CPHS Application – Word version
Please note that this template is provided for planning and convenience purposes only. All submissions to CPHS require that the
responses to these questions be entered (i.e. cut and pasted) directly into the RAMP online system for further routing and review.
C O VER P AG E (Q1-Q3)
Please pick your review type:
Exempt
Category ____? (1-6, see: http://www.uh.edu/research/compliance/irb-cphs/categories/)
Expedited
Category ____? (1-7, see: http://www.uh.edu/research/compliance/irb-cphs/categories/)
Full Review
1. Title:
2. Research Reason: (multiple answers are acceptable)
Unfunded Research
Funded Research/Research Proposed for Funding
Senior Honor's Thesis
Pilot Study
Multi-Phase Study
Longitudinal Study
Candidacy/Professional Paper
Master's Thesis
Doctoral Dissertation
Independent Study
Other (Explain)
2.01) If the project is funded or proposed for funding, please indicate if UH is/will be:
The direct recipient of the funds from the funding agency
a sub recipient of the funds (or other collaborative agreement)
N/A
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3. If this application supports a proposal for funding, provided funded research project ID. (Proposal
Abstract or Statement of Work must be uploaded with this application).
Key Personnel
Add/Delete Personnel Name
Personnel Type
Is External?
Is Student?
Faculty Sponsor
(Note: RAMP allows search and dropdown functions here. Please ensure that all individuals involved in the
research (including recruitment, consent, study procedures, analysis of identifiable data, etc.) are included and
have completed CITI training. Student investigators require a faculty sponsor.)
R ESE AR C H PR O J ECT R EVI EW S U MM AR Y (Q4-Q10 ):
4. State the specific research hypotheses or questions to be addressed in this study:
5. What is the importance/significance of the knowledge that may result?
6. Type of Subject Population (check all that are appropriate; multiple responses are acceptable)
Adults
Elderly (65yrs and above)
Cognitively or Psychologically Impaired
Prisoners or Parolees
Children or minors (<18 in Texas and most states)
Institutional Residents
Non-English speaking
UH Faculty, Staff, or Students
6.01) Expected maximum number of participants:
This number should account for withdrawals and/or those lost to follow-up over the course of the study. The
number stated on the consent form should be consistent. If specific study groups are designated, provide the
breakdown between groups in addition to the total number.
6.02) Age of proposed subject(s) (check all that apply):
Infants (2yrs and under)
Children (3yrs-10yrs)
Adolescents (11yrs-14yrs)
Adolescents (15yrs-17yrs)
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Adults (18yrs-64yrs)
Elderly Adults (65yrs and above)
6.03) Inclusion Criteria:
6.04) Exclusion Criteria:
6.05) Justification. Justify the inclusion/exclusion criteria specified above:
6.06) Determination. How will it be determined that the subject meets these criteria?
7. If this study proposes to include children, this inclusion must meet one of the following criterion for
risk/benefits assessment according to the federal regulations (45 CFR 46, subpart D). Check the appropriate
box:
(404) Minimal Risk
(405) Greater than minimal risk, but holds prospect of direct benefit to subjects
(406) Greater than minimal risk, no prospect of direct benefits to subjects, but likely to yield
generalizable knowledge about the subject's disorder or condition.
8. If the research involves any of the following, check all that are appropriate:
Interview
Clinical Studies
Survey/Questionnaire
Behavioral Observation
Study of Existing Data
Study of Human Biological Specimens
For Venipunture and Biological (Proof of IBC approval may be required)
Data Analyses Only
Other (Explain – ex: focus group)
9. Location(s) of Research Activities:
UH campus
Other (Explain)
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If recruitment/study conduct takes place at a location other than UH (for example, at a school, privately
owned business, or community group), a letter of permission/cooperation may be required. If other
institutions are engaged in the research, additional IRB approval documentation may be required. Contact the
CPHS for guidance.
10. Informed Consent of Subjects: Your study protocol must clearly address one of the following areas:
(Model consent documents are available on the CPHS website and must be attached to the protocol)
http://www.uh.edu/research/compliance/irb-cphs/informed-consent/
Informed Consent. Signed informed consent is the default.
Cover Letter. You may request a waiver of documented informed consent with Appendix A - Request for
Waiver of Documentation of Consent. If this option is requested, Appendix A will populate as question 26.
(Commonly used for non-sensitive/anonymous surveys)
No Informed Consent. You may request a waiver of informed consent with Appendix B - Request for
Waiver/Modification of Informed Consent. If this option is requested, Appendix B will populate as questions
27-30. (Commonly used for archival data)
R ESE AR C H P R O T O CO L (Q11-Q21):
11. Describe the research study design. Describe the research methods to be employed and the variables to
be studied. Include a description of the data collection techniques and the statistical methods to be employed.
12. Describe each task subjects will be asked to perform. The CPHS must understand the subjects’ experience
from the beginning to the end of their participation. If interviews or focus groups will be audio or videorecorded, or if subjects will be photographed, this should be stated in this section). A table or flow chart may
be attached for complex studies.
13. Describe how potential subjects will be identified and recruited? How will subjects find out about the
study? How will you obtain contact information? Will screening be conducted? Attach all information that will
be provided to potential subjects (flyers, recruitment emails, phone or presentation scripts should be
attached. All written materials must contain the following: “This project has been reviewed and approved by
the University of Houston Committees for the Protection of Human Subjects (713)743-9240.”
14. Describe the process for obtaining informed consent and/or assent. How will investigators ensure that
each subjects participation will be voluntary (i.e., free of direct or implied coercion)? When, where and by
whom will the consent process take place? How will documents be provided to and returned by subjects, and
how will you provide subjects the opportunity to ask questions about the study?)
15. Briefly describe each measurement instrument to be used in this study (e.g., questionnaires, surveys,
tests, interview questions, observational procedures, or other instruments) AND attach to the application a
copy of each (appropriately labeled and collated). Please provide final versions. If surveys are online, a direct
link to the survey must be provided.
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16. Describe the setting and mode for administering any materials listed in question 15 (e.g., telephone,
one-on-one, group). Include the duration, intervals of administration, and amount of time required for each
survey/procedure. Also describe how you plan to maintain privacy and confidentiality during the
administration.
17. Approximately how much time will be required of each subject? Provide both a total time commitment
as well as a time commitment for each visit/session.
18. Will Subjects experience any possible risks involved with participation in this project?
18.01) Risk of Physical Discomfort or Harm
Yes
No
If yes, explain the risk and any strategies to mitigate.
18.02) Risk of Psychological Harm (including stress/discomfort)
Yes
No
If yes, explain the risk and any strategies to mitigate.
18.03) Risk of Legal Actions (such as criminal prosecution or civil sanctions)
Yes
No
If yes, explain the risk and any strategies to mitigate.
18.04) Risk of Harm to Social Status (such as loss of friendship)
Yes
No
If yes, explain the risk and any strategies to mitigate.
18.05) Risk of Harm to Employment Status
Yes
No
If yes, explain the risk and any strategies to mitigate.
18.06) Other Risks
Yes
No
If yes, explain the risk and any strategies to mitigate.
19. Does the research involve any of these possible risks or harms to subjects? Check all that apply.
Use of a deceptive technique (attach debriefing)
Use of incomplete or generalized information to the subject regarding the actual purpose of the study
(attach debriefing)
Use of private records (educational or medical records)
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Manipulation of psychological or social variables such as sensory deprivation, social isolation,
psychological stresses (attach debriefing)
Any probing for personal or sensitive information in surveys or interviews
Presentation of materials which subjects might consider sensitive, offensive, threatening or degrading
Possible invasion of privacy of subject or family (may require additional consent)
Other (Explain):
20. What benefits, if any, can the subject expect from their participation?
Benefits refer to the likelihood that individual subjects will benefit. (Examples: improved physical condition or
measurable improvement in performance.) Payment is not a benefit. For no/low risk studies, it is acceptable to
state “there is no direct benefit to participants, however the study may provide insight into….X.”
21. What inducements or rewards (e.g., financial compensation, extra credit, and other incentives), if any,
will be offered to potential subjects for their participation?
If compensation is provided, be specific regarding form of payment (ex: specify type of gift card) and whether
compensation is pro-rated per visit or paid only if subject completes all visits/procedures.
R ESE AR C H D AT A (Q22-Q25):
22. Will you record any direct identifiers, names, social security numbers, addresses, telephone numbers,
patient or student ID numbers, etc.?
Note: if you are obtaining written consent, contact information, audio-recordings, etc., you will have
identifiers.
Yes
No
If yes, what identifying information will you record?
23. Will you retain a link between study code numbers and direct identifiers after the data collection is
complete? If you are thinking of contacting subjects for future or follow-up research, please ensure the consent
document provides a checkbox for subjects to make a choice regarding this option.
Yes
No
If yes, for what purpose?
24. Will anyone outside the research team have access to the links or identifiers?
Yes
No
If yes, who, and for what purpose?
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25. Where, how long, and in what format (such as paper, digital or electronic media, video, audio or
photographic) will data be kept? In addition, describe what security provisions will be taken to protect
these data (password protection, encryption, etc.).
University of Houston policy on data retention requires that research data be maintained for a minimum of 3
years after completion of the project. All research data collected during this project is subject to the University
of Houston data retention policy found at http://www.uh.edu/research/sponsored-projects/proc-polguide/data-retention/}. A room number where data will be maintained must be provided. For student research,
a student must name a person on campus responsible for maintaining the data for 3 years following data
analysis. For audiotapes, please indicate if recordings can be destroyed following transcription (recommended,
as voice is considered an identifier).
(Fill one of these sections out ONLY if you requested “no informed consent” or “cover letter” in Q 10,
A PP EN DI X A (Q26):
Request for waiver of documentation of consent (cover letter)
Informed consent shall be documented by the use of a written consent form approved by the IRB and signed
by the subject or the subject’s legally authorized representative. (45 CFR 46.117)
26. Documentation of consent may be waived if either of the following conditions are true of the proposed
research activity (Choose one). An explanation must be provided.
The only record linking the subject and the research would be the consent document and the principal risk
would be potential harm resulting from a breach of confidentiality. Each subject must be asked whether the
subject wants documentation linking the subject with the research and the subject's wishes will govern; OR
The research presents no more than minimal risk of harm to subjects AND involves no procedures for
which written consent is normally required outside of the research context.
Explain:
A PP EN DI X B (Q27-Q30):
Request for waiver of informed consent (no informed consent)
In order to be eligible for a waiver of informed consent, you must meet all of the criteria outlined below.
27. Does the proposed research, in its entirety, involve greater than minimal risk? (Minimal risk is defined as
the probability and magnitude of harm or discomfort anticipated in the research which 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.) (If yes, your study is ineligible for waiver of informed
consent under 45 CFR 46.116(d).)
Yes
No
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28. Could the proposed research be practically carried out without the waiver? (If yes, your study is
ineligible for waiver of informed consent. If no, please explain)
Yes
No
Explain:
29. Will the requested waiver of informed consent affect the rights and welfare of the subjects? (If yes, your
study is ineligible for waiver of informed consent. OR If no, please explain)
Yes
No
Explain:
30. If applicable, will pertinent information be provided to subjects later? (If yes, please explain OR If no,
your study is ineligible for waiver of informed consent)
Yes
No
Explain:
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