The REC is responsible for insuring that human subjects research conducted through Spalding University is in compliance with the Common Rule as required by the U.S Department of Health & Human Services Office for Human Research Protections regulations at 45 CFR 46. The purpose of the REC is to protect the safety and privacy of human subjects research participants and therefore to insure that participation is equitable and risks to subjects are minimized and reasonable in relation to ancticipated benefits of the proposed research.
The REC must review all human subjects research conducted by Spalding University faculty, staff or students.
A systematic investigation designed to develop or contribute to generalizable knowledge.
A living individual about whom an investigator obtains information or biospecimens through intervention or interaction with the individual(s) OR generates or uses identifiable private information or biospecimens.
Note that generation or use of information about an organization (rather than about an individual) is not considered human subjects research. For example, collecting information about the number of COVID and influenza cases at various urgent care centers would not be human subjects data as long as you are not obtaining individual information.
1) Scholarly and journalistic activities that focus directly on the specific individuals about whom the information is collected.
2) Collecting public health information to be used by public health officials to inform public health based decisions.
3) Collecting information for criminal justice purposes.
4) Collecting information for national intelligence, homeland security or other federal agencies.
If you are collecting information solely for the purpose of program development, evaluation, or process improvement within an organization, this may not be considered research. There is no one size fits all answer to is program evaluation considered research?” In some cases it is and in some it is not.
To determine whether or not it falls under REC regulations, consider the goals of the activity:
- If the goal is to contribute to generalizable knowledge in the field, it is research.
- If, in order to effectively evaluate the program / process, you will collect information about an individual, that is considered human subjects research.
Even if internal process improvement may be a component of the activity, if you are taking a systematic approach to collecting information in order to contribute to a broader wealth of knowledge about certain institutional processes, that IS considered research and must be reviewed by the REC.
Note that only the research component of the project needs to be reviewed by the REC. That is, if you are implementing a program per standard clinical practice (i.e. it is not experimental in nature), then having individuals participate in that is not part of the research and therefore does not need to be described as part of the detailed research procedures as long as it is clear that it is not experimental.
Please see the FAQs on the OHRP website for more detailed information regarding quality improvement / program evaluation activities.
Click here to complete a REC Review determination form to help you determine if you need to submit a proposal to the REC
What about Exemptions?
Certain types of human subjects research may be considered exempt from the HHS regulations. It is up to the REC to determine whether or not proposed research qualifies as exempt. Below is an overview of the types of research that may be exempt. Please refer to the decision charts button to help you determine whether or not your research qualifies for exemption. If you still need more information, the OHRP website contains a full list of exemptions, including associated criteria.
Even if your research qualifies as exempt, you must still submit your proposal to the REC for determination and approval of exempt status prior to initiating your research.
Categories of Exemption:
Note, these exemptions may not apply to certain vulnerable populations such as children and prisoners, please see the OHRP website linked above for more information.
- Research conducted in established or commonly accepted educational settings, involving normal educational practices.
- Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior, EXCEPT when participants can be identified and such disclosure results in risk.
- Research involving benign behavioral interventions (i.e., brief in duration, harmless, painless, not physically invasive, no significant adverse lasting impact, and not offensive or embarrassing to participant) in combination with the collection of information, EXCEPT when participants can be identified and such disclosure results in risk.
- Secondary research for which consent is not required (e.g., participants identity cannot be readily ascertained, identifiable information is publicaly available, identifiable information was originally collected for non-research purposes, or collection and analysis of identifiable information are for the purposes of “health care operations,” “research,” or “public health activities and purposes).Taste and food quality evaluation and consumer acceptance studies.
- Research and demonstration projects conducted or supported by a federal department or agency that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs.
- Taste and food quality evaluation of consumer acceptance studies.
- Storage or maintenance for secondary research for which broad consent is required.
- Secondary research for which broad consent is required.