| SECTION ONE: SUMMARY INFORMATION |
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Date:
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Status at Thiel:
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Principal Investigator name:
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Principal Investigator email:
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| Note to student applicants: Your IRB application will not be considered without approval from the faculty supervisor of your project (this does not mean your academic advisor, but the faculty member who is overseeing your project, or, in the case of fellowships, the person recommending you). Approval is given via the online submission process. |
| Students, please fill out the following information: |
Supervisor's name:
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Supervisor's email:
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| Is this research part of your senior research project?
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Job Title and Department or Office:
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Title of Project:
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| Purpose of this Project: |
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Intended use of information gathered:
(This might be for a senior paper, for a public presentation on campus, for a presentation at an academic meeting, for possible publication, to assist the library staff in planning, etc.)
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Consultants or co-investigators, if any, and their department affiliations (their institutional affiliations if they are not employed by Thiel)
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Estimated duration of total project (note: approvals are granted for no more than one year from the date of review):
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Estimated total number of subjects (including control subjects):
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Age range of subjects:
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Sex of subjects:
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Where will this study be conducted (for example, on campus, in Greeville elementary schools, in Pittsburgh, Pa., in Los Angeles, etc.):
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Source of subjects (note: Investigators are discouraged from enrolling subjects with status relationships with the investigators (e.g. faculty-students; student advisees of faculty-students). Approval may be granted with a compelling justification or employment of a mechanism ensuring anonymity of participation):
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Grant support for project (if any):
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Commercial support for project (if any):
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SECTION TWO: INFORMATION FOR IRB REVIEW |
| Please answer each specific question and use as much space as needed to answer fully. |
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2-1. Provide a brief historical background of the project with reference to the investigator's personal experience and to pertinent scientific literature:
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2-2. The plan of study. |
(A) State the hypothesis or research question you intend to answer. Describe the research design, methods, interventions, and procedures (including standard or commonly used interventions or procedures) to be used in the research. Specifically, identify any interventions, procedures, or equipment that are innovative, unusual, or experimental.
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(B) Describe any deception procedures employed in this study, if applicable. Please explain why deception is necessary. Examples of deception used for research purposes: withholding relevant information, use of a confederate (someone who poses as someone they’re not), false performance feedback, offering fictitious information about the true purpose of the study, etc.
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2-3. Possible risks. (A) Indicate what you consider to be the possible risks (or inconveniences) to subjects and indicate the precautions to be taken to minimize or eliminate these risks. If any data monitoring procedures are needed to ensure the safety of subjects, describe them.
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(B) If deception is used, please explain possible risks and precautions to be taken to minimize or eliminate these risks.
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| SECTION THREE: SELECTION OF SUBJECTS AND THE INFORMED CONSENT PROCESS |
3-1. Indicate whether this project involves any of the following subject populations:
Minors (Minors or “children” are defined in Pa. law as persons under age 18.)
Prisoners
Pregnant women
Cognitively impaired or mentally disabled subjects
Economically or educationally disadvantaged subjects
None of the above |
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3-2. If you indicated any of the above, additional safeguards will need to be implemented in order to protect these populations from excessive risk, coercion or undue influence. Please describe the precautions that you will take to minimize all possible risks given the unique setting or circumstance faced by these individuals.
See federal guidelines by clicking here.
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3-3. Describe how subjects will be recruited and how informed consent will be sought from subjects or from the subjects’ legally authorized representative. If children are subjects, discuss whether their assent will be sought and how the permission of their parents or legal guardians will be obtained. Use additional sheets as needed.
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3-4.
(A.) Will your subjects receive any compensation for participation in cash or in kind?
Yes.
No.
If so, please describe the amount or kind of compensation in the space below.
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(B.) Will your subjects receive course credit (either extra credit or fulfillment of a course requirement?). Note: Students must be offered an equally desirable, non-research option for receiving the same amount of course credit.
Yes.
No.
If so, please describe the amount or kind of credit received for research participation AND please describe the optional procedure for receiving credit.
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| SECTION FOUR: PRIVACY AND CONFIDENTIALITY OF DATA AND RECORDS |
Will identifiable, private, or sensitive information be obtained about the subjects or other living individuals? Whether or not such information is obtained, describe the provisions to protect the privacy of subjects and to maintain the confidentiality of data.
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SECTION FIVE: INVESTIGATOR'S PLEDGE |
I certify that the information furnished concerning the procedures to be taken for the protection of human subjects is correct. I will seek and obtain prior approval for any modification in the project design or informed consent document and will report promptly any unexpected or otherwise significant adverse effects encountered in the course of this study. I certify that all individuals named as consultants or co-investigators have agreed to participate in this study.
Certification is recorded by submitting this form via the Thiel IRB online application system.
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| SECTION SIX: CERTIFICATION OF SUPERVISOR OR DEPARTMENT HEAD |
| Supervisor’s Certification (in case of student applications) |
I certify that I have read this application in full and that I have discussed with the project investigator(s) the ethical treatment of the human subjects who will participate in this project, as well as the procedures to protect the privacy of the subjects and the confidentiality of data generated.
Certification is recorded via the Thiel IRB online approval system
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SECTION SEVEN: ATTACHMENTS
Please be sure to read through the "Any Additional Attachments" page that appears after your IRB submission is complete for more information. |
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| SECTION EIGHT: COMMON PITFALLS TO AVOID |
In most cases your application will be processed within 10 days. There are certain conditions that may elevate risk to the point where we would require adjustments (e.g. removal, restatement, etc.) and/or further clarification and justification. This process takes time, and in some cases, may result in non-approval. In order to expedite your review, please consider and address the following possible pitfalls in your application, if relevant:
- Photos, audiotapes, names (identifiable information): The IRB considers the privacy and confidentiality of all participants to be of utmost importance. Thus, if at all possible, you will want to avoid obtaining names and other identifiable information (e.g. photos), or at the very least, keep names/identities separate from the data obtained. If, however, you intend to reveal the identity of your participants, you must fully explain and justify this need for the purpose of research (i.e. using photos and names simply to enhance the entertainment value of a public presentation would not, in most cases, be allowed). And you must fully inform, request and obtain explicit permission to use such information in the informed consent process.
- Unfamiliar populations (e.g. prisoners; citizens of remote countries): Please keep in mind that the IRB may not be familiar with the context in which certain individuals live and the possible risks faced by such people, thus you will want to fully explain the nature of risk given the participant’s local context; and when obtaining informed consent, insure that participants fully understand the nature and scope of their participation (e.g. what they will do and who will hear about it). This may require the involvement of a local translator and detailed, culturally sensitive explanation of your research.
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Verification Information
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