1. PROJECT TITLE
2. PRINCIPAL INVESTIGATOR
West Chester University Institutional Review Board
Office of Research and Sponsored Programs http://www.wcupa.edu/research/irb.aspx
irb@wcupa.edu
Name (Last, First, MI): E-mail:
If any contact information has changed since last IRB review – provide below:
College
Department Name :
Campus Mailing Address: Fax:
PROTOCOL ID
Phone:
Is there a change in the Principal Investigator?
Emergency phone:
☐ Yes

Complete Appendix A
☐ No
Faculty Advisor (If Principal Investigator is student)
Name
Department and College e-mail
Check here if there has been a change in faculty advisor ☐
3. CO-INVESTIGATOR(S)
Are there any changes in Co-Principal Investigator? ☐ Yes

Complete Appendix A
☐ No
4. EXTERNAL CO-INVESTIGATOR(S) & KEY PERSONNEL (non-WCU personnel only)
Are there any changes in external study personnel? ☐ Yes

Complete Appendix A
☐ No
5. REQUIRED TRAININGS
Are the human subjects protection education requirements current* for all WCU investigator(s) and key personnel?
*Trainings must have been completed within three years of submitting this form.
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☐
Yes
☐ No
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West Chester University Institutional Review Board - CONTINUING REVIEW OF HUMAN SUBJECTS RESEARCH
6. FUNDING OR OTHER SUPPORT a.
What is the current funding status of the research?
☐ None
☐ Funded
If funded

Specify sponsor b.
Is any support other than monetary (e.g., drugs, equipment, etc.) being provided for the study?
☐
Yes
☐
No
If Yes

Specify support and provider: c.
Is there a new, revised, or renewal grant application since the last IRB review?
☐
Yes
☐
No
If Yes

Forward a copy of the current grant application with this submission.
7. LOCATION OF THE RESEARCH a.
List the specific site(s) at which the WCU research was or is being conducted (include both domestic and international locations).
Provide copies of all current IRB approvals for non-WCU sites, as applicable.
Location Name (or description) Address (street, city and state, or country)
8. EXPEDITED REVIEW
Are you requesting Expedited Review ?
☐ Yes

Complete Appendix B
☐
No
9. RESEARCH STATUS a.
Indicate the status of the research:
☐ No research participants have been enrolled (or participant records, specimens, etc. obtained).
Explain:
☐ Research participants have been enrolled (or participant records, specimens, etc. obtained) b.
If participants have been enrolled, check all that apply:
☐ Recruitment is ongoing
☐ Recruitment has been completed
☐ Participants have not completed research interventions.
☐ All participants have completed all research interventions.
☐ Research remains active only for long-term follow-up (or re-contact) and data analysis.
☐ Research remains active only for data analysis.
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West Chester University Institutional Review Board - CONTINUING REVIEW OF HUMAN SUBJECTS RESEARCH
10. SUMMARY OF THE RESEARCH
Summarize the research using non-technical language that can be readily understood by someone outside the discipline. Explain briefly the research design, procedures to be used, risks and anticipated benefits, and the importance of the knowledge that may be expected to result. Use complete sentences (limit 300 words).
11. RESEARCH PROGRESS a.
Summarize the progress of the WCU research, including any interim findings. b.
For multi-site studies, summarize the overall progress of the research. ☐
N/A c.
Summarize any IRB-approved amendments or changes made to the research since last IRB review (initial or continuing). If IRB approval was not obtained for changes, provide an explanation.
☐ N/A d.
Summarize recent literature or other new information relevant to the research, if any, since last IRB review (initial or continuing). e.
Discuss significant new findings (e.g., affecting risks, benefits, or alternatives), if any, that could affect participants’ willingness to continue in the research and how participants have been or will be informed. f.
Projected or actual completion date: (month and year) g.
Are you requesting any changes to the research, other than a change in study personnel or participant numbers (e.g., change in PI or changes to protocol, data collection forms, recruitment or consent processes, etc.)? h.
Describe the change(s) to the research and provide a rationale for each change.
Yes
No


Complete h,i,j and k
☐
☐ continue to question 12
N/A
N/A i.
Will there be any change in the risk(s) to participants? Yes
No
If Yes

Explain:
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West Chester University Institutional Review Board - CONTINUING REVIEW OF HUMAN SUBJECTS RESEARCH j.
Will there be any change in the benefit(s) to participants? Compensation is not to be considered a benefit.
Yes
No
If Yes

Explain: k.
Could the proposed change(s) affect participants’ willingness to take part in the research? Yes
No
If Yes

How will information be communicated to currently enrolled subjects (e.g., revised consent form, letter to participants, etc.)?
12. NUMBER OF PARTICIPANTS
The number of participants is defined as the number of individuals who agreed to participate (i.e., those who provided consent or whose records were accessed, etc.) even if all do not prove eligible or complete the study. The total number of research participants may be increased only with prior IRB approval. a.
Is this a multi-site study?
☐ Yes

Indicate the total number of participants to be enrolled across all sites:
☐
No b.
For research approved by West Chester University IRB, provide:
1) IRB approved number of participants (or records, specimens, etc.):
2) Total number of participants enrolled in the research to date:
3) Number of participants enrolled since last IRB review (initial or continuing): c.
If actual total enrollment to date (14b.2) is significantly different (over or under) from IRB approved number (14b.1),
provide an explanation: d.
Are you requesting an increase in the total number of participants?
☐
Yes

Complete questions below
☐
No

Continue to question 14
1.
Current West Chester University IRB approved maximum number of participants (or records, specimens, etc.):
2.
Requested number of participants (or records, specimens, etc.) to be added:
3.
Total requested maximum number of participants (1 + 2):
4.
Rationale for adding participants:
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West Chester University Institutional Review Board - CONTINUING REVIEW OF HUMAN SUBJECTS RESEARCH
13. PARTICIPANT POPULATION a.
Specify the age(s) of the individuals who may participate in the research:
Age(s): b.
Specify the participant population(s) – check all for which you have approval:
☐ Adults ☐ Pregnant women/fetuses
☐ Children (< 18 years)
☐ Adults with decisional impairment
☐ Non-English speaking
☐
☐
☐
Neonates (uncertain viability/nonviable)
Student research pools (e.g., psychology, linguistics)
Specify:
☐ Prisoners Unknown (e.g., research using secondary data/specimens, non-targeted surveys, program protocols)
14. RECRUITMENT & INFORMED CONSENT PROCESS a.
Were recruitment materials used to enroll participants?
☐
Yes
☐
No
If Yes

Are recruitment materials still being used?
☐ Yes

Provide copies of the current recruitment materials
(ads, radio/TV scripts, internet solicitations, etc.).
☐ No b.
How was/is informed consent or assent obtained? Check all that apply. Provide blank copies of all current documents .
☐ Assent – Form
☐ Assent – Verbal Script
☐ Informed Consent – Form
☐ Informed Consent – Verbal Script
☐ Informed Consent – Addendum
☐
☐
☐
☐
☐
Parental Permission – Form
Parental Permission – Verbal Script
Translated Consent/Assent – Form(s)
Waiver or Alteration of Consent Process
Waiver of Consent Documentation c.
Is deception of participants part of the research?
☐
Yes
☐
No
If Yes

Provide copy of current debriefing script or other information sheet(s) used to inform participants.
15. HIPAA RESEARCH AUTHORIZATION
Is individually identifiable protected health information (PHI) accessed, used, or disclosed in the research?
☐ Yes
☐
No
If Yes

Check all that apply:
☐ Written Authorization

Provide current Authorization Form
☐ Partial Waiver (recruitment purposes only)
☐
Full Waiver (entire research study)
☐ Alteration (written documentation)
☐
Informed consent (or waiver) was obtained for all participants prior to April 14, 2003
16. RISK ASSESSMENT a.
Provide an assessment of the risks and potential benefits based on study results since last IRB review (initial or continuing).
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West Chester University Institutional Review Board - CONTINUING REVIEW OF HUMAN SUBJECTS RESEARCH b.
Since the last IRB review (initial or continuing), did any unanticipated problems involving risks to subjects or others or adverse events occur in research at WCU or at a site(s) approved by the WCU IRB?
☐ Yes

Complete questions c and d
☐ No

Continue to question 17 c.
Have there been any unanticipated problems involving risks to subjects or others?
☐ No
☐ Yes

Provide a summary of new risk information. Do not list each event separately or include participants’ personally
identifiable information. d.
Have there been any adverse events that were unexpected or that occurred at GREATER THAN the expected frequency or level of severity as documented in the research protocol, the consent form, and/or other available information (e.g., investigator brochure)?
☐ No
☐ Yes

Provide a summary of new risk information. Do not list each event separately or include participants’ personally
identifiable information.
17. PARTICIPANT COMPLAINTS & VOLUNTARY WITHDRAWALS a.
Have any participants made complaints about the research since the last IRB review (initial or continuing)?
☐
Yes
☐
No
If Yes

List and describe each complaint and any actions taken to resolve the complaint(s).
b.
Have any participants voluntarily withdrawn from the research since last IRB review (initial or continuing)? Do not include individuals whose participation was discontinued by the investigator or sponsor because of unanticipated problems, study completion, etc.
☐
☐
Yes
No
If Yes

List and describe each withdrawal and any actions taken (e.g., changes to the research or consent process) in response to the withdrawal(s).
18. APPLICATION CONTENTS
Indicate the documents submitted for this continuing review. Check all appropriate boxes.
Continuing Review of Human Subjects Research Application
Appendix A: Change in Study Personnel
Appendix B: Expedited Review – Continuing Review
Currently Approved Consent Form(s), Assent Form(s), Permission Form(s), and Verbal Script(s) including translated documents
HIPAA Research Authorization Form(s)
Data Collection Form(s) for Investigator-Initiated Studies – only if new or being revised
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West Chester University Institutional Review Board - CONTINUING REVIEW OF HUMAN SUBJECTS RESEARCH
Recruitment Materials (e.g., ads, flyers, telephone or other oral script, radio/TV scripts, internet solicitations) – only if still being used (
Script(s) or Information Sheet(s), including Debriefing Materials
Instruments (e.g., questionnaires or surveys completed by or administered to participants) – only if new or being revised
Current IRB approvals/Letters of Support from non-West Chester University sites, as applicable
Complete Grant Application or Funding Proposal, as applicable - (new, revised, or renewals only)
Other supporting documentation and/or materials
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West Chester University Institutional Review Board - CONTINUING REVIEW OF HUMAN SUBJECTS RESEARCH
Complete this form to add or delete WCU study personnel, or external personnel if the WCU IRB will provide/has provided approval for their research activities.
A: Add or Remove West Chester University PRINCIPAL INVESTIGATOR(S)
Degree(s):
College:
Phone:
Degree(s):
College:
Phone:
Degree(s):
College:
Phone:
☐ Add ☐ Remove Personnel
Name (Last, First, MI):
Department:
E-mail
☐ Add ☐ Remove Personnel
Name (Last, First, MI):
Department:
E-mail
☐
Add
☐
Remove Personnel
Name (Last, First, MI):
Department:
E-mail
1.
Provide rationale for change in PI:
2.
Explain the proposed PI’s qualifications to assume responsibility for the research:
3.
Has the sponsor or funding source of the study been notified of the change in PI? ☐
Yes
☐
No
☐
N/A
If No , explain:
4.
Will the former PI continue to have a role in the research? ☐
Yes
☐
No
If Yes , explain role (e.g., co-investigator, consultant, etc.):
B: Add or Remove West Chester University CO-INVESTIGATOR(S)
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West Chester University Institutional Review Board - CONTINUING REVIEW OF HUMAN SUBJECTS RESEARCH
☐ Add ☐ Remove Personnel
Degree(s): Name (Last, First, MI):
Department:
E-mail
College:
Phone:
☐ Add ☐ Remove Personnel
Name (Last, First, MI):
Department:
E-mail
☐
Add
☐
Remove Personnel
Name (Last, First, MI):
Department:
E-mail
Degree(s):
College:
Phone:
Degree(s):
College:
Phone:
C: Add or Remove EXTERNAL CO-INVESTIGATOR(S)
☐ Add ☐ Remove Personnel
Name (Last, First, MI):
Organization:
E-mail:
Mailing Address:
☐
Add
☐
Remove Personnel
Name (Last, First, MI):
Organization:
E-mail:
Mailing Address:
☐ Add ☐ Remove Personnel
Name (Last, First, MI):
Organization:
E-mail:
Mailing Address:
Degree:
Phone:
Degree:
Phone:
Degree:
Phone:
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West Chester University Institutional Review Board - CONTINUING REVIEW OF HUMAN SUBJECTS RESEARCH
Complete this form to request expedited review for the continuing review of the research. If the research qualifies for expedited review, protocol review will be carried out by the IRB chair or by one or more experienced reviewers designated by the chair from among members of the IRB outside the convened IRB meeting.
See 45 CFR 46 and 21 CFR 56 for more information.
Conditions required for expedited IRB review:
1) The Federal Regulations establish two main criteria for an expedited review: a) The research may not involve more than "minimal risk." (This does not apply to category 8b.) "Minimal risk" means that “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” ( 45 CFR 46.102
(i) and 21 CFR Part 56.102
(i)). b)
2)
3)
4)
5)
The entire research project must be consistent with one or more of the federally defined categories.
The categories in this list apply regardless of the age of the participants, except as noted.
The expedited review procedure may not be used where identification of the participants and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the participants financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
(This does not apply to category 8b.)
The expedited review procedure may not be used for classified research involving human subjects.
Investigators and IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review (i.e., expedited or convened) utilized by the IRB.
☐
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.
☐ 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 participants, 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.
(b) from other adults and children (defined as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” 45 CFR 46.402(a) ), considering the age, weight, and health of the participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these participants, 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.
☐ 3) Prospective collection of biological specimens for research purposes by non-invasive means.
Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if
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West Chester University Institutional Review Board - CONTINUING REVIEW OF HUMAN SUBJECTS RESEARCH 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.
☐ 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 participant or an invasion of the participant'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.
☐ 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 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 made 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 refers only to research that is not exempt.)
☐ 8) Continuing review of research previously approved by the convened IRB as follows:
☐ a.
Where (i) the research is permanently closed to the enrollment of new participants; (ii) all participants have completed all research-related interventions; and (iii) the research remains active only for longterm follow-up of participants; or
☐ b.
Where no participants 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.
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