IRB:
Application for Approval for Research Involving Human Subjects
REQUEST FOR EXPEDITED OR FULL COMMITTEE REVIEW
SUBMISSION PROCEDURES
Investigator must submit most recent application, signature page, and any accompanying documents via
email to irb@chapman.edu
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
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





For any questions, please refer to the IRB website or contact the IRB staff at irb@chapman.edu or (714)628-7392.
☐ Expedited (no more than minimal risk involved)
☐ Full Committee Review (greater than minimal risk or vulnerable subject populations involved)
Project Title:
Project Title
Submission Date:
XX/XX/20XX
Externally Funded?
Proposed Start Date:
☐Yes ☐No Funding Agency:
XX/XX/20XX
Funding Agency
Grant #:
Grant #
☐Yes ☐No
Multi-Site Research Study?
Chapman Principal Investigator: (see “Submission Procedures”)
☐
This is a Student-Directed Project and I am serving as Faculty Advisor
Name:
PI Name or Faculty Advisor
Institute/Center/Department:
School/College:
Email:
Email
Institute/Center/Department
Choose or type a School/College...
Role: Choose an item or type
Phone:
Access to Subjects?
Y or N
Phone Number
Training Completed?
Choose or type
Student Investigator: (see “Submission Procedures”)
☐
Graduate
Name:
☐
Undergraduate
Program/Major: Program/Major
Undergraduate Co-Investigator
Institute/Center/Department:
School/College:
Email:
Email
Institute/Center/Department
Choose or type a School/College...
Role: Choose an item or type
Phone:
Access to Subjects?
Y or N
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Chapman University – Upt. 7.10.2015
Phone Number
Training Completed?
Choose or type
Materials and Procedures of Proposed Project: Check all that apply.
CONSENT FORMS:
☐ Informed consent (18+)
☐ Parental/Guardian Consent
☐ Child Assent
☐ Passive consent* (waiver of written consent)
*Consent Information Sheet required with Passive Consent
INTERVIEW(S):
☐ Video-Recorded Interview
☐ Simple
☐ Audio-Recorded Interview
SURVEY(S)/QUESTIONNAIRES(S)
☐ Written
☐ Computer-Administered
☐ Web-Administered
ADDITIONAL PROCEDURES:
☐ 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
☐ Debriefing Subject
☐ 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
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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?
Name
Name
Name
Name
Name
Name
Name
Name
Name
Name
Email
Phone
Email
Phone
Email
Phone
Email
Phone
Email
Phone
Email
Phone
Email
Phone
Email
Phone
Email
Phone
Email
Phone
Choose or type
Choose or type
Choose or type
Choose or type
Choose or type
Choose or type
Choose or type
Choose or type
Choose or type
Choose or type
Y or N
Y or N
Y or N
Y or N
Y or N
Y or N
Y or N
Y or N
Y or N
Y or N
Training (CITI,
NIH, Other)
Choose or type
Choose or type
Choose or type
Choose or type
Choose or type
Choose or type
Choose or type
Choose or type
Choose or type
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
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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 Investigator and/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.
Please see Compliance website (http://www.chapman.edu/campus-services/campus-controller/financial-services/contracts-andgrants.aspx) for all definitions and the full policy. Go to
https://mywindow.chapman.edu/depts/controller/financialservices/grants/Pages/Forms.aspx for the Financial Disclosure form.
☐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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IRB:
PAGE INTENTIONALLY LEFT BLANK
PLEASE DOWNLOAD THE SEPARATE
SIGNATURE PAGE FROM THE WEB
AND
SUBMIT IT AS AN ATTACHMENT WITH THIS
APPLICATION
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CATEGORIES OF RESEARCH THAT QUALIFY FOR EXPEDITED REVIEW: The following categories of research may be reviewed
through an expedited review procedure per Federal regulation 45 CFR 46.110. Please indicate the type(s) of expedited research you
are requesting. For more information on each of these categories, see the Expedited Research Guidelines at the IRB Website. If your
research does not fall into any of these categories, your research must be submitted for full committee review.
☐
1) Clinical studies of drugs and medical devise only when condition (a) or (b) is met:
☐
1) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
☐
2) Prospective collection of biological specimens for research purposes by noninvasive means. (See 45 CFR
46.110 for a full list of examples for this category)
☐
3) 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.) (See 45 CFR 46.110 for a full list of examples for this 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). (NOTE: Some research in
this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR
46.101(b)(4). This listing here refers only to research that is not exempt.)
☐
6) Collection of data from voice ☐, video ☐, digital ☐, or image recordings ☐ made for research purposes.
☐
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. (NOTE: Some research in this category may be exempt
from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing
here refers only to research that is not exempt.
☐
8) Continuing* review of research previously approved by the convened IRB as follows:
a) Research on drugs for which an investigational new drug application is not required.
b) Research on medical devices for which (a) an investigational device exemption application is not required; or (b) the
medical device is cleared/approved for marketing and the medical device is being used in accordance with its
cleared/approved labeling
a)
from healthy, nonpregnant adults who weigh at least 110 lbs. 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 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 my 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.
a)
Where (1) the research is permanently closed to the enrollment of new subjects; (2) all subjects have completed all
research-related interventions; and (3) the research remains active only for long-term follow-up of subjects; or
b) where no subjects have been enrolled and no additional risks have been identified; or
c) where the remaining research activities are limited to data analysis.
9) Continuing* review of research, not conducted under an investigational new drug application or
investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has
determined and documented at a convened meeting that the research involves no greater than minimal risk
and no additional risks have been identified.
*Complete Continuing Review Request application in lieu of new Request for Expedited or Full Review
☐
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EXPEDITED AND/OR FULL CERTIFICATION RESEARCH DESCRIPTION
1. NON-TECHNICAL SUMMARY: Provide a non-technical summary of the proposed research project that can be understood by
IRB members with varied research backgrounds, including non-scientists and community members. The summary should include a
brief statement of the purpose of the research and related theory/data supporting the intent of the study as well as a brief
description of the procedure(s) involving human subjects. (This should not exceed ½ page).
Non-technical summary
2. PURPOSE AND BACKGROUND OF THE RESEARCH: *Describe the purpose of the research project and state the overall
objectives, specific aims, hypotheses (or research question) and scientific or scholarly rationale for performing the study. *Provide
the relevant background information on the aims/hypotheses (or research question) to be tested and the
procedures/products/techniques under investigation. *Include a description of the predictor and outcome variables, as appropriate
(particularly those related to the involvement of human subjects). *Include a critical evaluation of existing knowledge, and
specifically identify the information gaps that the project intends to address. *Describe previous research with animals and/or
humans that provides a basis for the proposed research. Include references/citations, as applicable. (Not to exceed 4 pages)
Purpose and Background
3. RESEARCH METHODOLOGY/STUDY PROCEDURES: Provide a detailed chronological description of all study activities and
procedures. Include a succinct explanation of the study design. Indicate how much time will be required of the subjects, the setting
where each procedure will take place or be administered and how many times the procedure will be administered and the time
span between administrations.
Be sure to submit data collection instruments (e.g., measures, questionnaires, interview questions, observational tools, etc.)
FOR MEDICAL STUDIES ONLY: For studies involving routine medical procedures, make clear whether procedures are being done for
clinical reasons or study purposes. If the standard procedure is not explicitly required by the study protocol, a description is not
required. If the standard procedure is a main focus of the study or is explicitly required by the study protocol, a full description of the
procedure and risks is required. It is strongly recommended to include a table of visits, tests and procedures. If photographs, or
audio/video recordings will be collected, specify any identifiable information and identifiers that will be collected, if any. Describe
how the subject’s privacy will be protected during the research procedures.
Research Methodology/Study Procedures
4. SUBJECTS (PERSONS/BIOSPECIMENS/DATASETS/RECORDS/CHARTS):
4A.) Number of Persons/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. This number should include screen failures and early withdrawals. For
Mail/Internet surveys, include the number of people directly solicited.
☐ Biospecimens:
#
Biospecimens
☐ Charts/Records
Target Sample
Size:
Target Sample
Size
Target Sample
Size:
#Charts/Records
Target Sample
Size
4B.) Justify the numbers of subjects listed above:
Justify the sample sizes listed above
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☐ Individuals in
dataset:
Target Sample Size:
# Individuals
Target Sample
Size
4C.) For studies where multiple groups of subjects will be evaluated, provide and justify the breakdown per group:
(e.g. controls vs experimental subjects; children vs adults; by age group; etc.):
Describe and justify breakdown of multiple subject groups
4D.) For multi-center research, indicate the overall sample size for the entire study (across all sites):
☐ Not Applicable – This is not part of a multi-center research study
Overall sample size across all multi-center sites, if applicable
4E.) Subject Population Characteristics: Describe the characteristics of the proposed subject population. At a minimum,
include age and gender information of the study population. Describe different subject groups separately (e.g., students and
teachers; control group and treatment group(s); children and adults).
Describe Study Population Characteristics
4F-1.) Inclusion and Exclusion Criteria: Provide the inclusion and/or exclusion criteria for the proposed subject population, as
applicable.
☐ Not Applicable
Describe Inclusion and/or Exclusion Criteria
4F-2.) If exclusion is based on age, gender, pregnancy/childbearing potential, social/ethnic group, or language spoken
(e.g., non-English speakers), provide a scientific rationale:
☐ Not Applicable
Scientific rationale for exclusion
5. SUBJECT RECRUITMENT
5A. SUBJECT RECRUITMENT METHODS: Please check ALL applicable recruitment methods that apply below:
5A-1.) 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:
☐ Other method(s):
Subject Pool
Other Passive Recruitment Method(s)
5A-2.) 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 not approach 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)
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5B. SUBJECT RECRUITMENT PROCESS: Please describe the details of the recruitment process (i.e. when, where, by whom and
how potential subjects will be approached). 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.
6. INFORMED CONSENT: Please check all that apply below and describe the informed consent process:
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.
☐ 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 – Request for waiver of written (signed) consent – 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.)
Describe the 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).
7. RISK/BENEFIT ANALYSIS
7A.) RISKS AND DISCOMFORTS: Describe the risks/potential discomforts (e.g. physical, psychological, social, and economic)
associated with each intervention or research procedure. Describe the expected frequency or probability of a given side effect or
harm and its severity. If subjects are restricted from receiving standard therapies during the study, describe the risks of those
restrictions. If collecting identifiable information, address the risk of a potential breach of confidentiality. Then discuss the steps
taken to prevent or minimize any risks/potential discomforts to subjects.
7A-1.) Risks and potential discomforts:
Describe risks and potential discomforts
7A-2.) Steps to prevent/minimize risks and discomforts:
Describe steps to minimize risks or discomforts
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7B.) POTENTIAL BENEFITS: Discuss the potential benefits that may accrue directly to subjects, if any (compensation is not defined
as a benefit). Then describe the potential societal/scientific benefit(s) that may be expected from this study.
7B-1) Potential benefits to subject:
☐
No benefit to the subject
Describe the potential benefit to the SUBJECT
7B-2) Potential benefits to society or science:
Describe the potential SOCIETAL/SCIENTIFIC benefits
7C.) RISK/BENEFIT ASSESSMENT: Explain why the study risks are reasonable in relation to the potential benefits to subjects and
society.
Explain why the risks are reasonable in relation to the benefits
8) ALTERNATIVES TO PARTICIPATION: Describe the standard or usual care activities at Chapman University (or study site) that
are available to prospective subjects who do not enroll in this study, as applicable. Describe other appropriate alternative
procedures to study participation that are available to prospective subjects, if any.
☐
No alternatives exist. The only alternative to subjects is to not participate in the study.
Alternatives to Participation
9) ADVERSE EVENT REPORTING/INJURY MANAGEMENT & COMPENSATION FOR INJURY
9A) Adverse Events and Unanticipated Problems: Please review Chapman University’s Adverse Events/Complication policy and
procedures at www.chapman.edu/irb.
☐
Yes
☐ No
Does this study involve intervention with research subjects?
If Yes, please explain how the research team will manage adverse events and unanticipated complications that may
occur during the study or after completion of the study (i.e. outline a plan):
Adverse Events plan
If No, and this study does NOT involves intervention with research subjects (ie., it only involves the use of records,
charts, and/or biospecimens, etc.), the researcher must be aware that unanticipated complications may still arise and
must follow the stated policies and procedures of reporting.
9B) Compensation for Research-related Injury: (FULL COMMITTEE PROTOCOLS ONLY) Please review Chapman University’s
policy regarding practice and procedures for treatment and compensation for injury at www.chapman.edu/faculty-staff/riskmanagement/index.aspx.
Explain in the space below, the potential liabilities involved and how the costs of treatment for potential research
related injury will be covered.
Explain the potential liabilities and procedures for compensation for research-related injury
10) PARTICIPANT COSTS: Please explain any costs to participate in the study. If subjects or their insurers will be charged for study
procedures, identify and describe those costs.
☐
There are no costs to subjects/insurers
Explain any costs to participate for subjects or their insurers
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11) PARTICIPANT REMUNERATION: If subjects will be compensated for their participation, explain the method/terms of
payment (e.g. money order, check, extra credit, gift certificate) and whether or not compensation is part of the study design.
Describe the schedule and amounts of compensation including the total amount subjects can receive for completing the study.
Specify whether subjects will be reimbursed for out-of-pocket expenses, and any requirements for reimbursement, if applicable.
(NOTE: If compensation is over $599.00, taxes must be filed with IRS and the appropriate tax forms must be filled out by subjects).
☐
No compensation will be provided to subjects
☐
No reimbursement will be provided to subjects
Describe any participant renumeration
12) CONFIDENTIALITY OF RESEARCH DATA: Please fill out all sections below
12A) Indicate all IDENTIFIERS that may be included in the research records for the study. Check all that apply:
(Note: if this information is being derived from medical records; added to a medical record; created or collected as part of
health care, or used to make health care decisions, it qualifies as Protected Health Information (PHI) under HIPAA.)
☐
No Personally Identifiable Information is obtained (i.e. researchers will not collect information that can link the subjects
to their data)
☐
Names
☐ Social Security numbers
☐
Device identifiers/Serial numbers
☐
Dates*
☐ Medical record numbers
☐
Web URLs
☐
Postal address
☐ Health plan numbers
☐
IP address numbers
☐
Phone numbers
☐ Account numbers
☐
Biometric identifiers
☐
Fax numbers
☐ License/Certificate numbers
☐
Facial photos/Images
☐
Email address
☐ Vehicle ID numbers
☐
Any other unique identifier
*birthdate, treatment/hospitalization dates, etc.
☐
Other (specify all):
Specify other identifiers
12B) How will data be RECORDED? Check all that apply:
☐
Paper documents/records
☐
Video recording
☐
Electronic records/database
☐
Photographs
☐
Audio recording
☐
Biological specimens
☐
Other(s) (specify all):
Other means of data recording
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12C) Indicate how and where data will be STORED and SECURED (including paper records, electronic files,
audio/video, biospecimens, etc.):
12C-1) Electronic Data (check all that apply):
☐
De-Identified/Coded data; code key is kept separate from data in secure location
☐
Data includes Personally Identifiable Information (Encryption software is required). (Provide rationale for maintaining
personally identifiable information:
Rationale for maintaining personally identifiable information
☐
Data will be stored on a Chapman-issued computer on a Chapman secure network server.
☐
Data will be stored on stand-alone desktop or personal computer not connected to the Chapman network.
Where will the computer be located?
Computer location
IMPORTANT: If storing data on a personal computer, you MUST work with Chapman University’s IS&T department to ensure that
the personal computer adheres to Chapman’s security policies and that data is sufficiently protected and encrypted in case of loss
or theft.
☐
Data will be stored on a Chapman University encrypted/protected, or cloud server
Please specify service:
☐
Other (specify here):
Cloud service
Other electronic storage
12C-2) Hardcopy Data, Recordings, and Biospecimens (check all that apply):
☐
Coded data; code key is kept separate from data in secure location
☐
Data includes personally identifiable information. (Provide rationale for maintaining personally identifiable info):
Rationale for maintaining personally identifiable info
☐
Data will be stored in locked file cabinet or locked room at Chapman University
☐
Data will be stored in locked lab/refrigerator/freezer at Chapman University
☐
Other (specify here):
Other hardcopy storage
12C-3) Data on Portable Devices: Please review Chapman University’s IS&T policy at http://www.chapman.edu/campusservices/information-systems/security/index.aspx. Describe the portable device(s) to be used (e.g. laptop, iPad, portable hard
drive/flash drive, etc). Specify whether personally identifiable data will be stored on the device. If so, justify why it is necessary to
store subject identifiers on the device.
(Note: Only the “minimum data necessary” should be stored on portable devices as these devices are particularly susceptible to loss
or theft. If there is a necessity to use portable devices for initial collection of identifiable private information, the portable storage
devices or research files MUST BE ENCRYPTED, and subject identifiers transferred to a secure system as soon as possible.)
☐
Not applicable – no study data will be maintained on portable devices
Specify portable devices and justify use
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12C-4) Data Access: Specify who, besides the entities listed below*, will have access to subject identifiable private data and
records. If there is a code key, specify who on the research team will hold the key and who will have access to the key. If
publications and/or presentations will include subject identifiable information, specify where the data will be published and/or
presented and address how the study team will obtain permission from subjects.
*(Authorized Chapman University personnel such as the research team and the IRB, the study sponsor (if applicable), and regulatory
entities such as the FDA and OHRP, may have access to study records to protect subject safety and welfare. Any study data that
identifies the subjects should not be voluntarily released or disclosed without the subjects’ separate consent, except as specifically
required by law. Publications and/or presentations that result from this study should not include personally identifiable information;
unless the subject’s separate consent has been obtained).
Specify who will have data access
12C-5) Data Retention: Specify how long personally identifiable research data will be retained. Please note, under the Common
Rule, if an investigator obtains private information about living individuals for research purposes and retains a link to that data (i.e.
separate code key), it is considered personally identifiable information to the investigator.
☐
Not applicable – No personally identifiable information will be retained.
☐
Destroy once data collection is completed.
☐
Destroy at the earliest opportunity, consistent with the conduct of this research.
Specify timeframe:
Specify timeframe
☐
Destroy after publication/presentation.
☐
Maintain for approximately:
☐
Maintain in a repository indefinitely. Other researchers may have access to the data for future research. Any data
shared with other researchers will not include name or other personal identifying information.
☐
If children involved, research records will be retained for seven years after all children enrolled in the study reach
the age of majority (based on state definitions).
☐
Research records will be retained for 25 years after study closure as this study involves in-vitro fertilization studies
or research involving pregnant women.
☐
If an FDA regulated study, research records will be retained for two years after an approved marketing application.
If approval is not received, the research records will be kept for two years after the investigation is discontinued
and the FDA is notified.
☐
Other (please specify):
# weeks/months/years?
Please specify
12C-6) Data Destruction: If photographs, audio or video recordings will be taken, specify the timeframe for the transcription
and/or destruction of the audio or video recordings.
☐
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):
☐
Photographs maintained indefinitely
Specify timeframe
12C-7) Certificate of Confidentiality: (NIEHS Website: http://www.niehs.nih.gov/research/clinical/coc/index.cfm)
A Certificate of Confidentiality has been or will be requested from the National Institutes of Health
☐Yes ☐No
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Chapman University – Upt. 7.10.2015