Methodological Approaches for Whole Person Research

Request for Approval under the “Conference, Meeting, Workshop, and Poster Session Registration Generic Clearance (OD)”

(OMB#: 0925-0740 Exp Date: 07/31/2022)

TITLE OF INFORMATION COLLECTION: Methodological Approaches for Whole Person Research (NCCIH)

PURPOSE:

This workshop will focus on the methods needed for rigorous research on interconnected systems, multicomponent interventions, and multisystem or multiorgan outcomes. The goal is to identify research methods from other fields that can be applied to whole person research, as well as gaps, opportunities, and needs that could be met via new research. Invited speakers will discuss study design and methodological challenges for whole person research.

DESCRIPTION OF RESPONDENTS:

Basic and clinical researchers, members of the public, advocates, policymakers, journalists, NIH Employees, and other interested parties.

TYPE OF COLLECTION: (Check one)

[ ] Abstract [ ] Application

[X] Registration Form [ ] Other: ______________________

CERTIFICATION:

I certify the following to be true:

1. The collection is voluntary.

2. The collection is low-burden for respondents and low-cost for the Federal Government.

3. The collection is non-controversial and does not raise issues of concern to other federal agencies.

Name:

Wen Chen, Ph.D., Branch Chief and Program Director, Basic and Mechanistic Research in Complementary and Integrative Health Branch, NCCIH

To assist review, please provide answers to the following question:

Personally Identifiable Information:

1. Is personally identifiable information (PII) collected? [X] Yes [ ] No

2. If Yes, is the information that will be collected included in records that are subject to the Privacy Act of 1974? [X] Yes [ ] No

Gifts or Payments:

Is an incentive (e.g., money or reimbursement of expenses, token of appreciation) provided to participants? [ ] Yes [X] No

Amount: _________

Explanation for incentive: (include number of visits, etc)

ESTIMATED BURDEN HOURS and COSTS

Category of Respondent	No. of Respondents	No. of Responses per Respondent	Time per Response (in hours)	Total Burden Hours
Individuals (Registration)	500	1	10/60	83
Totals		500		83

Category of Respondent	Total Burden Hours	Hourly Wage Rate*	Total Burden Cost
Individuals	83	$48.45	$4,021.35
Total			$4,021.35

*Source of the mean Hourly Wage Rate is provided by the Bureau of Labor Statistics, Occupation title “Medical Scientists” 19-1040 https://www.bls.gov/oes/2020/May/oes_nat.htm#00-0000

FEDERAL COST: The estimated annual cost to the Federal government is $1,725.00

Staff	Grade/Step	Salary**	% of Effort	Fringe (if applicable)	Total Cost to Gov’t
Federal Oversight
Program Director	GS15-7	$172,500	1%		$1,725.00
Contractor Cost
Travel
Other Cost
Total					$1,725.00

**The salary in the table above is cited from https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/21Tables/html/DCB.aspx

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions:

N/A

The selection of your targeted respondents

Do you have a customer list or something similar that defines the universe of potential respondents and do you have a sampling plan for selecting from this universe? [] Yes [X] No

If the answer is yes, please provide a description of both below (or attach the sampling plan)?

If the answer is no, please provide a description of how you plan to identify your potential group of respondents and how you will select them?

We will promote the meeting through the NCCIH public website, NCCIH communication channels, and third-party organizations such as professional associations and research societies who are interested in whole person research. We will contact individual researchers interested in this topic as identified through NIH databases.

Administration of the Instrument

How will you collect the information? (Check all that apply)

[X] Web-based or other forms of Social Media

[ ] Telephone

[ ] In-person

[ ] Mail

[ ] Survey Form

[ ] Chart Abstraction

[ ] Other, Explain

Will interviewers, facilitators, or research coordinators be used?

[ ] Yes [X] No

Please make sure that all instruments, instructions, and scripts are submitted with the request.

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