IRB Reseach Proposal Form

Proposal No. _____ (Internal Use) Research Proposal Form Note: Please complete this form and attach responses to the issues raised, keeping in mind that the primary concern is the potential risk – physical, emotional, or other – to the participants, as well as the protection of their rights. Provide copies of all questionnaires, consent forms, or other documents to be used in the inquiry. In addition, for each investigator associated with the project, please attach a “Certificate of Completion” from the National Institutes for Health (NIH) Office of Extramural Research indicating the successful completion of the NIH Web-based training course “Protecting Human Research Participants” within three years of your submission of this document. The Institutional Review Board (IRB) must have enough information about the transactions with the participants to evaluate the risks of participation. Assurance from you, no matter how strong, will not be substitute for a description of the transactions. Submit the proposal and supporting documents to the Institutional Review Board. Principal Researcher: Title: Division/Department or Other COS Affiliation: Campus (Select One): Hanford Tulare Visalia External Affiliations (if any): Phone: Email: Other researchers in project (provide same information as for principal researcher): ____________________________________________________________________________________ Research Title: ________________________________________________________________________ Data Collection Start/End Dates (Grant Project start and end dates): __________to________________ Page 2 of 5 Purpose of Project (check all that apply): □ To fulfill requirement related to course or degree program at a college/university. Course name: ______________________________________________________________________ Thesis/Dissertation (Attach summary of proposal made to institution). Title: _____________________________________________________________________________ □ Grant Project. Grant Name: ___________________________________________________________ □ As a part of an externally funded project. Funding agency: __________________________________ □ For my own scholarly interest. □ Other, please describe: Address the following in a narrative. Briefly describe the purpose of your study and, in non-technical terms, what will the participants be asked to do, what are the processes and procedures for data collection. Append relevant instruments (protocols, questionnaires, surveys, etc.). Describe the value-added knowledge of your project (i.e., describe how your project contributes to the teaching/learning environment at College of the Sequoias or to the college’s policies, procedures, or operations.) Your application must include letters of approval/support from cooperating entities/organizations (both COS and external) and/or supervisor Describe the procedures in place regarding maintaining the confidentiality or anonymity of the participant within the limits of the law. Page 3 of 5 Which of the following activities describe your research (check any that apply): □ Research conducted in established or commonly accepted educational setting, involving normal or special education practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. (46.101b 1) □ Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures interview procedures, or observation of public behavior, unless (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside of 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. (46.101b 2) □ Research involving elected or appointed officials or candidates for office, even when confidentiality cannot be maintained or disclosure places the participant(s) at risk. (46.101b 3) □ Research involving the collection or study of existing data either publicly available or recorded by the researcher(s) in a manner that maintains confidentiality (i.e. human subjects can NOT be identified, directly or through identifiers linked to the subjects.) (46.101b 4) □ Research and demonstration projects that are conducted by or subject to the approval of [federal] department or agency heads, and that are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) Procedures for obtaining benefits or services under those programs; (iii) Possible changes in or alternatives to those programs or procedures; or (iv) Possible changes in methods or levels of payment for benefits or services under those programs. (46.101b 5) □ Research involving taste and food quality evaluation of either wholesome foods without additives or food with ingredients at or below levels found to be safe by the Food and Drug Administration. (46 101b 6) If at least one box was checked above, your research may be considered “exempt” (contingent upon determination by COS IRB) .You may sign this form and return to the Office of Research, Planning and Institutional Effectiveness. If you did NOT check any of the above boxes, please address the prompts on the following pages. Page 4 of 5 Describe any potential risks or benefits (emotional, physical, social, or political) to your participants. Give the anticipated ages, sex and number of participants, and explain how and where they will be recruited. Describe the procedures for obtaining informed consent as provided for the Code of Federal Regulations, section 46.116. Append any forms used. If minors are involved, describe the procedures for obtaining consent to participate from the minors capable of giving consent, as well as the procedures to obtain parental or guardian consent. If risk is involved, explain how the knowledge to be gained and/or the benefits to the research participants from the proposed research justify any risks the participants might incur. Explain what, if any, support services will be provided in the event of harm to a participant. Page 5 of 5 Certification I certify that I have read and understand the policies and procedures for research projects that involve human participants and that I intend to comply with the College of the Sequoias procedures for research involving human participants. Significant changes in the research protocol for an approved study must be submitted to the IRB and approved prior to those changes before being put into practice. Researcher(s): Signature: ________________________________________________ Date ______________________ Signature: ________________________________________________ Date _______________________ Signature: ________________________________________________ Date _______________________ Attachments. Attach all that apply to your proposal and check the ones you have included. □ Certificate(s) of Completion for each participating researcher from the NIH Web-based training course “Protecting Human Research Participants” □ Informed Consent Form(s): first page(s) on letterhead □ External support award letter or proposal □ Letters of approval/support from cooperating entities/organizations (both COS and external) and/or supervisor □ Research methods (research design, data source, sampling strategy, etc.) □ Questionnaires, surveys, or other data-gathering forms □ Letters, flyers, etc., that will be distributed to the study subjects □ Copy of thesis/dissertation, approved proposal, or prospectus □ If the research is part of a research proposal submitted for federal, state, or external funding, submit a copy of the FULL proposal IRB Certification I/We certify that the above researchers have submitted the appropriate documentation to the COS Institutional Review Board and have been approved to conduct research according to the research protocol indicated by the researchers and in compliance with the College of the Sequoias procedures for research involving human participants. Signature: ________________________________________________ Date _______________________ IRB Co-chair Signature: ________________________________________________ Date _______________________ IRB Co-chair .

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