Yale University Institutional Review Boards
Application to the Yale Human Subjects Committee
for Research Methods Classes
100 FR 14
Section I: To Be Completed by Course Instructor
Responses to questions in Section I apply to ALL student projects described under Section II. For research methods classes,
the class instructor serves as the PI and is responsible for oversight of the student projects.
A. Class Number and Class Title:
Class Instructor / Principal Investigator:
Yale Position:
Select From List
Department:
Address, Phone Number, e-mail address:
B. Project Period:
C. List ALL Students on the study. ALL research personnel (class instructor and all students) MUST complete human subjects
protection training before they may participate in projects that do not qualify for exemption. Training can be completed at
http://www.yale.edu/training or a member of the HSC staff can provide a training session for the class.
D. PI Certifications:
I certify that to the best of my knowledge and belief the statements herein are accurate and complete. I agree to inform the
Human Subjects Committee should there be any changes in the protocol or problems arising from this protocol. I accept
responsibility for the conduct of this research, the supervision of students, and the maintenance of informed consent
documentation as required.
Do you or any family members (spouse, child, domestic partner) have any incentives or interests, financial or otherwise, that
may affect or be affected by the conduct of this research or that may affect the protection of the human subjects involved in
this project?
Yes
No If yes please attach a description of the interest.
As Class Instructor, I certify that I have reviewed the application and approve it for submission. I further certify that the
students are competent to perform the proposed research involving human subjects.
____
_____________________
Instructor / PI name, typed
HSC Application for Research Methods ver. 01/2008
________________________
Instructor / PI’s signature
Date
Yale University Institutional Review Boards
E.
Common Aspects of Student Data Collection
In order to streamline submissions for methods course work, it is recommended that wherever possible, the course
instructor standardize methods for data collection, data handling, and process of consent. If possible, student
projects should be designed to qualify for exemption, most commonly by collecting data anonymously and not
involving regulatorily defined vulnerable populations (e.g., children or prisoners).
1.
Describe the procedures students will use to obtain subject consent or attach a template consent form
to be used by the students.
2.
Describe whether or not students will be collecting identifiers and if so, describe those identifiers and
the procedures the students will use to maintain confidentiality.
HSC Application for Research Methods ver. 01/2008
Yale University Institutional Review Boards
Section II: To Be Completed by Students
Instructions: Students should complete Section II of the Application for each individual project. Although there is no
limit to the length of the proposal, the ability to describe the relevant issues concisely is appreciated. The parameters
established in Section I of the application pertain to all projects undertaken in the class.
A. Name of student(s):
B. Description of Project. Provide a paragraph describing the project, and include goals, research methods, and
the study location. For studies that involve a location outside of Yale, do you have an affiliation or relationship with
this research site?
Yes
No If yes, please describe.
If deception is used, please justify.
C. Describe any possible Risks and Benefits you can foresee that participants will have while in the study, or
because of their participation in the study.
D. Answer the following about the subject population.
1. Who? Describe the population’s characteristics and how they will be recruited.
2.
How many participants will be involved in the study?
3.
Will vulnerable subjects such as minors (under age 18), prisoners, economically or educationally
disadvantaged persons or those with a limited ability to make decisions for themselves be enrolled?
Yes
No If so, identify the vulnerable population and describe any special precautions that will
be taken to safeguard their rights and welfare.
If NOT described in Section I, please describe the following:
E. Data Security: Will names or other information that could individually identify a person be collected?
If so, describe what information will be collected and how this information will be kept confidential.
F.
Yes
How will informed consent be obtained? Describe the consent process and attach a copy of the consent form,
information sheet or verbal statement to be used.
HSC Application for Research Methods ver. 01/2008
No
Yale University Institutional Review Boards
Section III: To Be Submitted by Student
The following items should be included with the application, as appropriate:
___ Letters of support from the appropriate authorities responsible for access to the subject pool (for example, a
letter from the school superintendent or church pastor indicating their willingness to allow participation of
their students/parishioners).
___ If deception is used, the debriefing form that will inform subjects about the deception at the end of the study.
___ Copies of surveys, questionnaires, or draft list of interview questions which the participants will receive.
___ Sample recruitment letter or advertisement.
___ Certificate of training in the ethical treatment of human subjects if other than the Yale on-line training or an
in class presentation by the HSC.
HSC Application for Research Methods ver. 01/2008
Yale University Institutional Review Boards
APPLICATION TO THE HUMAN SUBJECTS COMMITTEE
Research Methods Courses Application
Instruction Summary
For more detailed information please see the HSC Guide for Investigators
Completing the Application
Section I: General Information. The Class Instructor who serves as PI should fill in the appropriate response to
the items in Section I, with the understanding that all student projects will abide by the responses given.
Section II: Project-specific Information. Each individual project should have a separate Section II completed by
the student.
Section III: Attachments. Students should attach copies of all documents as appropriate following the checklist.
Changes in Existing Protocols
The investigator must submit any proposed changes to an existing protocol prior to their implementation. The
proposed changes may not be implemented until approval is granted by the Committee. Such changes may
include alterations of the procedures to be used, size or composition of the subject pool, etc. A researcher
planning a change should submit to the Committee a Request for Approval of a Change Form outlining the
proposed changes.
Adverse Events
The Committee must be notified promptly (within 5 working days) of any serious adverse event, whether
anticipated or not, which occurs in the process of conducting research involving human subjects. The Committee
is to be notified via letter or e-mail from the investigator describing the event which has occurred and any
corrective actions which are being taken. All correspondence with the Committee should include the protocol
number.
For Additional Information
Human Subjects Committee
55 College Street
P. O. Box 208010
New Haven, CT 06520-8252
203-436-3650; FAX: 203-432-4033
human.subjects@yale.edu
www.yale.edu/hsc
HSC Application for Research Methods ver. 01/2008