Part 2 – Balancing Society’s Mandates: I.R.B. Review Criteria

Part 2 – Balancing Society’s Mandates: I.R.B. Review Criteria


[Woman 1] These protocols, you know these
new investigators, especially these multiple-center protocols, are really getting to be a problem. I don’t know if we should try and develop
some sort of checklist or something like that, but you know, the third time in it seems like,
you know, we would not have to go through so much. Let’s just take a look at this one one more
time, and see, can we get it straightened out. [Woman 2] Sure, it’s a multi-center protocol,
you’ve seen it before. We didn’t get enough information human subjects
part of the protocol itself, and the consent form has some difficulties, too. [Woman 1] Was it the language difficulty primarily,
or—? [Woman 2] There’s a lot of scientific terms
in it, and I believe the committee wouldn’t agree that there was enough description of
the type and amount of blood that’s going to be drawn. [Woman 1] Okay. Does it give them an idea of how many visits
they have to make? [Woman 2] I think it’s weak in that area,
too. [Woman 1] Okay, alright, okay. What we gotta do—you talked to him? [Woman 2] I talked with him several times,
he’s enthusiastic, he’s a young investigator, it’s the first time he’s tried to go through
the committee. I think right now, he doesn’t understand
what they want, and he’s getting angry. [Woman 1] Okay, so he’s at the hostile level
now, so—? [Woman 2] Almost. Nice guy, I mean, he’s approachable. [Woman 1] So you think I should call him,
or—? [Woman 2] I think that would be wise. [Woman 1] Okay, alright, okay. Let’s look at this behavioral one that’s
a problem. Okay. This investigator wants to do this video tape,
and I’m really concerned about, you know, whether the people will know that he might
use it for teaching purposes. I don’t want him to be tempted to do that. [Woman 2] I think it’s gonna be difficult
to explain that to this fellow. He’s already upset because he feels that
the IRB is interfering with his work. He wants to go ahead, and—
[Woman 1] So you’re afraid if he tells them, that he won’t be able to get people to participate,
or—? [Woman 2] I think he’s afraid of that, I
don’t think he wants the consent form to be any longer than it is. [Woman 1] Okay, alright. [Woman 2] I also think… [Man 1: Edmund Pellegrino] I’m Edmund Pellegrino,
Director of the Kennedy Institute for Ethics at Georgetown University, and professor of
medicine. The comments you just heard reflect some of
the common confusions and misunderstandings about the functions of an IRB and the criteria
an IRB uses to evaluate a protocol. These comments are typical of the viewers
of the scientific community, of the people who direct research, and even the general
public. The IRB is carrying out an important moral
and social responsibility. Scientific research involving human volunteers
is permitted by society to advance medical knowledge for the benefit of all. But if we are to continue to have that privilege,
investigators must always stress the safety of the volunteer, and the evaluation of the
benefits gained. The process of review, therefore, is designed
first, to protect the subject; second, to provide guidance to the design and experiment
that will produce the results being sought. The IRB process also assures society that
those who are knowledgeable, but not immediately involved, will independently review the experiment,
give it approval, and provide assurances that society’s moral mandate will be fulfilled. What we will be seeing today is the review
of a specific protocol designed to investigate the effects of strenuous exercise on blood
clotting. The subjects will be normal volunteers. They will be subjected to a series of examinations
involving the drawing of blood, underwater weighing, exercise on a treadmill, monitoring
of cardiovascular and respiratory function. The benefit to the volunteers will be minimal;
by and large, the significance of the experiment lies in the information it will provide for
our understanding of normal exercise and its effect on blood clotting and heart disease. Let’s look now at the criteria the IRB will
be using to evaluate this protocol. We want to examine the criteria themselves,
the way they actually work, and what their purposes are. [music interlude]
First, the risks to the subject must be reasonable, in relationship to the benefits to the subject,
and the importance of the knowledge to be obtained by the research. The risks themselves must be kept to the minimum
possible to achieve the purposes of the research. There must be an equitable selection of subjects. Informed consent must be obtained and documented,
to safeguard the right of the subject to accept or refuse participation in the study. The privacy and confidentiality of the subject
must be safeguarded. There must be a continuous monitoring of the
data. In January of 1981, the Food and Drug Administration
and the Department of Health and Human Services issued the regulations that now govern the
performance of research involving human volunteers, the aim of the regulation being to protect
those volunteers in the process of the clinical investigations. For the next few moments, let’s look at
these criteria in a little more detail. First, we must look at the protocol. It must be scientifically sound. It must be properly designed so that the knowledge
being sought will, in fact, be obtained, and the methods will yield the knowledge that
is sought, and the knowledge itself must have an importance for understanding human health
or human behavior. We must always remember we are exposing human
subjects to a certain number of risks. We have to have some kind of a moral sanction
to do that. If we were to start out with protocol, for
example, that had certain scientific weaknesses, one that wasn’t properly designed, then
we’d be unnecessarily exposing people to risks. The Institutional Review Board has a responsibility
to assure itself that, in fact, the criteria of scientific probity have been fulfilled. It needs evidence of that fact. That, in itself, is also a moral requirement. We have to look at the whole protocol from
the subject’s point of view as well. If you were a subject, you would want to know
if the information to be gained would be worthwhile for yourself or for some other person. The subject cannot give valid consent unless
he feels the risks are worth running. So, whether it’s biomedical research or
behavioral research, the first criterion is exactly the same: important scientific knowledge
must be obtained, and the generally accepted canons of good scientific research must be
fulfilled. Now the second criterion. What are the risks? We have to admit that in every experiment
involving humans, clinical and behavioral, there is some risk of pain, discomfort, or
even harm to the volunteer. Every effort must be made to minimize risk. Even though we have a very significant possibility
of helping someone, we would have to assure ourselves and the IRB that the investigator
had taken every possible precaution to reduce those risks to the minimum necessary to fulfill
the purpose of the research. Has the research, for example, incorporated
safeguards to protect against the risks? Insofar as possible, does the researcher intend
to use procedures already indicated for the individual subject’s condition? Selection of subjects is very important to
avoid discrimination, or over-selection of vulnerable subjects. Here, the IRB should be interested in who
is selected, and from what populations. Are particularly the susceptible populations
being chosen? Prisoners, for example, students, older people,
sick people, children, people with malignant diseases, psychotic or emotionally disturbed
persons, people for whom there are language problems. People who are particularly vulnerable must
receive special protection. Informed consent is the central ethical issue
in experimentation. Under no circumstances may we involve a human
being in experimentation without his consent. What do we mean by informed consent? Informed consent means that the subject has
to have a full disclosure of procedures, risks, and benefits. What is going to be done, for what reasons,
what risks are there, what are the dangers, the kind and the possibility of discomfort,
the loss of time, perhaps even the loss of dignity. The benefits, the alternatives, all those
circumstances that go along with being a research subject, must also be made clear to the subject. The investigator has the responsibility to
ensure himself that the person does, in fact, understand. That means that we have to be dealing with
competent individuals, or their legally authorized representatives. Persons who can perceive and process the information
can make a decision which is their own, on the basis of their own values, and express
their decision clearly to us. The decision must be free of coercion. The individual truly must volunteer. Throughout the entire experiment, subjects
must know they have the right to discontinue, to withdraw from the experiment at any time
they wish to do so. Once involved, subjects are sometimes afraid
to withdraw. The experiment has a certain momentum of its
own; subjects need to be told that not only do they have a right to refuse to participate,
but they can withdraw at any time. And they must be able to withdraw without
being penalized for any agreed-upon fee or associated treatment. Society gives us a mandate to involve humans,
because it’s the only way we can find out about the effects of new drugs, new treatments,
or new psychiatric maneuvers of various kinds. Those new procedures have to be tried out
in some human being, somewhere, sometime. Before we can involve someone as the subject
of an investigation, we must be sure to respect their rights as a person. Under all circumstances, privacy and confidentiality
must be stringently safeguarded. This means that the IRB must assure itself,
both from the protocol and from the questioning of the investigators, that any information
detected about the volunteers will be kept confidential, and limited to those who are
authorized to know. And the subject must be told who it is that
has access to this information. That information might be damaging, for example,
to the person’s reputation, to his social status, or even to his job. The information itself might create anxiety
for the subject. Subject privacy and capacity to control his
way of life must not, in any way, be compromised. Throughout the entire experiment, the data
must be monitored by the investigators or, preferably, by some other group. In the course of the experiment, it may become
apparent that the treatment is so beneficial that to continue to have controls would be
doing a disservice to the controls. Or the other way around: it may become evident
that the drug is very toxic or ineffective. Then it ought to be withdrawn before the study
is finished. In the case of behavioral research, emotional
trauma to subjects may be such that the information, even though significant, is not worth getting. This means there must be continual feedback;
every one of the criteria must be monitored in the light of how the experiment is actually
going. Approval for an IRB is not unconditional. These are the six criteria that form the basis
upon which an IRB conducts its review. Now, let’s turn to an actual experiment. We’ll follow it from the time the investigators
are preparing for IRB review, through to the actual conduct of the experiment. [Investigator 1] And then, if you take too
much blood, it might affect the performance of the athlete. [Pellegrino] Now let’s look at the way the
research team prepares well in advance for the IRB presentation. [Investigator 2] … I think that’s pretty
clearly outlined. But this raises a bigger issue altogether,
about the consent form. I based the consent form on, you know, on
previous runs we’ve had, and I mean, is it readable? Is it understandable for the average subject
who’s coming in here? [Investigator 3] Well I don’t think that
the average subject is going to know what 50 mLs is. So I think if you could put it in terms of
teaspoons, tablespoons, something like that, then certainly a woman is going to be able
to understand how much it is. [Pellegrino] Here’s another critical point,
raised by one of the members of the research team. Are the terms understandable to the subject? Great care must be taken to provide the information
in terms of the educational background, the language, and the culture of the volunteer. This may be crucial when patients are the
volunteering subjects. They are particularly prone to confuse treatment
and experiment. Now let’s look at the same protocol as it
is presented to the IRB at the hospital sponsoring the research. Again, you’ll see that the criteria serve
to focus a thorough discussion. [IRB Member 1] So, I wonder if you could start
by giving us a breakdown on this proposal. [Investigator 4] Okay, in this protocol, we’re
looking at how the fibrinolytic system – that is, clot formation, clot dissolving – responds
to acute exercise, and whether this response differs in people of different conditioning
levels. Specifically, we’re going to be look at
women, and we’re going to be looking at highly trained women, moderately trained women,
and then a group of untrained women. We hope to do about 80 women in all, half
on birth control pills and half not on pills, since the pills seem to affect the clot formation
system. Essentially what we’ll be asking the women
to do is come in and take a maximal exercise stress test, and we’re going to be taking
blood before and after this exercise bout. And we’ll also be monitoring several other
factors – oxygen consumption, temperature monitoring, and we’ll have an EKG hooked
up so that the people will be monitored continually while they’re up there. This stress test will be under the supervision
of a physician, and the physician will be in the room conducting the test, and the physician
draws the blood. And then in addition, after that test is over,
we will be weighing the subject under water to determine her percent body fat. [Pellegrino] These are the kinds of details
that the IRB should ask for, because it must make some judgement about whether the investigators’
claims to protect the safety of the subject are, in fact, true. Reviewing what was written in the protocol
is necessary to bring out possible contradictions. Nothing should be left to chance. [Investigator 4] We generally recruit subjects
by posting announcements, say, within university, or using in-house papers or in-house papers
at other local universities who are not—occasionally we’ve had an article in the newspaper soliciting
subjects. [IRB Member 2] Sue, in using humans in experimentations,
it’s very important that we completely be aware of the benefit. So not just the quality of the science, but
whether or not it’s worth—the purpose of the experiment is worth the risk to the
individual. In this experiment, what exactly is the significance
of the results you hope to obtain? How important is clotting factors in people
exposed to stress? Is it really that clinically significant? Health significant? [Pellegrino] At this point, the IRB member
is testing two things. First, whether or not the design of this experiment
is sufficiently rigorous, and the information sufficiently significant, to warrant doing
the experiment in the first place. That is to say, to justify putting these subjects
under the discomfort of a stress test. The second thing is to determine whether or
not there is some benefit to the subjects from the information to be gained. [Investigator 4] One of the underlying theories
of—or, one of the current theories of how atherosclerosis develops involves clotting,
the laying down of small clots in the arteries. And I think the feeling is that if exercise
changes this clotting system, it may help to prevent in the laying down of those clots,
or maybe even help dissolving clots that have already been laid down. [IRB Member 1] Well, you said exercise, then,
how much exercise do you—are they going to take? I mean, what are these highly conditioned
women going to do? [Investigator 4] Okay, the highly conditioned—well,
first of all, let me say that the stress test is what’s called volitional max, which means
the subject herself determines when the test stops. We ask the woman to go as long as she possibly
can, because we are looking for a max test. We want an indication of her maximum capacity
for exercise. But on the other hand, she’s the one who
determines when that point comes, assuming we don’t see any reason to stop the test. So that it is volitional. [IRB Member 3] When are the participants informed
that they can stop the test? [Pellegrino] Two very important points are
being explored here. The first is the assurance the subject can,
at any time, ask for discontinuance of the test. Whether because of discomfort or simply because
of anxiety. And the second point is to examine whether
or not the elements of informed consent have indeed been provided for. Even before the subject agreed to participate,
she should know that she can withdraw at any time. How does the investigator respond? [Investigator 4] Actually, she’s told at
least twice. The first time is in—when I have an initial
sort of interview with her, usually over the phone, and I’m explaining the entire protocol
procedure to her. I will tell her in that that she may stop
at any time. She’s essentially the one that determines
when the max point occurs, and then she will be reminded of that again, before she gets
on the treadmill. [IRB Member 4] Where is the test being conducted? [Investigator 4] In our lab, in the university
here. [IRB Member 4] So not in the hospital? [Investigator 4] That’s right. [IRB Member 5] What kind of equipment is available
in the lab in case of an immediate emergency, such as when you’re drawing blood or during
the stress test? [Pellegrino] Here we have another repetition
of the criterion of safety. To determine what measures are available in
case of a mishap. Are there safeguards, and are they sufficient
to minimize the risk to the subject? [Investigator 4] We have a crash cart which
includes a defibrillator and emergency drugs. And the physician is present, supervising
the test, and then everyone in the lab has been trained in CPR, so we’re all capable
of doing emergency resuscitation. [IRB Member 6] How much blood is going to
be drawn? And how often is it going to be drawn? [Investigator 4] We have the subject seated
in a blood-drawing chair, essentially, prior to the test, and that’s where the initial
pre-exercise sample is drawn. And then after she runs, she sat back down
again, in that chair, and draw another. [IRB Member 6] How much? How much blood will be drawn in each sitting? [Investigator 4] Each draw is 50 cc’s, so
that the total is around 150, which is about a quarter of what you would give if you were
to give a blood donation. [IRB member 7] Somehow, the way you just said
that, it came through to me as more blood being taken than I was aware of when I read
this study, and I identify from that where if I were a subject, I think—possible that
I might have missed it, too. [Investigator 4] I generally tell the women,
when I’m explaining to them, I say almost exactly what I just said then, that it’s
about a quarter of the amount—the total amount is about a quarter of what you would
give if you went to give a blood donation. So then it’s—
[IRB Member 7] Okay, I wonder from that, though, if it shouldn’t be – as opposed to being
dependent on, you know, you could get sick or something, someone has to take over and
then it’s not there. I wonder if shouldn’t be in the consent
form, in that sort of clarity. [IRB Member 8] Well I second your thought,
Randy, because I just saw it as three little blobs about that big. [IRB Member 9] Yes, yes. [IRB Member 8] Three times. [Pellegrino] At this point, the IRB member
is pursuing the question of a proper consent form, and assuring himself and the board that
it has been properly executed. But over and above that, the IRB member is
making a contribution to the way the consent should be obtained. The IRB review process is not simply a judicial
one, or a legal one. It also provides actual participation in improving
protocol. So as you can see, the IRB can be a help to
the investigator, as well as to the subject. [IRB Member 9] Who’s responsible for withdrawing
the blood from the participants? [Investigator 4] In our lab, it’s usually
actually a physician who does the blood drawing. [IRB Member 8] So there was a lot of concern
here about women and the stress test. There were some male studies I notice also,
and was there anything adverse that came up in those studies that would help us here? [Investigator 4] I think there was—well,
let me first say I was not here at the time that study was done. But I think there was one incident where a
person collapsed after having run on a treadmill during that study. And I believe that he was able—he was resuscitated
in the lab, and that we didn’t have to call in any emergency equipment. So that’s kind of encouraging, and it indicates
to me that we have the capability to handle that kind of emergency in the lab. [Pellegrino] At this point we can see how
important careful and consistent probing of the protocol can be. The response, in this case, indicates that
one patient actually had collapsed while on the treadmill test. If one listens to the language of the investigator,
we even hear the word “resuscitated.” Up to this point, the full extent of the danger
to the subject had not yet been elaborated. The investigator is conscientious, but the
IRB process has served to uncover important information of significance to the subject. [IRB Member 3] So I was wondering if you could
tell me, I know some of the women are going to be taking oral contraceptives, but are
you checking as to whether they’re taking any other medication? [Investigator 4] We specifically ask and check
to be sure. We eliminate everybody who’s on anything
other than oral contraceptives, and that includes even aspirin. Well, particularly aspirin, because of its
effects on the clotting system. So we do check for that and we do eliminate
subjects on any kind of medication. [IRB Member 2] Could you tell me just what
is being done to protect the confidentiality of the participants in this? Suppose, for example, the testing comes up
with some information that the volunteer would rather not have known. What kind of protection is built into the
system? [Pellegrino] Here, we have an exploration
of still another criterion: the protection of the privacy of the subject, and the confidentiality
of the information obtained during the investigation. Information can be damaging to the patient
if it is revealed when it should not be, or if it is withheld when the subject should
know about some unsuspected disorder. [Investigator 4] The only people that have
access to an individual’s files are our lab group and the individual themselves. And we would not release that information
without her consent. [IRB Member 2] Are the files coded, or do
they have people’s names on them? [Investigator 4] In the past, they’ve had
people’s names on them. However, recently, we’ve started coding
so that they are assigned numbers now. So that the person couldn’t just walk in,
rifle through the files, and find the one they were looking for. [IRB Member 1] If, as a result of this study,
you uncover some completely unexpected information – for example, say as a result of the blood
count, you estimated that the patient might have leukemia, just to give example – what
do you do about that? [Investigator 4] Dr. Ferguson would inform
the person of that finding, and then I think recommend that they see their own physician. Or, if they needed recommendation of someone
to go to, we could supply them with that. [IRB Member 7] I think that when people volunteer,
they should know what they’re going to get out of the experiment. And in this case, for the subjects who aren’t
runners or volunteering for that reason, they’re going to volunteer so that they can get cleared
and say “I’m okay to go running now.” And it’s unclear from this whether such
persons will have grounds for being cleared to go running, or whether they won’t, and
I think they should know that. [Pellegrino] The question of benefit to the
subject is an important one. It should be inquired into closely, as it
is being done here. A subject might volunteer for an experiment
simply out of a feeling of beneficence for his fellow human beings, even if he or she
receives no personal benefit. [Investigator 4] If that is what the person’s
intent, in coming in to take the test, would be for us to give the data to their physician
and let them discuss with their physician what kind of exercise they wanted to undertake
based on the results of this test. And I’d certainly hope that their physician
would caution them about how reliable it is to interpret this test as meaning that it’s
alright for them to start exercising. I don’t think anybody can give them 100%
assurance on that. [IRB Member 2] So do you have any personal
hesitancy about being a volunteer for this study? [Investigator 4] No. As a matter of fact, I was a subject in a
pilot study. So I don’t have any problems with the protocol,
although I realize from my own experience in the lab, that sort of the more I do as
a subject, the less any of it bothers me. So I try to keep that in mind when I’m talking
to people who aren’t routinely subjects in protocols of any kind. No, I wouldn’t have any problem taking part
in this study. [Pellegrino] There are some who would insist
that the investigator always subject himself or herself to the proposed procedure in a
pilot test. It is very reassuring that the investigator
did just this, and experienced some of the discomforts the subjects would undergo. Having seen the IRB during part of its deliberation
over this protocol, we might now move on and look at how some of the concerns of the board
are carried out during the actual experiment. Here we have an opportunity to see the actual
process, obtaining informed consent. You can observe two key elements: the contractual
or content aspects of consent – providing the information, getting a signature – but
also, the investigator is providing the subject an opportunity to ask questions. [Subject 1] So the form doesn’t really go
into the actual risks that would be involved. I was wondering if you could tell me a little
bit more about that. [Investigator 4] Okay. The risks range all the way from some relatively
minor things, like maybe twisting your ankle on the treadmill, losing your balance and
falling, or we’ve even had—one woman had an allergic reaction to the electrodes on
her chest. So they range from that kind of thing all
the way up to possibility of heart attack or some underlying heart disease showing up
while you’re on the treadmill. [Pellegrino] The investigator is elaborating,
not just providing information on a yes or no basis. The interaction allows the investigator to
interject into the proceeding a moral quality and assurance that, beyond the signature,
there is indeed understanding. Here we see the actual conduct of the experiment. Even though consent has been obtained, the
investigator reassures himself. He checks again. He wants to be sure he has provided all the
information necessary to protect his subject. It’s conceivable that between the time the
consent was given and the experiment actually carried out, some change may have occurred. This process of rechecking is very important
to actually carrying out the protocol. [Investigator 2] Okay, I don’t think there
are any problems. I think we can get started now. I need to get some baseline blood now at this
point. [Subject 1] Well in terms of the amount of
blood you’ll be drawing, do you think that in any way would affect my performance on
the treadmill, or how long I could stay on? [Investigator 2] Well, I have no way of knowing
that one way or the other, but because the protocol is really designed to study effects
of exercise on blood, I must take the blood, and we’ve—
[Pellegrino] Notice how important it was, that even though the subject has given consent,
new questions arise. Reassurance is necessary. The need to keep the subject informed is not
a one-time event. [Investigator 1] Okay. Now the purpose of this is we want to measure
your percent body fat, and fat doesn’t weigh anything underwater. And so the heavier you are on the scale, the
less percent body fat you’ll be, because we’re just measuring your lean body mass
on the scale. So you want to be as heavy as possible, okay? [Pellegrino] In this experiment, we’re dealing
with normal volunteers. It’s even more important to keep informing
sick patients of what is happening to them. They, after all, are more vulnerable, more
dependent on the physician, and less apt to bring up the kinds of questions that this
normal subject raises with ease. [Investigator 2] Now you’ve got a lot left
in you. You’re doing real well. In about 30 seconds, we’re going to go up
a little higher and a little faster. It’s still going to be a walk for you. If you feel more comfortable jogging, go right
ahead, but it should be still at a pace that you can keep up with it simply by walking. Do you feel alright? [Investigator 4] Yeah, you’re doing fine. [Pellegrino] Here we are observing another
criterion, the provision for constant monitoring to ensure adequate safeguards for the volunteer. Not only monitoring of the physiological data,
but of the subject’s responses. This is important, so that if any difficulty
should occur, the experiment could be stopped before doing any harm to the volunteer. [Investigator 2] Okay, why don’t you go,
but you’ve got a little bit left in you. [Investigator 4] Hang on there, next click. You’re doing great. [Investigator 2] Next click, go one more after
that. Want to try? No? [Investigator 4] Hang in there, okay? [Investigator 2] Is that it? [Investigator 4] Hang on and straddle if you
want. [Investigator 2] Grab the [inaudible] and
just straddle it. [Investigator 4] That’s it. Great. Okay. [Investigator 2] Hang on. That’s 10 points—clicks. [Investigator 4] Okay, now what you want to
do is step back over the blue cable just like we did before. Back down here, yeah. Okay, great job, good job. [Investigator 4] Yeah, good job. Hold real still, now. We’ll get another EKG. [Pellegrino] We’ve just seen how an IRB
functions. It looked at the way some of the criteria
are actually applied by one IRB. The criteria that we’ve reviewed are essential. If, in our democratic society, we are to be
permitted to continue to ask human beings to participate in investigative procedures
– which, in the long run, affect all of us – if we are to do this, then we must
be particularly careful to protect the rights and the dignity of the volunteers. The purpose of the IRB and the regulations
that go with it, are not, thinking back to the opening of our program, a hindrance to
research. They are not meant to stand in the way of
good science; they are motivated by the moral obligation that an investigator imposes on
himself, when he undertakes to acquire knowledge from other human beings, putting them by that
fact at some risk, and causing them some discomfort. The ends are worthwhile. The means must be very carefully scrutinized. That’s why we need to know why the information
is worth having, we must know that the scientists who are doing it have put a great deal of
effort into designing the experiment so that it can be useful. That we’ve done every attempt to minimize
the risks, that we’ve taken every step to be sure that the subject knows exactly what’s
going to happen, knows the risks that he or she runs. To be sure that the investigators continue
monitoring their experiments. These are the minimum requirements in a humane
society for the continuance of something vital to that society: the acquisition of knowledge,
knowledge that can be a benefit for all of us.

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