Institutional Data Collection Form Instructions All data collection activities involving human subjects must be carried out with the protection of human subjects in mind. Departments and persons collecting data should avoid pressuring employees, students, or others to participate; they must make it clear to their human subjects that they are under no obligation or requirement to participate in the activity, and that they may withdraw or decline to answer any or all questions without penalty. The purpose of this form is to address data collection activities that DO NOT meet the definition of “research.” That is, data collection activities intended for internal purposes only. This form is designed to help ensure the following: Individuals participating in data collection activities understand that their participation is voluntary. Individuals participating in data collection activities are protected from risk including Breach of confidentiality (which may cause embarrassment, emotional distress, economic harm, social sanction, etc.). Deception (intentional and unintentional). Data collection activities conducted by NWHSU faculty, staff, or students are consistent with NWHSU’s mission, values, and strategic plan. Data collection activities are coordinated to prevent duplication of effort. Definitions Data collection A systematic gathering of information. May or may not meet the definition of “research.” Human subject A living individual about whom a person obtains either a) Data through investigation or interaction with the individual or b) Identifiable private information Research A systematic gathering of information designed to develop or contribute to generalizable knowledge (i.e., will be presented outside the University or published). Note: All data collection activities conducted at NWHSU that meet the definition of “research” are subject to the policies and procedures of NWHSU’s IRB. See http://www.nwhealth.edu/institutional-review-board/ How to complete your application 1. This form must not be handwritten 2. Fill out all of the questions on this form completely 3. Prepare an informed consent statement 4. Obtain the appropriate signature from the department head or dean. If the data collection activity originates in the Faculty Senate or Employee Council, approval must be obtained from the respective organizational president. 5. Submit the original signed form and any other supporting materials to Linda Hanson Wolfe-Harris Center for Clinical Studies x 316 Northwestern Health Sciences University lhanson@nwhealth.edu Institutional Data Collection Application 1 IRB Records Institutional Data Collection Form Version 1.2 Updated: August 20, 2014 Date received: __________ 1. Date: 2. Project Title: 3. Primary Person(s) List the primary person(s) responsible for the data collection activity. Include any individual(s) who will have responsibility for data collection, consent, and/or reporting findings. Name: Position: Faculty Staff Student Position: Faculty Staff Student Position: Faculty Staff Student Department: Name : Department: Name : Department: 4. Human Subjects Does your data collection activity involve human subjects (people)? That is, are you asking people to provide responses as part of your data collection activity? Yes No → STOP. You do not need to submit this form. 5. Generalizable Knowledge Is your proposed data collection activity a systematic investigation designed to develop or contribute to generalizable knowledge (will results of the data collection activity be presented in any form, including the Internet or meetings and/or publications external to this institution)? Yes → STOP. You must complete an IRB application available on the IRB website: http://www.nwhealth.edu/institutional-review-board/. No 6. Purpose of Data Collection Why are you collecting this data? (i.e., What will you accomplish?) Institutional Data Collection Application 2 7. Methodology How will you be collecting the data? Email survey Paper survey Telephone survey Focus group Face-to-face interview Other - specify: 8. Participant Population Who will be asked to participate in the data collection activity? Check all that apply: NWHSU Faculty NWHSU Staff NWHSU Students Alumni Other - specify: 9. Data Management a. List the individuals who will have access to raw data (i.e., data in it’s original form as collected from participants): b. How will the raw data will be stored? Password protected computer hard drive of computer Locked file cabinet Other - specify: c. List information that will be collected that could potentially link individuals to their responses (i.e., information that could identify individuals as participants in data collection process). None. - specify method for anonymous data collection: Email address Employee ID Name Other - specify: Institutional Data Collection Application 3 d. If identifying information will be collected, how will it be managed? Identifying information will remain unaltered and individuals will be informed that they could be identified. Identifying information will be removed prior to summary/analysis. Other - specify: 10. Informed Consent Statement Prepare a consent statement for the data collection activity. (For an example of a Informed Consent Statement, see the template on the following page.) 11. Signature Enter the name of the department head, dean, or organizational president authorizing this data collection activity. If this is a committee activity, enter the name of the appropriate President. Name: I acknowledge that this data collection activity is in keeping with the standards set by my department and I assure that primary person(s) responsible for the activity met all departmental requirements for review and approval. Original signature of authorizing official Date Thank-you for completing this application. Institutional Data Collection Application 4 Title of data collection activity Background You are invited to participate in this type of activity (e.g, survey) on general description. The purpose of this type of activity is to summary of the purpose. Primary responsible person, department is the primary person responsible for this data collection activity. Confidentiality Name(s) of all individuals who will have access to raw data will have access to the raw data. State whether or not he/she/they will also have access to data that could identify individual respondents (e.g., email addresses). Data will be stored securely as follows: describe how. When the data is analyzed and reported, describe whether or not individuals could be identified from the data. A summary of results will be presented to [identify who will see results] for their consideration. If tape recordings or videotapes are made, explain who will have access, if they will be used for education purposes, and when they will be erased. Voluntariness Participation in this study is voluntary. Your decision whether or not to participate will not affect your current or future relations with Northwestern Health Sciences University or with other cooperating institutions, insert here. If you decide to participate, you are free to not answer any question or withdraw at any time. Questions If you have questions or concerns, you may contact primary responsible person, phone, email. Consent By choosing to participate in this data collection activity, you are acknowledging consent to the above conditions. Institutional Data Collection Application 5 Informed Consent Statement Example The following provides an example using the Consent Statement Template with a fictitious survey. Bolding indicates inserted language. Car Pool Survey Background You are invited to participate in this survey on car pooling. The purpose of this survey is to find out NWHSU employees feel about car-pooling. Joe Smith, Assistant Professor (NWCC), and Jane Doe, Assistant Professor (MCAOM) are the primary persons responsible for this data collection activity. Confidentiality Joe Smith, Jane Doe, and Chris Miller (Administrative Assistant, NWCC) will have access to the raw data. Chris Miller will also have access to data that identifies you through your email response to this survey. Data will be stored securely as follows: Data from the survey will be entered into a password-protected Excel spreadsheet on Chris Miller’s computer. Your email will NOT be entered into the spreadsheet. When the data is analyzed and reported, only summarized data will be presented. No individual responses will be included in the results. The results will be presented to the NWHSU Planning Committee for their consideration. Voluntariness Participation in this study is voluntary. Your decision whether or not to participate will not affect your current or future relations with Northwestern Health Sciences University. If you decide to participate, you are free to not answer any question or withdraw at any time. Questions If you have questions or concerns, you may contact Joe Smith (x 999) or jsmith@nwhealth.edu. Consent By choosing to participate in this data collection activity, you are acknowledging consent to the above conditions. Institutional Data Collection Application 6