Comment ED-2023-OPEPD-0110-0022

Docket ID: ED-2023-OPEPD-0110

The comment was received on: 2024-02-26T05:00:00Z

Original comment on regulations.gov

To:<span style='padding-left: 30px'></span>Office of Planning, Evaluation and Policy Development, U.S. Department of Education Date:<span style='padding-left: 30px'></span>February 26, 2024 Re:<span style='padding-left: 30px'></span>Response to Request for Comment on Education Department General Administrative Regulations (EDGAR) (Docket ID ED-2023-OPEPD-0110) MDRC is a nonprofit, nonpartisan research organization that conducts rigorous studies of programs and policies affecting people with low incomes, actively disseminates the lessons to policymakers and practitioners, and works directly with schools, programs, and government agencies to help improve their effectiveness. Since 1974, we have conducted more than 200 studies that examine interventions meant to help students succeed in elementary, secondary, and postsecondary education. We appreciate the opportunity to respond to the Department of Education’s (ED’s) proposed revision of the Education Department General Administrative Regulations (EDGAR) (Docket ID ED-2023-OPEPD-0110). We commend ED for its goal of updating and strengthening EDGAR — especially elevating the importance of grantees conducting independent evaluations and improving public access to rigorous research and evaluation reports. In particular, we are enthusiastic about the inclusion of terms related to research transparency and accessibility of data to third-party researchers. MDRC is also highly committed to open science and research replicability, including the creation of data files that protect the identity of individual study participants and that enable outside researchers to verify and extend our research. As a matter of course in our work, we make available public use data files and restricted use data files from our evaluations for other researchers to access via data libraries and archives. With this commitment and our experience in mind, we recommend a slight but significant modification to clarify the language of Sec. 75.590 (c)(3) (Grantee Evaluations and Reports) to more fully advance this goal. The new proposed rule permits the department to require grantees to make the data they acquire available to third-party researchers, “consistent with applicable privacy requirements.” We are concerned that this condition is not stated broadly enough, considering our experience acquiring and collecting data for evaluations. The states and districts with which we work to access extant data for evaluations often prohibit any uses of the data other than for the proposed study. Our experience is that most districts and states have policies in place that would prohibit sharing the data with third-party researchers, and the districts and states requires that these prohibitions be included in data-sharing agreements with researchers. In addition, for any primary data collection, the Federal Policy for the Protection of Human Subjects (known as the “Common Rule”) requires researchers to specify in the informed consent process the purpose for which the data is collected, and whether the data will be used beyond the current study. Institutional Review Boards (IRBs) may operationalize the Common Rule in their own judgment of ethical obligations to research participants, and researchers must comply with the terms of the IRB review and approval. Therefore, we think that this condition should be stated more explicitly, to make it clear that data should be made available, consistent with legal, ethical, and privacy considerations, as well as the terms set by data providers in data-sharing agreements. Below is our proposed redline revision to Sec. 75.590 (c)(3): Ensure that the data from the independent evaluation are made available to third-party researchers, to the extent permitted by and consistent with applicable privacy requirements, any legal and ethical obligations, the requirements of data-sharing agreements with data providers, and Institutional Review Board approvals consistent with applicable privacy requirements. As an organization committed to research transparency and with deep experience acquiring and collecting data, we think that this suggested change does not alter the intent of the provision. It does, however, make the provision clearer about the legal and ethical obligations of researchers accessing and collecting data from human subjects. We hope this comment is useful, and we welcome the opportunity to discuss these ideas further. Sincerely, Virginia Knox President, MDRC M E M O R A N D U M To: Office of Planning, Evaluation and Policy Development, U.S. Department of Education Date: February 26, 2024 Re: Response to Request for Comment on Education Department General Administrative Regulations (EDGAR) (Docket ID ED-2023-OPEPD-0110) MDRC is a nonprofit, nonpartisan research organization that conducts rigorous studies of programs and policies affecting people with low incomes, actively disseminates the lessons to policymakers and practitioners, and works directly with schools, programs, and government agencies to help improve their effectiveness. Since 1974, we have conducted more than 200 studies that examine interventions meant to help students succeed in elementary, secondary, and postsecondary education. We appreciate the opportunity to respond to the Department of Education’s (ED’s) proposed revision of the Education Department General Administrative Regulations (EDGAR) (Docket ID ED-2023-OPEPD-0110). We commend ED for its goal of updating and strengthening EDGAR — especially elevating the importance of grantees conducting independent evaluations and improving public access to rigorous research and evaluation reports. In particular, we are enthusiastic about the inclusion of terms related to research transparency and accessibility of data to third-party researchers. MDRC is also highly committed to open science and research replicability, including the creation of data files that protect the identity of individual study participants and that enable outside researchers to verify and extend our research. As a matter of course in our work, we make available public use data files and restricted use data files from our evaluations for other researchers to access via data libraries and archives. With this commitment and our experience in mind, we recommend a slight but significant modification to clarify the language of Sec. 75.590 (c)(3) (Grantee Evaluations and Reports) to more fully advance this goal. The new proposed rule permits the department to require grantees to make the data they acquire available to third-party researchers, “consistent with applicable privacy requirements.” We are concerned that this condition is not stated broadly enough, considering our experience acquiring and collecting data for evaluations. The states and districts with which we work to access extant data for evaluations often prohibit any uses of the data other than for the proposed study. Our experience is that most districts and states have policies in place that would prohibit sharing the data with third-party researchers, and the districts and states requires that these prohibitions be included in data-sharing agreements with researchers. In addition, for any primary data collection, the Federal Policy for the Protection of Human Subjects (known as the “Common Rule”) requires researchers to specify in the informed consent process the purpose for which the data is collected, and whether the data will be used beyond the current study. Institutional Review Boards (IRBs) may operationalize the Common Rule in their own judgment of ethical obligations to research participants, and researchers must comply with the terms of the IRB review and approval. Therefore, we think that this condition should be stated more explicitly, to make it clear that data should be made available, consistent with legal, ethical, and privacy considerations, as well as the terms set by data providers in data-sharing agreements. Below is our proposed redline revision to Sec. 75.590 (c)(3): Ensure that the data from the independent evaluation are made available to third-party researchers, to the extent permitted by and consistent with applicable privacy requirements, any legal and ethical obligations, the requirements of data-sharing agreements with data providers, and Institutional Review Board approvals consistent with applicable privacy requirements. As an organization committed to research transparency and with deep experience acquiring and collecting data, we think that this suggested change does not alter the intent of the provision. It does, however, make the provision clearer about the legal and ethical obligations of researchers accessing and collecting data from human subjects. We hope this comment is useful, and we welcome the opportunity to discuss these ideas further. Sincerely, Virginia Knox President, MDRC