Obligations of the Investigator. Research Staff, and Institution A. That the Data Files will be used solely for statistical analyses: that no attempt will be made to identify specific individuals, families, households, schools, institutions, or geographic locations not provided by Add Health; and that no list of Sensitive Data at the individual or family level will be published or otherwise distributed. B. That if the identity of any person, family, household, school, institution or geographic location should be discovered inadvertently, then: 1. No use will be made of this knowledge; 2. Add Health will be advised of the incident within ten (10) business days of Investigator’s, Research Staff’s, or Institution’s discovery of the incident; 3. The information that would identify the person, family, household, school, or institution will be safeguarded or destroyed as requested by Add Health and a written certification of destruction provided to Add Health; and 4. No one else will be informed of the discovered identity. C. To avoid inadvertent disclosure of persons, families, or households by using the following guidelines in the release of statistics derived from the Data Files. 1. In no table should all cases in any row or column be found in a single cell. 2. In no case should the total for a row or column of a cross-tabulation be fewer than ten (10). 3. In no case should a cell frequency of a cross-tabulation be fewer than ten (10) cases. 4. In no case should a quantity figure be based on fewer than ten (10) cases. 5. Data Files released should never permit disclosure when used in combination with other known data. D. That no persons other than those identified in this Agreement, or in amendments subsequent to this Agreement, as Investigator or Research Staff, be permitted access to the contents of Data Files or any files derived from Sensitive Data or Data Files. 1. That within ten (10) business days of becoming aware of any unauthorized access, use, or disclosure of Sensitive Data, the unauthorized access, use, or disclosure of Sensitive Data will be reported in writing to Add Health. E. To comply fully with the Sensitive Data Security Plan, which is included as Attachment A to this Agreement. Approval of the Sensitive Data Security Plan expires at the end of the Contract Period. F. To respond fully and in writing within ten (10) working days after receipt of any inquiry from Add Health regarding compliance with this Agreement or the expected date of completion of work with the Sensitive Data and any data derived therefrom. G. To make available for inspection by Add Health, at a mutually agreeable time during business hours, the physical housing and handling of all Data Files and any other information, written or electronic, solely relating to this Agreement and which does not constitute the confidential information of a third party. H. To supply Add Health with a copy of each of the following: 1. Investigator Information form 2. Agreement for the Use of Restricted-Use Data, each with Investigator and Institutional Signatures page 3. Sensitive Data Security Plan (Attachment A) 4. Data Files form (Attachment B) confirming data order, and including explanatory statements for constructed datasets (if requested)
Appears in 4 contracts
Samples: Data and Material Use Agreement, Data and Material Use Agreement, Data and Material Use Agreement
Obligations of the Investigator. Research Staff, and Institution
A. That the Data Files will be used solely for statistical analyses: that no attempt will be made to identify specific individuals, families, households, schools, institutions, or geographic locations not provided by Add Health; and that no list of Sensitive Data at the individual or family level will be published or otherwise distributed.
B. That if the identity of any person, family, household, school, institution or geographic location should be discovered inadvertently, then:
1. No use will be made of this knowledge;
2. Add Health will be advised of the incident within ten (10) business days of Investigator’s, Research Staff’s, or Institution’s discovery of the incident;
3. The information that would identify the person, family, household, school, or institution will be safeguarded or destroyed as requested by Add Health and a written certification of destruction provided to Add Health; and
4. No one else will be informed of the discovered identity.
C. To avoid inadvertent disclosure of persons, families, or households by using the following guidelines in the release of statistics derived from the Data Files.
1. In no table should all cases in any row or column be found in a single cell.
2. In no case should the total for a row or column of a cross-tabulation be fewer than ten (10).
3. In no case should a cell frequency of a cross-tabulation be fewer than ten (10) cases.
4. In no case should a quantity figure be based on fewer than ten (10) cases.
5. Data Files released should never permit disclosure when used in combination with other known data.
D. That no persons other than those identified in this Agreement, or in amendments subsequent to this Agreement, as Investigator or Research Staff, be permitted access to the contents of Data Files or any files derived from Sensitive Data or Data Files.
1. That within ten (10) business days of becoming aware of any unauthorized access, use, or disclosure of Sensitive Data, the unauthorized access, use, or disclosure of Sensitive Data will be reported in writing to Add Health.
E. To comply fully with the Sensitive Data Security Plan, which is included as Attachment A to this Agreement. Approval of the Sensitive Data Security Plan expires at the end of the Contract Period.
F. To respond fully and in writing within ten (10) working days after receipt of any inquiry from Add Health regarding compliance with this Agreement or the expected date of completion of work with the Sensitive Data and any data derived therefrom.
G. To make available for inspection by Add Health, at a mutually agreeable time during business hours, the physical housing and handling of all Data Files and any other information, written or electronic, solely relating to this Agreement and which does not constitute the confidential information of a third party.
H. To supply Add Health with a copy of each of the following:
1. Investigator Information form
2. Agreement for the Use of Restricted-Use Data, each with Investigator and Institutional Signatures page
3. Sensitive Data Security Plan (Attachment A) 4. Data Files form (Attachment B) confirming data order, and including explanatory statements for constructed datasets (if requested)
5. Supplemental Agreement with Research Staff (Attachment C) signed by each Research Staff person and the Investigator
6. Security Pledges (Attachment D) for the Investigator and each Research Staff person
7. A copy of the document, originated by the Investigator and signed by Institution’s Institutional Review Board (IRB), approving the research project.
I. To provide to UNC-Chapel Hill the Processing Fee. Payment may be made by credit card or check payable to “The University of North Carolina at Chapel Hill.” An exemption to the Processing Fee may be made if the request for Data Files is from an Investigator at one of the Add Health funding agencies or institutes. To request a waiver of the Processing Fee, please include a letter from the head of the funding agency requesting that the fee be waived.
J. To include in each written report or other publication based on analysis of Sensitive Data from Add Health, the following statement: This research uses data from Add Health, a program project designed by J. Xxxxxxx Xxxx, Xxxxx X. Xxxxxxx, and Xxxxxxxx Xxxxxx Xxxxxx, and funded by a grant P01-HD31921 from the Xxxxxx Xxxxxxx Xxxxxxx National Institute of Child Health and Human Development, with cooperative funding from 17 other agencies. Special acknowledgment is due Xxxxxx X. Xxxxxxxx and Xxxxxxx Xxxxxxxx for assistance in the original design. Persons interested in obtaining Data Files from Add Health should contact Add Health, The University of North Carolina at Chapel Hill, Carolina Xxxxxxxxxx Xxxxxx, Xxxxxxxx Xxxxxx, Xxxxx 000, 000 X. Xxxxxxxx Street, Chapel Hill, NC 27516 (xxxxxxxxx_xxxxxxxxx@xxx.xxx). No direct support was received from grant P01-HD31921 for this analysis.
K. That all journal articles based on analysis of confidential Sensitive Data from Add Health receive a PubMed Central reference number (PMCID). Journal articles must be submitted to PubMed Central to receive a PMCID. The method of PubMed Central submission and Investigator responsibility for submission depend on the journal and journal publisher.
1. Some journals automatically submit published articles to PubMed Central. For a list of journals that submit articles to PubMed Central please visit the NIH website: xxxx://xxxxxxxxxxxx.xxx.xxx/submit_process_journals.htm
2. Some journal publishers may submit the articles to PubMed Central automatically or upon request by the author. For a list of journal publishers that submit articles to PubMed Central please visit the NIH website: xxxx://xxxxxxxxxxxx.xxx.xxx/select_deposit_publishers.htm#b
3. If neither the journal nor the journal publisher will submit the article to PubMed Central, the Investigator will be responsible to submit the final peer-reviewed manuscript to PubMed Central via the NIH Manuscript Submission System (NIHMS). For detailed instructions on the process of submitting a journal article to PubMed Central, please see the NIH website: xxxx://xxxxxxxxxxxx.xxx.xxx/submit_process.htm
L. To complete the following protocol upon separation from Institution or the expiration of Investigator’s contract:
1. Destroy all Data Files at the originally approved site.
2. Submit a letter stating that all Add Health Data Files have been securely erased with the secure erasure program listed in the security plan for the originally approved site.
3. Return all CDs containing Data Files, within thirty (30) days of the expiration of the Contract Period as specified on the Institutional Signatures page, or submit a renewal application. Add Health shall be able to visit within a year of contract termination, at a mutually-agreeable time during regular business hours, to confirm the data have been destroyed. This obligation of destruction shall not apply to Investigator’s scholarly work produced during the Contract Period that is based upon or that incorporates the Restricted-Use Data.
M. To notify Add Health in the event Investigator plans to separate from Institution during the Contract Period. Such notification must be in writing and must be received by Add Health at least six (6) weeks prior to Investigator’s last day of employment with Institution. Investigator’s separation from Institution will terminate this Agreement. Investigator may, however, reapply to receive Data Files from Add Health in Investigator’s capacity as an employee of his or her new institution. A fee will be charged to the investigator for the administration of this process (see Attachment G: Contract Processing Fees at the end of the contract). Concurrent with Investigator’s notice to Add Health regarding a pending separation from Institution, Investigator must:
1. Return the Data File CDs to Add Health at the following address: Add Health Contracts Carolina Population Center UNC-Chapel Hill Carolina Square, Suite 210 000 Xxxx Xxxxxxxx Xxxxxx Xxxxxx Xxxx, XX 00000
2. Destroy all electronic and paper files at the originally approved site prior to the date of relocation and submit a letter stating that all Add Health files including Data Files have been securely erased with the secure erasure program listed in the Sensitive Data Security Plan for the originally approved site. This obligation of destruction shall not apply to Investigator’s scholarly work produced during the Contract Period that is based upon or that incorporates the Sensitive Data.
N. To obtain approval from Add Health prior to transferring this Agreement to another Investigator at the same Institution. A fee will be charged for the administration of this process (see Attachment G: Contract Processing Fees table at the end of the contract). In order to obtain such approval, Investigator must:
1. Inform Add Health in writing six (6) weeks prior to the proposed date of transfer.
2. Submit a complete copy of this Agreement in the name of the new Investigator signed by an official representative of Investigator’s new institution.
3. Maintain responsibility for the security of all Data File CDs until the transfer contract has been approved.
O. To submit annual reports to Add Health on or before each anniversary of the initial date of the Contract Period. Such reports must include:
1. A copy of the annual IRB approval for the research project
2. A list of public presentations at professional meetings using results based on the Data Files
3. A list of papers accepted for publication using these Data Files, with complete citations
4. A list of grants that have been awarded for use of the Add Health Data Files
5. A list of graduate students using the Add Health Data Files for dissertations or theses, the titles of these papers, and the dates of completion
6. A current data user roster including the names of all Research Staff member(s) who have access to Data Files and their relationship(s) to the project
7. A list of users no longer associated with your contract since your last annual report Such reports shall be signed by Investigator. Add Health reserves the right to terminate this Agreement in the event that the reports are not timely submitted.
P. That Institution hereby acknowledges that any breach of the confidentiality provisions herein may result in irreparable harm to UNC-Chapel Hill that may not be adequately compensable by money damages. Institution hereby agrees that UNC-Chapel Hill may seek the imposition of injunctive relief in the event of breach, in addition to money damages to the extent allowable by applicable law. Should Investigator, Research Staff, or Institution commit a material breach of this agreement that is not cured within thirty (30) days after Investigator or Institution receives notice of such breach from Add Health, Add Health and UNC-Chapel Hill reserve the right to terminate the Agreement, in which case all electronic and paper files will be securely erased; a letter will be submitted by the Investigator, stating that all Add Health files and Data Files have been securely erased with the secure erasure program listed in the security plan; and CDs containing Data Files are to be returned. Investigator and Research Staff understands, and Institution agrees, that a violation of any of the terms and conditions of this Agreement may constitute a violation of state and federal statutes and may subject Investigator, Research Staff, and/or Institution to the criminal, civil, and administrative penalties associated with violations of those statutes, in addition to constituting a material breach of this Agreement with attendant legal liabilities.
Q. That to the extent permitted under applicable law, both Parties agree to be responsible for the negligent acts or omissions of its employees and agents with respect to this Agreement, and nothing herein shall be considered a waiver of sovereign immunity. Sections V.P and V.Q shall survive the termination of the Agreement.
R. Institution shall ensure that Investigator and Research Staff comply with the provisions of this Agreement. Institution shall be solely responsible for the compliance of Investigator, Research Staff and/or Institution and no legal action will be taken by Add Health against individual members of Institution staff, except in the case of willful misconduct or injunctive relief.
Appears in 2 contracts
Samples: Agreement for the Use of Restricted Use Data, Agreement for the Use of Restricted Use Data
Obligations of the Investigator. Research Staff, and Institution
A. That the Data Files will be used solely for statistical analyses: that no attempt will be made to identify specific individuals, families, households, schools, institutions, or geographic locations not provided by Add Health; and that no list of Sensitive Data at the individual or family level will be published or otherwise distributed.
B. That if the identity of any person, family, household, school, institution or geographic location should be discovered inadvertently, then:
1. No use will be made of this knowledge;
2. Add Health will be advised of the incident within ten (10) business days of Investigator’s, Research Staff’s, or Institution’s discovery of the incident;
3. The information that would identify the person, family, household, school, or institution will be safeguarded or destroyed as requested by Add Health and a written certification of destruction provided to Add Health; and
4. No one else will be informed of the discovered identity.
C. To avoid inadvertent disclosure of persons, families, or households by using the following guidelines in the release of statistics derived from the Data Files.
1. In no table should all cases in any row or column be found in a single cell.
2. In no case should the total for a row or column of a cross-tabulation be fewer than ten (10).
3. In no case should a cell frequency of a cross-tabulation be fewer than ten (10) cases.
4. In no case should a quantity figure be based on fewer than ten (10) cases.
5. Data Files released should never permit disclosure when used in combination with other known data.
D. That no persons other than those identified in this Agreement, or in amendments subsequent to this Agreement, as Investigator or Research Staff, be permitted access to the contents of Data Files or any files derived from Sensitive Data or Data Files.
1. That within ten (10) business days of becoming aware of any unauthorized access, use, or disclosure of Sensitive Data, the unauthorized access, use, or disclosure of Sensitive Data will be reported in writing to Add Health.
E. To comply fully with the Sensitive Data Security Plan, which is included as Attachment A to this Agreement. Approval of the Sensitive Data Security Plan expires at the end of the Contract Period.
F. To respond fully and in writing within ten (10) working days after receipt of any inquiry from Add Health regarding compliance with this Agreement or the expected date of completion of work with the Sensitive Data and any data derived therefrom.
G. To make available for inspection by Add Health, at a mutually agreeable time during business hours, the physical housing and handling of all Data Files and any other information, written or electronic, solely relating to this Agreement and which does not constitute the confidential information of a third party.
H. To supply Add Health with a copy of each of the following:
1. Investigator Information form
2. Agreement for the Use of Restricted-Use Data, each with Investigator and Institutional Signatures page
3. Sensitive Data Security Plan (Attachment A) 4. Data Files form (Attachment B) confirming data order, and including explanatory statements for constructed datasets (if requested)
5. Supplemental Agreement with Research Staff (Attachment C) signed by each Research Staff person and the Investigator
6. Security Pledges (Attachment D) for the Investigator and each Research Staff person
7. A copy of the document, originated by the Investigator and signed by Institution’s Institutional Review Board (IRB), approving the research project AND the secure use, storage, and handling of the Add Health Data Files outlined in the Sensitive Data Security Plan.
I. To provide to UNC-Chapel Hill the Processing Fee. Payment may be made by credit card or check payable to “The University of North Carolina at Chapel Hill.” An exemption to the Processing Fee may be made if the request for Data Files is from an Investigator at one of the Add Health funding agencies or institutes. To request a waiver of the Processing Fee, please include a letter from the head of the funding agency requesting that the fee be waived.
J. To include in each written report or other publication based on analysis of Sensitive Data from Add Health, the following statement: This research uses data from Add Health, a program project designed by J. Xxxxxxx Xxxx, Xxxxx X. Xxxxxxx, and Xxxxxxxx Xxxxxx Xxxxxx, and funded by a grant P01-HD31921 from the Xxxxxx Xxxxxxx Xxxxxxx National Institute of Child Health and Human Development, with cooperative funding from 17 other agencies. Special acknowledgment is due Xxxxxx X. Xxxxxxxx and Xxxxxxx Xxxxxxxx for assistance in the original design. Persons interested in obtaining Data Files from Add Health should contact Add Health, The University of North Carolina at Chapel Hill, Carolina Xxxxxxxxxx Xxxxxx, Xxxxxxxx Xxxxxx, Xxxxx 000, 000 X. Xxxxxxxx Street, Chapel Hill, NC 27516 (xxxxxxxxx_xxxxxxxxx@xxx.xxx). No direct support was received from grant P01-HD31921 for this analysis.
K. That all journal articles based on analysis of confidential Sensitive Data from Add Health receive a PubMed Central reference number (PMCID). Journal articles must be submitted to PubMed Central to receive a PMCID. The method of PubMed Central submission and Investigator responsibility for submission depend on the journal and journal publisher.
1. Some journals automatically submit published articles to PubMed Central. For a list of journals that submit articles to PubMed Central please visit the NIH website: xxxx://xxxxxxxxxxxx.xxx.xxx/submit_process_journals.htm
2. Some journal publishers may submit the articles to PubMed Central automatically or upon request by the author. For a list of journal publishers that submit articles to PubMed Central please visit the NIH website: xxxx://xxxxxxxxxxxx.xxx.xxx/select_deposit_publishers.htm#b
3. If neither the journal nor the journal publisher will submit the article to PubMed Central, the Investigator will be responsible to submit the final peer-reviewed manuscript to PubMed Central via the NIH Manuscript Submission System (NIHMS). For detailed instructions on the process of submitting a journal article to PubMed Central, please see the NIH website: xxxx://xxxxxxxxxxxx.xxx.xxx/submit_process.htm
L. To complete the following protocol upon separation from Institution or the expiration of Investigator’s contract:
1. Destroy all Data Files at the originally approved site.
2. Submit a letter stating that all Add Health Data Files have been securely erased with the secure erasure program listed in the security plan for the originally approved site.
3. Return all CDs containing Data Files, within thirty (30) days of the expiration of the Contract Period as specified on the Institutional Signatures page, or submit a renewal application. Add Health shall be able to visit within a year of contract termination, at a mutually-agreeable time during regular business hours, to confirm the data have been destroyed. This obligation of destruction shall not apply to Investigator’s scholarly work produced during the Contract Period that is based upon or that incorporates the Restricted-Use Data.
M. To notify Add Health in the event Investigator plans to separate from Institution during the Contract Period. Such notification must be in writing and must be received by Add Health at least six (6) weeks prior to Investigator’s last day of employment with Institution. Investigator’s separation from Institution will terminate this Agreement. Investigator may, however, reapply to receive Data Files from Add Health in Investigator’s capacity as an employee of his or her new institution. A fee will be charged to the investigator for the administration of this process (see Attachment G: Contract Processing Fees at the end of the contract). Concurrent with Investigator’s notice to Add Health regarding a pending separation from Institution, Investigator must:
1. Return the Data File CDs to Add Health at the following address: Add Health Contracts Carolina Population Center UNC-Chapel Hill Carolina Square, Suite 210 000 Xxxx Xxxxxxxx Xxxxxx Xxxxxx Xxxx, XX 00000
2. Destroy all electronic and paper files at the originally approved site prior to the date of relocation and submit a letter stating that all Add Health files including Data Files have been securely erased with the secure erasure program listed in the Sensitive Data Security Plan for the originally approved site. This obligation of destruction shall not apply to Investigator’s scholarly work produced during the Contract Period that is based upon or that incorporates the Sensitive Data.
N. To obtain approval from Add Health prior to transferring this Agreement to another Investigator at the same Institution. A fee will be charged for the administration of this process (see Attachment G: Contract Processing Fees table at the end of the contract). In order to obtain such approval, Investigator must:
1. Inform Add Health in writing six (6) weeks prior to the proposed date of transfer.
2. Submit a complete copy of this Agreement in the name of the new Investigator signed by an official representative of Investigator’s new institution.
3. Maintain responsibility for the security of all Data File CDs until the transfer contract has been approved.
O. To submit annual reports to Add Health on or before each anniversary of the initial date of the Contract Period. Such reports must include:
1. A copy of the annual IRB approval for the research project
2. A list of public presentations at professional meetings using results based on the Data Files
3. A list of papers accepted for publication using these Data Files, with complete citations
4. A list of grants that have been awarded for use of the Add Health Data Files
5. A list of graduate students using the Add Health Data Files for dissertations or theses, the titles of these papers, and the dates of completion
6. A current data user roster including the names of all Research Staff member(s) who have access to Data Files and their relationship(s) to the project
7. A list of users no longer associated with your contract since your last annual report Such reports shall be signed by Investigator. Add Health reserves the right to terminate this Agreement in the event that the reports are not timely submitted.
P. That Institution hereby acknowledges that any breach of the confidentiality provisions herein may result in irreparable harm to UNC-Chapel Hill that may not be adequately compensable by money damages. Institution hereby agrees that UNC-Chapel Hill may seek the imposition of injunctive relief in the event of breach, in addition to money damages to the extent allowable by applicable law. Should Investigator, Research Staff, or Institution commit a material breach of this agreement that is not cured within thirty (30) days after Investigator or Institution receives notice of such breach from Add Health, Add Health and UNC-Chapel Hill reserve the right to terminate the Agreement, in which case all electronic and paper files will be securely erased; a letter will be submitted by the Investigator, stating that all Add Health files and Data Files have been securely erased with the secure erasure program listed in the security plan; and CDs containing Data Files are to be returned. Investigator and Research Staff understands, and Institution agrees, that a violation of any of the terms and conditions of this Agreement may constitute a violation of state and federal statutes and may subject Investigator, Research Staff, and/or Institution to the criminal, civil, and administrative penalties associated with violations of those statutes, in addition to constituting a material breach of this Agreement with attendant legal liabilities.
Q. That to the extent permitted under applicable law, both Parties agree to be responsible for the negligent acts or omissions of its employees and agents with respect to this Agreement, and nothing herein shall be considered a waiver of sovereign immunity. Sections V.P and V.Q shall survive the termination of the Agreement.
R. Institution shall ensure that Investigator and Research Staff comply with the provisions of this Agreement. Institution shall be solely responsible for the compliance of Investigator, Research Staff and/or Institution and no legal action will be taken by Add Health against individual members of Institution staff, except in the case of willful misconduct or injunctive relief.
Appears in 2 contracts
Samples: Agreement for the Use of Restricted Use Data, Agreement for the Use of Restricted Use Data
