How Do You Get Started?

There are numerous questions that you need to ask before you jump into the Application ProcessFirst, is your study considered to be “research”? This may seem to be inconsequential but it is a major question. If your study is defined as “research” according to federal guidelines, you must submit your research proposal to HPRB for review. Second, is it possible your study will qualify for “exempt” status when you submit it for review?

Here is a synopsis of what is available in answer to these key questions and explained in much greater detail in the PLU HPRB Policy Manual. Contact one of the faculty or staff serving with HPRB with your questions.

What is "research"?

The term “research” is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

“Generalizable knowledge” refers to any systematically gathered data that are intended for dissemination beyond the institutional setting, and which might reasonable be generalized beyond the research sample. In other words, if you publish the results of your study or present them at a professional meeting, you are contributing to generalizable knowledge.

What is NOT considered "research" for HPRB purposes?

Precedent and practice has established the principle that certain kinds of activities might be called “human subjects research” but may not require review for protection of human subjects. Examples of such activities include: (a) accepted and established service relationships between professionals and clients where the activity is designed solely to meet the needs of the client; (b) research using only historical documents, and (c) research using only archaeological materials or other historical or pre-historical artifacts.

Quality improvement and quality assurance activities conducted solely for the purpose of maintaining or improving quality of services provided by an institution are not considered research activities. However, if the data collected are generalizable and intended to be shared outside of the institution through discussion, presentation, or publication, the activity qualifies as research.

Classroom projects: Maybe or maybe NOT "research"?

Classroom activities may or may not be considered to be “research.” If the sole purpose of the activity is to teach research techniques or methodology and not to develop or contribute to generalizable knowledge, it is not considered research.

For more information on the types of questions you need to ask to decide your next steps on this topic, go to Conducting Classroom Projects.

What is an "exempt" study?

There are six specific types of research activities that are considered as “exempt” according the the Code of Federal Regulations [45 CFR 46.101] because of their low risk potential for research participants.  Several of the major categories that typically relate to research conducted at PLU are research activities:

  • Conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special educational strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods; or
  • Involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless (a) the information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (b) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation; or
  • Involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

Examples of exempt (and non-exempt) studies are available within the HPRB Policy Manual (Chapter 3, paragraphs II.A and II.B; pages 4-6) and on the HPRB Form: Request for Exempt Status. Anonymity is a key factor; in the case of a classroom survey in which students are research participants, the investigator would need to give evidence that students’ responses are anonymous OR that there are procedures in place to ensure that students’ responses will have no influence on grades or other aspects of the course. The term “anonymous” implies that no person, including the investigator(s), can link the identity of the research participants with the data collected in the research study.

What may disqualify a project from "exempt" status?

According to federal guidelines, a research project cannot be classified as “exempt from HPRB review” if: a) the information is recorded in such a manner that research participants’ identities can be determined by the recorded data, either directly or through identifiers; b) the research is with (or about) minors (under 18 years of age in WA State); or c) the research requires sensitive information to be revealed. Other existing conditions may also disqualify a project from exempt status.

How is the decision regarding exemption made?

There is a place to note that you are requesting consideration for “exempt” status on the HPRB Research Proposal 2015-2016. There is also an additional form HPRB Request for Exempt Status for you to provide your justification/explanation for your request. A faculty or student investigator can request an exemption when submitting the HPRB application to hprb@plu.edu. Both the HPRB academic unit designate and the HPRB chairperson must approve the exemption.

An investigator cannot exempt his/her own research proposal from HPRB review. Similarly, a faculty member supervising a student research project cannot exempt the same students’ research proposal. Finally, a research proposal cannot be given exempt status after the research is underway.

Can data gathered by other researchers qualify as exempt in my study?

If you are using existing data (e.g., governmental agencies or another researcher), it may classify as “exempt research,” but you are still required to submit a research proposal for approval by the HPRB chairperson. Even if you worked with the original investigator in obtaining the existing data, you must obtain HPRB approval to use the data for a new purpose. Student-faculty research projects that use existing data also must be reviewed by the HPRB.