OHRP: General Informed Consent Requirements


This video guidance represents OHRP’s current
thinking on this topic at the time of production and should be viewed as recommendations, unless
specific regulatory requirements are cited. The use of the word “must” in OHRP guidance
means that something is required under HHS regulations at 45 CFR Part 46. The use of
the word “should” in OHRP guidance means that something is recommended or suggested but
not required. An institution may use an alternative approach if the approach satisfies the requirements
of the HHS regulations at 45 CFR Part 46.

Hi, Dr. Mitchell. Thank you so much for taking
the time to meet with me… is this still a good time for us to talk?

Absolutely!

Thank
you. I just had a few questions that I wanted to go over with you about this protocol that
I am about to submit to the IRB for review. 

Sure, no problem. And by the way thank
you very much for dropping it off yesterday so that I had a chance to go over the protocol
and the informed consent document. I looked at them last night. What can I help you with
today?

Well, as you know, this is a randomized, double-blind, placebo controlled study of
the effects of Memoride on the cognitive function in subjects with schizophrenia. The purpose
of this study is to test whether Memoride improves the memory. Subjects with schizophrenia
will be admitted to the hospital for approximately two weeks. During the first week of the study,
subjects will undergo a physical exam, psychological and cognitive testing, and an MRI of the brain.


During the second week of the study, subjects will receive either Memoride or a
placebo three times a day for seven days. Also during the second week, they will be
doing an extensive series of cognitive tests to help us establish whether or not the subject’s
memory is improving. They will also receive a second MRI at the end of the second week.


Tell me, will subjects need to come off of their medications to be eligible for
this study? As you are well aware, taking someone with schizophrenia off of their medications
could potentially make their symptoms worse.

Right. Actually no, we will not. Memoride will be
added on to their current medications. So, my question is, as the study will be focused
on subjects with schizophrenia, and a main symptom of their disorder is psychosis and/or
a thought disorder, if subjects are unable to give informed consent, what are my options?


Well, let’s just take a look at the regulations here. The regulations specifically
state that “no investigator may involve a human being as a subject in research covered
by the regulations unless the investigator has obtained the legally effective informed
consent of the subject or the subject’s legally authorized representative.” So,
one option is that if you felt the subject could not give his or her own consent, you
could discuss with the IRB the possibility of having the subject’s legally authorized
representative give consent. 

If I did it that way, I think I would include the caveat
that should the subject regain or develop their own capacity to consent, then his or
her consent must be obtained for any further research. 

That’s a great idea and that
certainly makes sense. So, it sounds like you would want to come up with a way to determine
if a subject has the capacity to give informed consent. Now perhaps this is something you
could consult about with some of your colleagues with respect to options for dealing with that
issue. If subjects are found to be unable to give their own informed consent, you could
either have their legally authorized representative consent for them, or another option is you
can decide that if they do not have the capacity to give their own informed consent, that they
simply could not participate in the study. Now of course if you chose to exclude subjects
that lacked the capacity to give informed consent, you would want to consider if that
would affect the overall validity of the study. You and your team should think about what
would be most appropriate, present it to the IRB for its consideration, and then of course
the IRB would make the final determination in that regard. 

OK, well those are both
really good ideas, thank you very much. Are there other aspects of the informed consent
that I should be mindful of?

That’s an excellent question, and the answer is yes.
The regulations state that prospective subjects or their representative must have sufficient
opportunity to consider whether or not they wish to participate. 

OK, well I plan
on sending the informed consent document to prospective subjects prior to meeting with
them, and of course will give them ample opportunity to ask questions and to think about whether
or not they would like to participate when I meet with them in person. 

OK, that
sounds great. You also want to ensure that the possibility of coercion or undue influence
would be minimized. And, as you know, the informed consent must be in a language that
is understandable to the subject or the representative, and there can be no exculpatory language used
in the consent.

OK, well I’ll be sure to double check the informed consent process
to make sure that it meets these requirements. Thanks so much for taking the time to meet
with me. It was very helpful and instructive.

Oh, it’s been my pleasure, and please feel free
to stop by anytime.

Have a great weekend. 

You too. Take care.



Hi, Mr.
Smith, thank you so much for coming in today. I wanted to spend a little bit of time talking
to you about your possible participation in the study.

Well, thank you for inviting
me, Dr. Presley. I’m glad to be here.

Sure. A few weeks ago I sent you a copy of the informed
consent document. Did you receive it? And if so, did you get a chance to read it?

Yes,
I brought it with me. I did get a chance to read it over when I got it in the mail, thanks.

Great.
Did you have any questions about what you’ve read so far? 

So far I think I’m OK,
but I might have questions as we go along.

OK, that’s totally fine. The first thing I would
like to emphasize is that the informed consent process is actually a process. It’s not
just having you sign this document today. This means that we will be providing you with
information throughout the study, and that you should always feel free to ask questions
at any time, even after the study is over.

OK, that’s good to know.

OK, well let’s
get started then. Although I know that you’ve already read the informed consent document,
I am going to go over it again with you to just be sure that we all feel comfortable
with what has been explained to you, and that all of your questions have been answered.
And then at that point, you will have the opportunity to take all the time that you
need to decide whether or not you would like to participate in this study. 

OK, that
sounds good. 

First of all, we want you to understand that this study involves research.
Research is very different from the clinical care that you receive from your regular psychiatrist
in the community. Your regular doctor is treating you and is giving you care based on known
scientific facts. In this study, we are asking a question that we don’t yet know the answer
to. 

Well I think I understand that because I met with my psychiatrist before I came here
and he explained that to me.

OK, great. Well, now I’d like move on and give you
a little more information about the study. The purpose of this study is to see if Memoride
improves memory, the ability to concentrate, and problem solve in people with schizophrenia.


That’s great, because I sometimes have problems with those symptoms. I have trouble
with concentrating sometimes, I have trouble with my memory, so it would really benefit
me a lot to be in the study.

Well again, we don’t know if this will work or not,
and that’s why we are doing this study. We don’t want you to have the misconception
that this drug is going to improve that problem, because at this point we don’t know whether
it will or not. Although you may not benefit from this study directly, you will be contributing
to determining if this drug improves cognitive abilities in people who have schizophrenia.


Well I guess even if I don’t benefit, then it I’m glad that other people might benefit
who have schizophrenia. So, that’s a good thing.

Well, we appreciate that. As you
know, this is an inpatient study, which means that you will be staying in this hospital
on the research unit while you are in the study. The study will last for approximately
two weeks. We do realize that two weeks is a long time to be in the hospital, but as
long as your symptoms are under control and that we feel that you are safe, the staff
will take you off the unit during the day to participate in a variety of activities.

That’s
good to know. Will there be any games or computers on the unit for me to use? 

Actually,
yes. There is a computer and a TV with some video games.


OK, good, because otherwise
I think I might get a little bored because it’s two weeks.

Very understandable.
OK, so let me move on and tell you a bit about the study design. This study is called a “double-blind
placebo controlled study.” I realize that’s very much of a mouthful, so let me try and
break that down a little bit for you. Do you know what a placebo is?

Isn’t that like
a sugar pill, or a fake pill, or something like that? 

Right, that’s about right.
The placebo pill will look the same as the pills containing Memoride but it won’t have
any Memoride in it. The second part is the “double-blind study” part, which means that
neither you nor the research team will know if you are taking the study drug or the placebo.
This is a very common type of research design, as it helps the researchers avoid being biased
when assessing study subjects. 

Right, but that’s kind of scary. Will anybody know
if I’m taking the drug or not?

Definitely, yes. The pharmacist will know, and if there
is ever any problem, all we need to do is call down to the pharmacy and they can “break
the blind,” which means that they will tell us if you are on the study drug or not.

And
if that happens, will I then have to come off the study?

Yes, actually, once the
blind is broken we would take you out of the study.

I see.

So, finally, let me
explain the last part of that, which is “randomized.” Let me explain what randomized means.

Well,
I think I know what that means already. Isn’t that like when you flip a coin, so I might
either go on the drug if I get heads, or tails I might not go on the drug and get the placebo?

Exactly!
So you’re going to have a 50-50 chance of being on the study drug. 

So let’s
move then and talk a little bit now about what procedures you’re going to partake in
if you join the study. Once the study begins, you will be asked to take some psychological
and cognitive exams that will test your ability to pay attention, problem solve, and remember
things. During that first week, you will also have an MRI of your brain as well as a physical
exam. In the second part of the study, the second week, you will be given either Memoride,
or a placebo that looks like Memoride, three times a day for seven days. OK?

OK, so
will I still be on the medicications that I’m currently on, or will I have to come off
of those.

No, you will still continue to take your medications that you psychiatrist
already put you on, and the Memoride or the placebo will be added on to those medications.


So, moving along, you will also be given some more cognitive tests as well as a second
MRI towards the end of the second week. Two weeks after you actually finish the study,
we will call you at home to follow up with you to make sure that you haven’t had any
additional side effects or problems, and to answer any additional questions that might
have come up for you at that time. Do you have any questions about what I have told
you so far?

OK, this sounds really great but I’m wondering that if the drug really
works for me can I get the drug when I go off the study? Can I start it up again?

We
would welcome you to share the results of the study with your personal psychiatrist
so that together, you can make an appropriate decision regarding your care. Do you have
any other questions at this point?

Well, I’m kind of worried about insommnia, because
sometimes I have trouble sleeping. Is this one of the side effects of Memoride? 

There
are a number of risks from participation in this study, which include possible side effects
from Memoride. The side effects that have been reported for this medication include
nausea, vomiting, and the lack of appetite. Insomnia is not a known side effect, but it
is possible that you might have a different reaction to it that is yet unknown.

There
are a few other possible risks from participation in the study. As I mentioned, you will be
doing some cognitive testing, however this will be done at a relaxed pace, but it’s
possible that taking the tests may produce some discomfort from you feeling anxious or
nervous. These tests can usually be completed in about 75-80 minutes, and if it becomes
too difficult, we can stop.

OK, what about the MRI. Isn’t there risk associated
with the MRI?

There are some minor risks associated with getting an MRI. For example,
you will be asked to lie on your back for about an hour, and it may get uncomfortable
for you to lie still for that long. In addition, the MRI machine makes a lot of noise, but
we will give you some ear plugs that will hopefully help with that. Also, some people
get claustrophobic from being in the MRI scanner. Do you know what claustrophobia means?

Yes,
I think so. Isn’t that like when people freak out if they’re in really tight spaces?

Right,
that’s correct. Some people get very anxious or might even have a panic attack. Has that
ever happened to you?

No, that’s never happened to me, so I think I’m OK.

That’s
good to hear. Also, because an MRI is a very large magnet, it has the ability to move or
attract metal. So before you enter into the room with the MRI scanner, we would ask you
to remove all jewelry, and if you have any metal in your body (like metal plates, or
shrapnel, or a pacemaker, for example), we would not allow you to have the MRI, as it
could place you at risk.

Got ya–well, I don’t have any metal in my body, so I should
be fine. 

Good, thanks for letting us know that. As I mentioned earlier, you will
have a full physical exam before participating in the study, so we will go over your entire
medical history in order for us to know more about your health.

I also wanted to mention
again that participation in this study is not designed to benefit you directly. However,
the information that we learn from the study may help people with schizophrenia in the
future.

Yes, I understand that. What happens if I decide not to participate? 

Well,
one alternative to participating in this study is not to participate. Also, not participating
or withdrawing from this study would not exclude you from possibly participating in other studies
that we have or from things that you would otherwise be entitled to, such as medical
care.

So, will my psychiatrist or any one of my family members be able to review
my research records?

No. All of your information will be kept confidential, unless
you request, in writing, that the information be released to a particular person or persons.


Well, I think that sounds pretty reasonable. I do have one other question. I noticed somewhere
in the informed consent that there was something about getting payments for participation.
Can you talk a little more about that?

Sure, yes, there is a small amount of compensation,
which will hopefully cover your transportation, and some other minor expenses that you may
incur from participation in the study. Besides these costs, we don’t foresee you having
any additional costs associated with the study.

So how much will I get?

The compensation
is broken up into 3 parts. For the first week of the study, you will receive $50.00. For
the second part of the study when you will be getting either the study drug or the placebo,
which again I mentioned is a sugar pill, you will receive $150.00. And if you get the MRI
scans, you will receive an additional $150.00. So, if you complete the entire study, you
would get a total of $350.00. 

OK. Well, that doesn’t sound like a lot of money, but
I guess I’m really doing it for different reasons.

Well, we appreciate that. Also,
I wanted to inform you that if you do sustain an injury during the time that you’re participating
in the study that is related to your being in the study, we will provide short-term care
at no cost to you.

Does that include anything that might happen if I have side
effects from the medication? 

Yes. It includes any problems you that have while
you’re in the study that are related to your participation in the study. Also, if
you do have any problems, it’s really important that you immediately let the nurses or the
doctors know. There are nurses on the unit 24 hours a day, so someone will always be
there to help you. In addition, if you need to reach me, as you see here on the consent
form, there’s my phone number and my pager number.

So I can call you at any time?

Yes,
definitely. Separate but related, you’ll also find the name and phone number of the
patient advociate, the Subject Advocate. Feel free to contact her if you have any questions
or concerns that you don’t feel comfortable talking to the research team about. 

Is
she really nice?

She is very nice, she is. Do you have any questions? 

I think
I’m very interested in participating in the study. It’s something that I think is going
to help other people, and I’d really like to help out.

OK, I know I told you this
a few times already, but I just wanted to remind you that participation in this study
is entirely voluntary, and that you may choose not to take part, or you may end your participation
in the study at any time, and there would be no penalty for doing so. And I want to
emphasize that withdrawing from the study would not make you lose any benefits to which
you are otherwise entitled. 

OK, that sounds fine.

There was one last thing
I wanted to mention that is related to withdrawing from the study. Not only can you stop the
study at any time, but I can stop it too. So, for example, if your symptoms worsen to
the point that we feel it is no longer safe for you to continue in the study, we would
withdraw you from the study at that point. Or, if we get information about newly discovered
side effects from the study drug, we may stop the study then too. It’s important that you
know that your safety is always more important than the research.

Well, It’s good to
know that you’re looking out for me, so I appreciate that.

Sure. Well now that
we’ve gone over the information about the study, have you made a decision about whether
you’d like to participate, or would you like to have some more time to think it over?

I
think that I have had enough time. I would like to participate. I think it would be very
interesting and I think it would be helping other people out. So, I would like to.

Great,
well we very much appreciate your willingness to be part of our study, and again, at any
time if you change your mind, just let us know. So, since you’ve read over the consent
form and if you have no further questions, I’d like to ask you to sign the document.
And as a reminder, signing the informed consent document is acknowledging that the information
in the consent form has been explained to you, and that you have been given the opportunity
to discuss it and ask questions, and that you do, indeed, consent to take part in the
study.

OK, so where do I sign?

Right here, and here’s a pen.

Great. Again,
I want to thank you for agreeing to be a part of this study, and I very much look forward
to working with you.

I think it will be interesting. Thanks, thanks alot.

I’ll
be right back. I’m just going to go make a copy of this consent form for you. 

OK,
I’ll wait.

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