Human Subjects Application


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Human Subjects Application

  1. 1. Human Subjects Application, Cover Sheet CSUS Psychology Department STUDENT Request to Use Human Subjects Submit two [2] copies of your human subjects application (this form and all attached materials described on the Application Summary on the back of this page) to Professor Greg Hurtz, Chair of the Human Subjects Committee. Please turn in your completed application to one of the office staff in Amador 350. Title of Project: (exactly as listed on the Psychology Research web site if you use the subject pool) The Effects of Supraliminal vs. Subliminal Presentation and Deep vs. Shallow Levels of Processing on Explicit Memory Test Performance in Older Adults Names and Affiliations of All Researchers Involved in this Project Dr. John Schaeuble – Thesis Chair (Statistics and Research Methodology) Dr. Kelly Cotter (Developmental Psychology) Dr. Emily Wickelgren (Visual Perception and Cognition) Dr. Greg Hurtz (Statistics and Research Methodology) Contact Person for this Project: Name _Felicia Oropeza E-mail ____feoropeza@gmail.com_________________________ Phone Numbers (916)616-9672 (day) (916)454-3779 (evening) Research Course (Circle One): 101 102 194 195 199 294 295 299 500 Other (Please explain) ______________________________________________________________ If you plan to use the Psychology Department subject pool, please complete the following section: (a) Total number of subjects requested for this semester _______ (b) Credit assigned per subject _______ (½ hour of credit for each half hour or less of participation) (c) Total number of subjects hours requested for this semester: (a) × (b) = _______ If you plan to use subjects from a source other than the Psychology Department subject pool… (e.g., classes on our campus, preschools, elementary schools, high schools, county employee offices, etc.), you MUST indicate the source and attach written evidence of permission from each institution (evidence must be signed by an agency representative on agency letterhead). Source(s): Senior Spectrum (Ted Gallagher-Invoice), Senior Magazine (Susan Lewis-Invoice), UCDavis Health System Human Resources Employees (Cindy Oropeza) , (Invoice), Linda Hoschler from Ethel Hart said she will be able to put a flyer in August. Therese Schulz from Senior Center in Elk Grove (Emailed her letter of approval from the organization’s board and will submit the signed form during the week of May 10th) I have also contacted the following organizations: Leisure Manor, Albert Einstein Residences, Campus Commons Residential Community, Sterling Suites, Pioneer Retirement Homes, West Sacramento Senior Center, Broadway Senior Center, Zencar, Camellia Commons Senior Residences, Arden Park Villa, St. Francis Senior Residence, Swanston Senior Residences, Rotary Club but they have not responded as of yet. I will be making follow up calls to these organizations during the week of May 10th. I will contact Soroptomist International, the Elks Club, Northridge Country Club if I do not receive enough letters of permission from the organizations I already contacted.
  2. 2. Faculty Sponsor: All research must be sponsored by a faculty member in the CSUS Psychology Department. By signing below as faculty sponsor, I certify that I have thoroughly read the information contained in this application, I approve of the research procedures, and all researchers and sponsors of this project are affiliated with CSUS unless otherwise noted. Sponsor’s Name (print) _Dr. John Schaeuble_________ Date: _________________ (signature) _______________________________________________________
  3. 3. This summary describes the sections that must be completed in your human subjects application. Be sure that your submission contains all of the information described below. Incomplete applications will be returned un-reviewed. You should include this cover sheet and page 1 (from this handout), and attach your own copies of pages 2-6 +. Page 1. Potential Risks to Participants Indicate whether or not your research does (or potentially could) involve risks to the participants. Use the page provided (page 1) to check “yes” or “no” for each of the risks listed. Page 2. Consent Form Construct and attach a copy of the consent form you will use. All subjects must give informed consent prior to participating in the study, and the consent form must contain enough information to enable them to choose whether or not to participate. A template is provided for you to use in constructing a consent form for your study; please follow the template closely in content and format. Page 3. Procedures Briefly describe the procedures to be used in the study. You should provide enough information for the reviewer to know exactly what the research participants will be asked to do during the study. Be sure to specify how the subjects’ confidentiality and anonymity will be protected. If you have identified any potential risks to the participants on page 1 of your application, also explain on page 3 what you will do to minimize those risks. Page 4. Debriefing Script Provide a transcript of what you will say to subjects when they complete their participation in your research. A template is provided to assist you in developing a debriefing script; please follow this template closely. Your main goals during the debriefing are to explain the true nature of your research, and to provide educational value to the research participants. Page 5. If you will be using the Psychology Department subject pool, you must attach a copy of the project description page that you printed after registering your project on the Psychology Research web site, Pages 6+. Materials (may require multiple pages) Attach copies of surveys, tests, and other materials to be presented to participants. NOTES: (1) If you download this form from the website and edit it electronically, make sure the cover sheet and page 1 remain on two separate pages, preserving the original format. (2) The on-line version of this application has sample materials that may be helpful when preparing your application. We encourage you to look at them.
  4. 4. Human Subjects Application Page 1 Potential Risks to Participants (to be completed by the applicant) Does (or potentially could) the proposed study involve any of the following risks? _ Yes x__ No Exposure to material generating aversive emotions _ Yes x_ No Emotionally painful recollections _ Yes x_ No Subjection to stressful instructions or tasks _ Yes x_ No Exposure to negative evaluation _ Yes x_ No Misleading information about the true nature of the research (deception) _ Yes x_ No Provision of any personally sensitive information from the participant (e.g., information about drug use, sexual orientation, etc.) For Human Subjects Committee Use Only _______ Approval Number Risk Assessment _________ Exempt This approval goes to the end _________ No Risk of the current semester. Submit _________ Minimal Risk a Project Continuation Form _________ At Risk if you need to extend your research into the next semester. Action Recommended _________ Approved _________ Approved with the following conditions: _________ Returned for the following information: __________________________________________ _______________ Signature of Human Subjects Committee Reviewer Date __________________________________________ _______________ Signature of Human Subjects Committee Chair Date
  5. 5. Human Subjects Application Page 2 CONSENT FORM I hereby agree to participate in a research study on cognitive aging by Felicia Oropeza, a graduate student in psychology at Sacramento State University. Some potential benefits of this study include the development of effective memory treatments for Alzheimer’s patients or the increased use of instructional media to prevent the onset of Alzheimer’s disease in the aging population. The research will involve a telephone interview, a computerized four-phase visual presentation of words lasting approximately 5 minutes, and a pen and pencil fill in the bubble 40 question exam at the end of the experiment. When the researcher initiates contact with me by telephone, I will answer a list of about 25 questions related to my general knowledge of facts, ability to make inferences, and capacity for mental arithmetic. Over the telephone, the researcher will also ask me for the following information: 1) name, (2) age, (3) email, (4) willingness to participate in the study, (5) phone number, and (6) education level. After this initial telephone contact, the researcher will ask me to individually meet her at a place and time of my convenience and will show me a list of words on her computer. Then I will be asked to complete a forty question “Yes”/”No” test. This study will take approximately 15 minutes to complete. The researcher and I will mutually decide on a time and place for the experiment. I understand that I will receive a $5 Walmart gift card as compensation for my time spent participating in the study. I understand that I might feel mild stress when tested on the words in this study, but I also know that I can decline to participate or stop at any time without any penalty other than loss of the gift card. I also understand that the researcher may discontinue my participation at any time during the experiment. My anonymity will be protected through the use of codes rather than names to identify participants. To protect my confidentiality, only group results will be reported, not individual scores. This information was explained to me by Felicia Oropeza. I understand that she will answer any question I have now or later about this study. Felicia Oropeza can be reached at Signature Date
  6. 6. Human Subjects Application Page 3 Procedure The purpose of this study is to examine the effect of supraliminal vs. subliminal presentation of visual word stimuli on the facilitation of levels of processing on explicit memory performance in older adults. This experiment is a 2x2 within subjects design. After the researcher receives the contact information from the prospective participants, the participants will be screened with the Telephone Interview for Cognitive Status (Brandt, Spencer, & Folstein, 1988). Refer to Attachment 2. This test is designed to detect various types of cognitive impairment, the severity of the ailment, and the progression of the illness, if any impairment is detected. The scoring rubric for this exam provides a cut-off score of 31 so the researcher can easily distinguish the cognitively impaired from those of normal cognitive status. Thus, the researcher will include those who scored 31 points and over in the study and eliminate those who scored less than 31 points from the study. The participants will see four phases of a serial presentation of visual word stimuli flashed on a computer monitor. One independent variable is evidenced through the timing of the presentation of stimuli. In the experiment, the participants will be exposed to four phases of presentation. In two phases, words will be flashed on a computer screen for 2 seconds (supraliminal). In the other two phases, words will be flashed for at total of .05 seconds (subliminal). The manipulation of the second independent variable is reflected through the relatedness of the words to the other words presented in their respective phase. In this experiment, the researcher chose words from the “Zoo Animal” theme to comprise the two thematically related word lists. The researcher randomly generated the two non-thematically related word lists from a website. Refer to Attachment 2 for complete word list. The words on the thematically related list will be pilot tested by raters when they fill out a reliability questionnaire assessing the relatedness of each thematic word. Please see Attachment 3 for the inter-rater questionnaire. The dependent variable is the participants’ ability to recognize words that were both subliminally presented and deeply processed. The exam consists of forty “Yes”/”No” questions asking the participants whether they recognize the word from the previously presented series of words. Responses are assessed on a 1 point scale where the score can either be “0” or “1.” The researcher will meet with each participant at a place and time of his or her own convenience. Upon arrival to a venue appropriate for testing, the researcher will distribute the consent form for the participant to sign. When these forms are signed and returned, the researcher will place the consent form in a separate envelope to prevent one from tracing the identity of the participant from the information provided by the form. Additionally, the participants’ anonymity will be protected through the use of codes to identify participants. Their rights to confidentiality will not be violated for the presented results will be based on group rather than individual averages. Furthermore, the participants will be instructed not to put or draw any identifying information on their materials. Once the participants have completed the four phases of the experimental trials, the participants will receive the recognition exam. Please see Attachment 4. Upon the completion of the exam, the researcher will collect the exam and will place it in a different envelope from the consent form so the participant’s data cannot be linked with his or her identity. The researcher will give an oral debriefing and answer any pending questions. Then the researcher will distribute the debriefing page to the participant. The researcher will thank the participant and provide the participant with a $5 gift card from either Wal-Mart or Starbucks. Finally, the researcher will dismiss the participant.
  7. 7. Human Subjects Application Page 4 DEBRIEFING Purpose The purpose of this study was to investigate the effects of very short vs. longer presentation of words and whether words have related meanings or not on the ability to remember in older adults. Your memory for the words was measured in the forty item recognition test that you completed in the latter half of the experiment. In Phases I-IV of the current study, you saw a series of words presented on a computer screen. Twenty of those words were not related and twenty words had meanings related to the category “Zoo Animals.” Ten words were presented very quickly, to encourage unconscious processing, and ten words were presented for a longer time, to encourage conscious processing. My hypothesis is that words presented very quickly will be remembered more easily if they have related meanings than if they do not. I also expect that words having related meanings will be more easily remembered even when presented very quickly than when presented for a longer time. Only group results for this study will be reported, not any individual scores. Contact Information The results of this study will be available by the first week of the Fall semester in 2010. If you would like further information about this study, please contact Felicia Oropeza at at your convenience. Do you have any questions? THANK YOU FOR YOUR PARTICIPATION!!
  8. 8. Human Subjects Application Page 6 Attachment 1. TELEPHONE INTERVIEW FOR COGNITIVE STATUS (TICS) Name_______________________________ Date____________________________________ Directions :( 1) Explain exam to subject (or patient’s caregiver). (2) Get address. (3) Be sure distractions are minimal (e.g. no T.V. or radio on, remove pens and pencils from reach). (4) Be sure sources of orientation (e.g. newspapers, calendars) are not in subject’s view. (5) Caregivers may offer reassurance. but not assistance. (6) Single repetitions permitted, except for items 5 and 8. Instruction Scoring Criteria Score 1."Please tell me your full name?" 1pt.for first name, 1pt.for last name. _ _____ 2. "What is today's date?" year, day of week, and season. If incomplete, ask Specifics (e.g., "What is the month?" "What seasons are we in?") 1 pt. each for month, date, year, day of week, and season. If incomplete, ask specifics (e.g., "What is the month?" "What season are we in?") 3. "Where are you right now?" , street, city, state, zip. If incomplete, ask specifics (e.g., "What street are you on right now?") 1 pt. each for house number, street, city, state, zip. If incomplete, ask speciics (e.g., "What street are you on right now?") 4. "Count backwards from 20 to 1."the first trial; 1 pt. if completely correct on second trial; 0 pts. for anything else. 2 pts. if completely correct on the irst trial; 1 pt. if completely correct on second tial; 0 pts. for anything else. 5. "I'm going to read you a list often words. Please listen carefully and try to remember them. Ready? The words are: cabin, pipe, elephant, chest, silk, theatre, watch, whip, pillow, giant. Now tell me all the words you can remember."
  9. 9. 1 pt. for each correct response . No penalty for repetitions or intrusions .me as many words as you can, in any 6. "One hundred minus 7 equals what?" "And 7 from that?", etc. Stop at 5 serial subtractions. 1 pt. for each correct subtraction. Do not inform the subject of incorrect responses, but allow subtractions to be made from his/her last response (e.g., "93- 85-78-71-65" would get 3 points). 7. "What do people usually use to cut paper?" 1 pt. for "scissor" or "shears" only. lpt. for "12." "How many things are in a dozen?" "What do you call the prickly green plant that lives in the desert?" "What animal does wool come from?" 1 pt for "cactus" only. 1 pt. for "sheep" or "lamb" only. 8. "Say this: 'No ifs, ands or buts" "Say this: 'Methodist Episcopal'." 1 pt. for each complete repetition on the first trial. Repeat only if poorly presented. 9. "Who is the President of the United States right now?" "Who is the Vice-President?" 1 pt. for correct first and last name. 1 pt. for correct first and last name. 10. "With your finger, tap 5 times on the part of the phone you speak into." 2 pts. if 5 taps are heard; 1 pt. if subject taps more or less than 5 times. 11.I'm going to give you a word and I want you to give me its opposite. For example, the opposite of hot is cold. What is the opposite of "west '?" "What is the opposite of '"generous'?" 1 pt. for "east." 1 pt. for "selish," "greedy," "stingy," "tight," "cheap,"
  10. 10. Human Subjects Application Page 7 Attachment 2. CompleteWord Lists usedduring the Non-thematic/Supraliminal, Non- thematic/Subliminal, Thematic/Supraliminal, Thematic/Subliminal Phases. Non-thematic bankruptcy motorcycle torchlight buddy unfasten thumbprint technician rottweiler middlebrow grandchild baron groin exhilarate bandanna incongruity skirt drive test notion compactor Thematic (“Zoo Animals”) zebra penguin rhino hyena giraffe lion hippo orangutan tiger leopard elephant bear chimp alligator gorilla crocodile
  11. 11. kangaroo gazelle lizard antelope Four Distracter Non-thematic words for Recognition Test nostril vigorous breastbone purse Four Distracter Thematic words for the Recognition Test camel llama chinchilla panther Six Distracter Thematic words for the Inter-rater Questionnaire camel chinchilla llama panda snake panther
  12. 12. Human Subjects Application Page 8 Attachment 3. Questionnaire used to assess the thematic relatedness of words in the thematic word list. Instructions: Please study these words carefully and rate how strongly you agree that each word on the list is related to the word list theme, “Zoo Animals” Fill in the bubble that represents your level of agreement of the relatedness of the word to the word list theme. 1= strongly disagree 2=somewhat disagree 3=neither disagree nor agree 4=somewhat agree 5=strongly agree zebra 1 2 3 4 5 penguin rhino hyena giraffe
  13. 13. lion hippo kangaroo tiger leopard elephant bear chimp alligator gorilla
  14. 14. crocodile lizard gazelle orangutan antelope camel chinchilla llama panda snake
  15. 15. panther Human Subjects Application Page 8 Attachment 4. Forty-Item forced-choice recognition test Instructions: Please study these words carefully and checkmark either the “Yes” or “No” box indicating whether you remember seeing the following words during the previous computer screen session. Yes No bandanna alligator breastbone chinchilla antelope chimp lion unfasten gorilla panther torchlight
  16. 16. elephant nostril rhino buddy kangaroo groin vigorous middlebrow llama penguin lizard grandchild orangutan test camel
  17. 17. notion gazelle skirt exhilarate thumbprint giraffe rottweiler compactor hyena hippo drive zebra bankruptcy
  18. 18. nte s din p rtic a , p a ec nta t Fe iaOro e , M.A. P yc lo y c nd a . C 16 16 6 re te a ip ting le s o c lic p za s ho g a id te :(9 )6 -9 72 Or e a fe ro e @ g a o m il o p za m il.c m Humans Subjects Application Page 9 Attachment 5. Recruitment Flyer used in Senior Residential Communities Volunteers Needed for Cognitive Aging Study ur convenience. You have a choice of one $5 gift card to either Dollar Tree, Safeway, Target, or Wal-Mart as a reward fo Recruitment Flyer distributed through Senior- Spectrum Magazines, Senior Magazine, AARP, Ethel Hart Senior Center, Campus Commons, SacPress, and Senior Journal Cognitiv Cognitiv Cognitiv Cognitiv Cognitiv Cognitiv Cognitiv Cognitiv Cog e Aging e Aging e Aging e Aging e Aging e Aging e Aging e Aging e Ag Study Study Study Study Study Study Study Study Stud (916)61 (916)61 (916) (916) (916) (916) (916) (916) (916 6-9672 6-9672 616-967 616-967 616-967 616-967 616-967 616-967 616 2 2 2 2 2 2 2
  19. 19. If inte s din p t te ting p a ec nta t Fe iaOro e a 9 -6 -9 72 re te ilo s , le s o c lic p za t 16 16 6 Or e a he a fe ro e @ g a o m il r t o p za m il.c m Human Subjects Application Page 9 Attachment 6 . Recruitment Flyer to distribute among friends and family members for pilot study testing and to establish inter-rater reliability for word lists . Volunteers needed for Pilot Study Testing Who can participate:  I will be recruiting twenty individuals between the ages of 15 and 54 to test my cognitive aging experiment. What is involved :  Ten testers will be asked to rate the degree of relatednes s of twenty words to a specified theme using a scale from 1 to 5.  Ten testers will go through the entire experiment to ensure that the experimental conditions measure the variables they are suppos ed to measure . o These testers will determine whether the written test produces the hypothesized results .  The experiment will involve a 3 minute presentation of 40 words and a 15-20 minute written test after the computerized trials.  I will compensate the participants for their time with a $5.00 gift card from Starbucks . Cognitiv Cognitiv Cognitiv Cognitiv Cognitiv Cognitiv Cognitiv Cognitiv Cognitiv Cog e Aging e Aging e Aging e Aging e Aging e Aging e Aging e Aging e Aging eA Study Study Study Study Study Study Study Study Study Stu (916)61 (916)61 (916) (916) (916) (916) (916) (916) (916) (91 6-9672 6-9672 616-967 616-967 616-967 616-967 616-967 616-967 616-967 616 2 2 2 2 2 2 2 2