*Some research involving human participants may be classified as exempt from human subjects regulations, providing certain conditions are met. Before completing this form, refer to the IRB Policies & Procedures Manual, in particular the sections on levels of IRB review, to determine whether your project requires this form or Form B (expedited and full IRB review). The determination of exempt status is made by the IRB.
Date:
Principal Investigator
E-mail:
Faculty Sponsor (if applicable)
Title of Research:
Estimated beginning date
Trinity College faculty/staff/administrator
Trinity College student
Other (please specify)
Phone:
Course Name & Number (if applicable)
Estimated completion date
Choose one Exempt Category (definitions below): 1 2 3 4 5 6
EXCEPTIONS: Research involving vulnerable populations such as the mentally or cognitively impaired, prisoners, parolees, pregnant women, and fetuses, cannot be exempt from review even though it meets the criteria of one of the categories below.
EXEMPTION CATEGORIES (45 CFR 46.101(b)): Research activities in which the only involvement of human subjects will be in one or more of the following categories:
1.
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, curricular or classroom management methods.
2.
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 the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employment or reputation. Research using survey procedures or interview procedures upon children cannot be exempt. Research involving observation of children’s behavior cannot be exempt if the investigator is a participant in the
behaviors observed. [45 CFR 46.401(b)]
Trinity College IRB Form A
Revised 1/5/2016

3.
4.
5.
6.
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) of this section 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 involving the collection or study of existing (“in existence on the day the study is approved”) 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 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.
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 U.S. Food and
Drug Administration or approved by the Environmental Protection Agency or the Food and Safety and Inspection Service of the U.S. Department of Agriculture.
JUSTIFICATION AND PROJECT DESCRIPTION:
You must justify how your study qualifies for exemption by addressing the critical elements of the exemption category you choose. The critical elements for each category are:
Category 1: Specify whether 1.i or 1.ii applies and briefly explain.
Category 2: Assure that condition 2.i will be met and briefly explain how; or assure that condition 2.ii applies. If claiming exemption within this category, attach a copy of test/survey/interview questions or items.
Category 3: If claiming exemption within this category, explain subjects’ public office and how it precludes anonymity (i.e., 3.i), or briefly explain that condition 3.ii applies.
Category 4: Briefly explain the nature of the existing data/documents and briefly explain either their public availability or the procedures to ensure anonymity and confidentiality.
Category 5: Briefly explain method by which the project is reviewed and approved by a department/agency head; and identify and describe which of the 5.i – 5.iv categories apply.
Category 6: Assure that condition 6.i will be met; and assure via documentation regarding approved safety levels that condition 6.ii will be met.
Trinity College IRB Form A
Revised 1/5/2016

1. Please describe the intent of the project:
2. Please describe the project procedures:
3. Please describe how project records and/or data will be maintained and secured:
RESEARCH PERSONNEL:
Please list ALL research personnel involved in the conduct of this study. All personnel must complete the IRB approved educational program on the protection of human subjects.
Name
Position (e.g., Faculty,
Student)
Date of Completion of CITI Online
Training
HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA)
IF YOU ARE USING HEALTH INFORMATION Please address the following questions regarding the use of protected health information:
Yes
Yes
Yes
No
No
No
Will health information be obtained from the covered entity (a health care provide who bills health insurers, e.g., Hartford Hospital or Trinity College Health
Center)?
Will the study involve the provision of health care in a covered entity?
If the study involves the provision of health care, will a health insurer or billing agency be contacted for billing or eligibility?
If you answered “NO” to all three questions you are not subject to HIPAA. If you answered
“YES” to any of the questions above, you are subject to HIPAA and are required to address the following additional questions:
1.
How do you plan to protect the identifiers, used to identify potential subjects?
2.
Provide details of why the research could not practicably be conducted without access to and use of the protected health information.
3.
Do you have an adequate plan to protect identifiers from improper use and disclosure? Provide details.
4.
Do you have an adequate plan to destroy all identifiers at the earliest opportunity consistent with the conduct of the research? Explain if there is a research or health justification for retaining identifiers or if retention of identifiers is otherwise required by law.
5.
Provide an expiration date for the disclosures or if this is a therapeutic study, state far enough in the future to satisfy the sponsor’s need for data/information.
Trinity College IRB Form A
Revised 1/5/2016

6.
Confirm in writing to the IRB that protected health information will not be re-used or disclosed to any other person or entity, except as required by law or for authorized oversight of the research project.
ASSURANCES: I certify that this research meets the requirements for exemption from review by the IRB. I also certify that I have the appropriate credentials and privileges to conduct this study and that the facilities are adequate.
Researcher’s Full Name Project Title
Email Address Phone Number
Faculty Advisor/Supervisor
Date
Completing Form A:
1.
Once you have filled out the form completely, save the Word document using a unique filename.
(It is suggested that you use your surname and the date in the filename.)
2.
Send the completed Form A and all supporting materials as e-mail attachments to irb@trincoll.edu
.
IRB Administration Use Only:
For IRB Use Only:
The proposal is exempt from further review.
The proposal is eligible for expedited review.
The proposal should be given a full IRB review.
Exemption Category # Expiration Date
Per:
Full Name of Reviewing IRB Member Date
Trinity College IRB Form A
Revised 1/5/2016