Data Contract Condition Language for:
The National Longitudinal Study of Adolescent Health

sorted by Category and Condition

April 24, 2014, 2:51 pm

Data Use

Data used for statistical purposes

V. 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 Confidential Data at the individual or family level will be published or otherwise distributed.

No re-identification

V. 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 Confidential Data at the individual or family level will be published or otherwise distributed.

No redistribution of data

V. 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 Confidential Data Files.

1. That within one (1) business day 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 ICPSR.

Work files to be destroyed periodically

Referenced in the data protection plan (Attachment A question #3) found at www.cpc.unc.edu/projects/addhealth/data/restricteduse/security

3. Only one complete copy of the Add Health data is permitted; however, time-delimited temporary data analysis files may be created. Temporary data analysis file(s) must be deleted every six months and recreated, as necessary, to complete analysis. Temporary data analysis files should be deleted upon completion of a project.

Inspections & Penalties

Penalty

V. P. That Investigator and Institution hereby acknowledge that any breach of the confidentiality provisions herein will result in irreparable harm to The University of Michigan that are not adequately compensable by money damages. Investigator, Research Staff, and Institution hereby agree to the imposition of injunctive relief in the event of breach, in addition to money damages. 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 ICPSR, ICPSR reserves 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 have been securely erased with the secure erasure program listed in the security plan; and CDs containing Data Files are to be returned. Investigator, Research Staff, and Institution understand and agree 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.

Inspections & Penalties

Site Inspections can/will occur

V. G. To make available for inspection by Add Health, during business hours, the physical housing and handling of all Data Files and any other information, written or electronic, relating to this Agreement.

Publication

Cite/acknowledge data

V. J. To include in each written report or other publication based on analysis of Confidential Data from Add Health, the following statement:
This research uses data from Add Health, a program project directed by Kathleen Mullan Harris and designed by J. Richard Udry, Peter S. Bearman, and Kathleen Mullan Harris at the University of North Carolina at Chapel Hill, and funded by grant P01- HD31921 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, with cooperative funding from 23 other federal agencies and foundations. Special acknowledgment is due Ronald R. Rindfuss and Barbara Entwisle for assistance in the original design. Information on how to obtain the Add Health data files is available on the Add Health website (http://www.cpc.unc.edu/addhealth). No direct support was received from grant P01-HD31921 for this analysis.

Disclaimer language

This research uses data from Add Health, a program project directed by Kathleen Mullan Harris and designed by J. Richard Udry, Peter S. Bearman, and Kathleen Mullan Harris at the University of North Carolina at Chapel Hill, and funded by grant P01-HD31921 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, with cooperative funding from 23 other federal agencies and foundations. Special acknowledgment is due Ronald R. Rindfuss and Barbara Entwisle for assistance in the original design. Information on how to obtain the Add Health data files is available on the Add Health website (http://www.cpc.unc.edu/addhealth). No direct support was received from grant P01-HD31921 for this analysis.

Disclosure Requirements

V.C.1-5 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 three (3) cases.
3. In no case should a cell frequency of a cross tabulation be fewer than three (3) cases.
4. In no case should a quantity figure be based on fewer than three (3) cases.
5. Data released should never permit disclosure when used in combination with other known data.

No case listings in publications

V.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.

PMCID

V. K. That all journal articles based on analysis of Confidential 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: http://publicaccess.nih.gov/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: http://publicaccess.nih.gov/select_deposit_publishers.htm#b.

3. If neither the journal nor the journal publisher will submit the article to PubMedCentral, 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: http://publicaccess.nih.gov/submit_process.htm.

Security

Remote Access Policy

Permits remote access, but must complete a form for permission for remote access.

Security plan incorporated by reference

V. E. To comply fully with the Sensitive Data Security Plan included as part of the IDARS application. The Sensitive Data Security Plan expires at the end of the Agreement Period.

Work location defined

Legal Details

Data Breach

V.D.1 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 Confidential Data Files.
1. That within one (1) business day of becoming aware of any unauthorized access, use, or disclosure of Confidential Data, the unauthorized access, use, or disclosure of Confidential Data will be reported in writing to ICPSR.

Inadvertent Discovery

V.B.1-4 That if the identity of any person, family, household, school, or institution should be discovered inadvertently, then:
1. No use will be made of this knowledge;
2. ICPSR will be advised of the incident within one (1) business day 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 ICPSR; and
4. No one else will be informed of the discovered identity.

Extras Administration

Administrative fee for data

V.I. To provide to ICPSR a nonrefundable processing fee in the amount of $800 (ICPSR member institution)/$850 (ICPSR non-member). Payment may be made by check, payable to "The University of Michigan." The nonrefundable processing fee will be used to cover the expenses of producing and shipping Data Files and codebooks, of consulting, and of administering this Agreement.

An exemption to the nonrefundable 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 nonrefundable processing fee, please include a letter from the head of the funding agency requesting that the fee be waived.

Affidavits

V. H. 6. Security Pledges for the Investigator and each Research Staff person (Attachment D)

Annual/progress report required

V.O.1-6 To submit annual reports to ICPSR via IDARS on or before each anniversary of the initial date of the Agreement 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 and PMCIDs
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

Certificate of Confidentiality

VI. Research subjects who participated in Add Health are protected by a certificate of confidentiality issued by the Department of Health and Human Services in accordance with the provisions of section 301(d) of the Public Health Service Act (42 U.S.C. § 241(d)). Institution is considered to be a contractor or cooperating agency of UNC-Chapel Hill under the terms of the Confidentiality Certificate; as such, Institution, Investigator, and Research Staff are authorized to protect the privacy of the individuals who are the subjects of Add Health by withholding their identifying characteristics from all persons not connected with the conduct of the study. Identifying characteristics are all Add Health Data Files which are defined as sensitive under the terms of this contract.

Contract length and/or extension

I. I. "Agreement Period" is the three (3)-year period that begins immediately after receipt of the official e-mail approval of the IDARS application from ICPSR.

Investigator requirements

II.A.B. Investigators must meet the following criteria:
A. Have a PhD or other terminal degree; and
B. Hold a faculty appointment or research position at Institution.

IRB required

V.N.1 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

Removal of Personnel on contract

V. O. 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

Return/destroy media

V.K . To destroy all Data Files at the originally approved site; 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; and 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 to submit a renewal application. Add Health shall be able to visit within a year of contract termination, 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 Sensitive Data