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Should I Submit to the REC?

OHRP

DECISION

CHARTS

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. 

Additional information regarding private information and the use of coded data can be found on the OHRP website at the following links.

OHRP information on secondary use and consent requirements for coded data 

OHRP guidance on coded data

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 an activity falls under REC regulations, consider the following:

1) Goals of the activity

  • If the goal is to contribute to generalizable knowledge in the field, it is research. 
  • If the only purpose of the project is to evaluate or improve processes specifically within an organization, it is not considered research.  

Even if internal process improvement is a component of the activity, taking a systematic approach to collecting information in order to contribute to a broader wealth of knowledge about certain institutional processes IS considered research and you must then consider whether or not human subjects are involved. 

2) Does it involve human subjects?

  • If you ask questions only about the program or services, it is NOT considered to be human subjects research. 
  • If you ask questions about the individuals, that would otherwise be considered private, it IS considered to be human subjects research.

Many projects include a program development or evaluation component together with a research component. In this case, only the research component of the project needs to be reviewed by the REC, unless the program being developed is experimental in nature. 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

To review the types of research and determine what level of review your project may need click here.

Overview of OHRP Decision Charts