REC Review Determination Form

The purpose of this form is to help you determine whether or not your proposed research needs to go through the standard REC proposal submission process and is not required for proposal submission.

Name*

First NameLast Name

Email*

example@example.com

Faculty Advisor Name

First NameLast Name

Faculty Advisor email

example@example.com

Title of your project*

Some projects involve multiple components. Please select all that apply to the proposed research.

records reviewprogram evaluationuse of publicly available data (institutional data or data with no individual identifiers)other data collection

Records review: if you are accessing existing records (clinical data, education records etc.) for any portion of your project, you will need to complete the application to conduct records-based research. Note that some projects involve multiple components such that records review will take place in addition to prospective data collection. In this case you will still need to complete the records-based research application in addition to the proposal submission form.

Use of publicly available data or institutional data: if you are accessing data that is publicly available and does not include individual identifying information, this does not qualify as human subjects research and does not need REC review. Likewise, data that is “institutional” or “organizational” in nature does not qualify as human subjects research. That is, if you are generating or utilizing data about an organization, rather than an individual, that is not human subjects research. For example, accessing publicly available data about the number of stroke patients admitted in hospitals in the state of Kentucky. Another example would be contacting someone at an organization and asking about the number of new mental health patients they have added to their caseload in the past year. As long as no individual information is being collected, it is not human subjects research. If, after reviewing the information on the website, you are unsure about the nature of the data you are accessing you can complete the records-based research application or contact rec@spalding.edu

Is the purpose of your research solely to improve processes internally at a specific organization?

yesno

Program evaluation: In most cases, research that is solely for the purpose of program evaulation and / or process improvement within an organization does not meet the definition of human subjects research and therefore does not require REC review. Please see the questions below that ask about whether your research meets the human subjects research definitions. Note that research that includes program evaluation PLUS additional components that involve human subjects research will still need REC review.

Is the activity a systematic investigation designed to develop or contribute to generalizable knowledge (I.e. is it research)?

yesno

Does the research involve a LIVING individual about whom you will (select ALL that apply): [Note, anonymous survey IS an interaction and environmental modification IS an intervention]-the first option applies to most

obtain information via interaction or interventionobtain biospecimens via interaction or interventionobtain or generate identifiable private information or biospecimensNone of the above apply to my research

If you are not obtaining or generating (i.e. via records review or some other process) information about a living individual then your research is not considered human subjects research and does not need REC review. Note that use of an anonymous survey does qualify as an interaction for obtaining information. Likewise, envrionmental modification counts as intervention. Therefore, it is important that you review the information on the REC website to be sure that none of these options apply to your proposed research.

Use this space to provide a brief synopsis of what you are proposing to do and receive feedback on what type of submission you need to use moving forward. *

Use this space to attach any documents that might be helpful in determining if / what level of review is needed. E.g. survey / interview questions

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Does your study involve a vulnerable population? (i.e. as the research participants)

Please indicate the level of risk expected with participation in your proposed project. **Note risk is not limited to physical harm but also includes risk of emotional, social, financial, employment and legal harm /risk.**

Please indicate if / to what degree identifiable information will be used

If after completing this form you are still unsure about the need for REC review of your specific resarch project, please review the "Is REC review needed" section of the website https://rec.spalding.edu/ . There are also a number of links on the website to helpful information regarding what qualifies as human subjects research per the OHRP regulations. If after reviewing this information you still need help in determine whether or not your research needs REC review, please contact us at rec@spalding.edu