#3_Justif Memo_Self-Affirm7_17_2012

Date: July 16, 2012

To: Office of Management and Budget (OMB)

Through: Keith Tucker, Report Clearance Officer, HHS

Seleda Perryman, Program Clearance Officer, NIH

Vivian Horovitch-Kelley, PRA OMB Project Clearance Liaison, NCI

From: Rebecca Ferrer, Health Scientist Administrator

Division of Cancer Control and Population Sciences

National Cancer Institute (NCI)/NIH

Subject: Generic Sub-study, Self-Affirmation and Affect REVISED under “A Generic Submission for Theory Development and Validation (NCI),” (OMB No. 0925-0645, Expiry Date 12/31/2014)

Background/ Need and Use for Information

This information collection is identical to previously approved sub-study #1, on 3/30/2012, under the same generic clearance except for the request to add 250 more participants. Funds have become available to add 250 individuals to the survey and thus the reason for this “revised” sub-study request. All other components of this request remain the same as previously submitted.

This sub-study involves refining and validating a theory regarding the role of the self and affective experiences in responding to health communications about alcohol use. Using several survey conditions, a survey will be administered (Attachment 3A and 3B) that helps to refine a preliminary theory¹ concerning the role of self-affirmation – affirming one’s self value – and recall of affective experiences in responding to health communications. This will be the first survey to attempt to refine and validate a theoretical framework that best predicts responses.

The National Cancer Institute’s (NCI) Behavioral Research Program (BRP) is within the Division of Cancer Control and Population Sciences (DCCPS). BRP initiates, supports, and evaluates a comprehensive program of research ranging from basic behavioral research to the development, testing, and dissemination of interventions in areas such as tobacco use, screening, dietary behavior, and sun protection. The goal of BRP is to increase the breadth, depth, and quality of behavioral research in cancer prevention and control. BRP conducts varying programs of formative research to develop and validate cancer-related behavioral theories. This NCI office is requesting that OMB review this sub-study, which describes a voluntary, low-burden, non-controversial, formative behavioral research project related to theory development and validation. Data collection for this project is authorized under 42 USC § 285 and 285a-1 (Section 410 and 412 of the Public Health Service Act).

This data is collected through the TESS project, an opportunity for researchers to collect free data to examine psychological theories and hypotheses. A proposal was submitted for this study to TESS, and it was peer-reviewed by two reviewers, who recommended that it be accepted for fielding. Thus, data has been collected free of charge. TESS fields research through Knowledge Networks, an internet survey company.

Self-Affirmation, Affective Experiences, and Alcohol Intentions

It is predicted that self-affirmation – or bolstering one’s sense of self-value – is associated with greater acceptance of a health message about the link between alcohol and breast cancer, in that women who self-affirm will have greater risk perceptions related to breast cancer and alcohol, and greater intentions to reduce alcohol consumption. However, it is predicted that the link between self-affirmation and alcohol-related risk perceptions and intentions will depend on whether women recalled an affectively-charged autobiographical experience prior to the affirmation. Specifically, it is predicted that individuals charged with recalling a happy or angry experience will benefit most from self-affirmation, compared to those charged with recalling a neutral, hopeful, or sad experience. Examining this hypothesis would allow the theoretical framework to be refined and validated, and would set the stage for applied research examining real-world implications.

Selected Readings

For selected readings on self-affirmation, affect and alcohol intentions, see Attachment 3C.

Participants, Methodology, and Research Instrument

OMB had previously approved 800 participants. Now this request is to add an additional 250 women aged 18 or older who reported having consumed one alcoholic drink in the past month. Internal funding has become available to add 250 participants, which will increase our likelihood of correctly identifying patterns in the data that would support or disprove our theory-driven hypotheses. Individuals will be drawn from a Knowledge Networks internet panel, and will be paid a maximum of $10 for completing this survey. They are also compensated $4-6 per month for being on the internet panel. The survey (Attachment 3A) will be fielded entirely online (screenshots, Attachment 3B). Information will be kept secure to the extent permitted by law. Analyses will not yield results that can be generalized to the overall population.

Analyses will involve examining correlations and interactions among self-affirmation, recall of affective experiences, feelings of risk, affective responses to risk, and intentions to reduce alcohol consumption. Findings will be disseminated to relevant audiences –health psychologists/ public health researchers who capitalize on basic psychological science advances to develop efficacious health communications and interventions, and basic psychological scientists who study self-affirmation and affective experiences. We plan to disseminate findings at psychology or behavioral medicine conferences (Spring 2013), and hope to publish findings in specialized professional psychology, behavioral medicine, or judgment and decision-making journals (Summer 2013).

Other Considerations

An amendment to the previously approved IRB protocol (Attachment 3D) to support data collection for participants requested in the current sub-study #3, has been submitted to the NCI SSIRB on July 13, 2012.

Burden

A total of 1,050 participants will complete the survey; 800 that were previously approved, and 250 additional respondents for this request. For this request, the total burden is estimated to be 125 additional burden hours (525 total burden hours). To date, a total of 400 burden hours have been used of the 6,000 hours that were requested (counting towards the 525 total burden hours for this study). Estimated cost to the Federal Government, beyond cost specified for sub-study #1, is $0 for staff (staff time will not increase from estimated time specified in sub-study #1 ), and $2700 paid to Knowledge Networks for an additional 250 participants (paid from Behavioral Research Program in-house budget).

Estimates of Burden Hours
Types of Respondents	Instrument	Number of Respondents	Frequency of Response	Average Time Per Response (Hours)	Total Hour Burden
General Public	Survey (Attachment A)	250	1	30/60	125
General Public	Survey (Attachment A)	800 (previously approved)	1	30/60	400 (previously approved)
Total		1,050			525

List of Attachments

3A: Survey Instrument

3B: Survey Screenshots

3C: Selected Readings

3D: IRB Approval for Sub-study #1

1 Ferrer, R. A., Shmueli, D., Bergman, H., Harris, P., & Klein, W. (2011). Effects of Self-Affirmation on Implementation Intentions and the Moderating Role of Affect. Social Psychological and Personality Science. Epub ahead of print.

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