Institutional Review for Research with Human Subjects (Not Kittens!)

As an instructional designer, my research will typically be with human subjects which may require a review by an Institutional Review Board (IRB) among other reviews.  The IRB’s purpose is to ensure the welfare, privacy, beneficence, justice, respect, confidentiality, and other rights of the subjects are protected.  The IRB has the authority to approve, disapprove, or request modifications to a research project before it may proceed.

That said, being that most of my work is in education, much of it may be expedited or even exempt from an IRB review by being in the education field rather than medical or behavioral sciences.

Research may be eligible for exemption if all the activities associated with the research fall into one or more of the six categories under 45 CFR 46.101(b) (Hicks, 2015):

IRB-exemptions-human-subjects

[for full text of this image see the bottom of this blog: §46.101 To what does this policy apply?]

Some research may fall into these categories but remain non-exempt due to the characteristics of the participants (i.e. minors as determined by where the study is taking place; prisoners but not parolees; etc.).  Studies that involve interaction can be borderline and may fall into an expedited process rather than exemption.  It is best to prepare for as if an IRB review were to take place rather than the other way around.

At my university, Old Dominion University, much of the information is available online (including IRB meeting dates and web-form application) which makes the process much less stressful.  Being able to anticipate the process by reading up on it is helpful.  There are also resources to email and online submission trainings.  *sigh of relief*  However, it appears that exempt projects are still handled at my university through a PDF form rather than the web-form application.  This is not the end of the world, though, as the web-form application still utilizes attachments for most of the requirements.  An IRB package requires attachments for: description of the proposed study outlining exemptions; research protocols; references; all material provided to participants (i.e. questionnaires, flyers); and a full funding proposal if applicable.  At my level (graduate student), these items will all go to my advisor who will be my responsible project investigator (RPI) and submit my application after they have reviewed everything thoroughly.

I’ve been working a lot this past week on the potential methods of my research and speaking with others about the possibilities for it.  I have not yet gone back and refined my research questions but I know that they were not yet as strong as they needed to be and in my literature reading and discussions with others I am torn in the endless possibilities.  However, I do not want to get anywhere near an animal subjects experiment as this is specifically not meant to be animal testing and I am not qualified to perform such an experimental study, which is something I think others have trouble understanding.  In making my research more human-related, it gets too close to reaching the level of live-kitten interactions and I must avoid that.  Instead, I have found some interest in:

  • Simulations are said to be extrinsically motivated whereas neonatal kitten foster parents are said to be intrinsically motivated – this raises questions
  • Gaming participants report increased levels of decision making autonomy, supporting self-deterministic motivation – I was previously asking if the learners believed they would have better outcomes after training with the simulation which does have diagnostic and decision tactics in it, but maybe I should scope to decision autonomy
  • Simulation based training is superior to problem based learning – I found a good study that proves what I was after in nursing students (and they have information with neonatal babies though not in the study just literature), so maybe I can skip this as a part of my research although I still really want to quantitatively prove that my simulation intervention can reduce neonatal mortality rates because to me that is better than improved efficiency; it is improved effectiveness, proven.

 

 §46.101 To what does this policy apply?

(b) Unless otherwise required by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:

 (1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

 (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) 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.

 (3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if:
(i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

 (4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources 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.

 (5) Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:
(i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

 (6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

References

Hicks, L. (2015). The federal regulations – SBE.  Collaborative Institutional Training Initiative Program. Retrieved from: https://www.citiprogram.org/members/index.cfm?pageID=125

 

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