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What is Internal Validity?

❶If I ask you to imagine a dog, you probably won't think of Morris the Cat.

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For two decades I intermittently pursued it in different settings with varying degrees of success and failure. In , after one career as an academic and another as a conductor of contemporary music, I succumbed to my scientific and philosophical interests and founded a small interdisciplinary think tank. Since then "sitting for ideas" has been a major preoccupation.

Learning to use introspection productively is like perfecting an artistic skill. It takes commitment, time, and understanding. There's no substitute for commitment, but you'll hasten your progress if you understand the underlying process. The example of Elmer Gates demonstrates three things: The unconscious has access to information that lies outside our normal awareness; under certain conditions that information can be released into consciousness; some of it can be unique and useful.

What psychological conditions favor the release of such information? To answer that, we need to examine two mental processes that operate autonomously at an unconscious level: The unconscious is sensitive to form; it seeks closure. When something significant is perceived to be incomplete, the imagination is spontaneously activated; thoughts flow into consciousness. The thoughts are hypothetical possibilities for eliminating the incompleteness and arriving at closure.

Language, because of its ambiguity, can convey a sense of incompleteness. Some words refer to more than one thing—the pronoun he , for example, can refer to any male. When a word's referent is inexplicit, we find the word ambiguous; its meaning is incomplete. The incompleteness triggers an internal search, and the imagination generates possible referents to complete its meaning and establish closure.

Although most of us are unaware of this mental operation, we do it continually as we try to make sense of what we're being told. A word whose meaning is incomplete is a class. The various meanings that can be assigned to that word are members of the class.

Lassie is a member of the class dog because Lassie can complete the meaning of dog. Some classes have other classes as members. The class animal has the class dog as a member because dog can complete the meaning of animal. If I ask you to imagine a dog, you probably won't think of Morris the Cat. But if I ask you to imagine an animal, you might think of Lassie or Morris since both dogs and cats are animals. The more inclusive the class, the greater the number of meanings one can assign to it.

Let's state this another way: The more inclusive the class, the greater the number of psychological responses one can make to it. The late psychiatrist Milton H. Erickson, an innovative practitioner of clinical hypnosis, recognized this fact and incorporated such ambiguities into his trance inductions. By making suggestions to his patients in words whose meanings were incomplete, he was easily able to elicit novel unconscious responses.

A typical suggestion was: Exactly what those responses might be or where in the body they might be felt or when they might be felt is indefinite—thus, incomplete. Again, language is a good example. Go into any part of the community, randomly select an individual, and record what she says. If you analyze the structure of her speech, you will find that it is rule-based.

The rules may not be those of Standard American English, but they will form a coherent grammatical system. As children we internalize the fundamental rules of whatever speech environment we live in.

Something within the unconscious sorts through countless sentences, looks for common structural features, abstracts them, learns them, and uses them to talk.

The fact that we don't apply the acquired rules consciously or even know that they exist makes them no less real or operative. The unconscious' rule-finding ability is not limited to speech environments; it is active in all environments. Musicians, for example, unconsciously internalize the elements of their repertory that occur with high frequency. When piano students begin to compose, their first pieces contain simple common patterns that are present in works they have played.

Immerse the unconscious in any sort of environment and over time it will extract and utilize that environment's fundamental rules of organization. We continuously carry out this subliminal processing. So do animals, and by studying them under controlled conditions, we can better understand ourselves.

I had such an experience in a laboratory psychology class with Bob, a white rat. In the lab was a cage unfamiliar to Bob. Inside the cage at one end was a lever; at the other end was a tiny empty cup.

The lever would move if a rat chanced to push it; the cup could be filled with water if I activated it from outside the cage. Bob's task unknown to him was to learn to push the lever. Bob was placed in the unfamiliar cage near the cup. He began to move about randomly. When he first turned ever so slightly in the direction of the lever, I filled the cup with water. The noise from the cup caught his attention; he saw the water and drank it.

Any movement that brought him closer to the lever was reinforced with more water; any movement away from it was ignored. Soon he was hanging out near the lever. Then reaching in its direction. And finally pushing it. Astoundingly, all of this took only a few minutes.

By systematically rewarding Bob whenever his actions showed a tendency toward the desired goal, Bob's initial turning motion was transformed into the accomplished behavior of lever pushing. To experience systematic reinforcement—like Bob did—is to experience an environment that is organized according to a simple set of rules. Somehow, the unconscious sorts out such rules, internalizes them, and behaves compatibly.

An algorithm for internal research. An algorithm is a set of logical steps for accomplishing something. There is a mental algorithm that can be used to elicit useful information from the unconscious.

It takes advantage of the unconscious' completing and rule-finding abilities; that makes it an effective tool for training oneself to conduct internal research. One that gives the unconscious a wide range of response options is best. I have found a simple question—"What needs to be known? That's the kind I'm looking for. Otherwise, the sentence sets no limits: At one time such a committee was named the "Committee for the Protection of Human Subjects".

Originally, IRBs were simply committees at academic institutions and medical facilities to monitor research studies involving human participants, primarily to minimize or avoid ethical problems.

Today, some of these reviews are conducted by for-profit organizations known as 'independent' or 'commercial' IRBs. The responsibilities of these IRBs are identical to those based at academic or medical institutions, and they are governed by the same U. The regulations set out the board's membership and composition requirements, with provisions for diversity in experience, expertise, and institutional affiliation. For example, the minimum number of members is five, at least one scientist, and at least one non-scientist.

The guidance strongly suggests that the IRB contain both men and women, but there is no regulatory requirement for gender balance in the IRB's membership. The full requirements are set out in 21 CFR Unless a research proposal is determined to be exempt see below , the IRB undertakes its work either in a convened meeting a "full" review or by using an expedited review procedure. An expedited review may be carried out if the research involves no more than minimal risk to subjects, or where minor changes are being made to previously approved research.

Research activity cannot be disapproved by expedited review. The International Conference on Harmonisation sets out guidelines for registration of pharmaceuticals in multiple countries. It defines Good Clinical Practice GCP , which is an agreed quality standard that governments can transpose into regulations for clinical trials involving human subjects.

While the Belmont principles and U. Numerous complaints by investigators about the fit between the federal regulations and its IRB review requirements as they relate to social science research have been received. In , the Office for Human Research Protections OHRP , in conjunction with the Oral History Association and American Historical Association , issued a formal statement that taking oral histories , unstructured interviews as if for a piece of journalism , collecting anecdotes, and similar free speech activities often do not constitute "human subject research" as defined in the regulations and were never intended to be covered by clinical research rules.

Other federal agencies supporting social science have attempted to provide guidance in this area, especially the National Science Foundation.

In general, the NSF guidelines assure IRBs that the regulations have some flexibility and rely on the common sense of the IRB to focus on limiting harm, maximizing informed consent, and limiting bureaucratic limitations of valid research. Aspects of big data research pose formidable challenges for research ethics and thus show potential for wider applicability of formal review processes.

A article on the hope to expand ethics reviews of such research included an example of a data breach in which a big data researcher leaked 70, OkCupid profiles with usernames and sexual orientation data. Such challenges broach familiar themes, such as mistaken identity , precrime , and persecution , in new applications.

While the IRB approval and oversight process is designed to protect the rights and welfare of the research subjects , it has been the subject of criticism, by bioethicists and others, for conflicts of interest resulting in lax oversight. In one test, a fake product "Adhesiabloc" was submitted to a number of IRBs for approval for human tests.

The product, company, and CVs of the supposed researchers were all fictitious and documents were forged by the GAO. However, none of the IRBs approached detected that the company and product were fake. HHS has only three staff to deal with IRB registrations and assurance applications per month. HHS stated that it would not be worthwhile to carry out additional evaluation even if they had the staff to do it. Respiratory Care, 53, Uses and Abuses of Tuskegee. American Association for the Advancement of Science, , Multi-Institutional Healthcare Ethics Committees: From Wikipedia, the free encyclopedia.

This article is about research ethical oversight in the United States. For a worldwide perspective, see Ethics committee. Human subject research legislation in the United States. Institutional Review Board Guidebook. Journal of Medical Ethics and History of Medicine. Archived at the Wayback Machine. US 45 CFR Retrieved 19 August Food and Drug Administration United States. Archived from the original on 13 August

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