Supporting Statement A for
Electronic Application for NIH Certificates of Confidentiality (CoC E-application System)
OMB#: 0925-0689
Expiration Date: 1/31/2017
Request for OMB Extension
October 18, 2016
Name: Ann M Hardy, DrPH
Address: 6705 Rockledge Dr. Rm 3002,
Bethesda MD 20892
Telephone: 301-435-2690
Fax: 301-480-0146
Email: hardyan@od.nih.gov
Table of contents
Abstract
List of Attachments
A. JUSTIFICATION
A.1 Circumstances Making the Collection of Information Necessary
A.2. Purpose and Use of the Information COLLECTION
A.3 Use of Information Technology and Burden Reduction
A.4 Efforts to Identify Duplication and Use of Similar Information
A.5 Impact on Small Businesses or Other Small Entities
A.6 Consequences of Collecting the Information Less Frequently
A.7 Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
A.8 Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agency
A.9 Explanation of Any Payment of Gift to Respondents
A.10 Assurance of Confidentiality Provided to Respondents
A.11 Justification for Sensitive Questions
A.12 Estimates of Hour Burden Including Annualized Hourly Costs
A.13 Estimate of Other Total Annual Cost Burden to Respondents or Record
keepers
A.14 Annualized Cost to the Federal Government
A.15 Explanation for Program Changes or Adjustments
A.16 Plans for Tabulation and Publication and Project Time Schedule
A.17 Reason(s) Display of OMB Expiration Date is Inappropriate
A.18 Exceptions to Certification for Paperwork Reduction Act Submissions
abstract
Certificates of Confidentiality provided research participants with an additional layer of protection by allowing researchers with a CoC to refuse compelled disclosure of identifying information about participants. NIH, through its 24 funding Institutes and Centers (ICs), has issued Certificates of Confidentiality since 1997 to researchers who request this protection. In 2015, to imporve the efficency of the CoC process, NIH launched an on-line application system for researchers to request a CoC from all the NIH ICs. The system allows researchers to submit an application with all required documentation, track its status and receive automatic email alerts when the status changes. It also allows NIH staff to move the application through each IC’s review and approval process, to generate the Certificate for IC signature, to maintain a record of all CoC requests and to generate basic system metrics.
List of Attachments:
Attachment 1 - NIH Certificate of Confidentiality (CoC) Application form (“Attach 1 CoC online application form (pdf version)
Attachment 2 – List of HHS CoC Coordinators who have been kept informed about the NIH CoC Application System
A.1 Circumstances Making the Collection of Information Necessary
The successful recruitment of human research subjects into NIH funded studies is critical to the success of the agency’s mission to enhance health, lengthen life, and reduce the burdens of illness and disability. However, human research subjects are often concerned about the confidentiality of the information, including biosamples that they provide to researchers. This situation can make it difficult to recruit subjects, particularly for research projects on sensitive topics. Recognizing this problem, in 1970, Congress enacted legislation to permit the Department of Health and Human Services (DHHS) to issue Certificates of Confidentiality (CoCs) to authorize covered researchers to protect the privacy of research subjects by withholding their names and other identifying characteristics from those not connected with the research. The legislation was initially limited to research on the use and effect of drugs. Since then, the scope of the CoC legislation has been expanded several times, most recently in 1988 when it was expanded to include “biomedical, behavioral, clinical, and other research” (see Section 301(d) of the Public Health Service Act, 42 U.S.C. §241(d)). The regulations that describe DHHS implementation of this authority are codified at 42 CFR Part 2a. In 1997, DHHS delegated the authority to issue CoCs to NIH and the other DHHS agencies that fund research. The Director of NIH further delegated this authority within NIH to the individual NIH Institutes and Centers (ICs). NIH’s Office of Extramural Research (OER) is responsible for coordinating this activity across NIH.
The CoC regulations at 42 CFR Part 2a describe the required content of applications to DHHS for CoC protection. In addition, the regulations make clear that DHHS funding is not required to apply for a CoC. Within DHHS, NIH is the main agency that issues CoCs for research projects that are not federally funded; other agencies either only issue CoCs for research they fund or for research that clearly falls within their legislated jurisdiction (FDA). Within NIH, CoC’s are issued by the individual NIH ICs, either for research they fund or for research that is similar to the research an IC supports. With the goal of having a consistent application process across NIH, the Office of Extramural Research at NIH developed an online application system. OMB approval was obtained for this application system in 2014 (OMB No. 0925-0689, expiration 01/31/2017) and the system was launched in early 2015.
In the past, NIH has issued approximately 800-1000 CoCs each year. The new online system launched in 2015 has improved the efficiency of requesting a CoC through the use of a standard, electronic application system that is used by all researchers who wish to obtain a CoC from NIH. This electronic submission system can be accessed through the internet and has benefits for both requestors and NIH staff involved in the issuance of CoCs. Additionally, it has enabled the production of basic program metrics on a routine basis to help ensure efficient service to research organizations seeking this protection. In the FY2016 omnibus bill that funded NIH, Congress included language to require that all new and competing research projects funded by NIH that are designed to ”generate and analyze large volumes of data derived from human research participants” obtain a CoC. NIH is discussing options for implementing this language with HHS officials. For the purposes of this OMB clearance request, NIH estimates this new requirement will increase CoC applications by about 30%.
The information collected via the electronic CoC application system is used by the NIH IC’s to determine eligibility for a CoC and to help create the actual Certificate that will be issued to the requesting organization; see Attachment 1 for a PDF version of current application form. Additionally, the system assists NIH staff with the administrative management of requests, for example, by tracking progress of requests and key dates (receipt of request, issuance of CoC, expiration dates). Additionally, OER uses the data from the system for routine internal program monitoring for NIH. Between the time that OER obtained OMB approval for this application system in January 2014 and its launch in April 2015, OER continued system development, testing, and refinement, developed manuals for users, trained NIH staff in its use, and completely revised our public CoC internet site to guide users in the use of this new system. Between system launch in 2015 and June, 2016, NIH has received 944 applications and issued 872 CoCs in response, figures which are comparable to other years.
The CoC application is electronic; researchers access it from the CoC public internet site (http://grants.nih.gov/grants/policy/coc/ ). The application only requests information that is required by the CoC regulations to determine eligibility for a CoC and enables required documents (such as the signed assurance form) to be uploaded to the application. This system reduces the burden on the investigators by enabling the entire request to be done electronically. Since most NIH research grant applications are submitted electronically and communication between NIH and researchers is done through the NIH electronic research administration (eRA) system, researchers are quite able to use electronic research application and information systems. The system also keeps applicants informed about the status of their request through automatic notifications when applications are received and when NIH has made a determination regarding an application (CoC issued or request denied with explanation for denial); the system also provides a summary listing of all the requestor’s CoC applications at login.
The CoC application information submitted to NIH is maintained on protected NIH servers and will be accessible only to NIH staff involved in CoC administration. Each IC is able to administer permissions to access the system within the IC. Within OER, only the NIH CoC Coordinators have access to the system.
The required Privacy Impact Assessment (PIA) is pending and will be submitted prior to the final OMB approval request.
A.4 Efforts to Identify Duplication and Use of Similar Information
The proposed electronic CoC application is the only CoC application system for researchers applying for a CoC to NIH. NIH issues CoCs for research that is NIH- funded and also for non-federally funded research that is relevant to the mission of DHHS. The CoC-issuing DHHS agencies other than NIH each have their own CoC application processes.
Only small businesses that are conducting research would potentially apply for a CoC. We estimate that 10% of requests to NIH for a CoC will be from small business entities. We only require the minimum amount of information necessary in all CoC applications to make a determination about eligibility. The procedure for and the burden associated with a CoC application for small businesses that are conducting research would be the same as for other research organization that wants to request a CoC from NIH. The impact on small business or other small entities is anticipated to be negligible.
The information collected with the on-line application is a onetime collection to request a CoC for a specific research project. Applications to NIH for a CoC are submitted as necessary to obtain a CoC. There are no application deadlines.
There are no special circumstances related to the electronic CoC application.
8A Federal Register Notice:
An announcement was published in the Federal Register on August 18, 2016 (Document number: 2016-19523, pages 81 FRN 55207-55208) for public comment on the intent to extend this data collection system, thereby providing the research community with the opportunity to provide input into it. No comments were received.
8B Efforts to Consult Outside the Agency:
The status and continued development of the NIH CoC electronic application system has been discussed with the other DHHS agencies which issue CoCs at the regular bi-annual coordinators meeting held since late 2012 (see Attachment 2 for a list of these agency CoC Coordinators with contact information)
Not applicable; we do not pay applicants to apply for a CoC.
No assurance of confidentiality is provided to respondents.
Applicants log into the on-line application system using NIH’s single sign-on (SSO) which allows users to sign on using an Open ID login that they create through either Google or Pay Pal. The users are responsible for managing their login information and resolving any login issues (such as forgotten passwords) either through the Open ID login. Having a secure login service allows applicants to save their application in draft before submission if they desire and also allows them to track the status of applications after submission. After logging in, applicants are able to view a list of prior applications and their statuses (pending NIH review, under review, CoC issued, or CoC request denied). They are also able to start an application for a new CoC request.
The information collected in the NIH CoC electronic application is maintained on a secure NIH sever and requires the use of NIH login for access. The information is only used internally and is controlled via role based access controls (i.e., only IC and OER staff involved in CoC administration have permission to access the application information). Both the NIH COC Coordinator and the IC Coordinator are able to grant access to other IC staff involved in CoC administration system. The same NIH security standards are applied to the CoC application information as to other grant information that NIH maintains.
The application collects only information as required by the authorizing legislation to help NIH determine whether the applicant is eligible for a CoC and for administrative purposes. The information collected related to the PI and requesting institution is information that would be available publicly; there is no sensitive information collected.
We estimate that starting in 2017, NIH will receive approximately1300 new requests for CoCs each year. Based on our experience testing the online system and comments from system users, we estimate that each application takes 90 minutes to complete, including time needed to gather the necessary documents. Based on application submitted between January 1 and March 31, 2016, we estimate that 35% of requests will be from private research institutions and organizations, 5% will be from state/local research institutions/organizations, 10% will be from small business research organizations, and 5% will be from federal research organizations such as the VA.
Regardless of the type of research organization, applications are generally completed by researchers or research staff. The hourly wage rate used for all burden hours ($36) was estimated as an average of the mean hourly wage figures published in May 2015 by the Bureau of Labor Statistics (http://www.bls.gov/oes/current/oes_nat.htm#19-0000 ) for the following occupational categories: life/physical/and social science technicians and research assistants ($23), life scientists ($39), social scientists ($38) and medical scientists ($45)
A.12 - 1 Estimates of Hour Burden
|
||||
Type of Respondents |
Number of Respondents |
Frequency of Response |
Average Time per Response |
Annual Hour Burden |
CoC Applicants- Private |
455 |
1 |
90/60 |
683 |
CoC Applicants- State/local |
650 |
1 |
90/60 |
975 |
CoC Applicants- Small business |
130 |
1 |
90/60 |
195 |
CoC Applicants- Federal |
65 |
1 |
90/60 |
98 |
Total |
1,300 |
1300 |
|
1951 |
A.12 - 2 Annualized Cost To Respondents*
Type of Respondents |
Number of Respondents |
Frequency of Response |
Average Time per Respondents |
Hourly Wage Rate* |
Respondent Cost |
Researcher |
1300 |
1 |
90/60 |
$36 |
$70,200 |
*source: May 2015 Bureau of Labor Statistics (http://www.bls.gov/oes/current/oes_nat.htm#19-0000)
There are no special requirements for using the online CoC application system beyond internet access. Thus, there are no other costs to users.
A.14. Annualized Cost to the Federal Government
Cost Descriptions |
Grade/Step |
Annual Salary |
% of Effort |
Fringe (if applicable) |
Total Cost to Gov’t |
Federal Oversight |
|
|
|
|
|
NIH Extramural CoC Coordinator |
GS 15-9 |
$158,700 |
10 |
|
$15,870 |
|
|
|
|
|
|
|
|
|
|
|
|
Contractor Cost |
|
|
|
|
$22,000 |
|
|
|
|
|
|
Travel |
|
|
|
|
|
Other Cost (NIH IT security scan) |
|
|
|
|
$5000 |
|
|
|
|
|
|
TOTAL |
|
|
|
|
$42,870 |
The total costs to the Federal Government for the next three years of the CoC electronic application system is $128,620. This includes the costs of correction of minor system problems ($10,000 per year) and annual maintenance costs ($12,000 per year), annual NIH IT security assessment costs ($5,000 per year), and 10% annually of a GS15-9 FTE for oversight ($15,870 per year). The average annual cost for the 3-year period is $42,870.
There are no changes planned to the system for the next 3 years. This extension clearance is being submitted as an adjustment. Total burden hours have increased from the last submission due to the overall increase in the number of applications anticipated.
NIH will only use the application information to tabulate internal statistics for administrative purposes only. No publications of this information are planned.
A.16 - 1 Project Time Schedule
|
|
Activity |
Time Schedule |
Continue to make researchers aware of on-line application system for all CoC requests to NIH |
ongoing |
Continue to enable system access for researchers who wish to request a CoC |
ongoing |
Monitor system and correct any unrecognized system errors |
ongoing |
Tabulate annual system administrative metrics for internal NIH use |
annually |
Not Applicable; we are not seeking a waiver of this requirement.
This is not applicable to our request.
| File Type | application/msword |
| File Title | Supporting Statement 'A' Preparation - 04/05/2011 |
| Subject | Supporting Statement 'A' Preparation - 04/05/2011 |
| Author | OD/USER |
| Last Modified By | Abdelmouti, Tawanda (NIH/OD) [E] |
| File Modified | 2016-10-26 |
| File Created | 2016-10-12 |