response rate from the first 300 members, it will be decided whether or not an email invitation will be sent to a second batch of 300 members. This process will continue up to two more times until 300 respondents have completed the survey.

The invitation email that will be sent to up to 1200 randomly selected ASA and ASCB members will include an introductory recruitment letter explaining the survey purpose, the manner in which potential respondents were selected, the survey duration, and anonymity and confidentiality information. The email will also offer a $50 Amazon gift card to compensate them for their time, if they choose to participate.
The invitation email also will include screening questions such as “Have you conducted data management tasks during the past five years?” with Yes/No response options. If a member answers “No,” then the message “Thank you, but you are not eligible for the survey!” will appear. If a member answers “Yes,” the message “Thank you, please read the informed consent form!” and the consent form will appear.

Agreement to participate will then be indicated by the member selecting the “participate” button (as opposed to the “decline” button). Participating members will immediately receive an email providing them with a website link with the DMSOP survey, as well as survey completion instructions. It will not include names or any personal identifying information (such as social security numbers, email addresses, or phone numbers). The DMSOP survey will take approximately 30-45 minutes to complete. The survey asks what procedures and processes the respondent has adopted regarding data management operations.
  
ORI: https://ori.hhs.gov/
ORI submission to OMB: https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202209-0990-002 Click IC List for information collection instrument, View Supporting Statement for technical documentation. Submit comments through this webpage.
FRN: https://www.federalregister.gov/d/2022-26883

For AEA members wishing to submit comments, "A Primer on How to Respond to Calls for Comment on Federal Data Collections" is available at https://www.aeaweb.org/content/file?id=5806

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