Supporting Statement A for
Impact of Clinical Research Training and Medical Education at the Clinical Center on Physician Careers in Academia and Clinical Research
Date
Contact: Linda Wisniewski
Address: 10 Center Drive/1N252B
Bethesda, MD 20892-1352
Telephone: 301-402-4843
Fax: 301-435-5275
Email: [email protected]
Table of contents
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
List of Attachments:
Attachment 1: Titled ‘Attach 1’: Part 1
Attachment 2: Titled ‘Attach 2’: Part 2
Attachment 3: Titled ‘Attach 3’: Physician and Student Survey, Draft
Attachment 4: Titled ‘Attach 4’: Physician Survey, Draft
Attachment 5: Titled ‘Attach 5’: Physician, Nurse, and Other Survey, Draft
A.1 Circumstances Making the Collection of Information Necessary
This survey will help 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.
Need:
The mission of the NIH Clinical Center is:
As the nation’s clinical research center, the NIH Clinical Center is dedicated to improving human health by providing an outstanding environment that facilitates:
Development of diagnostic and therapeutic interventions
Training of clinical researchers
Development of processes to ensure the safe, efficient, and ethical conduct of clinical research…
To accomplish the mission of ‘Training of clinical researchers”, the Office of Clinical Research Training and Medical Education (OCRTME) develops, administers, and evaluates a comprehensive portfolio of clinical research training and medical education initiatives, including:
Clinical Electives Program (CEP)
Clinical Pharmacology Research Associate Training (ClinPRAT)
Clinical Research Curriculum Certificate (CRCC)
Graduate Medical Education (GME)
NIH-Duke Training Program in Clinical Research (NIH-DUKE)
Principles of Clinical Pharmacology Course (PCP)
Resident Electives Program (REP)
These programs and services are aimed at educating about and improving the conduct of clinical and translational research.
The purpose of the survey is to gather information regarding the long-term outcomes of the programs that the particular individual has participated in. The Clinical Center is the nation’s largest hospital dedicated to clinical research. As the Clinical Center’s central office of clinical research training and medical education, it is incumbent upon the office to re-adjust and refine the content of the programs so that they have an appropriate impact on the physicians that are trained and ultimately, the patient care that they deliver. Currently, there are no long-term consistent data collection projects regarding the outcomes of physician education.
The information that is collected is aimed at assessing the value of our program to former trainees and the extent to which they continue to be engaged in clinical research as they advance in their careers in academia, government agencies, or pharmaceutical industry. The information is shared with the Office of Clinical Research Training and Education office Director, and the Clinical Center Director. Programs that will be included in the survey include participants from those listed below.
The information collected from each of the program’s participants will be the tool to determine the outcome assessment as identified above and the results will be used to determine if any modifications to programs would be needed to improve the education and competency of the participants.
The Clinical Research Curriculum Certificate (CRCC) program was developed for individuals currently 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, and responsibilities of the clinical investigator.
The Accreditation Council for Graduate Medical Education is a private, non-profit council that evaluates and accredits medical residency programs in the United States. The mission of the ACGME is to improve health care by assessing and advancing the quality of resident physicians’ education through accreditation.
The Accreditation Council for Graduate Medical Education (ACGME) is responsible for the Accreditation of post-MD medical training programs within the United States. Accreditation is accomplished through a peer review process and is based upon established standards and guidelines. The ACGME is a nationally recognized organization within the nation’s medical education community.
NIH-Duke Training Program in Clinical Research (NIH-DUKE)
This collaborative training program between the NIH Clinical Center and the Duke University School of Medicine provides formalized academic training in the quantitative and methodological principles of clinical research for health professionals at the NIH. Designed primarily for physicians who are training for careers in clinical research, the program offers formal courses in research design, research management, medical genomics, and statistical analysis.
Principles of Clinical Pharmacology Course (PCP)
Because most medical schools lack a formal course in clinical pharmacology, and physicians, pharmacists, and other scientists in training may not have access to a formal educational curriculum in this discipline, this course was designed to assist interested individuals who are preparing to take the certifying examinations of the American Board of Clinical Pharmacology. Likewise, this course is offered to meet the needs of researchers with an interest in the clinical pharmacologic aspects of contemporary drug development and utilization.
Resident Electives Program (REP)
Our elective rotations offer residents or clinical fellows the opportunity to have direct experience in the care of patients enrolled in investigational protocols in the disciplines of allergy and immunology, anatomic pathology, critical care medicine/internal medicine, hematopathology, infectious diseases, medical genetics, and transfusion medicine. Participants will have first-hand exposure to the design, conduct, and management of clinical trials.
All information will be collected electronically which will minimize time and permit electronic submission of responses. The decision to use electronic submission was based on the minimal time required by the respondent and the ease of collection of data. A Systems of Record Notice (SORN) is in the process of being conducted with the Clinical Center Privacy Officer (Jerry King) and a Privacy Impact Assessment request has been made of the Clinical Center Privacy Officer (Jerry King) and the Clinical Center Information Systems Security Officer (ISSO) (John Franco).
Currently there is no similar information regarding the impact of clinical research training on participants academic or clinical research careers.
The respondents are primarily physicians, dentists, medical students, and dental students. The impact is expected to be minimal because the format for submission of the information will be electronic.
The collection of the information will help determine if the education provided to the participant has impacted the further development of clinical research or their academic careers. The National Institutes of Health has as a part of its mission and goals 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. Thus, the effectiveness of the training of clinical researchers is key to accomplishing the mission and achieving the goals.
To reduce the burden of the collection of data, an electronic system will be used to minimize paper and time burden on the public. Additionally, a request will be made of the respondents to update their information as their professional career status changes.
The proposed data collection is consistent with 5 CFR 1320.5
This is not a research project. Therefore, no consultation with persons outside the agency has been made. However, the directors of the affected NIH programs have been consulted as to what metrics would be appropriate to determine the effectiveness and impact of the clinical research training experience of the individuals involved.
Federal Register, Volume 74, No. 1/Friday, January 2, 2009, page 112.
No comments were generated from the Federal Register Notice.
There will be no payment or gifts given to respondents.
The Performance Work Statement for the contractors that will be hosting the database has included the NIH contract requirements for personally identifiable information as identified by the Clinical Center Information Systems Security Officer (CC/ISSO). Additionally, the Performance Work Statement and the contractor proposal will be reviewed and approved by the CC/ISSO.
No sensitive questions will be asked.
A.12 Estimates of Hour Burden Including Annualized Hourly Costs
Approximate number of respondents per year will be 825.
Frequency of response will be once a year, once, or when professional status changes.
Annual burden hours was calculated at 412. This was calculated using one-half hour for each response.
Type of Respondents |
Estimated Number of Respondents |
Estimated Number of Responses per Respondent |
Average Burden Hours Per Response |
Estimated Total Annual Burden Hours Requested |
Doctoral Level |
625 |
1 |
0.5 |
312.5 |
Students |
100 |
1 |
0.5 |
50 |
Nurses |
100 |
1 |
0.5 |
50 |
Total |
……………………… |
……………………… |
……………………… |
412.5 |
Type of Respondents |
Number of Respondents |
Frequency of Response |
Average Time per Respondents |
Hourly Wage Rate |
Respondent |
Cost |
|||||
|
625 |
1 |
0.5 |
$75.00 |
$662.50 |
Doctoral Level |
|||||
|
100 |
1 |
0.5 |
N/A |
$0.00 |
Students |
|||||
|
100 |
1 |
0.5 |
$50.00 |
$125.00 |
Nurses |
|||||
Totals |
825 |
|
|
|
$787.50 |
A system of collection currently in use will be used. No additional charges are expected as there is no modification to the system required.
Costs to government |
|
|
|
|
|
|
|
Item |
Cost per unit |
# of units |
Cost per item |
Salary for design time (unit=hour) |
$50 |
10 |
$500 |
Evaluation (unit=hour) |
$50 |
3 |
$150 |
Electronic Maintenance (yearly fee) |
$1,000 |
1 |
$1,000 |
Total costs |
|
|
$1,650 |
This is new collection of information.
There are no plans at this time for statistical analysis in publications.
A.16 - 1 Project Time Schedule
|
|
Activity |
Time Schedule |
Email sent to respondents |
1 - 2 months after OMB approval |
OMB# and expiration will be displayed.
No exceptions are requested.
| File Type | application/msword |
| File Title | Supporting Statement 'A' Preparation - 05/01/2008 |
| Subject | Supporting Statement 'A' Preparation - 05/01/2008 |
| Author | OD/USER |
| Last Modified By | curriem |
| File Modified | 2009-04-29 |
| File Created | 2009-04-28 |