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IRB Proposal

Page history last edited by Ashley Baker 9 years, 10 months ago

Cal Poly Pomona - Human Research Protections Program

Institutional Review Board (IRB)

                  Protocol Approval Application (version:  March  27, 2009)

IRB principles:  respect for persons, beneficence, justice

 

Cal Poly Pomona (CPP) is committed both to research in advancement of teaching and science and to the protection of the individuals involved.  As part of the assurance filed with regulatory agencies including the Dept. of Health and Human Services and policies from others like the State of California, the University has designated a human subjects’ committee, called the Institutional Review Board or IRB, to review proposals for research involving living persons.  This application, when submitted to the IRB, will be evaluated in terms of its compliance with ethical standards regarding the treatment of subjects (participants).  The type of review – full, expedited, or exempt – will be determined by the IRB.  While individual researchers are ultimately responsible for their practices, the IRB’s review is designed to provide objective input as additional protection for the subjects.  Further, it is of benefit to those who could be held accountable for the research practices – the researchers and the University.  All research conducted by students, faculty, and individuals sponsored by faculty must have prior IRB approval. 

 

Hints and help:

n Complete all sections in yellow about your research proposal.  There are blue highlighted links to additional information.

n Submit your completed application to the IRB office within the Office of Research and Graduate Studies (ORGS).   E-mail it and any attachments such as surveys, informed consent forms, and recruiting flyers to bkennedy@csupomona.edu.  To facilitate tracking, please include in the file name 1) your last name and 2) one or two key words describing its subject.

n Print off, sign, and mail this front page to the IRB at ORGS, Building 1, room 229.

n Training in the conduct of human subject research is critical and investigators must demonstrate their knowledge and awareness through the completion of appropriate coursework.   As of January 1, 2007, the IRB adopted the CITI “Course in The Protection of Human Research Subjects” (https://www.citiprogram.org) as the primary means of training and as a requirement of protocol approval.  Please provide documentation of your training with this application; you may be asked to pursue additional training appropriate to your proposal.

nMore information about the IRB at Cal Poly Pomona is available at the ORGS web page, http://www.csupomona.edu/~research/irb/.  There are sample protocols and consent forms, links to training materials, policies and procedures, etc.

n For other assistance, contact the Compliance Associate within ORGS, Bruce W. Kennedy MS RLATG CMAR, at 909-869-4215 and bkennedy@csupomona.edu.

 

Investigator information 

Primary investigator (faculty, student, etc.)

Others (your faculty advisor, co-investigators, etc.)

Name:

 

Dr. J. Pataray-Ching

Affiliation(college/dept):

CSU Pomona

 

Phone contact (office or cell):

 

 

Email contact: 

 

 

Title of IRB protocol:  The effectiveness of a physical science handbook for 5th-grade teachers

Date submitted:  5/18/2009

_X__new        ___amendment        ___renewal; previous number:  

Vulnerable subjects (risks)?:   ___minors      ___pregnant women      ___medically sensitive      __X_other:   NONE

       

DECLARATION BY ALL INVESTIGATORS:  This proposal is guided by the ethical principles regarding research involving human subjects as set forth in the Belmont Report.  I/We agree to abide by the policies and procedures of the IRB at CPP, including obtaining appropriate training in human subject research for myself and those involved in its conduct.  I/We will not initiate any research associated with this proposal on or off campus until authorized by the IRB.  I/We will inform the IRB of any adverse events that occur or of a need to modify the study design.  I/We understand that approval, when granted, is valid for up to one year and will submit a renewal for its continuation if needed.

(send this signed page to the IRB office)

Signature, certifying the above                                                   Date

primary investigator:  

 

all others, including advisors:  

 

 

 

IRB office use                                review type:   full IRB (risk involved)         expedited/designated review (minimum risk/harm)         exempt      PEIP       NA

date rc’d:                                 revised

assigned to:

training:    PI      others

approval date:

protocol #:

 

 

renewal date:

copies:    chair    file

final:  signed   ICF   approval-memo   authorizations   e-mailed

 

This protocol has been reviewed and approved for conduct by the IRB, California State Polytechnic University, Pomona.

David Adams PhD

Chair, IRB                                                                                                                Date

I.            DESCRIPTION OF THE RESEARCH PROJECT

Research is defined as “a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”  (45 CFR 46.102(d))

              A.          Purpose  --  What hypothesis are you testing?  Why are you conducting this study; explain the rationale?  What are the objective(s) and goal(s)? Provide enough detail such that a) the IRB member(s) reviewing your protocol will understand your research plan and b) to support a judgment of the risks and benefits in order to approve the “use” of the research participants.

The goal is to indirectly motivate elementary students to appreciate physical science, especially chemistry.   With so many future jobs involving the technological sector of the workforce, many students choose not to follow science related careers.  In many cases, elementary teachers themselves may not be fond of chemical concepts, which lead to an unmotivated effort in teaching these concepts.  Additionally, there is such a push at the elementary level to focus on reading, writing, and mathematically skills.  It is therefore difficult for elementary to teachers to find time within their busy day to implement a hands-on laboratory experiment that would fulfill a chemical concept and keep students engaged.  By having 5th-grade teachers implement a self-generated manual that address 5th-grade physical science standards, it is my hope to empower 5th-grade teachers to teach physical science with confidence, resources, and appreciation. 

 

Therefore, the purpose of this study, is to examine the effectiveness of this manual by focusing on teacher- and student-interviews, in-class assessments, standardized tests in the physical sciences.

              B.          Relevance -- State specifically the relationship of your proposed research to other, previous scientific investigations in the field.  Provide full citations (APA or MLA reference styles are good).  What literature is related to your research?  What are you doing that builds on that information? 

With increasing demand of high-skilled jobs, science education is becoming a more prominent aspect of not only secondary education, but also of primary education.  According to various resources, the latter years of primary education has seen a decrease in science interest by students.  Investigative studies have shown that a combination of content and time constraints as hindered science achievement in primary education.  Additionally, many elementary teachers are not comfortable with a variety of physical science topics that are required by the California Science Standards.  With the reading, writing, and mathematical skills being at the forefront of primary education, science is relegated to a few minutes a week.  It is this combination that hinders science achievement.  It is the intention of this project to equip primary educators with various hands-on experiments that will be designed to address the intrinsic time constraints of the school day and to be engaging to both student and teacher.

 

 

 

                     C.          Methods  --  Summarize the design (independent variables, interventions, treatments, etc.) of your proposed study.  Describe in detail all procedures to be done with human subjects.  What types of test(s) will be performed on or with the subjects?  How will you carry them out and with what data gathering instruments and apparatus?  When do you plan for the research to occur?  Where will the research be held (is authorization or permission needed)?  Who will conduct the research besides yourself?   Define terms, abbreviations, and procedures that may be specific to your discipline for the understanding of the IRB reviewer.  By authorization, it is meant for example, a company’s permission to use worker’s time or a school principal’s acknowledgement – if so, provide documentation to the IRB.

 

 

 

 

 

 

 

 

 

II.            AFFILIATIONS

These questions ask about how you are related to the institution and subjects where the research project is to be conducted. As examples:  you are a teacher using your students in a classroom setting as your subjects, or you work for the company where a marketing survey is to be conducted, or you have a financial interest in a product being tested, or you are working with a colleague in another country.

              A.          Are you collaborating with another group such as a school, community association, government agency, etc.?  Is IRB approval necessary, or being obtained, elsewhere (domestically or internationally)?  Is the project being sponsored or supported through a grant, contract, or other financial arrangement?  Describe as appropriate. The IRB is required to collect such data for OHRP (Office for Human Research Protections) on studies funded by DHHS (NIH, FDA, etc.). 

 

 

             B.           Personal gainDo you, as an investigator involved with the project, or any family member (spouse, child, etc.) have a financial or other interest in this study?  If yes, describe.

 

 

              C.          Are you a student?  Is this project part of a classroom experience or a graduate program?  Has your advisor/mentor reviewed your IRB application?  Describe as appropriate.

 

              D.          Do you have any pre-existing relationships of any kind with the subjects (participants) or institutions involved in conducting this study?  If so, please describe them.  If you work for a company and need to keep the identity confidential, note that here.

 

 

 

  E.           If you are not affiliated with Cal Poly Pomona, who is your sponsor on campus?

                          X      not applicable                  name and phone number of sponsor          .

 

              F.          Though there may not be one, could there be the perception of a conflict of interest for either you, as the investigator, or for the subjects in this study?  If so, how will you manage that?

 

 

 

III.            DATA COLLECTION

Collection methodologies include, but are not limited to:  surveys, interviews, focus groups, oral histories, participant observation, observations of public behavior, research in public schools, and the analysis of existing data.  Data include:  survey sheets and questionnaires, biological samples, audio and video tapes, transcripts of verbal communication, photographs, paper and electronic records, previously collected (existing) information, etc.

              A.          What data about the subjects will be collected?  In what format (see above)? How will it be coded or identified?  Will social security numbers be used?  What will become of the data at the end of the study (returned, destroyed, archived)?

 

 

              B.          If applicable, have you submitted a copy of the survey or questionnaire to the IRB?  Provide the URL for electronic surveys.  (It will be tested during IRB review; discard those data before ‘going live.’) 

                                          x   yes                                        in development                                comment:    see questions below       .

 

 

 

 

 

 

 

 

 

              C.          Who will have access to and use the data?  How will the raw data be kept protected and secure?  How will the data, results, and conclusions be utilized (e.g., presentations, publications, or other)? (per California law, CC 1798.24, the researcher must provide a plan sufficient to protect personal information from improper use and disclosures, including sufficient administrative, physical, and technical safeguards to protect personal information from reasonable anticipated threats to the security or confidentiality of the information.)

 

 

  D.          Does the research project have provisions or plans for the ongoing monitoring of data collection to ensure safety of subjects?  If so, describe the plan.

 

 

  E.          For studies involving medical records, explain compliance with the HIPAA privacy rule (Health Insurance Portability and Accountability Act) and disclosure of protected health information (PHI).  (see http://www.csupomona.edu/~research/irb/Hints_help_examples.htm for the “Experimental subject’s bill of rights – Medical research“ consent form if invasive procedures are to be performed)

        not applicable                      comment:            .

 

IV.            SUBJECTS

A human subject is a “living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or identifiable private information.”  (Dept. of Health and Human Services) 

              A.          How many subjects (or participants) will be involved in the research project?  It is acceptable to have a range, but it must be a close approximation.

 

 

            B.            Briefly describe the subject group(s).  See as well the section on recruitment of subjects. 

 

 

              C.          What are the benefits, if any, to the subjects from their participation in the study? This information – summarized – must be included in the consent form as well.

 

 

              D.          Will the subjects be compensated?  If yes, in what way (token of appreciation, money, gift, cash card, course credit, etc.)? This information – summarized – must be included in the consent form as well.

 

 

            E.            Describe the control and/or comparison group(s), if any.

 

 

V.            VULNERABLE SUBJECTS

           When a subject has limitations, is coerced or manipulated, there is a loss of capability to volunteer, and the subject may be vulnerable.  Research conducted with vulnerable subjects may require demonstration of training with that population.

A.          Minors  –  Will children, minors, or wards be recruited for this research?  If so, explain in what way.  How will their assent to participate be obtained?  Children in most circumstances are those less than 18 years of age.  Research with children involving no greater than minimal risk requires the permission of one parent and the assent of the child (45 CFR 46.404). 

 

 

 

 

              B.          Others  –  Explain research involving other vulnerable subjects such as prisoners, pregnant women, or culturally or medically vulnerable groups?

 

 

 

VI.            POTENTIAL RISKS AND THEIR ASSESSMENT

Definition of risk:  A potential harm, discomfort, or inconvenience associated with your research that a reasonable volunteer would be likely to consider significant in deciding whether or not to participate.  Risks include legal, social, emotional, or psychological issues, physical or biological hazards, revealing an identity, damage to reputation, exposure of behavior or medical character, illness, injury, side effects of applied or consumed products, revealing or loss of private information, etc.  Risk comes at various orders of magnitude.

              A.          What are the risks?  Describe any potential harm, discomfort, or inconvenience, however minimal, as you would explain them to the subjects.  This information – summarized – must be included in the consent form as well.

 

 

 

 

              B.          Describe your procedures for protecting against or minimizing the potential risks.

 

 

 

 

 

              C.          Explain why these risks should be determined as reasonable in relation to the anticipated benefits, if any, while conducting research with the subjects.  Include in your response the importance of the expected gain in generalizable knowledge, as evaluated against the risks.

 

 

 

 

 

              D.          Is the study anonymous or confidential?  Describe in detail your procedures meant to assure the protection of subjects’ information, sensitive data, and privacy.  (See the CPP IRB web page for a discussion of what is confidential and what is anonymous.)

 

 

 

 

 

 

VII.            RECRUITMENT

           As applicable, attach copies of flyers, e-mail text, etc., to be used for the recruitment of subjects in order to facilitate review by the IRB.  Include the statement as follows:  The Cal Poly Pomona Institutional Review Board has reviewed and approved for conduct this research involving human subjects under protocol YY - ### (meaning year and sequence number).

             A.           How and where will you recruit your subjects to participate in the study?  Will translation of materials be necessary to other languages or to a different reading and comprehension level? 

 

 

              B.          Describe the criteria you will apply when selecting and enrolling subjects into the study.  Inclusion criteria are those characteristics on which you will be recruiting and accepting subjects.  Exclusion criteria are characteristics on which subjects will be screened and potentially excluded from participating. 

 

 

   C.          Describe your procedures for the recruitment of a representative sample of the population based upon race, ethnicity, gender, health status, or other characteristic.  If this is not the case, discuss the reasons for not having such a balanced sample (such as, the research is focused on a certain subject group). 

 

 

VIII.            TRAINING

Formal training and practical experience in research with human subjects are critical for the protection of the participants and minimization of risk that might be associated with the conduct of the study.  Federal regulations require that investigators possess training.  The Cal Poly IRB adopted in 2006 the on-line CITI program as required training in human subjects research.  All investigators submitting applications to the IRB after January 1, 2007, must complete appropriate modules of CITI as a condition of approval of a protocol.  Other formal training will be considered by the IRB on an individual basis.

              A.          Describe the training possessed by you.  Include when it was obtained and the CITI completion report number.  Will you obtain any additional training related to this proposal?  If you are a student, your advisor or mentor must possess training as well, to be described in the next section. 

 

 

              B.          Describe the training possessed by others including your co-investigators, collaborators, students, staff, faculty members, a student’s mentor or advisor, etc., from Cal Poly or elsewhere, working on this study.  Include when it was obtained and the CITI completion report number.  

My advisor’s CITI Basic Course Reference # is XXXXXXXXX. No further training is needed.

 

 

IX.            INFORMED CONSENT

           The consent form is the means by which you as the PI convey the principles of human subjects protections to your subjects:  respect, beneficence, and justice.  Complete the accompanying consent form(s) below.  Include it when submitting this protocol application for review.

              A.          How will you obtain and document informed consent (for adults) or assent (for children)? Which study personnel will be involved in obtaining consent and/or assent? For certain types of  research, like on-line surveys, it is possible to obtain “implied consent.”  Contact the IRB for a determination and the requirements.

 

 

 

 

 

 

              B.          Will there be recruitment of subjects who cannot themselves provide informed consent?  If so, how will informed consent be documented for this population?

 

 

 

 

 

 

              C.          Describe how you will maintain the consent forms received from the subjects?

 

 

 

 

 

 

 

X.   CONSENT FORM

A properly written Informed Consent Form will include the following elements.  You, as the Principal Investigator, are responsible for addressing each when writing your consent and/or assent form.  Both federal and California regulations require the inclusion of these elements.  You may wish to use this page as a checklist.  Incomplete forms will be returned to you for revision.

  • A telephone number and/or e-mail address of all primary investigator(s) of this proposal, including faculty members and graduate students, who would be the point(s) of contact for the subjects
  • Affiliations (professional and institution) of the contacts and investigators
  • Clarification of the contacts in research projects involving multiple sites
  • Title of the protocol
  • Protocol number as assigned by the IRB (it will be provided after the protocol submitted)
  • A statement that the study involves research
  • An explanation of the purposes of the research
  • The expected duration of the subject's participation on the study
  • A description of the procedures to be followed in layman's terms (at the 5th grade reading level); the entire consent form may need to be translated into the subject’s language of fluency
  • Identification of any procedures which are experimental
  • A description of any reasonable and foreseeable risks or discomforts to the subject
  • A description of any benefits to the subject or others which may reasonably be expected (or not) from the research
  • A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
  • For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments would be available if injury occurs and, if so, what that would consist of or where further information may be obtained
  • California law, under Health & Safety Code Section 24172, requires that any person asked to take part as a subject in research involving a medical experiment, or any person asked to consent to such participation on behalf of another, is entitled to receive the Experimental Research Subject’s Bill of Rights 
  • An explanation of whom to contact for answers to pertinent questions about the research and research subject's rights, and whom to contact in the case of a research-related injury to the subject
  • A statement that participation is voluntary, that declining to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled
  • Printed name and signature lines for the subject and the date signed
  • A statement that the subject is entitled to receive a copy of the completed informed consent form

 

 

 

The IRB requests the header on the following page for all Cal Poly Pomona approved protocols that need informed consent. Additionally, if child assent is necessary, you must generate a Child Assent letter that is appropriate for the target group of minors and/or vulnerable population.

 

California State Polytechnic University, Pomona

Informed Consent Form for Research Involving Human Subjects

 

You are being invited to participate in a research study, which the Cal Poly Pomona Institutional Review Board (IRB) has reviewed and approved for conduct by the investigators named here.  This form is designed to provide you - as a human subject - with information about this study.  The Investigator or his/her representative will describe this study to you and answer any of your questions.  You are entitled to an Experimental Research Subject’s Bill of Rights and a copy of this form.  If you have any questions or complaints about the informed consent process of this research study or your rights as a subject, please contact the Compliance Office within Cal Poly Pomona’s Office of Research and Graduate Studies at (909) 869-4215.

 

Below is this header in Spanish:

Forma de Consentimiento Informada para Investigación que Implica Sujetos Humanos

Usted esta invitado a participar en un estudio de investigación que el Comité Examinador Institucional (CEI) de Cal Poly Pomona ha revisado y aprobado para ser conducido por los investigadores nombrados aquí. Esta forma esta diseñada para proporcionarle información acerca de este estudio en su calidad de sujeto humano.  El investigador o su representante le describirán este estudio y le contestarán cualquier pregunta que tenga. Usted tiene derecho a la Declaración de Derechos del Sujeto que participe en una Investigación Experimental y a recibir una copia de este documento. Si tiene alguna pregunta o quejas acerca del proceso descrito en dicho documento, por favor contacte a la Oficina de la Conformidad que forma parte de la Oficina de Investigación y Estudios de Postgrado de la Universidad de Cal Poly Pomona al (909) 869-4215.

 

 

 

 

 

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