Privacy Impact Assessment

Attachment 7 CC CRSS OCRTME Training Program PIA.docx

Application Process for Clinical Research Training and Medical Education at the Clinical Center and its impact on Course and Training Program Enrollment and Effectiveness (CC)

Privacy Impact Assessment

OMB: 0925-0698

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1. OPDIV

National Institutes of Health

2. PIA Unique Identifier

P-1110930-742633

2a. Name

CRSS OCRTME Training Program (2021 review)

3. The subject of this PIA is which of the following?

Minor Application (stand-alone)

3a. Identify the Enterprise Performance Lifecycle Phase of the system.

Operational

3b. Is this a FISMA-Reportable system?

No

4. Does the system include a Website or online application available to and for the use of the general public?

Yes

Accept / Reject Status

Undefined



Question 4 Comment




5. Identify the operator.

Agency

6. Point of Contact (POC)

POC Title

System Owner

POC Name

Simmons, Jennifer

POC Organization

NIH/CC/OCRTME

POC Email

[email protected]

POC Phone

301.402.0914

Accept / Reject Status

Undefined



Question 6 Comment




7. Is this a new or existing system?

Existing

8. Does the system have Security Authorization (SA)?

Yes

Accept / Reject Status

Undefined



Question 8 Comment




8a. Date of Security Authorization

10/27/2020



9. Indicate the following reason(s) for updating this PIA. Choose from the following options.

PIA Validation (PIA Refresh/Annual Review)

Other


Accept / Reject Status

Undefined



Question 9 Comment






10. Describe in further detail any changes to the system that have occurred since the last PIA.

A new Graduate Medical Education Survey has been added.

Accept / Reject Status

Undefined



Question 10 Comment




11. Describe the purpose of the system.

The Office of Clinical Research Training and Medical Education (OCRTME) Training Programs, also known as (aka) Clinical Research Student (CRS) records system, accepts applications from medical, dental, veterinary students; residents, and physicians applying for training programs at the NIH Clinical Center (CC). In addition to collecting applications, the system generates surveys to accepted training program students, residents and physicians to evaluate impact and effectiveness of the training programs.


The OCRTME programs include:

Medical Research Scholars Program

Graduate Medical Education

Clinical Electives Program

Resident Electives Program

Clinical Research Training Program and Medical Research Scholars Program (CRTP/MRSP) Alumni Survey

Graduate Medical Education Alumni Survey

Accept / Reject Status

Undefined



Question 11 Comment




12. Describe the type of information the system will collect, maintain (store), or share. (Subsequent questions will identify if this information is PII and ask about the specific data elements.)

The personally identifiable information (PII) collected includes name, personal mailing address, personal phone number, personal email address, educational records, and employment status. In addition, applicants submit:

Educational information including educational institutions attended, transcripts, test scores

Professional information including current profession, current Curriculum Vitae (CV), citizenship status

References


The information is used to process applicants for training programs sponsored by various Institutes and Centers (ICs) within the NIH. The information is submitted voluntarily by medical/dental students or physicians and is collected to determine the suitability of applicants for NIH clinical research training programs.


Those requiring access to OCRTME Training Program log in using the NIH Identity, Credential, and Access Management (ICAM) Services which maintains its own unique privacy impact assessment (PIA) on record, including all legal authorities documented. The purpose of the ICAM is to authenticate and authorize all users and computers in a Windows domain type network; assigning and enforcing information security policies for all computers and installing or updating software. The ICAM collects unique user names and passwords (user credentials) and stores them in an encrypted format. The ICAM is an essential service which facilitates and governs network access to various resources.


Individuals applying to the training programs are guided through the process for application on the OCRTME website An active link to each training program inlcudes the program's application and program requirements. Applicants do not have access to the information once it's submitted. If an update is needed, they email the support address and work with the support team.

Accept / Reject Status

Undefined



Question 12 Comment




13. Provide an overview of the system and describe the information it will collect, maintain (store), or share, either permanently or temporarily.

The OCRTME Training Program accepts applications from medical, dental, veterinary students; residents, and physicians applying for training programs at the NIH Clinical Center (CC).


The OCRTME programs include:

Medical Research Scholars Program

Graduate Medical Education

Clinical Electives Program

Resident Electives Program

Clinical Research Training Program and Medical Research Scholars Program (CRTP/MRSP) Alumni Survey

Graduate Medical Education Alumni Survey


The personally identifiable information (PII) collected includes name, personal mailing address, personal phone number, personal email address, educational records, and employment status. In addition, applicants submit:

Educational information including educational institutions attended, transcripts, test scores

Professional information: current profession, current CV, citizenship status

References


The information is used to process applicants for training programs sponsored by various ICs within the NIH. The information is submitted voluntarily by medical/dental students or physicians and is collected to determine the suitability of applicants for NIH clinical research training program. The information is shared with NIH training program administrators and selecting officials.


Those requiring access to OCRTME Training Program log in using the NIH ICAM Services which maintains its own unique PIA on record, including all legal authorities documented.


Individuals applying to the training programs submit their forms via the web link on the OCRTME external websites. Applicants do not have access to the information once it's submitted. If an update is needed, they email the support address and work with the support team.

Accept / Reject Status

Undefined



Question 13 Comment




14. Does the system collect, maintain, use or share PII?

Yes

Accept / Reject Status

Undefined



Question 14 Comment






15. Indicate the type of PII that the system will collect or maintain.

Name, E-Mail Address, Phone Numbers, Education Records, Mailing Address


ECurrent CV, citizenship status


References



Accept / Reject Status

Undefined



Question 15 Comment




16. Indicate the categories of individuals about whom PII is collected, maintained or shared.

Employees, Public Citizens



Accept / Reject Status

Undefined



Question 16 Comment




17. How many individuals' PII is in the system?

10,000-49,999

Accept / Reject Status

Undefined



Question 17 Comment




18. For what primary purpose is the PII used?

For evaluation and selection of participants for medical education and research training programs, and to evaluate the effectiveness / outcome of NIH clinical research training programs.

Accept / Reject Status

Undefined



Question 18 Comment




19. Describe the secondary uses for which the PII will be used (e.g. testing, training or research)

The information collected is used to validate the compliance of graduate medical education training programs sponsored by the Clinical Center with the requirements of external accrediting organizations, specifically the Accreditation Council for Graduate Medical Education.

Accept / Reject Status

Undefined



Question 19 Comment




20. Describe the function of the SSN.

Social Security Number (SSN) is not collected. It is acknowledged that SSN may appear on transcripts uploaded by the applicant. This collection would be unsolicited and incidental. The SSN is never used to consider an applicant.

Accept / Reject Status

Undefined



Question 20 Comment




20a. Cite the legal authority to use the SSN.

SSN is not collected.

21. Identify legal authorities governing information use and disclosure specific to the system and program.

42 USC 241, 263, 282

22. Are records on the system retrieved by one or more PII data elements?

Yes

Accept / Reject Status

Undefined



Question 22 Comment






22a. Identify the number and title of the Privacy Act System of Records Notice (SORN) that is being used to cover the system or identify if a SORN is being developed.

Published:

09-25-0014, Clinical Research: Student Records, HHS/NIH/OD/OIR/OE

Published:


Published:


In Progress

No



23. Identify the sources of PII in the system.

In-Person, Hard Copy: Mail/Fax, Email, Online, Members of the Public

Accept / Reject Status

Undefined



Question 23 Comment




23a. Identify the OMB information collection approval number and expiration date.

OMB Number: 0925-0698 (Application Process for Clinical Research Training and Medical Education at the Clinical Center and its impact on Course and Training Program Enrollment and Effectiveness)

24. Is the PII shared with other organizations?

Yes

Accept / Reject Status

Undefined



Question 24 Comment






24a. Identify with whom the PII is shared or disclosed and for what purpose.

Within HHS

Yes


Applicant names within the system may be shared with NIH training programs.

Other Federal Agency/Agencies

No



State or Local Agency/Agencies

No



Private Sector

Yes


Names of past participants of some training programs may be listed on the OCRTME and Foundation of NIH external facing websites after obtaining consent and permission from the participants.


Two third-party web application providers, under the direction of the Executive Director for Graduate Medical Education, provide online course registration functionality for NIH training programs and conduct Alumni tracking surveys for graduates of the NIH training programs, all sites hosted at NIH. The contractor may have incidental access to the PII when performing regular troubleshooting work and security maintenance.

24b. Describe any agreements in place that authorizes the information sharing or disclosure (e.g. Computer Matching Agreement, Memorandum of Understanding (MOU), or Information Sharing Agreement (ISA)).

There are no Memorandums of Understanding (MOUs) or Information Sharing Agreement (ISAs) for this system. The third-party web-application provider contracts stipulate that New Innovations and Digital Infuzion must follow all requirements in the Security and Privacy Language for Information and Information Technology Procurements and NIH Information Security Policy Handbook.

24c. Describe the procedures for accounting for disclosures.

N/A

Data is not shared outside of HHS.



25. Describe the process in place to notify individuals that their personal information will be collected. If no prior notice is given, explain the reason.

Individuals self-select for application and make the affirmative action to visit the NIH website(s) in question. Applicants are notified at the website where data is collected that submission of information is voluntary but necessary for program application and consideration.

Accept / Reject Status

Undefined



Question 25 Comment




26. Is the submission of PII by individuals voluntary or mandatory?

Voluntary

Accept / Reject Status

Undefined



Question 26 Comment




27. Describe the method for individuals to opt-out of the collection or use of their PII. If there is no option to object to the information collection, provide a reason.

Individuals may opt out by not applying to the program.

Accept / Reject Status

Undefined



Question 27 Comment




28. Describe the process to notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of original collection). Alternatively, describe why they cannot be notified or have their consent obtained.

No changes to the OCRTME program are likely to occur. If a change were to occur, applicant data would then be used to notify and obtain consent from applicants for any new use.

Accept / Reject Status

Undefined



Question 28 Comment




29. Describe the process in place to resolve an individual's concerns when they believe their PII has been inappropriately obtained, used, or disclosed, or that the PII is inaccurate. If no process exists, explain why not.

A Privacy Rights Complaint Form is available to individuals when they believe that their PII has been inappropriately used or disclosed. The Clinical Center's Privacy Office will review the complaint and respond to the concern within 30 business days. Complaints could also be submitted to the System Manager, who would investigate and share findings with CC Information Systems Security Officer (ISSO) and CC Privacy Officer.

Accept / Reject Status

Undefined



Question 29 Comment




30. Describe the process in place for periodic reviews of PII contained in the system to ensure the data's integrity, availability, accuracy and relevancy. If no processes are in place, explain why not.

The system owner regularly reviews and analyzes audit records for indications of inappropriate or unusual activity, investigates suspicious activity or suspected violations, reports findings to appropriate officials, and takes necessary actions (such as reporting security violations).

Accept / Reject Status

Undefined



Question 30 Comment




31. Identify who will have access to the PII in the system and the reason why they require access.

Users

Yes


OCRTME Users have access to PII in order to screen program applicants.

Administrators

Yes


Administrators may have incidental access to an applicant's PII during the performance of administrative functions.

Developers

Yes


Developers may have incidental exposure to PII when performing security updates and troubleshooting reported incidents.

Contractors

Yes


Users or administrators may be direct contractors

Others

Yes


The web application providers (New Innovations and Digital Infuzion) may have incidental access to the PII when performing regular troubleshooting work and security maintenance.

32. Describe the procedures in place to determine which system users (administrators, developers, contractors, etc.) may access PII.

Access to PII is assigned based upon job roles/responsibilities. An NIH ICAM account login is required to gain access to the stored PII data. The access rights of the user account determine file system permissions and whether PII may be accessed.

Accept / Reject Status

Undefined



Question 32 Comment




33. Describe the methods in place to allow those with access to PII to only access the minimum amount of information necessary to perform their job.

Appropriate access is granted to the system based on predefined roles and job descriptions, and administrative access is limited to authorized employees based on current roles. Dual factor authentication with NIH Personal Identity Verification (PIV) card and NIH ICAM will occur at time of login to the NIH Network. System owners are responsible for creating the proper security groups within their systems with the applicable permissions for group members to enforce least privilege.

Accept / Reject Status

Undefined



Question 33 Comment




34. Identify training and awareness provided to personnel (system owners, managers, operators, contractors and/or program managers) using the system to make them aware of their responsibilities for protecting the information being collected and maintained.

According to NIH policy, all personnel who use NIH applications must complete security awareness training every year. There are five categories of mandatory information technology (IT) training (Information Security, Counterintelligence, Privacy Awareness, Records Management and Emergency Preparedness).


Administrators and Privileged Users require additional training specific to their roles and responsibilities.

Accept / Reject Status

Undefined



Question 34 Comment




35. Describe training system users receive (above and beyond general security and privacy awareness training).

Application specific one-on-one peer training is provided as needed.

Accept / Reject Status

Undefined



Question 35 Comment




36. Do contracts include Federal Acquisition Regulation and other appropriate clauses ensuring adherence to privacy provisions and practices?

Yes

Accept / Reject Status

Undefined



Question 36 Comment




37. Describe the process and guidelines in place with regard to the retention and destruction of PII. Cite specific records retention schedules.

Records are retained and disposed of under the authority of the NIH Records Retention Schedule 06-601 Non-mission employee training program records.


Destroy when 3 years old, or 3 years after superseded or obsolete, whichever is appropriate, but longer retention is authorized if required for business use. DAA-GRS-2016-0014-0001

Accept / Reject Status

Undefined



Question 37 Comment




38. Describe, briefly but with specificity, how the PII will be secured in the system using administrative, technical, and physical controls.

Physical Controls: The IT hardware used to host protected information is located in a secured datacenter facility. The facility is only open to authorized personnel whose access is monitored by locking doors with badge readers for both ingress and egress. Each discrete ingress and egress event is logged. The facility is under 24-hour surveillance by facilities security for security and environmental hazards.


Technical Controls: IT hardware and software is segregated from default commodity public networks to prevent unauthorized or malicious access. Access controls lists and event logs are maintained and monitored to detect unauthorized, suspicious or malicious activity. Access lists are restricted to approved IT technical personnel. Two factor authentication must be used for access. File integrity and auditing software are employed on hardware.


Administrative Controls: All technical personnel who access IT systems which contain protected information have met background investigation criteria for Public Trust positions. All personnel have taken mandatory security and privacy training classes and annual refreshers. Administrative personnel accessing these systems use privileged and separate accounts for administrative access.

Accept / Reject Status

Undefined



Question 38 Comment








39. Identify the publicly-available URL.

https://ocrtmeapps.cc.nih.gov/mrsp

https://ocrtmeapps.cc.nih.gov/gme

https://ocrtmeapps.cc.nih.gov/rep/

https://ocrtmeapps.cc.nih.gov/survey

Accept / Reject Status

Undefined



Question 39 Comment




40. Does the website have a posted privacy notice?

Yes

Accept / Reject Status

Undefined



Question 40 Comment






40a. Is the privacy policy available in a machine-readable format?

Yes



41. Does the website use web measurement and customization technology?

Yes

Accept / Reject Status

Undefined



Question 41 Comment






41a. Select the type of website measurement and customization technologies is in use and if it is used to collect PII. (Select all that apply).

Web Beacons

No

Collects PII?

No

Web Bugs

No

Collects PII?

No

Session Cookies

Yes

Collects PII?

No

Persistent Cookies

No

Collects PII?

No

Other ...


Collects PII?

No



42. Does the website have any information or pages directed at children under the age of thirteen?

No

Accept / Reject Status

Undefined



Question 42 Comment






42a. Is there a unique privacy policy for the website, and does the unique privacy policy address the process for obtaining parental consent if any information is collected?

Undefined



43. Does the website contain links to non-federal government websites external to HHS?

No

Accept / Reject Status

Undefined



Question 43 Comment






43a. Is a disclaimer notice provided to users that follow external links to websites not owned or operated by HHS?

Undefined






REVIEWER QUESTIONS: The following section contains Reviewer Questions which are not to be filled out unless the user is an OPDIV Senior Officer for Privacy.

1. Are the questions on the PIA answered correctly, accurately, and completely?

Undefined

Reviewer Notes


Accept / Reject Status

Undefined



Question 1 Comment




2. Does the PIA appropriately communicate the purpose of PII in the system and is the purpose justified by appropriate legal authorities?

Undefined

Reviewer Notes


Accept / Reject Status

Undefined



Question 2 Comment




3. Do system owners demonstrate appropriate understanding of the impact of the PII in the system and provide sufficient oversight to employees and contractors?

Undefined

Reviewer Notes


Accept / Reject Status

Undefined



Question 3 Comment




4. Does the PIA appropriately describe the PII quality and integrity of the data?

Undefined

Reviewer Notes


Accept / Reject Status

Undefined



Question 4 Comment




5. Is this a candidate for PII minimization?

Undefined

Reviewer Notes


Accept / Reject Status

Undefined



Question 5 Comment




6. Does the PIA accurately identify data retention procedures and records retention schedules?

Undefined

Reviewer Notes


Accept / Reject Status

Undefined



Question 6 Comment




7. Are the individuals whose PII is in the system provided appropriate participation?

Undefined

Reviewer Notes


Accept / Reject Status

Undefined



Question 7 Comment




8. Does the PIA raise any concerns about the security of the PII?

Undefined

Reviewer Notes


Accept / Reject Status

Undefined

Accept / Reject Status

Undefined



Question 8 Comment




9. Is applicability of the Privacy Act captured correctly and is a SORN published or does it need to be?

Undefined

Reviewer Notes


Accept / Reject Status

Undefined

Accept / Reject Status

Undefined



Question 9 Comment




10. Is the PII appropriately limited for use internally and with third parties?

Undefined

Reviewer Notes


Accept / Reject Status

Undefined



Question 10 Comment




11. Does the PIA demonstrate compliance with all Web privacy requirements?

Undefined

Reviewer Notes


Accept / Reject Status

Undefined



Question 11 Comment




12. Were any changes made to the system because of the completion of this PIA?

Undefined

Reviewer Notes


Accept / Reject Status

Undefined



Question 12 Comment




General Comments

This component is under Clinical Research Support Services (CRSS), whose Universal Unique Identifier (UUID) is: 3E9D85ED-26F6-4A33-BEED-6B60B945A54C.


Status and Approvals

IC Status

IC Approved

OSOP Status

HHS Approved

OPDIV Senior Official for Privacy Signature


HHS Senior Agency Official for Privacy



  

                      

For Official Use Only (FOUO)

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AuthorMartin, Susan (NIH/CC/DCRI) [C]
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File Created2023-08-30

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