Supporting Statement A for
Application and Impact of Online Clinical Research Training Programs on Healthcare Professionals in Industry, Academia, and Clinical Research, Office of Clinical Research Education and Collaboration Outreach, OIR, NIH
OMB # 0925-0764 [Exp. 02/28/2026]
Date: May 2024
Check off which applies:
New
Revision
Reinstatement with Change
Reinstatement without Change
Extension
Emergency
Existing
Contact: Rebecca Hwang
Address: 1 Center Drive/208A
Bethesda, MD 20892-0155
Telephone:
Fax:
Email: [email protected]
Table of contents
A. ABSTRACT 4
A.1 Circumstances Making the Collection of Information Necessary 4
A.2 Purpose and Use of the Information Collection 5
A.3 Use of Information Technology and Burden Reduction 7
A.4 Efforts to Identify Duplication and Use of Similar Information 7
A.5 Impact on Small Businesses or Other Small Entities 8
A.6 Consequences of Collecting the Information Less Frequently 8
A.7 Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 8
A.8 Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agency 8
A.9 Explanation of Any Payment of Gift to Respondents 8
A.10 Assurance of Confidentiality Provided to Respondents 8
A.11 Justification for Sensitive Questions 9
A.12 Estimates of Hour Burden Including Annualized Hourly Costs 9
A.13 Estimate of Other Total Annual Cost Burden to Respondents or Record
keepers 11
A.14 Annualized Cost to the Federal Government 11
A.15 Explanation for Program Changes or Adjustments 12
A.16 Plans for Tabulation and Publication and Project Time Schedule 12
A.17 Reason(s) Display of OMB Expiration Date is Inappropriate 12
A.18 Exceptions to Certification for Paperwork Reduction Act Submissions 12
List of Attachments:
Attachment 1: Titled ‘OCRECO Learning Portal Registration’
Attachment 2: Titled ‘IPPCR Lecture Evaluation’
Attachment 3: Titled ‘PCP Lecture Evaluation’
Attachment 4: Titled ‘IPPCR Final Course Evaluation’
Attachment 5: Titled ‘PCP Final Course Evaluation’
Attachment 6: Titled ‘NIH Summer Course in Clinical and Translational Research Course Evaluation’
Attachment 7: Titled ‘Sabbatical in Clinical Research Management Course Evaluation’
Attachment 8: Titled ‘Ethical and Regulatory Aspects of Clinical Research (Asynchronous/Online) Final Course Evaluation’
Attachment 9: Titled ‘Privacy Act Memo’
Attachment 10: Titled ‘PIA form for OCRECO’
Abstract
The request for a revision under the existing clearance number 0925-0764 for information collection will continue to allow the assessment of the long-term impact and outcomes of clinical research training programs provided by the Office of Clinical Research Education and Collaboration Outreach (OCRECO), located in the NIH Office of Intramural Research on an annual basis. This revision request will also allow for the addition of a new clinical research training course to be delivered online through the same online learning management system as the other courses. The clinical research training programs include: the Introduction to the Principles and Practice of Clinical Research and Principles of Clinical Pharmacology, Sabbatical in Clinical Research Management, the NIH Summer Course in Clinical and Translational Research, and the new course, the Ethical and Regulatory Aspects of Clinical Research Course (Asynchronous/Online). Please note that the Office of Clinical Research Education and Collaboration Outreach (OCRECO) was formerly titled the Office of Clinical Research, until March 2023 with the change of office leadership.
The purpose of this revision is to continue to assess the satisfaction, applicability and impact these NIH training programs have on the short- and long-term outcomes of their graduates. As the unifying office for clinical research education at NIH, it remains incumbent upon the NIH Office of Clinical Research Education and Collaboration Outreach to assess and modify, as appropriate, its program offerings based upon trainee feedback.
A.1 Circumstances Making the Collection of Information Necessary
This survey helps fulfill the requirements of:
The March 3, 1998, White House Memorandum, “Conducting Conversations with America to Further Improve Customer Service,’ which directs Agencies to determine the kind and quality of service its customers want as well as their level of satisfaction with existing services.
This survey supports the Office of Clinical Research Education and Collaboration Outreach’s fulfillment of the mission of NIH, which is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. The goals of this agency are:
to foster fundamental creative discoveries, innovative research strategies, and their applications as a basis for ultimately protecting and improving health;
to develop, maintain, and renew scientific human and physical resources that will ensure the Nation's capability to prevent disease;
to expand the knowledge base in medical and associated sciences in order to enhance the Nation's economic well-being and ensure a continued high return on the public investment in research; and
to exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science.
Additionally, the mission of the Office of Clinical Research Education and Collaboration Outreach in the Office of Intramural Research is to facilitate the vision of excellence in clinical research at the NIH through the development of training and collaborations that optimize resource utilization and facilitate partnerships between the intramural and extramural communities. To fulfill this mission, the office provides a portfolio of clinical research training which include the following:
Introduction to the Principles and Practice of Clinical Research (IPPCR)
Principles of Clinical Pharmacology Course (PCP)
NIH Summer course in Clinical and Translational Research
Sabbatical in Clinical Research Management
Ethical and Regulatory Aspects of Clinical Research Course (Asynchronous/Online)
The information collected will allow the Office of Clinical Research Education and Collaboration Outreach to continue to assess the value of the training provided by the Office of Clinical Research Education and Collaboration Outreach on an annual basis, and the extent to which this training promotes research productivity. Under the existing OMB clearance number, successful information collection continued for 4 courses through 7 surveys. Due to the addition of a new course and a corresponding survey, there are now 5 courses using 8 surveys included in this revision request for approval. The information collection would begin September 1, 2024 and end August 1, 2025, and continue to be offered on an annual basis from September through August of each course year. The 8 surveys that are attached for review consist of the following: an OCRECO Portal Registration, IPPCR Final course evaluation, IPPCR lecture evaluation, PCP final course evaluation, PCP lecture evaluation, NIH Summer Course in Clinical and Translational Research course evaluation, the Sabbatical in Clinical Research Management course evaluations, and the new Ethical and Regulatory Aspects of Clinical Research (Asynchronous/Online) final course evaluation. These surveys will provide registration and impact metrics for the portfolio of clinical research training programs in the Office of Clinical Research Education and Collaboration Outreach. The data received from these surveys will continue to be presented to the training directors of the surveyed programs on a weekly and quarterly basis throughout the course year. Below are descriptions for each of the 5 training programs and the surveys that correspond with the potential respondents of each course.
This request for a revision under the existing clearance number will continue to allow the administration of 8 surveys: registration, post-completion, lecture evaluations for the Introduction to the Principles and Practice of Clinical Research course, the Principles of Clinical Pharmacology course, Sabbatical in Clinical Research Management, the NIH Summer Course in Clinical and Translational Research course, and the Ethical and Regulatory Aspects of Clinical Research Course (Asynchronous/Online). Information needs to continue to be collected through these surveys to streamline the evaluation process for all of these training programs and capture additional data for more meaningful and effective program outcome evaluations.
The Introduction to the Principles and Practice of Clinical Research course was developed initially for individuals currently working at NIH and who were engaged, or planning to become engaged, in clinical or translational research and wishing to acquire in-depth knowledge of clinical trial design, ethical concerns and human subject protection requirements, regulatory aspects of clinical research and the investigational new drug application (IND) process, including responsibilities of the clinical investigator. The course has expanded and is offered to qualified health professionals at extramural domestic and international sites who enroll and participate in the lectures and presentations through distance learning technologies.
II. Principles of Clinical Pharmacology Course (PCP) [Attachments 1, 3, 5]
This course is an online lecture series covering the fundamentals of clinical pharmacology as a translational scientific discipline focused on rational drug development and utilization in therapeutics. The course focuses on the following core principles of pharmacology: pharmacokinetics; drug metabolism and transport; drug therapy in special populations; assessment of drug effects; drug discovery and development; pharmacogenomics and pharmacotherapy. This course is offered to meet the needs of researchers with an interest in the pharmacologic aspects of contemporary clinical drug development and utilization.
III. NIH Summer Course in Clinical and Translational Research [Attachments 1 and 6]
The NIH Summer Course in Clinical and Translational Research is a two-week intensive introductory course offered by the NIH Office of Clinical Research Education and Collaboration Outreach. The purpose of the course is to demonstrate the role of PhD scientists in clinical and translational research, provide an overview and examples of how basic science and clinical observations lead to translational research, and increase awareness and access to PhD role models, research resources, and potential career opportunities at the NIH.
IV. Sabbatical in Clinical Research Management [Attachments 1 and 7]
The Sabbatical in Clinical Research Management at the National Institutes of Health is a 4- to 8-week independent study for clinical research investigators and managers of clinical research programs. While on approved sabbatical from their place of employment, participants are connected with NIH experts to learn best practices and develop new solutions to manage a clinical research enterprise. Sabbatical participants do not engage in clinical research at the NIH.
V. Ethical and Regulatory Aspects of Clinical Research [Attachments 1 and 8]
The Ethical and Regulatory Aspects of Clinical Research (Asynchronous/Online) course is a new online course recently developed in partnership with the NIH Clinical Center’s Bioethics Department to teach the ethics of clinical research with human subjects to participants external to the NIH. Course objectives include and are not limited to: utilizing a systematic framework for evaluating the ethics of a clinical research protocol, identifying, defining and considering ethical issues in the conduct of human subject research, applying appropriate codes and regulations governing the ethical conduct of human subject research to one’s own research, and appreciating ethical challenges with conducting international collaborative research in low- and middle-income countries.
All information will continue to be collected electronically to minimize participant time and survey burden. See Attachment 10, a Privacy Impact Assessment by the NIH Center for Information Technology Business Application Systems Division (CIT BAS), the Office of the Director Privacy Officer, and the Office of the Director Information Systems Security Officer (ISSO).
Currently there are no other similar efforts underway at the NIH to prospectively track and assess the outcomes of its clinical research trainees and their accomplishments in fulfillment of the Office of Clinical Research Education and Collaboration Outreach training mission.
The respondents are primarily physicians, dentists, medical scientists, and medical, PhD, pharmacy, nursing, and dental students. The impact of the survey on respondents is minimal because the format for submission of the information is electronic.
These surveys are distributed annually, and not more frequently, to program participants. Less frequent distribution would not permit meaningful longitudinal assessment and validation of program quality and effectiveness in accordance with the training mission of the NIH Office of Clinical Research Education and Collaboration Outreach since these courses are offered on an annual basis.
The proposed data collection is consistent with 5 CFR 1320.5
Notice was published in the Federal Register, July 31, 2023, Volume 88, pages 49472-49473. No public comments received.
No consultation with persons outside the agency was necessary to create or develop the content of any of the surveys referenced herein.
No incentives are offered. Neither payment nor gifts are given to respondents.
The system requirements for personally identifiable information to be private under the Privacy Act are identified, reviewed, and approved by the OD Information Systems Security Officer (OD/ISSO); see attachment 9, Privacy Act Memo. Additionally, a Privacy Impact Analysis (PIA) was performed in May 2022; please see attachment 10, PIA form for OCRECO. NIH Privacy Act Systems of Record Notice (SORN) 09-25-0014 entitled Clinical Research: Student Records, HHS/NIH/OD/OIR/OE was last published in the Federal Register, Vol. 67, No. 187/ September 26, 2002, Pages 60741-60794.
Sensitive questions are not relevant to course or training program assessment and are not asked.
A.12.1 Estimates of Hour Burden Including Annualized Hourly Costs
Based on Office of Clinical Research Education and Collaboration Outreach program participation data for calendar year 2023, the estimated number of respondents per year to all surveys included in this request is around approximately 21,290.
The annual burden hours for this request for revision were calculated using a maximum time allotment of 5 minutes for completion of each survey. The estimated total burden hours requested, therefore, is 1,773.
A.12-1: ESTIMATES OF HOUR BURDEN BY RESPONDENT TYPE
Form Name |
Type of Respondents |
Estimated Number of Respondents |
Number of Responses per Respondent |
Average Burden Per Response (in hours) |
Total Annual Burden Hours |
OCRECO Learning Portal Registration (Attachment 1) |
Healthcare Professionals |
2000 |
1 |
5/60 |
167 |
Students |
2000 |
1 |
5/60 |
167 |
|
General Public |
1000 |
1 |
5/60 |
83 |
|
IPPCR Lecture Evaluation (Attachment 2) |
Healthcare Professionals |
1000 |
1 |
5/60 |
83 |
Students |
2000 |
1 |
5/60 |
167 |
|
General Public |
1000 |
1 |
5/60 |
83 |
|
IPPCR Final Course Evaluation (Attachment 4) |
Healthcare Professionals |
1000 |
1 |
5/60 |
83 |
Students |
2000 |
1 |
5/60 |
167 |
|
General Public |
1000 |
1 |
5/60 |
83 |
|
PCP Lecture Evaluation (Attachment 3) |
Healthcare Professionals |
1000 |
1 |
5/60 |
83 |
Students |
2000 |
1 |
5/60 |
167 |
|
General Public |
1000 |
1 |
5/60 |
83 |
|
PCP Final Course Evaluation (Attachment 5) |
Healthcare Professionals |
1000 |
1 |
5/60 |
83 |
Students |
2000 |
1 |
5/60 |
167 |
|
General Public |
1000 |
1 |
5/60 |
83 |
|
NIH Summer Course in Clinical and Translational Research Course Evaluation (Attachment 6) |
Healthcare Professionals |
20 |
1 |
5/60 |
2 |
Sabbatical in Clinical Research Management Course Evaluation (Attachment 7) |
Healthcare Professionals |
20 |
1 |
5/60 |
2 |
Ethical and Regulatory Aspects of Clinical Research (Asynchronous/Online) Course (Attachment 8) |
Healthcare Professionals |
100 |
1 |
5/60 |
8 |
Students |
50 |
1 |
5/60 |
4 |
|
General Public |
100 |
1 |
5/60 |
8 |
|
|
Total |
|
21,290 |
……………………… |
1,774 |
A.12-2: ANNUALIZED COST TO RESPONDENTS
Type of Respondents |
Total Annual Burden Hours |
Hourly Respondent Wage Rate |
Respondent |
Cost |
|||
Healthcare Professionals |
511 |
$61.16 |
$31,252.76 |
Students |
839 |
$18.32 |
$15,370.48 |
General Public |
423 |
$40.72 |
$17,224.56 |
Totals |
1,773 |
………… |
$63,847.80 |
The annualized cost to respondents in table A.12-2 was calculated using median weekly wage data from the 2023 Current Population Survey obtained from the Bureau of Labor Statistics [BLS] (https://www.bls.gov/cps/cpsaat39.pdf), and annual student stipend data obtained from the pre-doctoral NIH IRTA and Visiting Fellows reflecting the 2023 NIH pre-doctoral stipend levels for graduate students “Individual Households” (see: https://policymanual.nih.gov/2300-320-7#D31625E0. Hourly wages were calculated assuming a 40-hour work week. Doctoral level respondents, “Healthcare Professionals,” included the following categories from the BLS Current Population Survey: physicians, pharmacists, dentists, and medical scientists. “General Public” included the following categories from the BLS Current Population Survey: nurses, nurse practitioners, and physician assistants. Wages included for each category of respondents in this table were calculated as averages for the aggregate respondents listed above based on data from the 2023 Current Population Survey obtained from the Bureau of Labor Statistics (https://www.bls.gov/cps/cpsaat39.pdf).
Not applicable.
Cost Descriptions |
Grade/Step |
Salary |
% of Effort |
Fringe (if applicable) |
Total Cost to Gov’t |
Federal Oversight – Program Manager |
13/3 |
125,827 |
20% |
|
$25,165.40 |
Contractor costs – NIH CIT BAS technology fees, on-line survey maintenance and distribution costs, and data analysis costs |
|
|
|
|
$27,000
|
Travel |
|
|
|
|
$0 |
Other Cost |
|
|
|
|
$0 |
Total |
|
|
|
|
$52,165.40 |
*The salary in table above is cited from https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/24Tables/html/DCB.aspx
Survey instruments included in this revision request have revised survey questions as well as a new survey altogether to account for the addition of a new clinical research training course, the Ethical and Regulatory Aspects of Clinical Research (Asynchronous/Online) course. The total estimated number of respondents per year to all surveys included in this request is less than the previous number cited in the extension request (22,040 respondents) based on 2023 program data. The maximum time allotment for completion of each survey was also changed from 10 minutes to 5 minutes. The estimated total burden hours requested in this current revision is 1,774 as opposed to the estimation of 3,674 burden hours in the previous extension request.
Survey results are tabulated only for the NIH Office of Clinical Research Education and Collaboration Outreach’s (OCRECO) internal use in assessing training program or course effectiveness. There are no plans at this time for statistical analysis in publications.
The schedule going forward will be as follows:
A.16 - 1 Project Time Schedule
|
|
Activity |
Time Schedule |
Open surveys on course portal |
1 week after OMB approval* |
Survey notification sent electronically to respondents through course portal |
September to the next August of each calendar year |
Data Analysis |
Weekly and every 3 months during course year |
Office of Clinical Research Education and Collaboration Outreach Program Evaluation Review |
September to the next August of each calendar year |
OMB# and expiration will be displayed.
No exceptions are requested.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | Supporting Statement 'A' Preparation - 05/01/2008 |
| Subject | Supporting Statement 'A' Preparation - 05/01/2008 |
| Author | OD/USER |
| File Modified | 0000-00-00 |
| File Created | 2024-08-01 |