Institutional Review Board Human Research Approval Form

Transcription

1 Institutional Review Board (submit completed form to Chair of the University IRB) Departmental Review Committee (submit completed form to Department Committee Chair) Institutional Review Board Human Research Approval Form Principal Investigator (must be MSUM faculty or staff): Date Submitted: Name: Exempt review example Dragon ID No: Department: Speech Language Pathology Telephone No: Building/Room No: Murray 233 address: Signature: NIH Training Certificate Attached? Yes No Previously submitted Co-Investigator (attach separate sheet if more than two) Co-Investigator (attach separate sheet if more than two) Name: XXXX Name: Faculty Graduate Student Undergraduate Student Faculty Graduate Student Undergraduate Student Department/Program: Speech Language Pathology Department/Program: Telephone: Telephone: address: address: Dragon ID No: Dragon ID No: NIH Training Certificate Attached? Yes No Previously submitted NIH Training Certificate Attached? Yes No Previously submitted Signature: Signature: Title of study: Survey: Clinical Fellowship Speech Language Pathologists Experiences in Graduate School Project starting date (must be after IRB approval date): Estimated project ending date: Does this study involve survey or interview questions? Yes No If yes, you must attach the survey/interview questions. How will the survey/interview questions be administered? Written (paper) Orally Electronically (Online) If electronic/online, are you using MSUM Qualtrics? Yes No We will be using Qualtrics for our survey, but only to analyze our date we receive. We will be sending out a paper survey for the participants to mail back and then entering that data into Qualtrics. If you are not using Qualtrics, what tool are you using to administer your survey/interview and why. Type of Review Requested (see checklist for required materials) Exempt Status (allow 10 working days for review) Expedited Review (allow 10 working days for review) Reason for requesting Expedited Review: Full Review (allow up to 30 days for review) Reason for requesting Full Review: Number of copies to submit: 1 paper copy OR 1 electronic copy in PDF format 2 paper copies OR 1 electronic copy in PDF format 10 paper copies OR 1 electronic copy in PDF format Institutional Review Board Recommendation: Exempt Status Approval: Yes No Revise and Resubmit (see attached) Expedited Review Approval: Yes No Revise and Resubmit (see attached) Full Review Approval: Yes No Revise and Resubmit (see attached) IRB Chair s Signature: Date:

2 Institutional Review Board (submit completed form to Chair of the University IRB) Departmental Review Committee (submit completed form to Department Committee Chair) Institutional Review Board Request for Exempt Status Name of Principal Investigator: Title of Study: Exempt Review Survey: Clinical Fellowship Speech Language Pathologists Experiences in Graduate School 1. How are the subjects at no more than minimal risk? The information on the survey does not contain any information of a sensitive nature that might cause the participants any psychological or emotional discomfort or harm. 2. How will informed consent be obtained? (Include copy of informed consent form or implied consent letter for surveys). The participants will be presented an informed consent letter as part of the paper survey mailed out to them. Their participation in the survey and mailing it back implies their consent as stated in the letter. 3. How will assent be obtained when minors or other vulnerable populations are used? Assent is not applicable to this study as minors or vulnerable populations will not be participants in this survey. 4. How will confidentiality be maintained? All information about the subjects is completely anonymous. No identifying information will be given. The co-investigators will receive collated data without any identifying information and will process the information in a private area while entering the data into the Qualtrics system. The paper surveys will be stored in a locked area in the primary investigator s department for three years and then destroyed. Once the data is in the Qualtrics system, only co-investigators can access the passwordprotected information. continued

3 5. Select the type of research that applies to your study and provide a brief explanation below*. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. This type of research is an area of exemption that may apply to minors, whereby the researcher is the minor's teacher, instructor, therapist, etc. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifies linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior that is not exempt under paragraph 2 of this section, if (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s)require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. This type of research is an area of exemption that may apply to minors. Research and demonstration projects which are conducted by or subject to the approval of federal department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefits or services programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs. Taste and food quality evaluation and consumer acceptance studies, (1) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environment contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. Brief explanation of how your selection above applies to your research: The research design is a survey distributed by mail to the potential participants that are 2014 graduates of Speech-Language Pathology (SLP) programs who are currently members of the American Speech-Language- Hearing Association (ASHA). A database of addresses will be purchased from ASHA and 1,000 surveys will be sent out. See attached survey. Data will be analyzed using descriptive statistics. This fits within the second category indicated above which includes survey procedures. The questions in the survey relate to the practice of Speech-Language Pathology, specifically regarding SLPs in their Clinical Fellowship experience and their graduate education, research, and clinical experiences. This research will contribute valuable information to the field of Speech-Language Pathology in regards to graduate school coursework, research, and clinical experiences. This form and complete instructions are available online at:

4 Project Abstract The purpose of this study is to explore the graduate school experiences of recently graduated Speech Language Pathologists and how prepared they were during the first year of employment. A paper survey will be sent out to 1,000 Speech-Language Pathologists who graduated in 2014 and are currently in their Clinical Fellowship experience. These potential participants are members of the American Speech-Language-Hearing Association (ASHA). The survey contains quantitative and open-ended questions relating to employment settings, types of graduate programs attended, and research completed in the graduate program. Results will be displayed using descriptive statistics. This study will contribute to the field of Speech Language Pathology by gathering detailed information in regards to graduate school coursework, research, and clinical experiences.

5 Consent Letter Survey: Clinical Fellowship Speech Language Pathologists Experiences in Graduate School To Speech-Language Pathologists (SLPs) currently completing their Clinical Fellowship experience: You are invited to participate in a study of investigation for Clinical Fellowship Speech Language Pathologists Experiences in Graduate School. The learning objective for this study is to expand the knowledge base of graduate education and clinical experience of SLPs. You were selected as a possible participant in this study because you are a member of the American Speech-Language-Hearing Association and you graduated in If this survey reached you in error and you do not meet the criterion of this survey of being a 2014 graduate from a Speech Language Pathology program in your clinical fellowship year, please feel free to pass on this survey to a colleague who meets this description. If you do meet this criterion and decide to participate, please complete the survey below. Your return of this survey is implied consent. The survey is designed to explore the preparedness of SLPs in their Clinical Fellowship experience related to their graduate education, research, and clinical experience. It will take approximately 10 to 15 minutes to complete this survey. Any discomfort or inconvenience to you derives only from the amount of time taken to complete the survey. Any identifying information will remain confidential and will not be disclosed. Feel free to ask questions regarding this study. You may contact Exempt Review if you have any additional questions by at exemptreview@mnstate.edu or by phone at Any questions about your rights as a participant can be directed to Dr. Lisa I, Karch, Chair of Minnesota State University Moorhead (MSUM) Institutional Review Board, at or by at lisa.karch@mnstate.edu. Thank you for your time. Sincerely, Exempt Review Associate Professor SLHS Dept, MN State University Moorhead 223 Murray Hall 1104 Seventh Avenue South Moorhead, MN 56563

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