Allegheny College IRB

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Request for Exemption from IRB Review

Part 1

Before requesting an exemption from IRB review for your research, please respond to the questions below.

Yes / No
Does the research use fetuses, neonates, pregnant women, children (persons under the age of 18), the elderly, prisoners, the physically or developmentally challenged, or other potentially vulnerable populations as participants?
Could the information collected put participants at risk of civil or criminal liability or be damaging to the respondent’s financial standing, employability, or reputation?
Does the data collection involve sensitive behaviors (i.e., information about sexual behavior, illegal activities, alcohol use)?
Is there any foreseeable risk to participants beyond the risks associated with everyday activities?
Does the research involve any deception, even minor deception such as cover stories?

If you have answered Yes to any of these questions, the research is not eligible for an IRB exemption. Please complete the IRB Review form where an expedited or full review can be requested.

If the answer to all the questions is No, there are two types of exemptions from IRB review that can be requested. Specific types of research identified in CFR 45, Part 46 are exempt. If the exemption request is based on those categories, please complete Part 2. The second type of exemption concerns research approved by an HHS registered IRB at another institution. To request that exemption, please complete Part 3.

Part 2

CFR 45, Part 6, § 46.101 identifies categories of research that are exempt from IRB review. While not comprehensive, the categories below include the many of the common types of research conducted by Allegheny College students, faculty, administrators, and staff that may be eligible for an exemption. Please look at the list carefully. To review the full list of research eligible for exemption, you may wish to consult the CFR 45, Part 6, § 46.101 at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.110

Please review the exemption categories listed below.

Exemption Requested
Categories of Research Eligible for Exemption / Yes / No
1. research conducted in an educational setting that
i. assesses educational strategies
OR
ii. examines “…the effectiveness of or comparison among instructional techniques, curricula, or classroom management methods”.
/
2. research using educational tests, surveys, interviews, or observation of public behavior unless
i. information can be directly linked to any individual participant
AND
ii. participation could damage the participant’s employability, financial standing, or reputation.
/
3. research that is not exempt in 2 above if
i. the participants are public office holders or candidates for such offices,
OR
ii. federal law requires confidentiality of participant responses.
/
4. research using available documents, records, data, etc. as long as responses are not personally identifiable. /

Please provide an explanation/justification for the type of exemption requested.

Principal Investigator (PI) ______Telephone ______

Email ______Date Submitted ______

Faculty Supervisor (if the PI is a student) ______Telephone ______

Email ______

Part 3

For data to be collected at Allegheny College by researchers at another institution, the researchers must have an Allegheny College faculty member or administrator serve as a sponsor who is responsible for completing all IRB requirements. Moreover, the Allegheny College sponsor must have completed the ethics certification program.

Has the research proposal been reviewed and approved by an HHS registered IRB at another institution?

Yes No

If yes, identify the institution approving the proposal and provide a letter of approval along with a list of the names and contact information of the researchers at the institution providing the approval.

Please complete the following information for all Allegheny College employees or students involved in the data collection and/or sponsoring the research. For status, please indicate whether the researcher is a faculty member (F), student (S), administrator (A), or staff (ST)

OHRP Certification
Name / Status / Yes / No / Certification Date

Allegheny Sponsor ______Telephone ______

Email ______Date Submitted ______