What is the purpose of the institutional review board?

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June 26, 2019
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What is the purpose of the institutional review board?

Please respond to the following questions, in 1-2 paragraphs per question. If you use a resource, please cite and reference the resource.

In the context of clinical research,

1. What is the purpose of the institutional review board?
2. What are essential documents?
3. What are investigator-initiated studies?
4. What is the relevance of Title 21 in the Code of Federal Regulations?
5. What is the difference between a case report form and source documentation?

 

Question 147

Topic Just “Sex”

Instructions

“We can have sex without love, and express love in other ways than sex. Also, sexual attraction is temporary and we can be attracted to many different people, while romantic love is a long-term, emotional, and exclusive relationship. So, we shouldn’t confuse sex with love. Indeed, sex need have no more meaning than any other transaction between people – like buying something, having a chat, or giving a gift, say. Like other transactions, as long as no force or deception is involved there is nothing wrong with having sex whenever, however, and with whoever we wish.”

Do you agree with this statement?

Explain why (not), with reference to Pinku’s ideas and to Benatar’s argument about the “casual” view of sex.

If you wish, you also might consider the following argument against “hook up” culture, by philosopher Robert M. Stewart.

Sexual acts that lack meaning are often gratifying but not fulfilling. A feeling of emptiness and pointlessness can follow, no matter how physically satisfying as well as technically satisfactory they can be; a mere handshake could have more meaning despite being less satisfying. A meaningless sexual experience is at best like a good massage or a fine but lonely meal that has no social aspect, no sharing of love or even friendship.

We should not forget, however, that human activities can have meaning of a negative sort when what may be perceived subjectively as a connection to higher values is in fact related to things that are objectively lacking in value, even disvalues. We can be mistaken about what has genuine value or meaning, just as we can be proud of shameful things.

Sexual practices and preferences motivated by or rooted in needs for things that are of little value, e.g., scoring and conquest, that are pursued to an extent out of proportion to their value and perhaps at great cost, or for the sake of things that cannot generally be obtained through those sorts of sexual pursuits, are likewise lacking in objective meaning, whatever one may subjectively think or feel. The perverse and unhealthy reasons for which some human beings engage in certain kinds of sexual habits and practices are varied and often complex. And there are also motivations not abnormal in themselves but taken to undue lengths and involving exaggerated desires and needs. Consider a narcissist whose sexual satisfactions are based on needing to be worshipped rather than truly loved, to dominate and subordinate others, and to be constantly reassured of her attractiveness and desirability. As with a craving for repeated novelty and excitement, when taken beyond reason, these motivations cannot be a basis for meaningful sexual experience.

Meaning requires deeper relationships, which in turn demand time, energy, consideration, appreciative awareness, and, to some degree at least, emotional investment. The widespread pursuit of hook ups on college campuses today appears of a piece with other social trends toward superficiality: the diminishing level of appreciation of higher culture and scholarship even among the educated, the decline in the number of avid readers and the quality of what is read, even among students, and the “dumbing down” and vulgarizing of most things other than the scientific or technical, especially entertainment, celebrity worship, and public discourse. Much of the sexual involvement on campuses nowadays represents a fast-food standard of human interaction: we are in an age of junk sex. As physical activities go, sex has become less like yoga, with its many possibilities for spiritual meaning and higher-level consciousness, e.g., tantra, and more akin to weight-lifting. How one looks and performs are the ultimate criteria of good sexual experience. All of these developments have a common feature – the devaluation of the intellect and the spirit.

What gives human beings our special moral status among creatures is our capacity for higher-level experiences and activities. It is the source of human dignity, the basis for morality, and the sine qua non of meaning.

But suppose one is convinced of this point – that experiences and activities that omit intellect and higher sensibilities are devoid of meaning and of less objective value – so usually to be disdained when something better is open to us. Is this any reason to condemn morally or even to avoid absolutely the lower pursuits and forms of experience?

Not by itself, perhaps, but insofar as lower-quality, less meaningful, or meaningless activities corrupt or stunt us, undermining or even destroying our capacity to enjoy the higher forms of human experience, then we have a good reason to eschew them, e.g., if our preferences for the finer and more elevated will not develop otherwise, or if we will lose our preferences for them, as drug addicts often do. Meaningless pursuits are sometimes worse than a waste of time and energy, a squandering of potential. They can dull our minds, coarsen our tastes, and make us emotionally insensitive.

Is there a moral reason to prefer, in general, the meaningful things to the relatively meaningless? The philosopher John Stuart Mill (1806–73) made a famous argument in chapter II of Utilitarianism for the rationality of generally preferring higher pleasures over lower ones on the basis of their quality – the argument being that this would be the preference of most if not all competent judges. This could also be interpreted as a case for preferring meaningful experiences over the meaningless, simply as such, in most situations. But the difficulties and shortcomings of Mill’s argument are equally well known. Even assuming that competent judges would have such a preference, why does this give all of us conclusive reason to share their priorities, especially if we are not likely to become competent judges, i.e., higher, more experienced, refined, and sensitive beings ourselves? Granting that higher pleasures will be more satisfying or fulfilling to a higher being, why become one? And were we to concede that Mill’s idea of happiness, as opposed to mere contentment, represents the best in human life, the utilitarian standard of morality is not the happiness of the individual but rather the maximization of social utility. Adapting this criterion to present purposes, there is little plausibility in the notion that moral rightness is a function of the amount of meaningful experience that we directly or indirectly bring about in society.

Immanuel Kant (1724–1804), the other most influential moral philosopher of the modern period, fails in his argument against the moral acceptability of sexual acts aimed solely at one’s own physical gratification, done outside the context of a loving marriage and without the intent of procreation. The categorical imperative, in its second formulation, forbids acts that do not respect all persons – oneself and others – as ends in themselves, including those that treat humans as mere means to one’s own subjective ends. The very idea that there are moral duties to oneself may strike us as unacceptable, and it is doubtful that sexual acts motivated only by lower pleasure are never autonomously chosen. The assertion that such sexual acts violate the requirement to respect others similarly lacks plausibility in those instances when no one is forced, misled, or in some way emotionally manipulated into becoming a sexual partner. The possibility of giving free and rational consent to a sexual encounter that has physical pleasure as its sole reason must be admitted.

But perhaps there is a different way in which sex for physical gratification alone is disrespectful to self and possibly others as well, a kind of disrespect which has no particular reference to autonomy. [In Tom Wolfe’s novel, I Am Charlotte Simmons,]Wolfe’s character Charlotte Simmons, a girl from a conservative rural family in the South, is crudely seduced by handsome Hoyt Thorpe; she feels complete shame and humiliation in consequence, a total worthlessness resulting from a failure to live up to her own standards and leading to a serious depression. Arguably, she was manipulated and misled by his false gestures of kindness and attention, of love and devotion, thinking he worshipped her as if she were the meaning of his life. Suppose, then, that instead she had merely been overtaken by the moment, by physical lust. Would this have been a moral failing on her part, and perhaps his as well? Or would it have been merely imprudent, a case of miscalculation and poor judgment at worst, not to be interpreted in ethical terms? This is how her friend Laurie would see it – in a more positive vein, taking a chance and learning from experience – as opposed to a reason for guilt and remorse, which only serves to amplify the badness of the situation. Attaching a moral meaning to virginity and its loss, another aspect of the religious morality with which she was raised, is at least part of the cause of the problem.

One can, however, lower oneself or another person without anyone being “used” in the usual moral sense. It undermines not only self-esteem but also self-respect if we allow ourselves to sink to certain kinds of sexual acts with unworthy partners, and it shows a lack of respect for those whom we entice. This need have nothing to do with autonomy; rather, it expresses a lack of respect for humans as capable of higher-quality, more meaningful experiences, and more importantly, may disregard that some people are better than others, or that not just anyone should be given the gift of our physical intimacy, however pleasurable it might be for a time. We need not say that sex of this sort is morally wrong in the sense of being unjust, violating a right, or failing to carry out a duty. But it is a serious failure of character and judgment evincing a lack of concern for excellence and value.

Respect is a matter of how people are regarded or treated by others or by themselves. Self-esteem amounts to confidence based on our accurate judgments about our excellence or worth in various dimensions of comparison (e.g., as professionals, as parents, as friends, as drivers, and many others), including these two forms of respect. When we lose the respect of others, often our self-respect, and in turn, our self-esteem, suffers. Recall how Charlotte Simmons feels herself worthless after succumbing to Hoyt; though understandable, her loss is out of proportion to what actually happened. Losing the respect or the esteem of ignorant or worthless people is not such a terrible thing unless they have some other ability to harm us. Nevertheless, it is often difficult to ignore, if only because it can lead us to question the accuracy of our own judgments of our worth – is our self-esteem too high or false? – and even the need to respect ourselves. (This is, of course, one of the reasons we need true friends, who can offer us legitimate assessments of our good and bad traits and acts, based on their knowledge, shared proper standards, and common basic interests.)

Normally, to degrade, demean, or abuse others, especially in the intimate context of sexual relations, is to inflict on them a considerable injury. The degradation of others (including taking advantage of those on their own downward spiral), then, is something we morally ought to avoid out of a respect for their potential as well as a regard for our own dignity. We need not love or befriend or even like or admire others – let alone believe in equality of human potential – to have moral respect.

There is, further, the matter of respecting the higher values themselves, as things we should want to have and to appreciate in ourselves and in our lives. We must not denigrate them as human ideals.

Returning to the central topic of sexuality, we should be able to agree that mere physical pleasure and tension release, though desirable in itself, is not a higher value that can give meaning, nor in general is a display of skill, power, or domination in this context. Procreation could in general give meaning to sexual intercourse, but only if we make optimistic assumptions about the value of our species continuing into the future and of the life offspring are likely to lead. Sexperimentation might or might not involve higher values, depending on the knowledge one seeks; self-knowledge of a deeper kind could certainly be a higher value. Raising one’s own self-esteem or expressing esteem for another through sexual contact could relate to higher values, since these aims concern self-love and love of another person; it is a matter of the details. Social acceptance or gaining the esteem of others per se is not usually a motive relating to higher values, at least not directly or necessarily. Wolfe’s novel offers painful illustrations of how nothing more than a false, subjective meaning could come from what is merely a boost in false self-esteem from hooking up with the “right” partners in the estimation of those with corrupt values. Love, provided that it is healthy and grounded in accurate assessment, is not the only value that can give true (objective) meaning to sexual relations, but it is surely the most significant.