HSPC/IRB Description of Research Form (For research projects involving human participants)

Transcription

1 HSPC/IRB Description of Research Form (For research projects involving human participants) This form is to be completed by the Principal Investigator (P.I.) of the research project being submitted to the HSPC/Institutional Review Board of Whittier College for exemption or review. Project Title: Submission Date: Principal Investigator: Affiliation: Department: Phone: Faculty/Staff Advisor (Advisor name required for student submissions): Advisor Advisor Phone: Research Team Members (investigator, affiliation, department, ): Organizations affiliated with the project: RESEARCH OVERVIEW A. Describe the type of research being proposed. You may check as many boxes as apply: Administrative or institutional research Faculty research (including student involvement in a faculty project) Thesis or independent undergraduate research Thesis or independent graduate research Course-related research Off-campus research Renewal Other (describe): B. If this is faculty research funded by an external research grant (i.e. from a federal agency) to the faculty member, provide the granting agency and grant number: C. Provide a brief paragraph overview of the proposed research (include research questions and/or hypotheses) D. Beginning and concluding dates of proposed activity:

2 DETAILED PRESENTATION OF RESEARCH To the Applicant: Please complete the following sections in adequate detail to provide the HSPC/IRB with an accurate and complete description of the proposed research project. I. PARTICIPANTS A. Check all groups that are part of your study (by design or circumstance): Adults (18 years of age or older) Minors (under 18 years of age) Economically or educationally disadvantaged persons Persons with physical or mental disabilities Pregnant women or fetuses Prisoners Individuals whose primary language is not English Other (please describe): B. Please describe in more detail what participants you will seek out and how you will recruit them. 1. Approximate number and ages of all requested participants? 2. Are there specific eligibility or screening criteria? If so, describe. 3. Source of subjects. If any organization or agency is being used to contact subjects, has the permission of this agency been obtained? 4. How will participants be recruited? (include as an addendum any flyers, advertisements, letters that will be used for recruitment) 5. Are there circumstances that might lead to the perception of coercion or undue pressure on the part of participants? 6. Will you offer incentives or compensation? If so, what inducements will they receive and why? II. RESEARCH METHODS A. Check all of the research methods you will use in your study: Observation of public behavior Educational testing or assessment Interview, focus group, or questionnaire Experimental procedures or testing Specimen collection (eg. blood, saliva) Use of records (eg. school transcripts, medical records) Existing data set (from: ) Other: B. Please describe your research procedure by answering the questions below. You must include all surveys, interview questions, rubrics, and other associated research materials that will be used for this

3 study with your application and refer to them in this section. If you are planning on voice or video recording any parts of your research, please mention in this section. (If you are using only existing data, describe the source and content of the data set and whether IRB approval was obtained for the original study). 1. Location where the research will take place (include the specific location (for example, two third grade classrooms, and the full address and name of agency or organization, if applicable): 2. Who will interact with participants and what are their qualifications for doing so? 3. What will participants be asked to do for this research study? 4. What behaviors or other measures will be collected and how? 5. Will the research involve audio or videotaping, and if so, how and with whom? 6. If any deception (withholding of complete information) is required for the validity of this activity, explain why this is necessary and attach a debriefing statement. 7. Explain the nature and amount of risk, substantial stress, loss of reputation, discomfort or invasion of privacy involved for participants? 8. What is the expected risk compared to the expected benefit? 9. What follow-up is planned as part of the procedures? 10. What plan do you have to handle possible adverse effects (the handling of adverse effects must be conducted by someone other than the principal investigator or any other investigators associated with the project)? III. BACKGROUND FOR PROPOSED RESEARCH ACTIVITY A. Please explain in adequate detail the rationale for the proposed research project: IV. INFORMED CONSENT, CONFIDENTIALITY, ANONYMITY A. Check all the types of informed consent that will be used in the study: Written participant consent Written parent/guardian consent Written minor assent Oral minor assent Oral participant consent Oral parent/guardian consent I will not be documenting consent Other: B. Written participant or parent/guardian (in the case of minors) consent is expected unless waived by the IRB. If you will not be obtaining written consent, please explain why. For participants under the age of 18 both written parent/guardian consent and participant agreement to participate (assent) is

4 expected unless waived by the IRB. If you do not plan to obtain parental consent and participant assent, please explain why. C. Will participation be anonymous (participants cannot be identified by person, name, or data by the researcher or others?)? If yes, how will this be assured? D. If participation is not anonymous, what steps are being taken to ensure confidentiality and/or informed consent? E. Include copies of all consent / assent forms. If the participants include non-english speaking populations, you will need to include forms in the home language of the participant population. If oral consent is planned, provide the verbal consent script. F. Describe the provisions for controls over access to documents and data. V. PRESENTATION OF RESULTS A. Explain how you will present results (publication, conference, etc.). INVESTIGATOR S ASSURANCE I certify that the information provided in this application is complete and correct. I understand that as Principal Investigator I have ultimate responsibility for the conduct of the study, the ethical performance of the project, the protection of the rights and welfare of human subjects, and strict adherence to any stipulations imposed by the Whittier College Human Subjects Protection Committee/Institutional Review Board. I agree to comply with all applicable Federal, State, and local laws regarding the protection of human subjects in research including the following: Performing the project by qualified personnel according to the approved protocol; Implementing no changes in the approved protocol or consent form without prior approval of the Whittier College Human Subjects Protection Committee/Institutional Review Board (except in an emergency to safeguard the well-being of subjects); Obtaining the legally effective informed consent from human subjects or their legally responsible representatives; Promptly reporting significant or untoward adverse effects to the Whittier College Human Subjects Protection Committee/Institutional Review Board; and In my absence, arranging for a co-investigator to assume direct responsibility. This person is either named as co-investigator in this application or the Committee is notified in advance of such arrangements. Principal Investigator s Signature Date You may use an electronic/typed signature here

5 ***Attention Student Researchers: You must have your Faculty Research Advisor/Supervisor sign the Faculty Research Advisor Assurance Section before your application can be reviewed.*** FACULTY RESEARCH ADVISOR ASSURANCE I certify that I have carefully read, edited, and reviewed the following items associated with this study and that they are complete and correct: 1) the information provided in this application, 2) the consent form associated with this study, and 3) all other documents associated with this study (interview questions, questionnaires, methodologies, etc.). As the Faculty Research Advisor for the Principal Investigator (a current undergraduate or graduate student of Whittier College) of this study, I fully understand that I am responsible for supervising the conduct of the study, the ethical performance of the project, the protection of the rights and welfare of human subjects, and strict adherence to any stipulations imposed by the Whittier College Human Subjects Protection Committee/Institutional Review Board. I will also ensure that the Principal Investigator will follow all Federal, State, and local laws regarding the protection of human subjects in research including the following: Performing the project by qualified personnel according to the approved protocol; Implementing no changes in the approved protocol or consent form without prior approval of the Whittier College Human Subjects Protection Committee/Institutional Review Board (except in an emergency to safeguard the well-being of subjects); Obtaining the legally effective informed consent from human subjects or their legally responsible representatives; Promptly reporting significant or untoward adverse effects to the Whittier College Human Subjects Protection Committee/Institutional Review Board; and In my absence, arranging for a co-investigator to assume direct responsibility. This person is either named as co-investigator in this application or the Committee is notified in advance of such arrangements. Faculty Research Advisor: Signature Date You may use an electronic/typed signature here