Application and Informed Consent Forms Must Be Submitted in a Word Document
IRB#:
Application for Approval for Research Involving Human SubjectsREQUEST FOR EXEMPTION
SUBMISSION PROCEDURES
- Investigator must submit most recentapplication, signature page, and any accompanying documents via email to
- Application and informed consent forms must be submitted in a Word document
- The Principal Investigator (PI) must be a faculty or academic professional staff member employed by Chapman University. Please check herefor PI eligibility.
- Student-Directed projects require a faculty advisor to serve as Principal Investigator
- All research applications require the approval of the Principal Investigator’s department chair or supervisor
☐ New Application / ☐ Continuing Research / IRB# / Previous IRB # (If continuing) /
Project Title:
/Project Title
/Submission Date:
/XX/XX/20XX
/Proposed Start Date:
/XX/XX/20XX
/Externally Funded?
/☐Yes☐No
/Study Sponsor:
/Study Sponsor
/Award #
/Award #
/Chapman Principal Investigator: (see “Submission Procedures” above)
☐ / This is a Student-Directed Project and I am serving as Faculty Advisor
Name:
/PI Name or Faculty Advisor
/Email:
/Institute/Center/Department:
/Institute/Center/Department
/School/College:
/Choose or type a School/College...
/Phone:
/Phone Number
/Role:
/Choose an item
/Access to Subjects?
/Y or N
/Training Completed?
/Choose or type
/Student Investigator: (see “Submission Procedures above”)
☐ / Graduate / ☐ / Undergraduate / Program/Major: / Program/Major /
Name:
/Undergraduate Co-Investigator
/Email:
/Institute/Center/Department:
/Institute/Center/Department
/School/College:
/Choose or type a School/College...
/Phone:
/Phone Number
/Role:
/Choose an item or type
/Access to Subjects?
/Y or N
/Training Completed?
/Choose or type
/Materials and Procedures for Proposed Project. Check all that apply.
CONSENT FORMS:
☐ Informed consent (18+) / ☐ Child assent form / ☐ Passive consent (waiver of written consent)
INTERVIEW(S):
☐ Simple / ☐ Audio-Recorded Interview / ☐ Video-Recorded Interview
SURVEY(S)/QUESTIONNAIRES(S) How will it be administered?
☐ Written / ☐ Computer-Administered / ☐ Web-Administered
Additional procedures include:
☐ Access to personally identifiable information or decoded identification
☐Vulnerable population (prisoners, children, pregnant women, diminished capacity)
☐ Video-Recorded Procedure(s). Please describe: Click here to enter text.
☐ Deception
☐Recruitment Advertisement(s)
Any other supplementary documentation. Please describe:
Click here to enter text.
Research Dissemination Plan: Please check the manner in which the results from this research will be shared:
☐ In-class assignment
☐ Thesis ☐ Dissertation ☐ Other Click here to enter text.
☐ Chapman University’s Student Research Day
☐ External conference
☐ Journal and/or other scientific publication
☐ Clinical Applications
☐ Other:
Describe other plan for sharing research results
RESEARCH TEAM:
List all remaining members of the research team, including their current contact information, role on the project, training and access to Human Subjects. All researchers who have access to human subjects (listed as Y for Access to Subjects in the tables below) should be listed on the informed consent document. Please attach another sheet if necessary.
Chapman Researchers
Name / Email / Phone / Role / Access to Subjects? / Training (CITI, NIH, Other)
Name / Email / Phone / Choose or type / Y or N / Choose or type /
Name / Email / Phone / Choose or type / Y or N / Choose or type /
Name / Email / Phone / Choose or type / Y or N / Choose or type /
Name / Email / Phone / Choose or type / Y or N / Choose or type /
Name / Email / Phone / Choose or type / Y or N / Choose or type /
Name / Email / Phone / Choose or type / Y or N / Choose or type /
Name / Email / Phone / Choose or type / Y or N / Choose or type /
Name / Email / Phone / Choose or type / Y or N / Choose or type /
Name / Email / Phone / Choose or type / Y or N / Choose or type /
Name / Email / Phone / Choose or type / Y or N / Choose or type /
Non-Affiliated Researchers (Non-Chapman Team members)
Name / Institution / IRB Approval? / Email / Phone / Role / Access to Subjects?
Name / Institution / Y or N / Email / Phone / Choose or type / Y or N
Name / Institution / Y or N / Email / Phone / Choose or type / Y or N
Name / Institution / Y or N / Email / Phone / Choose or type / Y or N
Name / Institution / Y or N / Email / Phone / Choose or type / Y or N
Name / Institution / Y or N / Email / Phone / Choose or type / Y or N
DISCLOSURE OF FINANCIAL INTEREST FOR ALL KEY PERSONNEL:Chapman University’s Financial Disclosure Policy for All Personnel Conducting Research requires that faculty conducting research involving human participants must disclose known significant financial interests. If the interest is deemed to constitute a conflict of interest with the proposed research, the conflict must be managed prior to the faculty member’s research with human participants. All personnel responsible for the design, conduct, or reporting of externally funded research (each, an “Investigator”) are required to disclose to Chapman’s Conflict Officer (the “CO”), or designee, all “Significant Financial Interest” of the Investigatorand/or the Investigator’s spouse, partner, parents, dependent, children, and any other relative or close associate if residing in the same households as the Investigator. Significant financial interests include, but are not limited to:
- An equity interest in an external entity that, when aggregated over the past 12 months and expected over the next 12 months exceeds $5000 in value, or represents more than 5% ownership interest.
- Salary, royalties, or other payments from an external entity that, when aggregated over the past 12 months and expected over the next 12 months are expected to exceed $5000.
☐Yes ☐No / Is there a conflict of interest? If “Yes”, please answer the following 3 questions. If “No”, move on to the Assurance Statement & Signature Page.
☐Yes ☐No / 1. Have you and all key personnel disclosed all significant financial interests (as described in Chapman’s policy) that are reasonably related to this research project?
☐Yes ☐No / 2. Do any of the investigators, their spouses/partners, parents, dependents, children, or other relative/close associate living in the household as the investigator have any significant financial interests that are reasonably related to this research?
☐Yes ☐ No / 3. Do any of the investigators, their spouses/partners, parents, dependents, children, or other relative/close associate living in the household as the investigator have any personal financial interest or commitment with any company or entity that sponsors or supports this research?
IMPORTANT: If you answered “Yes” to either #2 or #3, please contact Chapman’s Conflict Officer (“CO”) for guidance on next steps regarding disclosure, review of the financial interest and resolution of any real or apparent conflict of interest. The IRB is not able to review this project until it has been determined by the CO that no investigator involved in this research activity has a conflict of interest related to this research.
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Chapman University – Uptd.3.17.2017
IRB#:
PAGE INTENTIONALLY LEFT BLANK
PLEASE DOWNLOAD THE SEPARATE SIGNATURE PAGE FROM THE WEB
AND
SUBMIT IT AS AN ATTACHMENT WITH THIS APPLICATION
☐ / 1.) Research conducted in established educational settings, involving normal educational practices such as:
- Research on regular and special education instructional strategies
- Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
☐ / 2.) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, UNLESS:
- information obtained is recorded in a such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; AND
- 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.
☐ / 3.) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, or observation of public behavior that is not exempt under the above paragraph, IF:
- the human subjects are elected or appointed public officials or candidates for public office; OR
- federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
☐ / 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 (code keys) linked to the subjects.
☐ / 5.) Research and demonstration projects that are conducted by or subject to the approval of federal department or agency heads, and that are designed to study, evaluate, or otherwise examine:
- public benefit or service programs;
- procedures for obtaining benefits or services under those programs;
- possible changes in or alternatives to those programs or procedures; OR
- possible changes in methods or levels of payment for benefits or services under those programs.
☐ / 6.) Taste and food quality evaluation and consumer acceptance studies,IF:
- wholesome foods without additives are consumed; OR
- a food is consumed that contains a food ingredient, agricultural chemical or environmental contaminant at or below the level found to be safe as deemed by the FDA, EPA or the FSIS of the USDA.
If your research does not fall into any of the six categories above, your research may not qualify for Exempt Status and you will need to apply for Expedited or Full Review instead. The form for Expedited/Full Review can be found at If you have any questions, please contact the IRB at or 714-628-2833 or consult the current IRB Chair.
EXEMPTION CERTIFICATION RESEARCH DESCRIPTION
1. NON-TECHNICAL SUMMARY: Briefly describe the nature and purpose of the research, including why the question is important and how your study will attempt to answer it. Include how your literature review supports this. Do not include methodology here, see section 6 for Methodology.Non-Technical Summary /
2. RESEARCH OBJECTIVES: Briefly list your research objectives.
Research Objectives /
3. STUDY POPULATION: Describe the characteristics of the subject population, such as anticipated number, age range, gender, ethnic background and health status of the subjects. If you have multiple participant groups,describe each group separately (i.e. teachers and students).
Study Population /
4. SUBJECT RECRUITMENT:
4A.)Please check ALL recruitment methods that apply below:
Passive Recruitment (potential subjects initiate contact with study team):
☐ Chapman University IRB approved advertisement, flyers, notices and/or media will be used.
☐ An existing Chapman University human subject pool will be used.
Specify Subject Pool: / Subject Pool /
☐ Other method(s): / Other Passive Recruitment Method(s) /
Active Recruitment (Researchers contact potential subjects):
☐ Study team will recruit potential subjects who are unknown to them (e.g. convenience sampling, use of social
networks, direct approach in public situations, random digit dialing, etc.)
☐ Study team members will contact potential subjects who have provided permission to be contacted for
participation in future research studies
☐ Study team members will notapproach their own patients, students, employees for participation in the study
(participants will be recruited from classes other than team member’s own class)
☐ Other method(s): / Other Active Recruitment Method(s) /
4B.) SUBJECT RECRUITMENT PROCESS: Please describe the details of the recruitment process (i.e. when, where, by whom and how potential subjects will beapproached). If you will recruit by mail, email, or phone, explain how the potential subjects’ contact information will be obtained. If using active recruitment methods, explain how the individual’s privacy will be protected.
Describe Subject Recruitment Methods /
IMPORTANT: Attach a copy of ANY material that will be used to recruit subjects including but not limited to advertisements, flyers, telephone scripts, verbal recruitment scripts, etc.
5. PARTICIPANT COMPENSATION: If subjects will be compensated, provide detailed information about the amount and method/terms of payment (e.g. cash/check; extra credit; gift certificate), and describe the schedule of compensation (e.g. after each session; or on a prorated basis when multiple sessions involved). If no compensation will be provided, please check the box below.
☐ No compensation will be provided
Describe Participant Compensation /
6. RESEARCH METHODOLOGY/STUDY PROCEDURES: Provide a detailed chronological description of your research activities and methodologies/procedures involving human subjects.
Describe Research Methodology/Study Procedures /
7. INFORMED CONSENT: Please check all that apply below:
☐ Not Applicable – There will be no direct subject contact (e.g. archival/retrospective review). No consent process will
take place. (Please explain in the box below.)
☐ Written/signed consent WILL NOT be obtained – Informed consent, information will be provided (passive consent).
(Please explain in the box below.)
☐ Written/signed consent WILL be obtained – Signed informed consent, parental permission, and/or child assent
will be obtained from subjects as applicable. (Please explain in the box below.)
If there will be contact with subjects, specify the specific steps for obtaining informed consent, if applicable. Include information about when/where consent will take place and the length of time given to subjects to decide on participation. If children are involved in this study, describe the parental permission and child assent processes. If study team members will approach their own patients, students, or employees, explain the precautions to be taken to minimize potential undue influence or coercion, and how compromised objectivity will be avoided. Specify the process for obtaining HIIPAA authorization, if applicable.
Describe Informed Consent Process /
Non-English Speaking Participants:In order to consent subjects who are unable to read and speak English, the consent form must be translated into appropriate languages. (IRB approval and stamp is required for translated forms)
☐ / Not Applicable – Only English reading/speaking individuals are eligible for this study.
☐ / The English version of the consent form will be translated into appropriate languages. An interpreter will be involved in the consenting process. (Provide a letter from any translation services agency or verify who provided the translation and the individuals qualifications).
8. CONFIDENTIALITY OF RESEARCH DATA: Please complete sections 8A. – 8D. If research data includes subject identifiable information, the storage devices or research files must be encrypted or locked.
8A.) Explain how collected data will be identified:
☐ / No subject identifiers will be obtained (All data will be collected anonymously)
☐ / Names and other subject identifying information are obtained but are not shared with anyone except the study Staff (names will be changed/coded in the final analysis)
☐ / Names and other subject identifying information are obtained and potentially used in publications/presentations. (This will require separate written consent)
☐ Other (please specify): / Other Identification /
8B.) Explain the manner in which the data will be stored:
☐ Anonymous data only (i.e. no code key)
☐ Coded (de-identified) data with the code key kept in separate location. Key destroyed upon completion of the
research or (specify):
Specify key destruction timeframe
☐ Coded data with the code key kept in separate location. Key maintained beyond the completion of the research.
☐ Data includes subject identifiable information. (If electronic record/file, encryption software is required.)
☐ Other (please specify): / Other data storage method(s)
8C.) Explain how long subject identifiable research data will be retained:
☐ Not Applicable - No subject identifiers will be obtained
☐ Research records will be retained for seven years after all children enrolled in the study reach the age of
majority (based on state of subject residence) as this study includes children.
☐ Destroy once data collection is completed.
☐ Destroy after publication/presentation.
☐ Maintain indefinitely for future research.
☐ Maintain for future research (specify timeframe, e.g. 3 months, etc): / Specify timeframe /
☐ Other (specify): / Other data retention plan /
8D.) If audio or video recordings or photographs will be collected, specify the timeframe for the transcription and/or destruction of the recordings or photographs (separate consent is required):
☐ Not Applicable - No audio/video recordings or photographs will be collected.
☐ Audio or video recordings transcribed; specify timeframe: / Specify timeframe /
☐ Audio or video recordings destroyed; specify timeframe: / Specify timeframe /
☐ Audio or video recordings maintained indefinitely.
☐ Photographs destroyed; specify timeframe: / Specify Timeframe /
☐ Photographs maintained indefinitely.
Complete Section 9 below ONLY if you are applying for Exemption Category 4.
9. BIOSPECIMENS/DATASETS/RECORDS/CHARTS: For use with Exemption Category 4
9A.) Exemption Category 4 Eligibility:
☐Yes ☐ No1.) Will the investigators have interaction or intervention with subjects?
☐Yes ☐ No2.) Will investigators collect information that does not currently exist? (i.e. biospecimens that are not currently on the shelf or records thatdo not already exist as of the date of submission of this protocol)
☐Yes ☐ No3.) Is the information publicly available?
☐Yes ☐ No4.) If not publicly available, will investigators collect directsubject identifiers(subject name, address, SSN, or medical record number, etc);
OR will investigators have access to an indirect subject identifyingcode key linking subjects’ identities to the data or biospecimens?
If you answered NO to all of the above questions, please continue completing the rest of Section 9.
If you answered YES to numbers 1, 2 or 4 above, your protocol does not qualify as Exempt Research under Category 4. If another Exemption category does not apply, you must complete the Application for Expedited/Full Committee Research.
9B.) Number of Biospecimens/Charts/Records/Datasets: Specify the maximum number of records or biospecimens that will be reviewed/analyzed to compile the data necessary to address the research question or the maximum number of individuals that will comprise the dataset.
☐Biospecimens / # Amount / ☐ Charts/Records / # Amount / ☐ Individuals in dataset / # Amount /
9C.) Description of Biospecimens/Datasets/Records/Charts: If requesting permission to use biospecimens or existing datasets/records/charts, please complete the section below:
Attach a copy of the form that will be used to collect the data for this study.
9C-1.) Specify the type(s) of biospecimens/datasets/records/charts that will be studied:
☐Biospecimens (specify): / Specify biospecimens /
☐ Medical Records
☐ Individual level data from an established data bank or repository (specify): / Specify Databank/Repository /
☐ Publicly available information (i.e. DMV, US Census)
☐ NCI SEER (Surveillance Epidemiology and End Results)
☐ Datasets NOT including any of the 18 Protected Health Identifiers (NOTE: HIPPA List)
☐ Other (specify): / Specify other dataset(s) /
9C-2.) Specify the source(s) of the biospecimens/datasets/records/charts that will be studied and how the appropriate biospecimens/datasets/records will be provided to the study team:
Specify source(s) /
9C-3.) Were the biospecimens originally collectedsolely for research purposes?
(If YES, please submit with this application a copy of the IRB Approval Notice and
Consent Form for the original collection of these specimens.) / ☐ Yes ☐ No
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