IRB

Visit: https://pantherfile.uwm.edu/groups/sa/ltc/ePorfolioEval for the complete IRB protocol submitted.

November 13 th, 2009 Institutional Review Board University of Wisconsin-Milwaukee PO Box 413, ENG 270 Milwaukee, WI 53201 Dear Sir/Madam: Attached please find the Human Subjects Review IRB Submission Face Page, Protocol Summary Protocol, and the New Study Application Form for the study Exploring the Impact of ePortfolios on Student Success. Also, you will find the survey instruments and consent forms. Please let me know if you need any further information. If you have any questions feel free to give me a call. Sincerely, Tanya Joosten Acting Associate Director Learning Technology Center 414.229.4319 tjoosten@uwm.edu UW-Milwaukee Institutional Review Board March 2, 2009 Page 1 **DO NOT WRITE IN THIS SECTION – FOR IRB OFFICE USE ONLY** IRB Study# Subcommittee/Reviewer: **Date Stamp:** Logged Meeting Date: Exempt Expedited Full Board **IRB SUBMISSION FACE PAGE** Instructions: Print or Type. Complete the section(s) that applies to this submission, by checking all relevant boxes and following instructions in that section. Submit the correct number of copies and all applicable documents. If incomplete, your submission may be returned to you. Principal Investigator’s Name: Tanya Joosten PI’s Dept. Name: Learning Tech Center Contact’s Name (if other than PI): Contact’s Phone: 414.229.4319 **X SECTION A – NEW STUDY SUBMISSION** **A1. Check the type of review you are requesting. Submit the number of copies for the type of review checked.** XX Exempt: Expedited: Full Board: **A2. Check all documents that you are submitting.** XX New Study Application (required) XX Consent Forms/ Information Sheets Interview Questions XX Protocol Summary (required) Assent Form Flyers / Recruitment Materials Grant Application if Federally Supported XX Survey Instruments Other: **SECTION B – REVISIONS REQUESTED BY THE IRB (Condition Fulfillment)** //Complete this section if submitting revisions requested by the IRB (e.g., study was given Conditional Approval by the IRB).// **B1.** **Indicate your IRB Study #:** **B2.** **Submit 2 copies showing track changes.** **B3. Check and submit all documents below.** Original communication from the IRB requesting revisions (i.e., e-mail / letter). Letter from PI addressing the requested revisions (i.e., yes, no, justification). The documents that the IRB requested to be revised (e.g., consent form, protocol summary). **SECTION C – CONTINUING REVIEW FOR IRB APPROVAL** //If you are making any changes to your study, also complete Section D below and include an Amendment Form with this submission.// **C1.** **Indicate your IRB Study #:** **C2. Check the type of review you are requesting. Submit the number of copies for the type of review checked.** Study Closed/Complete: Submit signed original plus 2 copies. Expedited: Submit signed original plus 2 copies. Full Board: Submit signed original plus 14 copies. **C3. Check all documents that you are submitting.**Continuing Review form (required) Assent Form Flyers / Recruitment Materials Protocol Summary Survey Instruments Other: Consent Forms/ Information Sheets Interview Questions **SECTION D – AMENDMENT (MODIFICATION TO APPROVED STUDY)** //Complete this section if you are making changes to a study already approved by the IRB (e.g., change in study title, PI, or study materials, etc.).// **D1.** **Indicate your IRB Study #:** **D2. Check the type of amendment you are requesting. Submit the number of copies for the type of amendment checked.** Minor Amendment: Submit 3 copies (2 showing track changes, 1 clean version showing revisions) Major Amendment: Submit 14 copies (13 showing track changes, 1 clean version showing revisions) **D3. Check and submit all documents below.** Amendment / Modification Form The document(s) affected by this amendment (e.g., consent form, protocol summary). **SECTION E – REPORTABLE EVENT FORM** **E1.** **Submit original plus 1 copy** Submit electronically by email to irbinfo@uwm.edu. The email address of the sender must be that of the Principal Investigator's as that will serve as the electronic signature. Enter "New Study Submission" in the subject line and itemize the attached documents in the body of the email. UW-Milwaukee New Study Application Form Institutional Review Board v. 1.5 Page 1 of 11 March 2, 2009 **New Study Application Form** **Instructions:** Each Section must be completed unless directed otherwise. Incomplete forms will delay the IRB review process and may be returned to you. Enter your information in the **colored boxes** or place an **“X”** in front of the appropriate response(s). **SECTION A: Title & Date** **Section Notes…**  Study title must be the same on all study documents (e.g., consents, advertisements, grants, etc.). If not, a reason must be given in the Protocol Summary Form.  Mismatched titles between what the IRB approves and what is on the grant application may delay funding. **A1. Study Title:** **A2. Today’s Date:** **SECTION B: Investigators & Study Personnel** **Section Notes…**  IRB correspondence (e.g., Approval Letters, IRB revisions, etc.) will be emailed to the email addresses listed under the PI and contact person (B1 and B2).  Students **may not** be listed as the Principal Investigator (PI); only UWM faculty and staff may be listed as PI. However, students may be list Co-PI. **B1. Principal Investigator (P.I.)** (UWM faculty and staff only): **Name:** Tanya Joosten **Degree(s):** BA, MA, PhD abd **Title/Position:** Acting Associate Director **Department:** Learning Technology Center **Telephone:** 414-229-4319 **Email:** tjoosten@uwm.edu **B2. Contact person if the IRB has questions if other than P.I.** (if applicable) **:****Name:** **Degree(s):** **Telephone:** **Email:** **B3. Co-Investigators and Research Personnel and identify their role in the study** (e.g., Co-PI, Research Assistant, Graduate Student, etc) (if applicable) **:** **Name:** **Study Role:** **Name:** **Study Role:** **Name:** **Study Role:** **Name:** **Study Role:** **Name:** **Study Role:** Exploring the Impact of ePortfolios on Student Success November 13 th, 2009 UW-Milwaukee New Study Application Form Institutional Review Board v. 1.5 Page 2 of 11 March 2, 2009 **SECTION C: Review Type Requested** **Section Notes…**  C1: “Minimal Risk” is when the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than the harm and discomfort ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination.  C3: The most common Exempt Category for a social science study is 2. To help determine if your study qualifies for Exempt Status, see the checklist the IRB Reviewer uses.  C4: The most common Expedited Category for a social science study is 7.  Upon review, the IRB office may change the requested type of review. Disqualifiers from exempt or expedited may include but not limited to: use of deception; studies involving minors, prisoners, pregnant women, impaired adults, or students; study of illegal activities like drug use; or study of private activities like sexual behavior. **C1. Are the human subjects at more than** **“minimal risk”? More than minimal risk will require Full Board** **Review.** Place an “X” next to the appropriate response. **[__] Yes__** __**[XX] No** **C2. Will the study involve deception or incomplete disclosure to human subjects?** Place an “X” next to the appropriate response. **[**__**] Yes** **[XX] No** **C3. I am requesting the following review by the IRB: (Select “a”, “b”, or “c”. If “b” or “c” is selected,** **continue by selecting the appropriate category.)** Place an “X” next to the appropriate response. **[__] a. Full Board Review__** __(e.g., greater than minimal risk, the combination of a vulnerable population and sensitive information being collected, invasive procedures excluding blood draws); **OR** **[XX] b. Exempt Review where there is no more than “minimal risk” under** (select all that apply) **… OR** **[XX] Category 1** 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. **[**__**] Category 2** 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 identifiers 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. **[__] Category 3__** __Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt 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. **[**__**] Category 4** 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. **[__] Category 5__** __Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: **(i)** Public benefit or service programs; **(ii)** procedures for obtaining benefits or services UW-Milwaukee New Study Application Form Institutional Review Board v. 1.5 Page 3 of 11 March 2, 2009 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. **[**__**] Category 6** Taste and food quality evaluation and consumer acceptance studies. **[__] c. Expedited Review under where there is no more than minimal risk and__** __(select all that apply) **…** **[**__**] Category 1** Clinical studies of drugs and medical devices only when condition (a) or (b) is met. **(a)** Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.) **(b)** Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling. **[__] Category 2__** __Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: **(a)** from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or **(b)** from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week. **[**__**] Category 3** Prospective collection of biological specimens for research purposes by noninvasive means. //Examples:// (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization. **[__] Category 4__** __Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) //Examples//: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual. **[**__**] Category 5** Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). **[__] Category 6__** __Collection of data from voice, video, digital, or image recordings made for research purposes. **[**__**] Category 7** Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. UW-Milwaukee New Study Application Form Institutional Review Board v. 1.5 Page 4 of 11 March 2, 2009 **SECTION D: Study Funding** **Section Notes…**  D1: Federally funded studies (e.g., NIH, CDC, etc.) requires IRBs to review the grant application for consistency in human protections. Submit 2 copies of the grant application. **D1. This study’s funding source is or will be:** **[__]__** __a. Federally Funded (e.g., NIH, CDC, FDA, NIOSH, DOE, DOJ, etc.) **[**__**]** b. Industry, Foundation, Commercial, or Private **[__]__** __c. Internal – Research Growth Initiative **[**__**]** d. Internal – **not** Research Growth Initiative (e.g., department) **[XX]** e. Not Funded (SKIP TO SECTION E) **D2. If “a,” “b,” “c,” or “d” was selected in D1, complete this section:**a. Name of funding source(s): b. Address of funding source(s): c. UWM Proposal/ grant # (if applicable): **D3. If “a” or “b” was selected in D1, and the sponsor requires notification directly from the IRB,** **complete this section. Provide the name and the method of transmission (address/ fax/ email) of the** **individual who requested the notification. A letter will be prepared and forwarded.** **SECTION E: Study Locations** **Section Notes…** Federal regulations require all institutions engaged in human subjects research that is not exempt from the regulations and has adopted the Common Rule be covered by an OHRP approved assurance of compliance. The Federalwide Assurance (FWA) is the only type of assurance accepted and approved by OHRP. In general, an institution is considered to be engaged in human subjects research when its employees or agents: (1) obtain data about living individuals for research purposes through intervention or interaction with them, or (2) obtain individually identifiable private information for research purposes (45 CFR 46.102(d),(f)) []Simply informing potential subjects about a research study is not considered engagement in research. Also, providing written information about a research study, including how to contact the investigators for information and enrollment, and seeking and obtaining prospective subjects’ permission for investigators to contact them are not considered engagement in research. **However, seeking or obtaining informed consent from a** **research participant is considered engagement in research.**1. The Principal Investigator must contact the collaborating performance site to determine whether the site has an active FWA. If they do not he/she should provide them with a copy of the IRB-appropriate template (see below) and the link to the OHRP website [|(http://www.hhs.gov/ohrp/assurances/assurances_index.html]). 2. If a site does not have a registered IRB and the site requests to use UWM’s IRB as the IRB of Record, the Principal Investigator is responsible for obtaining appropriate local authorization. **Contact the IRB** **office.** UW-Milwaukee New Study Application Form Institutional Review Board v. 1.5 Page 5 of 11 March 2, 2009 **E1. Describe the location(s) where the study will take place.** The location should not be limited to interventions but also take into account recruitment, enrollment, data storage, and data analysis. For example: recruitment at nursing homes, chart reviews at Froedtert Hospital, data storage at UWM Engelmann Hall 270, etc. Courses from the University of Wisconsin-Milwaukee in several departments, including English, Visual Art, Business Administration, Foreign Languages, Health Sciences, and Education. **E2. List any other IRB, review committee, or institutional permission needed for this study and explain** **the status for each. Attach appropriate approval letters.** For example, “This study has also been submitted to MATC’s IRB and is awaiting approval. Milwaukee Public School’s Research Committee has already approved. Dr. Smith, the professor of Pych 101 has given me her permission to survey her class (see email correspondence Appendix G).” N/A **SECTION F: Study Duration** **F1. What is the expected start date?** //No study related activities (e.g., screening, recruitment, or enrollment)// //can begin until IRB approval has been granted. Format: January 25, 2007//December 1 st, 2009 **F2. What is the expected end date?** //Expected end date should take into account data analysis, queries, and// //paper write-up. Format: July 1, 2009//December 1 st, 2010 **SECTION G: Subject Population** **G1. Does the study involve direct human subject participation?** Place an “X” next to the appropriate response. **[XX] Yes** **[__] No (e.g., secondary data analysis)__** __**G2. State the subject group and total number to be enrolled for each group**. For example, teachers-50, students-200, parents-25, parent’s children-25, student control-30, student experimental-30, medical charts-500, dataset of 1500, etc. If this is a multi-center study, enter the total number of subjects to be enrolled for UWM. Total enrollment from all sites should be explained in the Protocol Summary Form. **Subject Group** **Number** Students 250 Faculty 25 UW-Milwaukee New Study Application Form Institutional Review Board v. 1.5 Page 6 of 11 March 2, 2009 **TOTAL:** 275 **G3. This study involves** (place an “X” next to all that apply) **…****[**__**]** a. Not Applicable (e.g., de-identified datasets) **OR** **[XX]** b. Students of PI or study staff **[XX]** c. Students to be recruited in their educational setting, i.e. in class or at school. **[XX]** d. UWM Staff or Faculty **[__]__** __e. Minors **[**__**]** f. Priso ners **[__]__** __g. Diag nosable Psychological Disorder **[**__**]** h. Institutionali zed **[__]__** __i. Poor/uni nsured **[**__**]** j. Pregn ant women **[__]__** __k. Fet uses **[**__**]** l. Nursing home residents recruited in the nursing home **[__]__** __m. Cognitively impaired **[**__**]** n. Psychiat rically impaired **[__]__** __o. Limited or non-readers **[**__**]** p. Wards of the state (e.g., foster children) **[__]__** __q. Terminally ill **[**__**]** r. Others vulnerable to coercion (Specify in the box below): **[__]__** __s. Other subjects not requiring special protections **[**__**]** t. Other (Specify in the box below) : **SECTION H: Study Involvement** **Section Notes…**  Internet Research is subject to additional guidelines. See IRB website. **H1. This study involves** (place an “X” next to all that apply) **…****[__]__** __a. Datas ets **[**__**]** b. Interviews /Focus Groups **[XX]** c. Que stionnaires/Surveys **[__]__** __d. Observation s **[**__**]** e. Videotapin g **[__]__** __f. Audiotapin g **[**__**]** g. Photography **[__]__** __h. Internet research **[**__**]** i. Records Review (e.g., medical, educational tests/scores, etc.) **[__]__** __j. Collection of Blood/ Blood Products **[**__**]** k. Geneti c Material **[__]__** __l. Diagnostic imaging (e.g., MRI, fMRI, X-Rays, etc.) UW-Milwaukee New Study Application Form Institutional Review Board v. 1.5 Page 7 of 11 March 2, 2009 **[**__**]** m. Exposure to psychological stress **[__]__** __n. Surge ry **[**__**]** o. Electri cal Shock **[__]__** __p. Chemical or Biological Agent (clinical) **[**__**]** q. FDA for “off label” use **[__]__** __r. Investigational New Device (clinical) **[**__**]** s. Investigational Drug Exemption (clinical) **[__]__** __t. Other invasive procedure (Specify in the box below): **SECTION I: Informed Consent Documents/ Assents** **I1. How will the consenting of subjects take place?** (place an “X” next to all that apply) **…****[XX]** a. Written informed consent with the subject’s or legal representative’s signature. Use IRB Template and attach to IRB submission. **Go to Section M****[**__**]** b. Waiver to obtain informed consent. E.g., dataset or chart study. **Complete Section J****[__]__** __c. Waiver to alter the required elements of the informed consent document. E.g., survey conducted over the telephone, short form of the consent. **Complete Section J and Section K**. **[**__**]** d. Waiver to document informed consent. E.g., informed consent process if done verbally. **Complete** **Section k**. **[__]__** __e. Assent for minors. Use IRB Template. **Complete Section L**. **SECTION J: Request to Waive Informed Consent/ Request to Alter Informed Consent** **Section Notes…**  Complete this section if you are requesting a Waiver to Obtain Consent or requesting to Alter Informed Consent.  Skip this section if you are **not** requesting a Waiver to Obtain Consent or requesting to Alter Informed Consent.  Answer all A’s **OR** all B’s **J1. Answer A’s OR** **B’s** **[**__**] A1.** The research or demonstration project is to be conducted by, or subject to the approval of, state or local government officials, and is designed to study, evaluate, or otherwise examine: (i) public benefit or service 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; and **Explain:****[__] A2.__** __The research could not practicably be carried out without the waiver or alteration. **Explain:** **[**__**] B1.** The research involves no more than minimal risk to the subjects; **Explain:** UW-Milwaukee New Study Application Form Institutional Review Board v. 1.5 Page 8 of 11 March 2, 2009 **[__] B2.__** __The waiver or alteration will not adversely affect the rights and welfare of the subjects; **Explain:** **[**__**] B3.** The research could not practicably be carried out without the waiver or alteration; and **Explain:** **[__] B4.__** __Whenever appropriate, the subjects will be provided with additional pertinent information after participation. **Explain:** **SECTION K: Request to Waive Documentation of Informed Consent** **Section Notes…**  Complete this section if you are requesting a Waiver to Document Informed Consent. o I.E., the research participant is not signing the consent form.  Skip this section if you are **not** requesting a Waiver to Document Informed Consent.  Answer all A’s **OR** all B’s o If A1, A2, or A3 is marked “No”, a request to waive documentation of informed consent cannot be granted. o If B1 or B2 is marked “Yes”, a request to waive documentation of informed consent cannot be granted. **K1. Answer A’s OR** **B’s** **A1.** If consent was documented, would the only record linking the subject and the research be the informed consent form? **[**__**] Yes** **[__] No__** __**A2.** If consent was documented, would the principal risk to the subject be the potential harm from a breach of confidentiality? **[**__**] Yes** **[__] No__** __**A3.** Will each subject be asked whether he/she wants documentation linking the subject with the research, and the subjects wishes will govern? **[**__**] Yes** **[__] No__** __**B1.** Does the research present more than minimal risk of harm to subjects? **[**__**] Yes** **[__] No__**__ UW-Milwaukee New Study Application Form Institutional Review Board v. 1.5 Page 9 of 11 March 2, 2009 **B2.** Are any procedures involved for which written consent is normally required outside of the research context? **[**__**] Yes** **[__] No__** __**SECTION L: Assent for Minors** **Section Notes…**  Permission (consent) of a parent or legally authorized representative must be obtained. Under certain limited conditions it may be possible for the minor to consent on her/his own behalf, without the need for parental permission. For example research concerning neglect and abuse. **L1. The assent will be for** (select all that apply): **[**__**]** a. Minors who are not wards of the state or other agency **[__]__** __b. Minors who are wards of the state or other agency **SECTION M: Subject Incentives/ Compensations** **Section Notes…**  If you intend to submit to the Travel Management Office for reimbursement purposes make sure you understand what each level of payment confidentiality means **(click here for additional** **information****).**o **Level 1:**  The payee's name, address, and social security number and the amount paid must be recorded.  When Level 1 is selected, a formal notice is not issued by the IRB and the Travel Management Office assumes Level 1.  Level 1 payment information will be retained in the extramural account folder at UWM/Research Services and attached to the voucher in Accounts Payable. These are public documents, potentially open to public review. o **Level 2:**  A list of names, social security numbers, home addresses and amounts paid.  When Level 2 is selected, a formal notice will be issued by the IRB.  Level 2 payment information, including the names, are attached to the PIR and become part of the voucher in Accounts Payable. The records retained by Accounts Payable are not considered public record. o **Level 3:**  Payments are made to the research subjects by either personal check or cash.  Gift cards are considered cash.  If a cash payment is made, the PI must obtain signed receipts.  The PI shall maintain a record of the research subject's name and corresponding coded identification. This will be the only record of payee names, and it will stay in the control of the PI. **M1. Does this study involve incentives or compensation to the subjects? For example cash, class extra** **credit, gift cards, or items.****[XX] Yes** **[**__**] No** **M1a. If applicable, select the appropriate confidentiality level for payments (see section notes):** **[__] Level 1__** __indicates that confidentiality of the subjects is not a serious issue, e.g., providing a social security number or other identifying information for payment would not pose a serious risk to subjects. UW-Milwaukee New Study Application Form Institutional Review Board v. 1.5 Page 10 of 11 March 2, 2009 **[**__**] Level 2** indicates that confidentiality is an issue, but is not paramount to the study, e.g., the participant will be involved in a study researching sensitive, yet not illegal issues. For example, a study of individuals with contagious diseases would fall into this category. **[__] Level 3__** __indicates that confidentiality of the subjects must be guaranteed. In this category, identifying information such as a social security number would put a subject at increased risk. An example of this type of study would be any research involving illegal activity. **SECTION N: HIPAA and Protected Health Information (PHI)** **What is it?** The Health Information Portability and Accountability Act (HIPAA) Privacy Rule is Federal legislation which regulates the way certain health care groups, organizations, or businesses, handle the individually identifiable health information known as **protected health information (PHI)**. The Privacy Rule establishes the conditions under which covered entities can use or disclose PHI for many purposes, including for research. Researchers seeking to use PHI from a UWM Covered Department or an external covered entity as part of their research study must comply with HIPAA. Compliance typically requires either obtaining a HIPAA Authorization during the informed consent process or obtaining a Waiver of such Authorization from the IRB. **What is PHI?** Protected health information **(PHI)** includes information relating to an individual's past, present or future physical or mental health or condition, the provision of health care services or the past, present or future payment for such services. It only covers information that is individually identifiable. There are 18 identifiers under the Privacy Rule, some of which include: names, dates, geographic locations, telephone numbers, medical record numbers, account numbers, biometric identifiers, and other unique identifying number or code. **What are UWM’s Covered Departments?** UWM is considered a "hybrid entity" under HIPAA because it has some departments and units that are covered by HIPAA and some that are not. All employees and volunteers in UWM's Covered Departments must comply with the Privacy and Security Rules, including in connection with research. UWM's Covered Departments are currently comprised of the following entities: A. Provider Units: 1. Athletics Trainers (Division of Student Affairs) 2. Hearing Evaluation Center ( College of Health Science) 3. Norris Student Health Center (Division of Student Affairs) 4. Psychology Clinic (College of Letters and Sciences) 5. Speech and Language Clinic ( College of Health Sciences) 6. Urban Health Partnerships ( College of Nursing ) B. Administrative Units: 1. Bursar's Office (Division of Finance & Administrative Affairs) 2. IT Personnel in Business & Financial Services (Division of Academic Affairs) 3. Information and Media Technologies (I&MT) (Division of Academic Affairs) 4. Institutional Review Board Members and Administrative Staff (Division of Finance & Administrative Affairs) 5. Internal Audit (Division of Finance & Administrative Affairs) 6. Office of Legal Affairs (Division of Finance & Administrative Affairs) 7. Risk Management (Division of Finance & Administrative Affairs) 8. Privacy Officers **How do I know if I am using PHI as part of my research study and have to comply with HIPAA?** If you answer “yes” to any of the below questions, you are using PHI: Are you accessing or using a participant’s health information from a UWM Covered Department or an external UW-Milwaukee New Study Application Form Institutional Review Board v. 1.5 Page 11 of 11 March 2, 2009 covered entity (such as a hospital, clinic or other health care agency)? Are you conducting research in connection or collaboration with an entity covered by HIPAA? Are you using information from a database that was created using health care information obtained by a UWM Covered Department or external covered entity? Note: If you are asking a participant to self-report his medical history outside a clinical/hospital setting and do not wish to see his/her medical record, you do not need to obtain the required HIPAA Authorization or Waiver unless you answer “yes” to one of the above questions. If you answered yes to any of the questions above, you must either obtain either an “Authorization Form for Research For the Use and Disclosure of Patient Health Information” from your Research Participants or IRB approval of an “Application for IRB Waiver of Authorization or Altered Authorization under the HIPAA Privacy Rule.” [|You also must complete online HIPAA training at www.hipaa.uwm.edu.]**Who do I contact to for more information on this?** Contact the UWM Office of Legal Affairs ( https://www4.uwm.edu/legal/hipaa/ ) **SECTION O: Investigator Assurances** **//As Principal Investigator, I certify the following://**  I have reviewed this protocol submission and acknowledge my responsibilities as Principal Investigator.  The information in this submission accurately reflects the proposed research.  I will not initiate this study until I receive written approval from the IRB.  I will promptly report to the IRB any unanticipated problems and adverse events, as well as any findings during the course of the study that may affect the risks and benefits to the subjects.  I will obtain prior written approval for modifications (amendments) to this protocol including, but not limited to, changes in procedures.  I have completed the UWM Human Subjects Training Module.  I have determined whether or not I am accessing protected health information as part of my proposed research, and if so, I accept responsibility for assuring adherence to HIPAA.  If I am using PHI in my research, I have visited the UWM HIPAA Training website [|(www.hipaa.uwm.edu) and have completed all required training, and I am complying with]HIPAA’s requirements for researchers.  I accept responsibility for assuring adherence to applicable Federal and State research regulations and UWM polices relative to the protection of the rights and welfare of the subjects enrolled in this study.  I understand that the UWM IRB operates under a Federal Wide Assurance (FWA) from the Department of Health and Human Services.  Unless given Exempt Status, I understand that this study is subject to continuing review and approval by the IRB.__ __Principal Investigator (PRINT NAME) Princi pal Investigator (SIGNATURE)__ __ DATE DATE UW-Milwaukee Protocol Summary Institutional Review Board v1.3 Page 1 of 4 January 23, 2008 **Protocol Summary** **Instructions:** In order to review research involving human subjects, the UWM IRB requires the completion and submission of the New Study Application Form and a Protocol Summary. The following guidelines are designed to help researchers develop a comprehensive yet concise research protocol to facilitate timely review by the IRB. Please note, Capstone, thesis, dissertation, grant, and funding proposals cannot be submitted as, or in lieu of, this Protocol Summary as they do not contain all the required information (45CFR46). Each Section must be completed unless directed otherwise. Incomplete forms will delay the IRB review process and may be returned to you. Enter your information in the **colored boxes**. The boxes will expand as you type. **SECTION A: Title and Date** Note that the study title must be the same on all study documents (e.g., consents, advertisements, grants, etc.). If not, a reason must be given in the Protocol Summary Form Section I. **A1. Project Title**: Exploring the Impact of ePortfolios on Student Success **A2. Today’s Date:** November 13 th, 2009 **SECTION B: Project Purpose/ Research Question/ Objectives** **In non-technical language, address the following:** **1)** Area of the research **2)** Describe the purpose/objective **3)** Significance of the research is **4)** Any relevant literature pertaining to the proposed research study 1) Educational Technology 2) Specifically, in this project, we will explore the impact of ePortfolios, which are used to gather students’ work products to showcase their success with their instructors, potential employers, and graduate admissions directors, on student satisfaction and success. We will explore students’ perceptions of satisfaction with the ePortfolio in successfully gathering materials and showcasing their learning and performance with others. We will also explore faculty members perception, including their satisfaction, of the ePortfolios on student success. 3) The research will assist us in evaluating the effective of ePortfolio for students and faculty leading to a broader implementation of the tool, if the research deems it is appropriate. 4) Batson, T. (2007, December 12) “The ePortfolio Hijacked,” Campus Technology, []Belanoff, P. & Dickson, M. (Eds.). (1991). Portfolios: Process and product. Portsmouth, NH: Boynton/Cook Publishers, Inc. Cambridge, B.L. (2001). Electronic portfolios as knowledge builders. In B.L. Cambridge (Ed.), Electronic portfolios: Emerging practices in student, faculty, and institutional learning. Washington, D.C.: American Association for Higher Education. Cambridge, B.L. (Ed.). (2001a). Electronic portfolios: Emerging practices in student, faculty, and institutional learning. Washington, D.C.: American Association for Higher Education. Chen, H.L. (in press). Using ePortfolios to support lifelong and lifewide learning. In D. Cambridge, B. Cambridge, K. Yancey (Eds.), Electronic Portfolios 2.0: Emergent Findings and Shared Questions. Sterling, UW-Milwaukee Protocol Summary Institutional Review Board v1.3 Page 2 of 4 January 23, 2008 VA: Stylus. Chen, H.L., & Mazow, C. (June 16, 2002). Electronic Learning Portfolios in Student Affairs, Net Results, []Hamp-Lyons, L. and Condon, W. (1998). Assessing the portfolio: Principles for practice, theory, and research. Cresskill, NJ: Hampton Press. [|Quinion, Michael. (November 28, 1998) “World Wide Words” http://www.worldwidewords.org/topicalwords/tw-]por1.htm Waters, John K. (2007, October 1) “ePortfolios Meet Social Software,” Campus Technology, []**SECTION C: Recruitment and Consent/Assent** **Describe the following:** **1)** How the **recruitmen**t will take place. E.g., through flyers, beginning announcement for X class, referrals, random telephone sampling, etc. **2)** **Inclusion** criteria. E.g., age, gender, health status/condition, ethnicity, location, English speaking, etc. **3)** **Exclusion** criteria. E.g., age, gender, health status/condition, ethnicity, location, English speaking, etc. **4)** How **consent/assent** will take place. E.g., in person, online web survey, “request to waive consent” as this is secondary data analysis only, etc. a. If participants do not speak English as a first language or might have trouble comprehending the consent, describe the process for obtaining consent (e.g., translated consent, verbal consent, etc.). 1) Recruitment will take place through the courses where instructors have nominated themselves as part of this ePortfolio pilot. 2) Students and faculty member that are 18 years are older and have participated in a course that utilized ePortfolios. 3) No participants will be excluded unless they are under 18 and did not complete a course learning activity using ePortfolios 4) Online web survey will include an item to verify consent. **SECTION D: Data Collection and Design** **In non-technical language, address the following:** **1)** Chronologically state the **study activities**. Describe both the activities conducted by the PI and the research participants. (E.g., screening, survey, taking a test, answering questions in an interview, completing a specific task, tasks on a computer, running on a treadmill, debriefing, etc.). If videotaping, photographs, or audiotaping will take place, explain for what and why. **2)** Explain how the **data will be analyzed** or studied (i.e. quantitatively or qualitatively) and how the **data** **will be reported** (i.e. aggregated, anonymously, pseudonyms for participants, etc.). 1) Subjects will be recruited faculty solicitation via class announcements and an e-mail. Subjects will complete survey online. PI will download and analyze response using quantitative and qualitative methods. 2) Relationships between variables will be identified using univariate and multivariate statistics. Thematic analysis of open-ended questions will be performed. Data will be reported in aggregated form for quantitative data. Qualitative data will be reported using pseudonyms. **SECTION E: Risks to Subjects** UW-Milwaukee Protocol Summary Institutional Review Board v1.3 Page 3 of 4 January 23, 2008 **Research risk is the probability of harm occurring as a result of participation in research. In non-****technical language, address the following:** **1)** The types of risks (e.g., physical, psychological, social, economic, legal, etc.) the subject may **//reasonably//** encounter. **2)** Identify the **frequency/likelihood** of those risks. **3)** Describe the **procedures/process** which will reduce or minimize risks: a. How the data will be safeguarded (e.g., data is anonymous, assigning pseudonyms, coded, etc.). b. Where data will be stored and who will have access to it. c. What will happen to the data after the study is complete. b. What happens if the participant gets hurt or upset? E.g., referred to Norris Health Center, PI will stop the interview, given telephone hotlines for abuse, etc. 1) There are no known risks to participants. 2) None 3) The data is anonymous. It be stored in a secure electronic database that is password protected. **SECTION F: Benefits** **1)** **Describe any direct benefits** participants could potentially receive **.** If there are no direct benefits, explain. **2) Explain how the risks compare to benefits.****3) If monetary or gift compensation will be given to subjects, explain:**d. In what form (i.e., cash, check, pens, etc.,). e. The amount or approximate value. f. When the participant will receive the item (e.g., $5 after completing each survey, subject will receive [item] even if they do not complete the procedure). **4) If extra credit will be offered, explain:** a. If an alternative task that is not study related will be offered for the same extra credit. b. If the task is a class requirement/assignment that students would be required to complete even if the study was not being conducted. 1) Direct benefits include a new tool to help students consolidate and showcase their course work to help them gain employment and access to graduate school. 2) There are no risks. 3) None, just extra credit. 4.) Faculty will give extra credit to students that complete the survey. It is not a requirement that they would be required to complete. The offering of alternative extra credit is at the instructors discretion. The PI will give the faculty members a list of ePanther IDs for those that completed the survey. **SECTION G: Deception/ Incomplete Disclosure (INSERT “NA” IF NOT APPLICABLE)** **If you cannot adequately state the true purpose of the study to the subject in the informed consent,** **deception/ incomplete disclosure is involved.** **1)** Describe the deception/ incomplete disclosure of information to the subjects. **2)** Explain why such deception/ incomplete disclosure is necessary. **3)** Explain the debriefing process, or explain why there will not be a debriefing process. 1) NA 2) NA UW-Milwaukee Protocol Summary Institutional Review Board v1.3 Page 4 of 4 January 23, 2008 3)NA **SECTION H: Conflicts of Interest** When researchers are involved with commercial ventures, there is the potential for diverting from their primary mission of research and education. Conflicts of interest can arise when the interests of the commercial venture differ from the interests and primary obligations of the researcher, or when the commercial venture consumes an undue share of employee time. Contact the Graduate School Research Services and Administration for more information. **Reminders:** 1. Make sure all questions that are applicable have been answered on this form. 2. Responses should be consistent with other forms (e.g., New Study Submission Form, Consent Form, etc.). Informed Consent Information I am Tanya Joosten at the University of Wisconsin-Milwaukee. I am conducting a study of how ePortfolios impact students. I would appreciate your participation in this study, as it will assist us in making recommendations for implementing ePortfolio on our campus. If you agree to be in this study, you will be asked to fill out an online survey about your experience using ePortfolio for your course(s) that will take 20 minutes to complete. There are no known risks associated with your being in the study. Possible benefits are that you will have a voice in helping shape the instruction that other students receive and will contribute to the literature on ePortfolios. The survey you fill out will be treated confidentially. YOUR NAME WILL NOT BE LINKED IN ANYWAY TO YOUR SURVEY RESPONSES. Data from this study may be published in professional journals. Only grouped data will be presented or published. As an online participant in this research, there is always the risk of intrusion by outside agents, i.e., hacking, and therefore the possibility of being identified. By checking the box below, you are stating that you are at least of 18 years of age and understand that any information about you will be treated in a confidential manner and that the data collected and the results obtained will be used for research purposes only. Your personal information will never be used to report any results of the projects. You understand that the records and data files related to this research project will be maintained in the UWM Learning Technology Center for a period no longer than ten years and that only personnel directly associated with this project will have access to them. You understand that you may refuse to participate in this study or withdraw at any time without penalty. You understand that you may be withdrawn from this study by the investigators if you do not meet the screening criteria. You understand that, should you withdraw or be withdrawn from the study, any information that you have provided will be destroyed. This study has been explained to you and your questions have been answered. If you have additional questions, you may contact the principal investigator: Once the study is completed, we would be glad to give the results to you. In the meantime, if you have any questions, please contact me: Tanya Joosten Acting Associate Director Learning Technology Center University of Wisconsin-Milwaukee PO Box 604 Milwaukee, WI 53201 tjoosten@uwm.edu 414.229.4319 I understand that if I have any complaints about my treatment in this study I may call or write: Institutional Review Board Human Research Protection Program Department of University Safety and Assurances University of Wisconsin – Milwaukee P.O. Box 413 Milwaukee, WI 53201 (414) 229-3173 Survey **PART 1: Likert Survey Items** //**Note: The following items would be randomized the survey. The reverse coded items**// **//are noted by (r) and are required to increase the reliability of this instrument. The// //headings in bold are specific to the variable they are measuring. Some of the survey// //items are taken from proven reliable surveys and are otherwise grounded in research// //examined. Once the survey is administered, I will run a factor analysis to make sure the// //items factor to their corresponding variable. Multiple regression will be run to analyze// //relationships between variables.// Sample instructions: The following statements address different aspects of your experience in taking a course that uses a student response system or clickers. For each of the statements, please enter 5 if you strongly agree with the statement with a range to 1 if you strongly disagree with the statement. (5) Strongly Agree | (4) Agree | (3) Neutral | (2) Disagree | (1) Strongly Disagree** ePortfolio – Communication **Sharing Work The dashboard allowed me to receive material sent by my instructor The dashboard allowed me to receive invitations to review others’ work The ePortfolio helped me successfully share my work with others. I liked being able to share my presentations. Sharing my presentations was useful. The presentations allowed for individuality. Receiving material sent by my instructor in my ePortfoliow was helpful. I liked receiving invitation to receive others’ works. I reviewed other student’s work. I left comments when reviewing other student’s work. I liked being able to share my reflections. Feedback The dashboard allowed me to receive recent comments left by peers Reflections allowed me to better understand what I had learned. Sharing my presentations allowed me to receive feedback on my work. Feedback on my artifacts was useful. Feedback on my collections was useful. The feedback I received on my presentations was useful. Being able to receive comments left by my peers helped me improve my ePortfolio. Receiving comments left by my peers made me feel confident with my work. I liked receiving comments on my reflections. ** ePortfolio - Organization of Work **The ePortfolio successfully stored the artifacts I created. The ePortfolio helped me organize my work. The tags helped me organize my work and find things quickly. I like that artifacts could be different kinds of materials, such as videos, presentations, pictures or documents I liked that I was able to control how my presentation looked.** General Satisfaction with ePortfolio **(Support, Use, Training, Fun, Overall)** Support **My instructor was able to answer any questions I had about using the ePortfolio My instructor did not answer my questions about using the ePortfolio (r) Technical support was available when I needed it I needed better technical support with the ePortfolio (r)** Ease of Use **Accessing the ePortfolio was easy I had few problems using the ePortfolio Using the ePortfolio was confusing (r) I found it easy to use the ePortfolio Using the ePortfolio in class was simple I had difficulty using the ePortfolio (r)** Training **The introductory explanations on how to use the the ePortfolio were clear and sufficient After the introduction, I still wasn’t sure how to use the ePortfolio (r)** Fun **Using the ePortfolio was fun Using the ePortfolio as a way of getting feedback on my work is exciting The ePortfolio was annoying (r) I really enjoyed using the ePortfolio** Overall Effectiveness **I was satisfied with using the ePortfolio The dashboard in the ePortfolio easy to use. The ePortfolio’s search engine was helpful. Overall, I am happy with using the ePortfolio Using the ePortfolio in a course is a waste of time (r) I would take another course that used the ePortfolio I will avoid classes using the ePortfolio in the future (r) I would recommend that the instructor continue to use the ePortfolio I would hope the instructor would think twice about using the ePortfolio in the future (r) I would recommend this course to others I would not recommend this course to a classmate (r)** Perceived Learning **The ePortfolio was beneficial to my learning. The ePortfolio had little impact on my learning. (r) The ePortfolio helped me to better understand what I had learned. The ePortfolio did not help me understand my progress in the course. (r) Using the ePortfolio helped me think more deeply about course materials. My ePortfolio helped me understand the course material. My ePortfolio helped me get feedback on my work. My ePortfolio helped me identify ways to improve. The clickers made it easy to connect ideas together. My ePortfolio did not provide helpful feedback on my work. ®** Perceived Performance **Using the ePortfolio helped me get a better grade in this class The ePortfolio made it difficult for me to get a good grade in this class (r)** PART II: Open-ended Questions //Note: Placed at the end of the survey and to be coded for thematic analysis// What did you like best about your experience using the ePortfolio in this class? What were some barriers to your use of the ePortfolio in this class? If you could fix one thing about the use of the ePortfolio, what would it be? Would you recommend this course to others, if it used the ePortfolio? Why or Why not?