#1_Justif Memo_Self-Affirm03_27_2012

Date: March 19, 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 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

In this proposed sub-study, we plan to refine and validate a theory regarding the role of the self and affective experiences in responding to health communications about alcohol use. Using several survey conditions, we will administer a survey (Attachment A) that will help 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. We will examine whether our theoretical framework best predicts responses; this will be the first survey to attempt to refine and validate this theoretical framework.

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 will be collected through the TESS project, an opportunity for researchers to collect free data to examine psychological theories and hypotheses. We submitted a proposal for this study to TESS, and it was peer-reviewed by two reviewers, who recommended that it be accepted for fielding. Thus, we will be able to collect this data free of charge once we receive OMB and human subjects approvals. TESS fields research through Knowledge Networks, an internet survey company.

Self-Affirmation, Affective Experiences, and Alcohol Intentions

We predict that self-affirmation – or bolstering one’s sense of self-value – will be 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, we predict 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, we predict 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 us to refine and validate our theoretical framework, 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 B.

Participants, Methodology, and Research Instrument

Respondents will be 800 women aged 18 or older who reported having consumed one alcoholic drink in the past month. 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 A) will be fielded entirely online (screenshots, Attachment C). 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. We will disseminate our findings 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

A request for Office of Human Subjects Research exemption was submitted on March 19, 2012, and we are awaiting approval. PII will not be collected in conjunction with these items.

Burden

A total of 800 participants will complete the survey, which has an anticipated length of 30 minutes; thus, the total hour burden is 400 burden hours. This effort will account for less than 7% of the total burden hours granted in the full generic OMB clearance package. To date, a total of 0 burden hours have been used of the 6,000 hours that were requested (note that 134 burden hours have been requested and approval is pending). Estimated cost to the Federal Government is $1275 for staff (estimated based on 3 FTE hours per week for 10 weeks); survey incentives, cost for administration, and other survey-associated costs will be assumed by the sponsoring organization (TESS).

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)	800	1	30/60	400
Total		800			400

List of Attachments

A: Survey Instrument

B: Selected Readings

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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