HSPC/IRB Application: Fall______Spring_____ 20______
EXEMPTION APPLICATION
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 to request exemption from HSPC/IRB review.
Project Title:
Submission Date:
Principal Investigator:
Affiliation:
Department:
Email:
Phone:
Faculty/Staff Advisor (Advisor name required for student submissions):
Advisor Email:
Advisor Phone:
Research Team Members (investigator, affiliation, department, email):
Organizations affiliated with the project:
YES / NO: Have you completed CITI Training (If a student: have you and your faculty advisor completed CITI training)? Applications will not be accepted if you have not completed CITI training.
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
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:
Research Exemption Status Request
The federal regulations include a very specific definition for what constitutes “research” (45 CFR 46.102(d)) and for what is meant by a “human subject” (see 45 CFR 46.102(f)). “Research” means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. “Human subject” means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.
If you believe that the proposed research is exempt from IRB review, please check any one or more of the items below that jointly describe your proposal in its entirety. Additionally, complete all sections of this application. If the Committee does not concur that this research is exempt, you will be asked to complete the full/expedited review application.
EDUCATIONAL PURPOSES: Research conducted in established or commonly accepted educational settings, involving normal educational 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. Research is not FDA regulated and it does not involve prisoners. (45 C.F.R. §46.101(b)(1))
EDUCATIONAL TESTS, SURVEYS, INTERVIEWS, PUBLIC OBSERVATION: Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior unless information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects (i.e. does not protect the confidentiality of subjects in all reporting); and (ii) 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. If research involves children as participants, procedures are limited to observations of public behavior where investigators do not participate in the activities being observed. Research is not FDA regulated and does not involve prisoners. C.F.R. §46.101(b)(2))
ELECTED OR PUBLIC OFFICIALS: Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) 46.101, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. Research is not FDA regulated and it does not involve prisoners. (45 C.F.R. §46.101(b)(3))
EXISTING DATA: 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. Research is not FDA regulated and it does not involve prisoners. (45 C.F.R. §46.101(b)(4))
PUBLIC BENEFIT / SERVICE PROGRAMS: Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which 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. Research is not FDA regulated and it does not involve prisoners. (45 C.F.R. §46.101(b)(5))
TASTE TESTS: Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. Research does not involve prisoners. (45 C.F.R. §46.101(b)(6))
Feel free to add additional information as to why you think this research is exempt:
RESEARCH DETAILS
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 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)?
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
***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
***Attention Student Researchers: You must have your Faculty Research Advisor/Supervisor sign the Faculty Research Advisor Assurance Section before your application can be reviewed.***