Sample CALIFORNIA STATE UNIVERSITY SAN MARCOS Application for Approval for Research Involving Human Subjects: Individual Investigator Projects To determine level of review, please check CSUSM human subjects research FAQs or video training at www.csusm.edu/irb . Full review X Expedited Review X New application Updated Application for Continuing Review* Title of proposed project: The comparative optimism in judgments of depression Faculty Research X Student Research Researcher Name: Date: 03/01/11 College/Dept: Psychology Faculty Sponsor (For student research projects): Faculty Phone: Faculty E-mail: Is this submission part of an external grant proposal? If Yes, SPAF # X No Faculty Verification on student research projects: By submitting this form, you are verifying that you have reviewed this proposal for completeness and verified that it is in compliance with IRB regulations. Submission Instructions Electronic Submission –This document may be submitted by email by faculty only. Students must submit the document to their faculty sponsor for review and forwarding to the IRB. Send to irb@csusm.edu. Word documents are preferred. The Consent Letter or Information sheet should be a separate Word document. Receipt via email from the faculty member’s email account will serve as their signature verifying that they have reviewed this proposal for completeness and that it is in compliance with IRB regulations. Expedited reviews are reviewed by one committee member with an average approval time of approximately three weeks. Approval paperwork will be sent to the email address provided on the application at the time of submission. Full reviews are reviewed by the full committee at an IRB meeting. Approvals on full reviews may take 4-6 weeks. Approval paperwork will be sent to the email address provided on the application at the time of submission. All “full review” applications are copied to Risk Management. *Continuing Reviews must include the continuing review form in addition to this application UPDATED. This update must include 1. any clarifications provided to the original reviewer, 2. any modifications previously approved, and 3.any modifications requested for approval as part of this submission. Please be sure that your changes can be identified easily such as using bold or italic font. If you have any questions, please refer to the IRB website or contact the IRB staff at (760)750-4029 or irb@csusm.edu. NOTE: Completeness of this application will impact the timeliness of the review process. Effective 8/1/2009, certification of training on Human Subjects Protection is required. To satisfy this requirement, a student may complete the CITI on-line training or attend the IRB workshop. Faculty must complete the CITI online training. Completion satisfies the training requirement for three years. . Rev. 9/2010 Summary of Research Protocol Please answer each section completely and as succinctly as possible. Use lay terms as IRB members have diverse academic backgrounds. Please indicate N/A if the question does not apply to your research. For assistance with completing this form, please review the following resources: Video Samples 1. Purpose of project and project background Describe your research question, including why the question is important, and how your study will attempt to answer it. Include how your literature review supports this. Depression (i.e., major depressive disorder) affects approximately 14.8 million American adults (National Institute of Mental Health, 2011) and nearly a third of the people suffering from major depressive disorder do not seek treatment (Substance Abuse and Mental Health Services Administration, 2008). Because treatments (e.g., medication, psychotherapy) are generally effective at reducing symptoms of major depressive disorder (e.g., de Maat, Dekker, Schoevers, & Jonghe, 2007), it is important to identify factors related to help-seeking for depression. Although optimism is often considered a positive outlook, comparative optimism (i.e., believing that one is better off than someone else in a similar situation) can be harmful. For example, people’s beliefs that their feelings of depression are not as bad as someone else with the same feelings could impede seeking help for those symptoms of depression. Using vignettes describing depressive symptoms, Spendelow and Jose (2010) found that people showed an optimism bias in judgments of depression. Some participants were asked to imagine that they were the person described in the vignette; others were asked to image that the person was a friend. All participants rated the severity of the symptoms, the importance of seeking help, and the prognosis of the condition. Participants who imagined that they were the person rated the symptoms as less severe, help-seeking as less important, and the prognosis as better than those who imagined a friend in the vignette. Similarly, Raviv, Sills, and Wilansky (2000) found that people were more willing to refer another individual suffering from an emotional problem to get assistance than they were willing to get assistance for their own problem. These findings suggest that comparative optimism could explain why people are hesitant to seek help for depression. There are additional factors that contribute to the likelihood that someone will seek treatment for depression. For example, belonging to certain racial/ethnic groups decreases this likelihood. Conner et al. (2010) found that among older adults, African Americans were more likely to perceive a stigma of mental health issues and express a less positive attitude toward mental health treatment than white counterparts. These attitudes lead to differences in behaviors. Cook et al. (2007) reported that members of racial/ethnic minority groups received less mental health treatment (based on medical expenditure surveys) than white Americans and McMiller and Weisz (1996) reported that mental health clinic intakes for child mental health issues were proportionately lower for African American and Latino families than for Caucasian families. Gender and socio-economic status are also related to help-seeking, with males and people of lower socio-economic status being less likely to seek help than females and people of higher socioeconomic status (e.g., McMiller & Weisz, 1996). The goal of the current study is to examine the relationships between ethnicity, socio-economic status, gender, and comparative optimism toward depression. The findings can identify factors that relate to comparative optimistim and help-seeking, which can help health professionals take actions to increase help-seeking among those who are underutilizing mental health treatment. Participants will read two short vignettes describing an individual experiencing depressive symptoms. The vignettes that will be used are based on those used by Spendelow and Jose (2010). One version of the vignette will be written in first-person narrative and participants will be asked to imagine that they are the person being described. The other version of the vignette will be in third-person narrative and participants will be asked to imagine a friend is being described. After reading each vignette, participants will be asked to rate the severity of, importance of seeking help for, and prognosis of the symptoms being described. Between reading the first and second vignettes, participants will fill out a demographic questionnaire that assesses their socio-economic status, gender, ethnic identity, and attitudes toward mental health treatment. 2. Recruitment procedures and participant population a. Expected number of participants: 300 b. Provide a profile of your proposed participant population including demographics. Explain why you are targeting this specific population. Participants will be undergraduate students taking lower division psychology courses that have a research requirement. The demographics of the psychology department’s human participant pool tend to match that of the university: 61% female and 39% male; and 45% non-Hispanic white, 24% Hispanic, 12% Asian/Pacific Islander, 4% black, and 15% from other ethnicities. Rev. 9/2010 c. Indicate whether anyone might be excluded from participating and explain why. No one will be excluded. d. Please indicate whether any of your participants include people whose ability to give informed consent may be problematic (e.g., children, prisoners, mentally disabled, sub-ordinate or at-risk populations)? No participants will be from at-risk populations. e. How will you find, recruit, or identify potential subjects? How will you select, from the volunteers, the final group of participants? Will you be offering an incentive? If yes, please explain Participants will be recruited through the psychology department’s human participant pool website (hpp.csusm.edu). The website will list the study and provide the url for the online study. Interested participants will sign up and click on the linked URL to begin the study. All participants who sign up and complete the online study will be included in the final group. f. Will you be offering an incentive? If yes, please explain procedure for any incentives that will be offered. Include how much participants must do to be eligible to receive credit. Participants will receive one HPP credit for signing up completing the online study. g. Will you use recruitment flyers or other forms of media/communication to solicit participants? If yes, please explain and provide sample(s). Yes X No 3. Informed consent process. See web page on Informed Consent. See also Language Requirements. Provide responses for each population participating in your research a. How and when will you explain the study and the required elements of Informed Consent? Will you be doing this or will it be handled by a research assistant? The elements of informed consent will be explained in an information sheet that is the first screen of the online study (included as an appendix). b. How much time will participants have to consider between receipt of the informed consent document (or information sheet) and the beginning of study? Because participants will complete the study at their convenience, participants can take as much time as they need to consider whether or not to consent. c. Are any subjects under age 18? If so, how will the study be explained to them? How will both parental consent and child assent be obtained? No subjects under 18. d. If you are requesting a Waiver of Signed Consent, explain why this waiver is needed. Outline alternative procedures for obtaining consent or providing study information (e.g., information sheet, introduction screen for web survey, telephone script). A waiver of signed consent is requested because data are collected online making it impractical to collect signed consent forms. The study poses only minimal risk and having participants return a signed consent form by mail would increase this risk by 1) increasing the time and effort of the participant and 2) providing a document that links the participant to the study that could be accessed by someone other than the researchers in the event that the mail ends up in the wrong place. e. Indicate the primary language(s) of your participants. If any participants’ primary language is not English, and they are not fluent and comfortable reading English, explain how you will ensure that participants’ understanding of the activity for which they are giving consent. Because participants are all students in lower-division psychology courses, they are all assumed to be proficient in English and the primary language of the majority of participants is predicted to be English. 4. Procedures and Methodology — research protocol a. Provide responses for each population participating in your research Provide a step-by-step explanation of your research activities and methodologies. Explain how each activity contributes to the purpose of your research. Be thorough. Participants will see a listing (with a brief description) of the study on the psychology department’s human participant pool website (hpp.csusm.edu). If they are interested in participating, they will click on the study Rev. 9/2010 and be given a URL to the website that will host the study (http://www.surveymonkey.com/s/optimism). The first page of the study will be the information sheet. Participants will read the information and click a button to continue if they consent to participate. They will then read brief instructions for the study. After the instructions, participants will read a vignette describing an individual experiencing depressive symptoms. After the participants read the first vignette, they will be asked how severe the symptoms described in the vignette are, how important it would be to seek help for the symptoms, and the prognosis for the symptoms. After these questions, participants will complete measures of their attitudes towards seeking psychological help (from Egisdottir & Gerstein, 2009), socioeconomic status (from Hollingshead, 1975), gender, and ethnic identity (from Phinney, 1992). They will continue to read a second narrative and then they will be asked the same three questions again (severity, importance of help-seeking, and prognosis). The two narratives differ in who is being described in them (the participant or a participant’s friend). Comparative optimism will be assessed by the difference in ratings for oneself versus a friend. After completing the last questions, participants will read a screen that debriefs them about the purpose of the study. b. State the specific dates/timeframe in which you plan to conduct your research. March 2011-February 2012 c. State the location where the research will be conducted. Online (www.surveymonkey.com/s/optimism) 5. Participants’ debriefing or feedback. If deception was involved in your research, participants should be debriefed about the nature of the study as soon as possible. All participants should be given the opportunity to request a copy of the results of the study/your final report. a. Describe any feedback or information you will offer participants. After the participants complete the study, they will see a debriefing screen that contains the purpose of the study and the contact information of the principle investigator (and her faculty advisor) and instructed to contact her if they want a summary of the results. They will also receive the contact information for Student Health and Counseling Services and be instructed to utilize that resource if they have any mental health concerns and be given the number of the IRB in case they have questions about their rights as research participants. 6. Potential risks to the dignity, rights, health or welfare of the human participants. Please be sure the risks listed here match the risks mentioned in your consent letter or information sheets. Consider this very carefully. This is a critical area. For more information on risks, see Examples of Risk. Include any ‘inconveniences’ including the time requirement. List risks for each population participating in the research and for each methodology. a. List and explain potential risks to your participants. Risks may be both physical and psychological responses such as strong emotional and/or negative reactions to research questions. Participants will read two short stories depicting a person experiencing depressive symptoms and asked to make judgments about the severity of these symptoms. Participants will also be asked about their socioeconomic status, gender, and ethnicity. It not expected that these activities will cause emotional distress. List risks related to confidentiality of data. Participants may be concerned about the confidentiality of their responses. 7. Confidentiality and safeguards to minimize risks. Please respond to each risk that you listed in #6 above. State how you will address each to minimize risks, protect confidentiality, and safeguard data. To minimize the riskes mentioned above the following precaoutions will be taken: In the information sheet, participants will be informed of the activities in the study (e.g., that they will be reading a short story of an individual experiencing depressive symptoms). This inform participants of what they will be doing during the experiment so they can make a well informed decision as to whether or not participate. The participants will not be asked to provide any any identifying information in their responses. b. List referrals and/or resources that may be offered if a participant has a strong emotional response or a physical injury (e.g., clinics Rev. 9/2010 or shelters, medical or psychological referrals). All participants will be received contact information of CSUSM’s Student Health and Counseling Services in the event that they have any mental health concerns. 8. Study benefits a. Discuss any potential individual and/or societal benefits. Note, often there is no direct benefit for the participants but rather the study contributes to the literature and/or future research. If this is the case, please state this and explain. Be sure this aligns with the ‘purpose’ of this research. Although there is no direct benefit for the participants for taking part in the study, the study has the potential to be beneficial to scientific literature and the public. The goal of the study is examine whether ethnicity, socio-economic status, gender, perceptions of severity of the psychological situation, and attitudes toward seeking psychological assistance influences comparative optimism toward depression. The findings can provide knowledge as to what factors contribute to comparative optimism and what factors influence utilization of psychological assistance. b. Do the benefits from this study exceed the risks to participants? Please explain. The benefits outweigh the risks. There are minimal risks and the study can benefit scientific literature and it can benefit the general public by expanding our understanding about optimism bias and the factors that potentially prevent people from seeking psychological help. 9. Researcher(s) qualifications and experience. a. Briefly outline the primary researcher(s)’s qualifications and experiences relative to the subject of this research. Be thorough. The principle investigator has completed CITI training, has taken a research methods course, and has completed upper division laboratory courses in psychology. All of these courses contain lessons on research ethics. b. If this is a student project, include faculty sponsor’s qualifications. The faculty sponsor has been conducting psychological studies for over 10 years. He has completed CITI training and similar training at Ohio University and UC Santa Barbara. He teaches research methods and upper division psychology lab courses that contain lessons on research ethics. He is also a member of CSUSM’s IRB. c. If using student assistants, include student(s)’s qualifications and training. No research assistants will be used. 10. Checklist Check which of the following items are included, as applicable: _X__ Certification of Human Subjects Protection training for each researcher and the faculty advisor. ___ Recruitment flier(s) or advertisements, scripts for radio or TV. ___ Letter/email of organizational support (Required if recruiting or interacting with participants at a specific site or through a specific organization outside of CSUSM.) If sent in an email, must include organization and position person who approved. _X__ Survey(s), questionnaires, or interview questions. _X_ Consent and/or child assent form(s) or information sheet(s): Use an appropriate language level for your population Provide unique forms for each population in your research. Use official letterhead or the masthead found in the samples on the IRB website Include contact information: researcher(s) and faculty sponsor’s phone number and/or email address, and the IRB office (760-750-4029) Be sure the information in your consent/information sheet MATCH your application information! Rev. 9/2010 Rev. 9/2010