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DATE:
TITLE:
PRINCIPAL INVESTIGATOR:
or
STUDENT RESEARCHER:
FACULTY SPONSOR:
PROPOSED PROJECT END DATE:
Committee for the Protection of Human Subjects
(CPHS) Faculty/Sponsor Application for
Investigation Involving Human Subjects
Attached at the end of the application is a copy of UHCL’s Federalwide
Assurance (FWA 00004068) approved by the Office of Human Research
Protections (OHRP). The applicant is to review this Assurance and
understand responsibilities for abiding by provisions of the Assurance.
Copy of FWA does not need to be forwarded with CPHS application.
For questions, contact the Office of Sponsored Programs at 281-283-3015 or
SponsoredPrograms@uhcl.edu
Principal Investigator Responsibilities Regarding Research on Human Subjects:
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Principal investigator (PI) acknowledges reviewing UHCL’s FWA
(Federalwide Assurance) (FWA #00004068) approved by the Office of Human
Research Protections (OHRP). PI understands the responsibilities for
abiding by provisions of the Assurance.
The PI cannot initiate any contact with human subjects until final approval is
given by CPHS.
Additions, changes or issues relating to the use of human subjects after the
project has begun must be submitted for CPHS review as an amendment and
approved PRIOR to implementing the change.
If the study continues for a period longer than one year, a continuing review
must be submitted PRIOR to the anniversary date of the studies approval
date.
PI asserts that information contained in this application for human subjects
assessment is complete, true and accurate.
PI agrees to provide adequate supervision to ensure that the rights and
welfare of human subjects are properly maintained.
Faculty sponsors are responsible for student research conducted under their
supervision. Faculty sponsors are to retain research data and informed
consent forms for three years after project ends.
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PI acknowledges the responsibility to secure the informed consent of the
subjects by explaining the procedures, in so far as possible, and by
describing the risks and potential benefits of the project.
PI assures CPHS that all procedures performed in this project will be
conducted in accordance with all federal regulations and university
policies which govern research with human subjects.
A. Data collection dates:
1. From:
2. To:
B. Human subjects description:
1. Age range:
2. Approx. number
3. % Male:
4. % Female:
C. Project Summary:
Complete application using commonly understood terminology.
1. Background and Significance
Provide a concise rationale for this project, based on current literature, information, or data. Include
references as appropriate.
2. Description of the Research
Purpose, Hypotheses/Research Questions, Goals of the Project. Briefly describe the purpose and
goals of the project (include hypotheses or research questions to be addressed and the specific
objectives or aims of the project. Describe or define terms or methods as needed for CPHS
reviewer’s understanding.
3. Research Method and Design
Provide an overview of research methodology and design; e.g., how the data are to be collected,
analyzed, and interpreted. Possible information to describe: (a) Rationale, (b) Method, (c)
Potential difficulties and limitations, (d) Data analysis (include power of the test), (e) Alternative
methods considered, (f) Evaluation, etc.
4. Instruments for Research with Human Subject
Indicate instruments to be used.
A. Submit copies electronically, if possible.
B. Submit copy of copyrighted questionnaire for CPHS review. Copy kept on file by CPHS.
C. Examples of instruments are as follows: (1) Educational Tests, (2) Questionnaires, (3)
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Psychological Tests, (4) Educational Materials, i.e., curriculum, books, etc., (5) Interview or
Phone Script, or (6) human subjects recruitment advertisements.
5. Human Subject Source and Selection Criteria
Describe the procedures for the recruitment of the participants. Indicate when human subject
involvement is expected to begin and end in this project. Example information to include:
A. Characteristics of subject population, such as anticipated number, age, sex, ethnic background,
and state of health.
B. Where and how participants are drawn for subject selection criteria. Coercion or undue
influence need to be considered and eliminated.
C. How ensuring equitable subject selection.
D. If applicable, criteria for inclusion and/or exclusion and provide rationale.
E. Children are classified as a vulnerable population. See Subpart D, §46.401, of federal
guidelines for additional safeguards aimed to protect the rights and welfare of these subjects.
6. Informed Consent
(See attached for basic elements to obtain informed consent.)
A. Describe procedure for obtaining informed consent.
B. Use language that is understandable to the subject.
C. Attach informed consent page.
D. If applicable, attach the following documents for review: (1) Parental consent form for
participation of minors (under 18 years of age). (2) Assent form for participants between ages 7
and 17.
7. Confidentiality
Describe how data will be safeguarded: (a) how confidentiality maintained; use of personal
identifiers or coded data; (b) how data collected and recorded; (c) how data stored during project;
(d) who has access to data or participant’s identifiers; (e) who is to receive data, if applicable; (f)
what happens to data after research is completed.
Note that research documentation, including signed informed consent forms, are safeguarded for
three years after completion of study for federal audit purposes. Faculty sponsors are responsible
for safeguarding research documentation completed by students.
8. Procedures
Provide step-by-step description of procedures and how they are to be applied. Procedures are to
begin from CPHS approval and end when data compiled and results reported. Possible information
to include: What are participants asked to do? When and where are they to participate? How
long will it take to participate? Describe type of research information gathered from participants,
i.e., data being collected.
Note that ethical responsibility of researcher to participant does not end until participant’s
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information has been destroyed. Research documentation cannot be destroyed for up to three
years after completion of a study.
9. Research Benefits
Describe any anticipated benefits to subjects as well as reasonably expected general results.
10. Risks
Describe any foreseeable risks to the subjects, whether physical injury, psychological injury, loss
of confidentiality, social harm, etc., involved in the conduct of the research. Explain precautions
taken to minimize these risks. If there are any foreseeable risks, provide contact information of
organization(s) for professional treatment.
11. Other Sites or Agencies Involved in Research Project
Indicate specific site if not UHCL, e.g., school districts or school, clinics.
(A) Obtain written approval from institution. Approval should be signed and on institution’s
letterhead. Other proof of documentation may be reviewed for acceptance by CPHS.
(B) Institution should include the following information: (B1) institution’s knowledge of study being
conducted on its site; and (B2) institution’s permission granting the use of its facilities or
resources.
(C) If at all possible, electronic copies of letter or other documentation are to be submitted with
CPHS application.
(D) If letters are not available at time of CPHS review, approval will be contingent upon their receipt.
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**Processing for Exempt and Expedited Review typically takes 2 to 3 weeks**
FEDERAL AND UNIVERSITY GUIDELINES
Minimum Risk Research
Applicable Minimum Risk Research protocols are processed by the CPHS committee (UHCL’s IRB,
Institutional Review Board) under the “expedited review process.” Minimum Risk to human subjects, in
general, means research where:
“the probability and magnitude of harm or discomfort anticipated in the research
are no greater in and of themselves than those ordinarily encountered in daily life
or during the performance of routine physical or psychological examinations or
tests.”
The following list of categories fall into the Minimum Risk definition AND are allowed review by expedited
review process:
Reference 45 CFR 46.110 (a) “a list of categories” for complete information and examples.
http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm
a. Prospective collection of biological specimens for research purposes by non-invasive means.
b. Collection of data through non-invasive procedures routinely employed in clinical practice,
excluding procedures involving x-rays or microwaves.
c.
Research involving materials that have been or will be collected solely for non-research
purposes.
d. Collection of data from voice, video, digital or image recordings made for research purposes.
e. Research on individual or group characteristics or behavior; or research employing survey,
interview, oral history, focus groups, program evaluation, human factors evaluation or quality
assurance methodologies. (Some research in these categories may be Exempt; see below.)
Exempt Research
Only designated UHCL CPHS representatives provide final determination that human subject
research is Exempt Research. A completed CPHS application, informed consent form, and instruments
are submitted for this determination. Application documents and CPHS approval are kept for federal
audit recordkeeping.
Categories of investigation generally exempt from federal requirements for the protection of human
subjects include, among others, are as follows:
Federal Exceptions: Exempt regulations 45 CFR 45 46.101(b) (1) thru (6) DO
NOT APPLY when research subjects are from the vulnerable populations:
prisoners, pregnant women, human fetuses, or neonates.
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UHCL does not allow Exempt Research if Children are involved: UHCL is
mandating stricter guidelines than those found in Subpart D, §46.401(b)(1) and
§46.401(b)(3) through (b)(6).
Reference 45 CFR 46.101(b) (1) thru (6) for complete information and examples.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.101
a. Research conducted in established or commonly accepted educational settings, involving
normal educational practices, such as 1) research on regular and special education
instructional strategies, or 2) research on the effectiveness of or the comparison among
instructional techniques, curricula, or classroom management methods.
b. Research involving the use of educational tests, survey procedures, interview
procedures or observation of public behavior, unless:
1. Information obtained is recorded in such a manner that human subjects can be
identified and
2. 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.
c.
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.
Informed Consent
Consent by Subject to Participate in Minimum Risk Research
Under UHCL’s CPHS Responsibility
[Refer to 45 CFR 46.116 (a) for basic elements and
(b) for additional elements of informed consent]
The following basic elements must be addressed on all informed consent forms for any minimum risk research
approved at the University of Houston-Clear Lake:
Informed Consent Checklist - Basic Elements
A statement that the study involves research
An explanation of the purposes of the research
The expected duration of the subject's participation
A description of the procedures to be followed
Identification of any procedures which are experimental, if applicable
A description of any reasonably foreseeable risks or discomforts to the subject
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CPHS Expedited Application Form
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A description of any benefits to the subject or to others which may reasonably be
expected from the research
A disclosure of appropriate alternative procedures or courses of treatment, if any, that
might be advantageous to the subject
A statement describing the extent, if any, to which confidentiality of records identifying
the subject will be maintained
An explanation of whom to contact for answers to pertinent questions about the
research.
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Provide name and contact information (phone number and email address) for
Principal Investigator(s); or Student Researcher(s) and Faculty Sponsor(s).
Waiving or appearing to waive any legal rights of subjects is prohibited. Releasing or
appearing to release the investigator, the sponsor, the institution or its agents from
liability for negligence is also prohibited.
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Include the following statement in ALL written informed consents.
THE UHCL COMMITTEE FOR PROTECTION OF HUMAN SUBJECTS (CPHS) HAS
REVIEWED AND APPROVED THIS PROJECT. ANY QUESTIONS REGARDING
YOUR RIGHTS AS A RESEARCH SUBJECT MAY BE ADDRESSED TO THE
UNIVERSITY OF HOUSTON-CLEAR LAKE COMMITTEE FOR THE PROTECTION
OF HUMAN SUBJECTS (281-283-3015). ALL RESEARCH PROJECTS THAT ARE
CARRIED OUT BY INVESTIGATORS AT THE UNIVERSITY OF HOUSTON-CLEAR
LAKE ARE GOVERNED BY REQUIREMENTS OF THE UNIVERSITY AND THE
FEDERAL GOVERNMENT. (FEDERALWIDE ASSURANCE # FWA 00004068)
A statement that participation is voluntary, refusal to participate will involve no penalty
or loss of benefits to which the subject is otherwise entitled, and the subject may
discontinue participation at any time without penalty or loss of benefits, to which the
subject is otherwise entitled.
Informed Consent Process
1. No principal investigator may involve a human being as a subject in research covered by the 45 CFR
46 unless the principal investigator has obtained the legally effective informed consent of the subject
or the subject's legally authorized representative.
2. A principal investigator shall seek such consent only under circumstances that provide the prospective
subject or the representative sufficient opportunity to consider whether or not to participate and without
undue influence or any element of force, fraud, deceit, duress or other forms of constraint or coercion.
3. The principal investigator is expected to explain the proposed activity to a potential subject in enough
detail and in language understandable so as to assure that the potential subject fully understands to
what he/she is consenting and that the decision is a well-informed one.
4. Each subject should be given a copy of the consent form he or she has signed.
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CPHS Expedited Application Form
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Tips on Informed Consent
http://www.hhs.gov/ohrp/humansubjects/guidance/ictips.htm
Children’s Assent and Parent’s Consent
The assent of children between the ages 7 through 17 years is to be obtained as well as the
consent of at least one of the parents.
Children should be ensured that they do not have to give their assent to participate because they
want to please their parents or because they may fear their parents will be upset if they do not assent.
Likewise, if there are children who do not assent to participation, parents should be reminded that it is
perfectly fine for their child not to participate. Prevention of embarrassment or other possible feelings for
either the child or parents is the primary purpose for such precautions.
8
CPHS Expedited Application Form
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CPHS Expedited Application Form
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CPHS Expedited Application Form
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CPHS Expedited Application Form
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