Highlighted changes to NDI

ATTACHMENT B: Highlighted changes to the currently approved NDI Application FORM APPROVED

OMB No. 0920-0215

Exp. Date xx/xx/20xx

NATIONAL DEATH INDEX APPLICATION FORM

As you complete this form, please call (301) 458-4444

if you have any questions

CDC/NCHS-6205-1 (Rev. 03/2014)

NDI APPLICATION FORM INSTRUCTIONS

1. Use of the NDI is restricted to statistical purposes in medical and health research. The NDI may not be used as a basis for legal, administrative, or other actions which may directly affect particular individuals or establishments as a result of their specific identification in a given study or project. If you are in doubt as to whether your application will be approved, please phone us.

2. Confidentiality Agreement signatures - To expedite the review of your application, you may e-mail your draft application form before you obtain all the required signatures on the Confidentiality Agreement and/or Supplemental Confidential- ity Agreement pages. (Unsigned forms must at least have the name, title, and the organization of the person that will be signing.) Once we receive your application form, we will send you your assigned NDI application number. Use your NDI number when mailing us your original, signed forms or any additional documentation.

3. IMPORTANT- The electronic version of the NDI Application Form contains boxes for all your responses. Please note that your responses need not be limited to the space provided in each box. Text size will adjust automatically.

4. A separate NDI application form must be submitted for each study or project.

5. New applications - All new applications and amendments (changes to the original application) are reviewed by a group of NDI advisors. Your application is considered complete when your final signed version and your study’s IRB approval is re- viewed by a group of NDI staff. Once your application is complete, it is sent to the advisors. Applications are usually sent to the advisors on the 15th and 30th of each month. The completed application must be received a day before the 15th and the 30th in order to be sent to the advisors. Once your application is sent to the advisors for review, please allow three to four weeks for the application to be approved.

6. Repeat requests - You can usually make future submissions for the same study or project without having to submit a new NDI application form. All future requests should be made using a one-page form entitled NDI Repeat Request Form. (You will receive this form along with the results of each search.) If nothing in your initial, approved application has changed, you will be notified in about 2 weeks that your repeat request has been approved.

7. Please call or e-mail us if you have questions. Mail or e-mail your NDI application form to:

NATIONAL DEATH INDEX

National Center for Health Statistics 3311 Toledo Road, Room 7318

Hyattsville, Maryland 20782

301-458-4444

[email protected]

Assurance of Confidentiality – We take your privacy very seriously. All information that relates to or describes identifiable characteristics of individuals, a practice, or an establishment will be used only for statistical purposes. NCHS staff, contractors and agents will not disclose or release responses in identifiable form without the consent of the individual or establishment in accordance with section 308(d) of the Public Health Service Act (42 USC 242m). In addition, NCHS complies with the Cybersecurity Enhancement Act of 2015. This law requires the Federal government to protect its information by using computer security programs to identify cybersecurity risks against federal computer networks.

Public reporting burden of this collection of information is estimated to average 4.5 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road, MS D-24, Atlanta, GA 30333, ATTN: PRA (0920-0215, Exp. Date xx/xx/20xx).

ii

DEPARTMENT OF HEALTH AND HUMAN SERVICES ^{Assigned NDI Application Number} Public Health Service

Centers for Disease Control and Prevention National Center for Health Statistics

NATIONAL DEATH INDEX APPLICATION FORM

1. Title Of Study Or Project

2. Individual and Organization Requesting Use of the NDI

Principal Investigator or Project Director:

Title: Organization:

Complete mailing address: (include street address, room number, city, state, and zip code)

Phone no.: Fax no.: E-mail:

Who should be contacted if more information is needed?:

Phone no.: Fax no.: E-mail:

3. Co-Principal Investigators (if any): If there are no Co-PI’s, type “None”. (Co-PI’s employed by the above organization must countersign the Confidentiality Agreement at the end of this application form. Co-PI’s in other organizations must complete and sign the Supplemental Confidentiality Agreement.)

Name(s)	Organization(s)	Phone number(s)

4. Type of NDI Search Requested

Estimated number of records to be submitted

Routine NDI file search only	May include KNOWN decedents for a routine search
NDI Plus coded causes of death	Status of study subjects UNKNOWN
NDI Plus coded causes of death	A separate file of KNOWN decedents

5. External Funding Sources (If none, type “Internal funding only.”)

List the names of all OTHER organizations providing funding for this project and indicate the type of support provided; i.e., grant, contract, cooperative agreement, interagency agreement, other (specify). (NOTE: Except for a Federal grant, each sponsor must complete and sign an NDI Supplemental Confidentiality Agreement at the end of this application form.)

Names of Organization(s) Type of Funding Support

6. Data Sources

List all organizations (including your own) which have collected (or will be collecting) data on the study subjects. Under each organization listed, describe the types of data collected. If any of the external organizations listed will be receiving identifying or identifiable death record information, they must also be listed in item 7 below. “Identifying or identifiable death record

information” refers to any information on death certificates, other paper documents, or in computer files which by itself, or if linked with other records, would permit the identification of one or more individuals or establishments. Furthermore, by identifying or identifiable data we mean such items as name(s), Social Security Number, exact dates, addresses, and death certificate number. Even with the removal of direct identifiers and linkable study subject identification numbers, there is still a special concern that some combinations of the remaining variables could potentially be used to identify an individual.

7. EXTERNAL organizations (other than the NDI applicant’s organization) receiving IDENTIFYING or IDENTIFIABLE death record information. (If there are no such external parties, type “None.”)

[Definition of “identifying or identifiable death record information” -- Any information on death certificates, other paper documents, or in computer files which by itself, or if linked with other records, would permit the identification of one or more individuals or establishments. Furthermore, by identifying or identifiable data we mean such items as name(s), Social Security Number, exact dates, addresses, and death certificate number. Even with the removal of direct identifiers and linkable study subject identification numbers, there is still a special concern that some combinations of the remaining variables could potentially be used to identify an

individual.]

List the names of all EXTERNAL parties (organizations or outside consultants) who will obtain identifying or identifiable death record information from the NDI, from state vital statistics offices and/or from death record followback investigations. Include administrative relationships such as consultants, outside nosologists, contractors, subcontractors, sponsoring or participating agencies or organizations, and other major divisions or departments in your organization. If applicable, REPEAT some or all of the organizations listed in Items 5 and 6 above. (Note: Each organization listed in item 7 must complete and sign a Supplemental Confidentiality Agreement at the end of this application form.)

IMPORTANT: Under each organization (or consultant) listed below, specify that organization’s role and what project activities will be performed. Also specify (1) what identifying or identifiable death record information will be received, (2) in what form it will be received (e.g., death certificates or computer files), and (3) how the information will “flow” from one organization to another.

Names of Organizations or Individuals* Administrative Relationship (consultant, contractor, etc.)

*NOTE: A “National Death Index Supplemental Confidentiality Agreement” (see end of application form) must be completed by, or on behalf of, each organization (or individual) listed in items 5 and 7 above and must be signed by responsible officials of that organization. This requirement is waived only for a FEDERAL GRANT listed in item 5 and then only when the NDI applicant gives assurances that identifying information obtained directly or indirectly from the NDI will not be provided to the granting agency.

8. Summary of Study Protocol or Project Activities

In responding to the following questions, please provide sufficient detail to describe your study or project and how data obtained via the NDI data will be used. Do not limit your responses to the space provided. The font size will be reduced if more space is needed. (You should not attach your complete study protocol or a detailed description of your project.)

1. Registries -- It is understood that some users of the NDI are only indirectly involved in research or statistical activities, such as preparing and maintaining data files for disease or non-disease registries (e.g., cancer registries or occupational exposure registries).

Will the information obtained via the NDI be included in a disease or non-disease registry? Yes No

All applicants must complete items 8.b and 8.c. If your application involves a registry, be sure also to include the following information in item 8.b. below: (1) the date the registry was founded, (2) the purpose of the registry, and (3) the eligibility criteria for including persons in the registry. A registry should also refer to Attachment B at the end of this application form for additional information to be included in item 8.c. below.

2. Purpose of study or project -- Describe the health or medical problem(s) addressed by your study or project. Include some background information to support why the study or project is being done. What are the primary objectives? If appropriate, include a description of hypotheses to be tested.

8.c. Study protocol or project activities — Please describe the study design, study population and sources of data, and study duration. Conclude your summary by describing how data obtained from the NDI, state death certificates, and death record “followback” investigations will be used. More information about death record followback investigations is requested in item 9. (NOTE: Registries should also refer to Attachment B at the end of this application form for additional information to be included in the response to item 8.c.)

9. Death Record Followback Investigations

1. Does this study or project plan to perform “death record followback” investigations? [By “followback investigations” we mean that once the NDI identifies that certain study subjects are deceased, your staff plans to collect additional information on those subjects’ by going BACK to individuals or establishments that are (or would probably be) mentioned in the subjects’actual death certificates. This would include efforts to contact next-of-kin, physicians, hospitals and/or other parties appearing on the death certificates and/or already included in the decedents’ research file.]

Yes No (If yes, refer to Attachment C for additional documentation needed.)

2. If yes, what type of respondents will be contacted? Check all that apply. Decedent’s next-of-kin

Physicians

Hospitals

Other individuals or establishments mentioned on death record

3. What information will be obtained from EACH type of respondent?:

4. Name the organization(s) or consultant(s) who will be contacting EACH type of respondent:

5. Methods to be used in conducting followback investigations, including how EACH type of contact will be made:

10. Institutional Review Board (IRB) for the Protection of Human Subjects

(as defined by the U.S. Department of Health and Human Services in the Code of Federal Regulations, Title 45, Part 46)

Evidence of a current IRB approval is REQUIRED for all NDI applications (please insure that applicant’s name is referenced in the approval letter). However, if this study or project involves death record “followback” investigations as described in item 9 above, a special letter from the IRB is REQUIRED (as explained in ATTACHMENT C at the end of the application form).

1. as this study or project been reviewed and approved by an IRB? Yes No

2. If Yes, attach a copy of the IRB approval and provide the following: Name of the IRB:

IRB’s Multiple Project Assurance (MPA) number or Federalwide Assurance (FWA) number:

Date of the IRB’s approval:

3. If the study or project DOES NOT have an IRB approval, please indicate the reason and attach a notice from an IRB indicating that the study is EXEMPT. [NOTE: If death record “followback” investigations will be performed as described in item 9 above, an explanation of why your organization does not require an IRB approval for such a study or project is not acceptable. If your organization does not have an IRB (which has been approved by the Office for Human Research Protections, Department of Health and Human Services), you may have the study reviewed by an approved IRB in another organization.]

10. Obtaining State Death Certificates

1. Based on the results of the NDI file search(es), will copies of

death certificates be requested from state vital statistics offices? Yes No

2. If you plan to request death certificates, what specific items of death certificate information do you expect to use in your

analyses and/or to verify questionable matches?

10. Maintaining the Confidentiality of Identifying (or Identifiable) Information

1. Name the organization(s), including your own, which will:

1. submit records of study subjects for the NDI file search(es):

(2) receive directly the results of the search:

(3) request copies of death certificates from the state vital statistics offices:

2. Describe how your organization will store and maintain the confidentiality of the identifying or identifiable death record information obtained from (1) the NDI, (2) state death records, and (3) death record followback investigations. “Identifying

or identifiable death record information” refers to any information on death certificates, other paper documents, or in computer files which by itself, or if linked with other records, would permit the identification of one or more individuals or establishments. Furthermore, by identifying or identifiable data we mean such items as name(s), Social Security Number, exact dates, addresses, and death certificate number. Even with the removal of direct identifiers and linkable study subject identification numbers, there is still a special concern that some combinations of the remaining variables could potentially be used to identify an individual.

Describe the following controls that would be used to maintain the confidentiality of the NDI data:

• Physical controls–limiting access to data such as building guards, identification badges, key cards, closed circuit TV, and locked offices.

• Technical controls – such as user identification, passwords, firewalls, encryption, virtual private network, intrusion

detection system, and stand-alone desktop use only.

• Administrative controls – such as how frequently files will be backed up, where backup files will be stored, methods

in place to ensure least privilege access, methods for ensuring NDI identifying information is not co-mingled with administrative records not part of this project, how use of NDI data will be monitored to prevent its use for purposes other than those approved for this project, how personnel using the system will be trained and made aware of their responsibilities for protecting the NDI information, methods for keeping track of who has access to the data, and methods for ensuring return or destruction of data.

10. Data Disposition Plan

Some state vital statistics offices have expressed concern about indefinite retention of “identifying or identifiable death record information” that could be used in the future by other persons for other purposes.

[Definition of “identifying or identifiable death record information” -- Any information on death certificates, other paper documents, or in computer files which by itself, or if linked with other records, would permit the identification of one

or more individuals or establishments. Furthermore, by identifying or identifiable data we mean such items as name(s), Social Security Number, exact dates, addresses, and death certificate number. Even with the removal of direct identifiers and linkable study subject identification numbers, there is still a special concern that some combinations of the remaining variables could potentially be used to identify an individual.]

All identifying or identifiable data received from the NDI must be removed from all research records at the conclusion of the study or within 5 years after receipt of the NDI data -- regardless of the data set in which the data are kept. This means that all identifiers or potentially identifiable data elements associated with cause of death codes must be removed from all analysis files unless there is no way to identify an individual decedent. This also means that any linked files (with crosswalks) are to be destroyed. (Note: Death

certificates obtained directly from state offices may have to be shredded in less than 5 years depending on each state’s requirements.)

While the NDI staff recognizes that some research studies can remain active for several years, each study is viewed to have a limited duration. At the completion of the study or within 5 years after receipt of the NDI data ALL identifying or identifiable information that came from the NDI match must be destroyed, regardless of storage medium, unless no possible link could be made to an individual. Note: As long as there are no identifiers or linkage variables remaining in the analytic or public-use file(s), cause(s) of death codes may remain in such file(s).

1. Based on the above requirements, when do you plan to dispose of all identifying or identifiable death record information you obtained from the NDI? (Give the proposed month and year of destruction – or state UNKNOWN if this is an open-ended or ongoing study that has no specific disposition plan at this time.)

2. Only complete items 2.a. and 2.b. if the above date is UNKNOWN or if the date is more than 5 years after the month and year that you submitted this NDI Application Form.

   1. Please provide a strong justification of why the data need to be retained beyond this 5-year period.

2. It is to be understood that within 5 years of submitting your NDI Application Form you are responsible for either (1) request- ing an extension or (2) certifying the NDI data have been returned to NCHS or destroyed. (See attachment A) The extension request or certification of data disposal must be submitted to NDI staff within 5 years – no later than the month and year stated in the box below.

14. Completion of Study or Project

1. Indicate the scheduled termination date for the study, or whether the study is on going or open-ended.

2. In what form and to whom will the results of your study or activities be released? (NDI would appreciate courtesy copy of any publications that may result from the use of NDI data)

3. Will study subjects be notified of study results? Yes No

If Yes, how will the subjects be notified?

14. Other Uses of the Data

REMINDER: NDI data may not be used for legal, administrative, or other actions which may directly affect particular individuals or establishments as a result of their specific identification. NDI data may not be re-released to others except as specified in item 7 of this agreement. Re-release means providing access to, copies of, or in any other manner sharing,

individual-level identifying information obtained from the NDI or the state death certificates to persons or organizations not specified in this approved NDI application form. The prohibition of re-release applies to microdata as well as to data in other form (e.g., copies of certificates). Aggregated tabular data without individual level identifying information from the NDI or state death certificates are not considered re-release so long as the tabular data are not so detailed as to permit identification of individuals.

Will the identifying information (obtained from the NDI, from the state vital statistics offices, and/or from death record followback investigations) be used either directly or indirectly for any study or project other than the one described in “Summary of Study

Protocol or Project Activities”? (See item 8 above.)

Yes No Maybe

If Yes or Maybe, briefly describe the other purpose(s) for which the data will be used. (NOTE: A separate application form must be submitted for each study or project which will be using identifying information obtained via the NDI.)

16. Types of Data To Be Submitted to NCHS

1. Each record which you submit will be searched against records in the NDI file ONLY if your record contains at least one of the following combinations of data items: (Check all that apply.)

First and last name and month and year of birth First and last name and Social Security Number

Social Security Number, month, day and year of birth, and sex

16.b. Which of the following NDI data set items will you be able to provide for the records you submit? You are encouraged to provide as many of these data items as possible. This will maximize the number of true matches that are generated and will assist you in assessing the quality of the matches that occur.

On approximately what percent of your records?

1. First name %

2. Middle name %

2. Last name %

2. Father’s surname %

2. Social Security Number (SSN) %

2. Month of birth %

2. Day of birth %

2. Year of birth %

2. Sex %

2. Race %

2. Marital status %

2. State of residence¹ %

2. State of birth %

2. Age at death (if known)² %

2. State of death² %

2. Date or year of death² %

2. Date or year of last contact³ %

¹This item refers to the last known state of residence. The item is useful in assessing the matching results.

²For users submitting records for KNOWN decedents, these items are useful in assessing the matching results.

³For users submitting records for subjects whose vital status is UNKNOWN and for whom different years of death need to be searched, providing the date or year of last contact is useful in assessing the matching results.

National Death Index Confidentiality Agreement

Study or Project Title:

The undersigned hereby agrees to the following terms and conditions associated with this National Death Index (NDI) application and to the use of the information obtained from (1) the NDI, (2) from State death records, and (3) from death record

followback investigations:

1. Except for persons or organizations specified in the approved NDI application form, no data will be published or released in any form to any party if a particular individual or establishment is identifiable. ALL REQUESTS FOR IDENTIFIABLE

DATA OBTAINED VIA THE NDI WILL BE REFERRED IMMEDIATELY TO NCHS. In accordance with Section 308(d)

of the Public Health Service Act, such identifiable data will specifically not be provided in response to a direct order from an official of any government agency, the Administration or Congress, nor in response to an order from a court of justice.

2. The identifying information will be used ONLY for statistical purposes in medical and health research.

3. The identifying information will not be used as a basis for legal, administrative, or other actions which may directly affect those particular individuals or establishments as a result of their specific identification in this project.

4. The identifying information will be used only for the study or project proposed and the purpose described in the approved NDI application form. Use of the information for a research project other than the one described in the application form will not be undertaken until after a separate NDI application form for that project has been submitted to, and approved by, the NCHS.

5. NCHS obtains death record information via contracts with the state vital statistics offices. These contracts contain specific restrictions on the use of the information by the NDI and by the NDI Plus service (which gives NDI users cause of death codes). By providing NCHS with these assurances, I understand that I am also providing the same assurances to the state vital statistics offices. Violation of the terms and conditions of this Agreement may subject the organization/researcher to immediate abrogation of the Agreement by NCHS, the requirement of the return of all NDI data and related materials, and denial of future use of the NDI. Violation of the terms of the Agreement may also be a violation of Federal criminal law under

18 U.S.C. Section 1001. NCHS will pursue all legal remedies in the event of unauthorized disclosure of identifiable information from NDI data. Violation of the terms of the Agreement are also subject to state legal remedies.

6. The original version of the NDI data must be retained at a single location and no copy or extract of identifiable information may be made available to anyone except those persons identified in the Agreement and who have signed a non-disclosure statement. The NDI data may not be re-released to others except as specified in item seven of this agreement.

7. Access to identifiable NDI data maintained in computer memory must be controlled by password protection. Servers housing NDI data must be protected by a firewall and not be directly accessible from the internet. All persons must have completed required computer security training required by their institution. All printouts, diskettes, personal computers with data

on hard disks, or other physical products containing identifiable information derived from the NDI must be kept in locked cabinets, file drawers, or other secure locations when not in use. Security procedures must be in place to ensure that identifiable NDI data cannot be used or taken by unauthorized individuals. Printouts, tabulations, reports and other materials must be edited for any possible disclosures of NDI identifiable data prior to making the information available to anyone other than those persons identified in this Agreement.

8. Except for data stored in registries, all identifying or identifiable data received from the NDI must be removed from all research records at the conclusion of the study or within five years after receipt of the NDI data – regardless of the data set in which the data are kept—unless an extension has been granted by NDI. The original version of the NDI data must be returned to NCHS or destroyed. Files-- including backup files and derived files--with NDI identifying or identifiable data must be both deleted and overwritten to prevent recovery of the data. (See Attachment A.)

9. The organization/researcher must notify NCHS within 24 hours upon discovering any loss or suspected loss of identifiable NDI data or any disclosure of identifiable NDI data to unauthorized parties. This must be reported to the DVS Director, Charles J. Rothwell (301-458-4468). Within three business days of the notification to NCHS, the organization/researcher must submit to the NCHS Confidentiality Officer, a more detailed written report including the date and nature of the event, actions taken or to be taken to remediate the issue(s), and plans or processes developed to prevent further problems, including specific information on timelines anticipated for action.

NDI Confidentiality Agreement (continued)

10. Authorized NCHS staff or agents may, upon request, be granted access to {name of user} facilities, where confidential NDI data are kept or used, for the purpose of inspecting the data security arrangements.

11. I understand that while state vital statistics offices may receive copies of this application, states may require additional information and/or assurances before responding to requests for copies of death certificates or for death record information. Some states may not be able to honor certain requests because of the proposed uses of the state data. Furthermore, once data from a particular state are received, I understand that users of the data are subject to that state’s laws and regulations relating to disclosure of information on individuals or establishments.

12. I have reviewed this NDI application. All the statements made in this application and in any confidentiality assurances related to this application are true, complete, and correct to the best of my knowledge and belief. My signature below indicates my agreement to comply with the stated statutorily-based requirements with the knowledge that deliberately making a false statement in any matter within the jurisdiction of any department or agency of the Federal Government violates 18 USC 1001 and is punishable by a fine of up to $10,000 or up to 5 years in prison.

* NOTE: The “official authorized to execute agreements” will vary among organizations. Whenever possible, the NDI prefers that this official be someone at a higher level of authority than the principal investigator or other persons responsible for the study or project; for example, a university official authorized to sign grant proposals, a company vice president, a government division or bureau director. By signing this agreement as the authorized official, you are declaring that you have the authority to make the above assurances on behalf of the university, company, agency or other organization and to bind the organization to the terms of this agreement and you take responsibility for the confidentiality assurances of all organizations or individuals who are participating in this study.

National Death Index Supplemental Confidentiality Agreement

A separate Supplemental Confidentiality Agreement must be completed and signed by each EXTERNAL organization or consultant funding or participating in this study, as listed in items 5 and 7 of the NDI Application Form. Co-principal investigators listed in item 3 and employed in external organizations must also sign this Supplemental Confidentiality Agreement. The Supplemental Confidentiality Agreement(s) must then be submitted as an attachment to the Application Form. THIS REQUIREMENT IS WAIVED ONLY FOR A FEDERAL GRANT, AND THEN ONLY WHEN THE NDI APPLICANT (GRANTEE) CAN GIVE ASSURANCES THAT THE IDENTIFYING INFORMATION OBTAINED DIRECTLY OR INDIRECTLY FROM THE NDI

WILL UNDER NO CIRCUMSTANCES BE PROVIDED TO THE GRANTOR.

Name and title of person responsible for project activities:

Organization name and complete mailing address:

Telephone Number: E-mail :

1. Will this organization (or individual) receive any of the identifying or identifiable death record information obtained from the NDI, state death records, and/or death record follow back investigations? (By “identifying or identifiable death record informa- tion” we mean any information on death certificates, other paper documents, or in computer files which by themselves, or if linked with other records, would permit the identification of one or more individuals or establishments.)

Yes No Maybe

2. Does this organization (or individual) have any contractual or other rights to the identifying information referred to above?

Yes No Maybe

IF you answered NO to both questions 1 and 2, skip questions 3 and 4 below and just provide the two requested signatures below. If you answered YES or MAYBE to either questions 1 or 2, please complete questions 3 and 4 below.

NDI Supplemental Confidentiality Agreement (continued)

3. In the box below, describe how your organization will store and maintain the confidentiality of the identifying or identifiable death record information obtained from (1) the NDI, (2) state death records, and (3) death record followback investigations. “Identifying or identifiable death record information” refers to any information on death certificates, other paper documents, or in computer files which by itself, or if linked with other records, would permit the identification of one or more individuals or establishments. Furthermore, by identifying or identifiable data we mean such items as name(s), Social Security Number, exact dates, addresses, and death certificate number. Even with the removal of direct identifiers and linkable study subject identifica- tion numbers, there is still a special concern that some combinations of the remaining variables could potentially be used to identify an individual.

Describe the following controls that would be used to maintain the confidentiality of the NDI data:

• Physical controls–limiting access to data such as building guards, identification badges, key cards, closed circuit TV, and locked offices.

• Technical controls – such as user identification, passwords, firewalls, encryption, virtual private network, intrusion

detection system, and stand-alone desktop use only.

• Administrative controls – such as how frequently files will be backed up, where backup files will be stored, methods

in place to ensure least privilege access, methods for ensuring NDI identifying information is not co-mingled with administrative records not part of this project, how use of NDI data will be monitored to prevent its use for purposes other than those approved for this project, how personnel using the system will be trained and made aware of their responsibilities for protecting the NDI information, methods for keeping track of who has access to the data, and methods for ensuring return or destruction of data.

NOTE: Be specific about how both hard copy and computer records will be stored and protected by the organization (or individual) specified above. For example, what precautions will be taken to ensure that copies of death certificates and other identifiable information obtained via the NDI will only be used for the study or project described in this application? Will the identifiable information be kept separate from your organization’s medical records or other types of administrative records which may be accessible for purposes other than described in this application? Will separate computer files be used to segregate identifiable information from other data on the study subjects? How will access to identifiable information be restricted?

3. How and when will your organization dispose of each of these types of identifying information? If your organization has

no plans to dispose of some or all of the identifying or identifiable information, please explain why.

NOTE: For your information, some state vital statistics offices have expressed concern about the indefinite retention of death certificates which could be used inadvertently in the future by other persons for other purposes. If you feel that the death cer- tificates and other identifiable information must be retained indefinitely, please provide a strong justification here and indicate what precautions will be taken to ensure that the information is not used inadvertently in the future for other purposes. Please note, however, that when you request certificates from the individual state offices, you will have to conform with each state’s data release policies or negotiate special arrangements.

NDI Supplemental Confidentiality Agreement (continued)

Study or Project Title:

5. The undersigned hereby agrees to the following terms and conditions associated with this National Death Index (NDI) applica- tion and to the use of the information obtained from (1) the NDI, (2) from State death records, and (3) from death record follow back investigations:

1. Except for persons or organizations specified in the approved NDI application form, no data will be published or released in any form to any party if a particular individual or establishment is identifiable. ALL REQUESTS FOR IDENTIFIABLE DATA OBTAINED VIA THE NDI WILL BE REFERRED IMMEDIATELY TO NCHS. In accordance with Section 308(d) of the Public Health Service Act, such identifiable data will specifically not be provided in response to a direct order from an official of any government agency, the Administration or Congress, nor in response to an order from a court of justice.

2. The identifying information will be used ONLY for statistical purposes in medical and health research.

3. The identifying information will not be used as a basis for legal, administrative, or other actions which may directly affect those particular individuals or establishments as a result of their specific identification in this project.

4. The identifying information will be used only for the study or project proposed and the purpose described in the approved NDI application form. Use of the information for a research project other than the one described in the application form will not be undertaken until after a separate NDI application form for that project has been submitted to, and approved by, the National Center for Health Statistics.

5. NCHS obtains death record information via contracts with the state vital statistics offices. These contracts contain specific restrictions on the use of the information by the NDI and by the NDI Plus service (which gives NDI users cause of death codes). By providing NCHS with these assurances, I understand that I am also providing the same assurances to the state vital statistics offices. Violation of the terms and conditions of this Agreement may subject the organization/researcher to immediate abrogation of the Agreement by NCHS, the requirement of the return of all NDI data and related materials, and denial of future use of the NDI. Violation of the terms of the Agreement may also be a violation of Federal criminal law under 18 U.S.C. Section 1001. NCHS will pursue all legal remedies in the event of unauthorized disclosure of identifiable information from NDI data. Violation of the terms of the Agreement are also subject to state legal remedies.

6. The original version of the NDI data must be retained at a single location and no copy or extract of identifiable information may be made available to anyone except those persons identified in the Agreement and who have signed a non-disclosure statement. The NDI data may not be re-released to others except as specified in item 7 of this agreement.

7. Access to identifiable NDI data maintained in computer memory must be controlled by password protection. Servers housing NDI data must be protected by a firewall and not be directly accessible from the internet. All persons must have completed required computer security training required by their institution. All printouts, diskettes, personal computers with data on hard disks, or other physical products containing identifiable information derived from the NDI must be kept in locked cabinets, file drawers, or other secure locations when not in use. Security procedures must be in place to ensure that identifiable NDI data cannot be used or taken by unauthorized individuals. Printouts, tabulations, reports and other materials must be edited for any possible disclosures of NDI identifiable data prior to making the information available to anyone other than those persons identified in this Agreement.

8. Except for data stored in registries, all identifying or identifiable data received from the NDI must be removed from all research records at the conclusion of the study or within 5 years after receipt of the NDI data – regardless of the data set in which the data are kept—unless an extension has been granted by NDI. The original version of the NDI data must be returned to NCHS or destroyed. Files-- including backup files and derived files--with NDI identifying or identifiable data must be both deleted and overwritten to prevent recovery of the data. (See Attachment A.)

9. The organization/researcher must notify NCHS within 24 hours upon discovering any loss or suspected loss of identifiable NDI data or any disclosure of identifiable NDI data to unauthorized parties. This must be reported to the DVS Director,

Charles J. Rothwell (301-458-4468). Within 3 business days of the notification to NCHS, the organization/researcher must submit to the NCHS Confidentiality Officer, a more detailed written report including the date and nature of the

event, actions taken or to be taken to remediate the issue(s), and plans or processes developed to prevent further problems, including specific information on timelines anticipated for action.

NDI Supplemental Confidentiality Agreement (continued)

10. Authorized NCHS staff or agents may, upon request, be granted access to {name of user} facilities, where confidential NDI data are kept or used, for the purpose of inspecting the data security arrangements.

11. I understand that while state vital statistics offices may receive copies of this application, states may require additional information and/or assurances before responding to requests for copies of death certificates or for death record information. Some states may not be able to honor certain requests because of the proposed uses of the state data. Furthermore, once data from a particular state are received, I understand that users of the data are subject to that state’s laws and regulations relating to disclosure of information on individuals or establishments.

12. I have reviewed this NDI application. All the statements made in this application and in any confidentiality assurances related to this application are true, complete, and correct to the best of my knowledge and belief. My signature below indicates my agreement to comply with the stated statutorily-based requirements with the knowledge that deliberately making a false statement in any matter within the jurisdiction of any department or agency of the Federal Government violates 18 USC 1001 and is punishable by a fine of up to $10,000 or up to 5 years in prison.

NOTE: If your response to both items 1 and 2 above was NO, you must still sign this form below; HOWEVER, it is understood that the terms specified in item 5 above do not apply to you or to your organization. And, because you will not be receiving identifiable NDI data, you would not need a Data Steward’s signature.

SIGNATURE of principle investigator, project director, project officer, or other responsible official.			*SIGNATURE of “official authorized to execute agreements
	Signature	Date		Signature	Date
	Name (Please type or print)			Name (Please type or print)
	Title			Title
	Organization E-mail:			Organization E-mail:

* NOTE: The “official authorized to execute agreements” will vary among organizations. Whenever possible, the NDI prefers that this official be someone at a higher level of authority than the principal investigator or other persons responsible for the study or project; for example, a university official authorized to sign grant proposals, a company vice president, a government division or bureau director. By signing this agreement as the authorized official, you are declaring that you have the authority to make the above assurances on behalf of the university, company, agency or other organization and to bind the organization to the terms of this agreement and you take responsibility for the confidentiality assurances of all organizations or individuals who are participating in this study.

National Death Index (NDI) Data Disposition Form

Attachment A

Use the multi-purpose form on the next page to notify the NDI program of one of the following events:

• When you have disposed of ALL the identifying or identifiable death record information obtained

from the NDI.

• If your initial NDI Application was submitted prior to April 1, 2007 and you are now submitting a Repeat NDI Request (and have never completed this form).

• To request an extension for the retention of your identifying or identifiable death record

information beyond 5 years from when your initial NDI application was submitted.

• If you have already been approved for a 1 to 5 year extension, to request another extension beyond your previously approved extension period.

Some State vital statistics offices have expressed concern about indefinite retention of “identifying or identifiable death record information” that could be used in the future by other persons for other purposes.

[Definition of “identifying or identifiable death record information” -- Any information on death certificates, other paper documents, or in computer files which by itself, or if linked with other records, would permit the identification of one or more individuals or establishments. Furthermore, by identifying or identifiable data we mean such items as name(s), Social Security Number, exact dates, addresses,

and death certificate number. Even with the removal of direct identifiers and linkable study subject identification numbers, there is still a special concern that some combinations of the remaining variables could potentially be used to identify an individual.]

All identifying or identifiable data received from the NDI must be removed from all research records at the conclusion of the study or within 5 years after receipt submission of your initial NDI Application Form -- regardless of the data set in which the data are kept. This means that all identifiers or potentially identifiable data elements associated with cause of death codes must be removed from all analysis files unless there is no way

to identify an individual decedent. This also means that any linked files (with crosswalks) are to be destroyed. (Note: Death certificates obtained directly from state offices may have to be shredded in less than 5 years depending on each state’s requirements.)

While the NDI staff recognizes that some research studies can remain active for several years, each study is viewed to have a limited duration. At the completion of the study ALL identifying or identifiable information that came from the NDI match must be destroyed, regardless of storage medium, unless no possible link could be made to an individual. Note: As long as there are no identifiers or linking variables remaining in the analytic or public-use file(s), cause(s) of death codes may remain in such file(s).

NDI Data Disposition (continued)

Attachment A

Date of initial NDI Application NDI Application Number

Title of study or project:

Phone no.: E-mail:

Principal Investigator

or Project Director:

Title:

Organization: Mailing address:

1. As the Data Custodian for the above listed study/project, I affirm that all electronic and paper files containing identifiable NDI data have been destroyed on:

(If not destroyed, put NA and answer items 3 – 5 below.)

2. I also affirm that all derivative and back-up copies have

been destroyed on:

(If not destroyed yet, put NA and answer items 3 – 5 below.)

3. When will the identifiable death record information be destroyed? (State UNKNOWN if this is an open-ended or ongoing study that has no specific disposition plan at this time.)

4. If the answer to item 3 is: (1) unknown, (2) more than 5 years after you submitted your NDI Application Form, or (3) more than 5 years after you last requested an extension for the retention of your data, please provide a strong justification for why the data need to be retained beyond the 5-year period.

5. If it has been more than 5 years since your initial NDI application (or since your last request for an extension), are you requesting an extension for the retention of identifiable NDI data?

6. If your extension is approved, you are responsible for submitting this form when your data have been destroyed OR within 5 years

from now but no later than the date you indicate in the box to the right.

YES NO

Data Steward (print name and title) Signature

Date

Principal Investigator or Project Director (print name

and title)

Signature

Date

Mail form to: National Death Index, NCHS, 3311 Toledo Road, Room 7318, Hyattsville, MD 20782

Attachment B

Disease And Non-Disease Registries:

Additional Information Required For The NDI Application Form

In addition to the information requested of all NDI applicants, the NDI Application Form submitted for both disease and non-disease registries must also include the following information in item 8.c of the Application:

1. Provide brief descriptions of examples of specific studies which are now being performed or planned. After describing such studies, the applicant should state the following:

“Should there be any significant deviations from such studies, we fully understand that an amended NDI application must first be submitted to and approved by NCHS.”

(The purpose of the above requirements is to provide evidence that the organization in fact will be using the registry mortality data base solely for “statistical purposes in medical and health research.”)

2. If the applicant indicates that no death record follow-back investigations will be implemented, the applicant must make the following statement:

“Should follow-back investigations become necessary, and involve death records obtained via the NDI, it is understood that first we must (1) submit an amended Application Form describing the follow-back investigations, (2) obtain and submit an approval from an Institutional Review Board for the Protection of Human Subjects, and (3) wait for the amended application to be reviewed by the NDI advisers

and approved by the NCHS Director. Furthermore, before follow-back investigations are initiated, it is understood that we will also obtain approvals from the states from which death records had been obtained.”

2. A specific statement that all hard-copy death record information obtained via the NDI, including copies of death certificates, will be flagged and stored separately from any administrative records or from statistical records that could be used in the future for purposes not described in the application.

Computer records containing death record information obtained via the NDI shall also be flagged so that they will not be used in the future for purposes not described in the application.

Attachment C

National Death Index (NDI) Requirements For Approval By An Institutional Review Board (IRB) For The Protection Of Human Subjects

General NDI Requirements for IRB Approvals:

1. The IRB approval be granted by (a) an institution which has a Multiple Project Assurances (MPA) or a Federal Wide Assurance (FWA) approved by the Department of Health and Human Services (DHHS) or

(b) by an independent IRB registered with DHHS.

2. If the NDI applicant’s institution has an institutional review board (or its equivalent) that is not approved by DHHS, the applicant must submit additional documentation describing the IRB and listing how its membership is constituted.

3. An “expedited” IRB review and approval is acceptable if performed by an institution having an MPA and if the research meets the conditions for “expedited” IRB review described in 45 CFR 46.110(a) or (b).

4. If an applicant’s study or project does not require an IRB approval, the applicant must at least submit documentation from an IRB that the study or project is EXEMPT from the IRB approval requirements.

4. The review and approval by an IRB must occur prior to the approval of the NDI application.

Specific NDI Requirements for Studies Involving

Death Record Follow-back investigations:

1. The applicant must obtain a letter from the IRB indicating specifically that the study’s death record follow-back methodology has been reviewed and approved and that the review of the study also included an assessment of any potential emotional harm and undue respondent burden which may be caused

by the proposed follow-back activities. (Of concern are any contacts made to next-of-kin, physicians, hospitals or other establishments based on information appearing on death certificates obtained via use of the NDI.)

2. The letter must include language similar to the following statement (but tailored specifically to the study which was reviewed):

“We have reviewed this study in conjunction with your application to use the NDI. We are satisfied that the procedure to be used to obtain additional information on deceased study subjects (from

next-of-kin, physicians, hospitals and/or others) provide appropriate protection to the respondents with respect to minimizing respondent burden, maintaining confidentiality, protecting their privacy, and avoiding or minimizing any emotional or other harm that may affect the respondent. Our review included an assessment of all existing and/or proposed contact letters, telephone techniques,

questionnaires and consent forms used in the death record follow-back investigations. These were all deemed to be satisfactory.”

3. If the applicant is unable to obtain such a letter from the IRB, the study’s IRB approval document must include attachments that clearly show that the IRB’s review included the death record follow-back methodology.

Attachment C (Continued)

Rationale:

It is understood that most studies using the NDI do not involve diagnostic, therapeutic, or any other forms of physical contacts with human subjects and consequently do not receive or need to receive IRB approvals based on requirements set forth by their own institution or by the regulations for the protection of human subjects promulgated by the DHHS (45 CFR 46). On the other hand, the National Center for Health Statistics (NCHS) and many state vital statistics offices are concerned about the invasion of privacy, potential emotional harm, and undue respondent burden that can result (from contacts made to next-of-kin, physicians, hospitals, and others) as part of death record follow-back investigations which are felt to be essential components of some

studies. Because of this concern, an IRB should review the follow-back methodology to be used in such studies, including review of all contact letters and/or telephone techniques, questionnaires and consent forms (for release of medical records), as well as procedures for insuring that the information obtained remains confidential.

Therefore, IRB approvals have been made a prerequisite for NDI approvals for studies involving death record follow-back investigations. We are hopeful that IRB committees will be both supportive and responsive to this requirement, even though reviews of such studies are neither customary nor required for other purposes and may even be “exempt” as defined by the DHHS regulations at 45 CFR 46.101(b)

NDI APPLICANTS AND IRB COMMITTEES REQUIRING ADDITIONAL INFORMATION ON THE ABOVE REQUIREMENTS SHOULD CONTACT THE NDI STAFF ON 301-458-4444.