Return of Research Test Results

Return of Research Test Results


Good morning everybody. It’s nice to be here. I am a 1984 graduate of Yale Law School, so
I lived in New Haven for four years of my life and so it’s nice to be back in Connecticut. It’s nice to be with all of you today. What I was originally asked to talk about
when I was called by the folks at OHRP and Hartford Hospital, was to talk about the final
issuance – the issuance of the final common rule. And that hasn’t happened yet. And so the topic of my talk therefore has
been taken from up from under us, and then the question was what I would talk about. So what I proposed to talk about, and what
I will talk about it, is the issue of return test results to human subjects. It is returning research test results to human
subjects and the regulatory and the ethical dilemmas in regard to returning those kinds
of results. And I will give you some of the regulatory
issues that we have talked about that you might be dealing with every day. But certainly, we within the HHS Secretary
Advisory Committee on Human Research Protection have been talking about for the last couple
of years. I will say however in the beginning a few
words about the possible issuance of the final rule. And what I tell you is based on gossip, here
say, and innuendos and nothing else. But that will not stop me from repeating it
and believe it to be true. And that is – I think – that before the
end of the Obama Administration we will see the issuance of a final set of amendments
on the common rule. I do believe that, that’s what I hear. The other thing that I hear, is that we will
likely see some significant change to what was proposed in regard to the bio specimen
consent. And if that is true, then that will be a welcomed
changed, I think from any of us. Because I think that many of us have been
afraid of what has been proposed in both the ANPRM and the NPRM would mean for future research
and human bio specimens. So we’re hopeful. We are holding our breath, but we don’t
know when it will come down. I hope it comes down sooner – let me just
tell you this. Those of you who were around research, will
remember, and around healthcare will remember that the HIPPA rule, the HIPPA privacy rule
was released in the last few days of the Clinton administration. And it was done in such a hurried fashion,
that it had many problems and inconsistencies in it. So the first thing that the Bush administration
– I think it was Mike Levitt that was Bush’s HHS secretary. One of the first things that Levitt did, was
actually to pull back the rule within days of George W. Bush taking office and proceeding
to another round of comments and amendments on the HIPPA privacy rule. So I am hoping – perhaps beyond hope – that
the issuance of the final common rule will not be quite so hurried and more deliverable
and will not need to be revoked or pulled back whoever it is that wins on November 8th. So what I will talk about today is the issue
of returning research test results. This issue is part of a larger set of issues
in regard to transparency of research. And we see demands for transparency research
in many different places, manifest themselves in many different ways. One of the things that I’m not going to
dwell on, but I think is worth mentioning is that there are some currents, some deep
currents, in regard to transparency of research results. Transparency of research itself. One of the things, of course, that many of
us are familiar with and that we have to deal with every day is registration our clinical
trials on clinicaltrials.gov. And then in turn of putting our results of
studies, once they are completed, into the results registry on clinicaltrials.gov. I think most people in this room are familiar
with that process. We also know that there are increasingly a
number of journals, including the British Medical Journal, that actually require – and
NIH in some cases that requires – that when one has a study that whose results are summited
to be considered for publication, one of the pledges that the author must take, is that
they make all of their data – their raw data be de-identified – but that their raw
data available to whoever, to whatever secondary researchers, whoever the secondary researchers
are, may ask for the data. We also know that the International Committee
of Medical Journal Editors, ICMJE, has endorsed in principal the theory that all ICMJ journals
would make it as a condition of publication of any results of any trials, experiments
in their journals that the authors would make raw data available to any qualify researcher
or secondary researcher that asked for it. Are those of you in the room familiar with
these things that are going on? The other thing that is going on in that regard
is that the Europeans Medicines Agency; which is the analogue of the E.U., of course of
our own FDA has indicated it too will require, that in a way overlaps some of the, what the
ICMJ is proposing in this way. That one has clinical – that one is an industry
sponsor of research one moves to, in the E.U., before the EMA to have one’s medicinal product
approved for marketing and advertising and marketing within the E.U. member states. That one would have to make all of the raw
data available, even on the web to anyone who might want to look at it, down to the
patient level. Not with identifiers, but available with all
the raw data as a condition as having one drug approved for marketing within the European
Union. This means that, unless you think that doesn’t
affect us, it actually does affect us very directly. Because it means all the clinical studies,
whether it’s done in Hartford or New Haven or Bridgeport or New York or California or
the E.U. or even Polynesia, or wherever the studies may be done, if the studies are going
to be submitted to support an EMR marketing application, which they will be, then that
means our data – our patient data – be de-identified but are our patient data down
to patient level. And I’m talking blood pressure reading,
if required by the research protocol will be all made available publicly to any secondary
researcher or any member of the public who would like to see these things. These are all sort of mega trends; these are
some individual manifestations of a megatrend for greater transparency in clinical research. It may be in the final issuance of the common
rule, one of the things that we will what was proposed in the NRPM, which was that consent
forms should be made available on the web for studies that are active. We may see that – it would not surprise
me, at all, if we see that in the final common rule. So what I’m about to talk about is another
aspect of the overall trend towards greater transparency in research. I have no direct conflicts of interest; I
believe in all this. So we’re going to go over these things. And this is quite a specific presentation
which may or may not impact you directly right now. But I believe that if it doesn’t impact
directly you right now in terms of research that you oversee, monitor, or conducting,
it will impact you at some point, because we see that these issues are emerging with
greater force. But what I’m going to talk about is basically
this – I’ll give you background of the issue. We’ll talk about the HIPPA right of the
individual patient or research subject to access their data, that are held by a covered
entity under HIPPA. Almost all of our Institution down to the
offices practices of individual physicians are all covered entities, there are only a
few exceptions to that. We’ll talk about the issuance of the joint
HIPPA CLIA common rule, that is the Clinical and Laboratory Improvement Act, which most
of us when entered research did not think we would be worried Clinical and Laboratory
Improvement act, but it actually matters very much as I’ll show you. There is a regulatory conflict between the
HIPPA right of acts and some of CLIA requirement, which I’ll talk about. SACHRP, the HHS Secretary’s Advisor Committee
to OHRP and to the HHS secretory on Human Research has some recommendation on recent
developments. And then I will talk a bit about the FDA regulations
because even if the HIPPA and CLIA things don’t apply to you or to the research you
are planning or conducting or overseeing or monitoring, then FDA regulation in this area
may well apply. So here’s a case study, an example, of one
of the things that can happen in this area. Our participants enroll in research involving
genetic sequence testing. You could also have biomarkers instead of
genetic sequence test. And they’re conducted in an academic medical
center or in any hospitals, HIPPA covered entity hospital, research lab. But the research lab itself, the research
lab is not the regular pathology laboratory. It is a separate research laboratory that
is in- that is within the lab of a particular PI. And most of our PI laboratories that are not
pathology labs, are not CLIA certified as most of you know. A participant knowing that he or she is enrolled
in research and that test results have been generated – could be genetic test results,
it could biomarker test results – ask for a copy of the final test results. How do the researcher and the medical center
or hospital respond to this? And how do the individual right of access
to these under HIPPA, how does it affect the analysis in this case? We know under HIPPA, and so that’s the paradigmatic
case that I’ll be referring to throughout the presentation. We know under HIPPA that a person, an individual,
has a right of access to the designated record set held about them by the covered entity. The only and again the only health care providers
that are not covered entities maybe the Shriner’s Hospitals, which don’t build Medicare and
Medicaid. And a few dental and psychiatry practices
that only take checks and cash. Otherwise, you perform one electronic transaction
for reimbursement and your entire operation is subjected to HIPPA for these purposes. HIPPA right of access is not actually a right
of access of the individual patient. It’s not a right of access to everything
held by the covered entity. But it is instead it is defined as a right
of access, to what is called Designated Record Set, or the DRS. A technicality which may be which may be known
pretty much only to your HIPPA privacy officers. But is quite important to this analysis today. What does that include? A designated record set includes medical records
and billing records that are maintained on the individual. It includes enrollment and payment information
and all the reimbursement information and claims information. But it most importantly, for this purpose,
it is any other records all of the records that are used in whole or in part by the covered
entity to make decisions about individuals. So it’s not just decisions about treatment,
but any decision. And it is not just a decision about the patient,
it’s a decision about any individual. This is the way that any designated record
set is defined. So the right of access is to designated record
set. In 2003, when the Bush administration came
out with the final privacy rule after all of its amendments, then the privacy rule provided
flexibility regarding the access right in respect to the information that is generated
during research. It did say – and I think all of us know
this – that in the informed consent, if you give research subject notice, you can
say to them you cannot have access even though we’re with a covered entity and this research
is done with a HIPPA covered entity, you can’t have access to your information, during the
course of the trial. But once the trial is over and your participation
has ended, then you can have access. Now why is that? Because otherwise people will be asking people
in the randomized control study would want to know immediately, if they were smart and
they actually knew what they were talking about and they knew what the research was
and how it was structured, they would ask immediately all of their medical records because
they would know whether they were in the control arm or the experimental arm of the study. But it has to be in the consent in order to
suspend the access right during the study. Under the 2003 privacy rule, in addition,
individuals could outside of research, they would often and they do today, they file records,
records request. And they get all of the pathology notes, progress
notes, they get everything. However, the privacy rule did not mandate
that laboratory that are covered entities either those that are CLIA exempt or those
like research labs, or those that are certified under CLIA provide individuals with direct
access. So they can get their results if it’s part
of their overall medical record. But if you go to a free standing laboratory,
even thought that is a covered entity under HIPPA, under 2003 privacy rule, the clinical
laboratory did not have to give you your raw results. And why is that? Because the HIPPA drafters were trying to
preserve the regulatory structure of CLIA, the Clinical Laboratory Improvement Act, which
basically said that individuals did not have a right of access to their test results from
the commercial or non-commercial CLIA Laboratory because CLIA wanted individuals to have to
go through a learned intermediary, that is the physician that would order the test in
order to get their test results. The CLIA folks are sort of behind the curve
and the transparency as I’ll get to in a minute. But they clearly behind the curve at this
point because they thought – the CLIA regulators who are within CMS, the Center for Medicare/Medicaid
Services, they want there to be greater control rather than greater access. And so they preferred in the regulations,
the CLIA regulations traditionally and so they are structured so that the doctor or
the provider stands in between the individual and his or her test results. So that that the doctor can interpret the
test results. So CLIA, if CLIA prohibited disclosure to
an individual the laboratory under HIPPA, under the original issuances, was not able
to provide access to those laboratory records. However, transparency the tide of transparency
either – I guess one can say – either lifts all boats or wrecks all boats depending
on your point of view. Whether your HIPPA access advocate, or whether
you are CLIA, a CLIA advocate who would prefer that individuals be protected in one way or
another from their information. It was a joint HIPPA/CLIA rule that was issued
in 2014, with an attempt to harmonize CLIA and HIPPA with regards to some of these individual
access rights. It was – had a compliance deadline of October
6 of 2014. It’s now been in effect for over two years. This act amended CLIA to allow labs to give
completed test results directly to a patient or to his or her legally authorized representative. And it amended HIPPA to require HIPPA covered
entity laboratories to provide access rights to patients. Now none of this effects yet, in what we are
talking about. It affects research. So under this rule therefore, Medpath, any
(indiscernible) path, the individual laboratory that are covered entities and they’re all
covered entities because they all apply for reimbursement to Medicare, Medicaid, and private
insurance and managed care. If you go as a patient, as a consumer to that
place that has run a test on you and you ask for your designated record set, they have
to give you all the information without going through the individual doctors. The individual right of access was protected
and allowed under this rule. Why the change? HHS was trying to be transparent and its consistent
with actually with some of what president Obama has said in regard to the Precision
Medicine Initiative, which is to give people more information about their health. The history of this act said that the idea
was to move barriers in the regulations to individual access to test reports maintained
by laboratory subject to or expect to CLIA, enabling individuals to be more proactive
and more inform with regard to their health through commitment to personalize medicine. And the preamble noted – and this is leaving
aside, the silencing really the objections of the traditional folks in CLIA who had this
idea that there should be, we should want an intermediary, the learned intermediary,
a physician to stand in between the patient and their laboratory test results. The preamble even when individual access to
test results may cause anxiety, such concerns are not sufficient to justify denial of access. So transparency triumphs in this 2014 act. So clearly it favors individual access but
here’s the problem. Under CLIA, what remained behind after the
2014 act, is the CLIA prohibition. On CLIA, non-CLIA certified laboratories being
able to give individuals test results. And CLIA says that a non-CLIA certified laboratories,
which is most of our research laboratories – that are genetic testing, that are doing
biomarker testing – most of these laboratories are not – our regular pathology labs – they’re
not CLIA certified and so this rule left behind the idea and the inconsistency in this law,
which says that if it’s not a CLIA, and this is still the law – if it is not a CLIA
certified laboratory, it is illegal under CLIA for the laboratory to give the test results. Now why is that? Why is that? Well there are some merits, there are some
merits on the side of the CLIA regulators. Because in general, what they are concern
about is the following. That is that the wrong test results could
be given out to the wrong people. That the test results could be inaccurate,
and remember that CLIA was enacted in the laboratory inspection system nationally, was
enacted at a time when there were problems with, for example, the chain of custody of
specimens, the accessioning process of specimens, the validity of testing, lack of quality control,
the control of laboratories. CLIA was enacted a number of years ago and
there was an inspection system which was at first at Centers for Disease Control, later
moved to, when CLIA itself moved into CMS about 35 years ago. The idea was to create a national quality
assurance system to make sure that people were getting their own lab results and were
getting lab results from validated testing and that the lab results were run by labs
with people who were qualified, knew what they were doing, and we could depend and providers
could depend on the results. And of course many laboratories that performed
the research studies, as I said, are not CLIA certified. And therefore, under CLIA they cannot report
test results to patients for the diagnosis, prevention or treatment of any disease or
impairment of, or the assessment of the health of individual patients. This is what the actual regulation within
CLIA says with the citation here. Here’s the problem though, our research
laboratories, let’s say within the University of Connecticut Medical Center Complex. A research laboratory that is not the regular
CLIA certified pathology laboratory, it is never the less part of a HIPPA covered entity. So therefore and here’s the inconsistency,
it cannot give out under CLIA these test results from a non-CLIA certifies laboratory. On the other hand, it is part of a HIPPA covered
entity, where the new rule demands that HIPPA covered entities including the non-CLIA certified
laboratory if they’re part of a covered entity, give people access upon request to
their teste results. And their lies the problem. So HIPPA requires us to honor individual right
of access within our covered entities. And CLIA forbids it when our laboratories
within a covered entity are not in fact CLIA certified. Now before the, this final rule as I said
before. There had been this kind of exception, which
took care of this because it actually, the earlier inclination of the HIPPA rule as I
said indicated that laboratory including research laboratories were not required had over their
results even if they were part of a covered entity. So therein lies the regulatory conflict. So as I said, under HIPPA the, to repeat,
make it crystal clear. Under HIPPA covered entity, laboratory non-CLIA
certified must hand over upon individual request the results. But under CLIA if it’s not a CLIA certified
laboratory. Regardless under HIPPA it is a felony under
federal law to hand over test results. You are ultimately, your entity, your entire
corporate entity could lose its CLIA certification for having a research laboratory that is non-CLIA
certified handing over test results to individuals. And this is why in these, in the virgining
area of biomarker and genetic research done by the non-CLIA certified laboratories, this
is why were so concerned about his issue. So then we said to CLIA a number of us, including
several presentations made at the HHS Secretary Advisory Committee. We said well what about if we, if instead
handing people over their results, instead of this from a non-CLIA certified laboratory
within a covered entity. What if we tell them instead there is a test
result – this is when we think that a test result is actionable. In other words, let me give you the scenario. A genetic test, a genetic sequencing done
in a non-CLIA certified laboratory that indicates a genetic variant that indicates in turn either
a prognosis or a diagnosis. But something for which the individual could
actually do something, could actually do something about their health by having more regular
monitoring by going to a physician that specialized in that disease or condition etc. an actionable
result. And remember there are two sides to this. One side about the non-CLIA research laboratory,
one side of it is responding to an individual demand or request for their medical records
including lab records. That’s responding to the individual to the
individual. That’s one perspective. The other perspective is voluntary, spontaneous
disclosure to an individual of test results that we find are actionable. Even though those test results come from a
non-CLIA certified laboratory. So if you find for example the BRCA gene in
a research study, if you’re a researcher and you have non-CLIA certified laboratory. And you find a genetic variant that is actionable
and the individual does not know enough to ask for his or her records, are you allowed
to voluntarily allowed to disclose that to the individual? Well CLIA says that if it’s not a CLIA certified
laboratory, you’re not allowed to do that. So then we said to CMS, well what about if
instead of telling someone what their result is from the non-CLIA laboratory from whom
we think the result is actionable. Instead of telling the result, we instead
tell them or their physician “We have reason to believe you should have a genetic test
for BRCA. So please go get it from a CLIA certified
laboratory.” Or you tell the physician to go order it from
a CLIA certified laboratory so that laboratory will actually be able to give the result. So we said to CMS instead of giving the result,
can we use the result to refer the patient to a CLIA certified laboratory. The answer from CMS was no. that’s a violation of law as well because
you are influencing treatment of the individual by handing over information that would lead
them to make some decision about their health from a non-CLIA certified laboratory. So they said that too is illegal. So this is what they, this is the regulatory
regime that we are under. So then we said what it is that you want us
to do when we have a non-CLIA certified laboratory that shows a genetic result or biomarker result
that is actionable. And they said, “Well the solution is simple. You should tell your research labs to get
CLIA certified.” And so they said. So we said the transaction cost are high for
that. Most of our research individual – and if
you think actually of the secondary the unintended secondary and tertiary consequences of all
research labs being required to be CLIA certified, you can imagine what that is. It would actually extinguish all of these
laboratories within out academic institutions. And instead there would be a mass research
laboratory. Which may have the benefit of being CLIA certified
and perhaps have wonderful accession system, but it would have a derivative effect of squelching
all the innovations that happens and the learning and he education that happens in all of the
individual research laboratories around the country. We also said by the way that doesn’t get
us out of all the problems because some of these research test results actually don’t
have validated test equivalence within CLIA certified laboratories. So they may indicate something for which one
could run another test, but the test itself wouldn’t be available within a CLIA certified
laboratory because it’s not validated because the test itself is a research cutting edge
test. So then with all of this is the background. SACHRP did step in and we had several sessions
in which we discussed in Washington. In one case, with CMS – actually in two
cases where CMS representatives present – and we made some recommendations. And it included that the recommendation; which
I think is pretty obvious and that is, we believe – I’m not a member of SACHRP as
I am maxed out on my term. I am instead the co-chair of one of the subcommittees
of SACHRP, the so called committee on harmonization of research regulations. And we recommended SACHRP itself and the subcommittee
recommend to CMS that it be allowable or there ought to be some enforcement discretion or
waiver so that it would be permissible to use a non-CLIA laboratory test result to refer
the individual to a certified CLIA laboratory. Or to refer the individual to a provider who
can in turn order a test from a CLIA certified laboratory. This is what we said. We also said, which is I think important even
if there is no regulatory change by CMS. That it is very important that in genetic
testing, biomarker testing, genetic sequencing research that the IRBs, the research administrators,
the IRB staff, and most importantly the investigators and the research team think very carefully
before they enter into a study as to whether their non-CLIA certified laboratory will be
producing results that actually will be actionable. They need to think about this before they
end up – after the horses have already left the barn. And they see that they got all these incidental
genetic variant findings that they never anticipated. And there’s been nothing in the informed
consent, nothing in the protocol, no consideration, nobody knows what to do with these incidental
findings. It’s much better to anticipate this and
plan on it. I mean if you plan to violate CLIA, at least
plan to violate CLIA in advanced. There is a judge here in Connecticut, 2nd
circuit named Guido Calabresi. Some of you know, may have heard of Guido,
he taught over at Yale who was actually one of my mentors many years ago. And Guido would tell a story in his first
year Torts class, tort is the law of civil liability, medical malpractice, injury law
etcetera. And basically the story goes like this, many
years ago a few hundred years ago. Before there were cars, there was a very learned
judge, and he was riding in a coach and some fire crackers went off. He was in his coach and it was a coachman
who was driving the coach. And it was firecrackers that went off and
scared the team of horses, so the horses took off through the town running. There were not able to be controlled by the
coachman, and so the learned judge realizing that there was an accident leaned out to the
coach man and said, “Whatever you do, hit the cheapest thing.” In other words, he knew that he had to pay
for something. So hit the haystack instead of the person
please. So in regard to CLIA and HIPPA, when you are
faced with the choice of either violating CLIA or violating HIPPA, and you believe that
there is an actionable result, an important, a health important, health critical result
that has been produced by a non-CLIA certified laboratory in the course of a research study. I mean what’s the cheapest thing to hit? Is it to conceal the result or not give over
the result to the individual? Therefore, obeying CLIA. Or is it better to disobey CLIA and hand over
the result that is subject critical? I mean – to me. And when I advise clients, including some
of you in this room. I always say I would rather be indicted by
CLIA for handing a health actionable results or at least using it to refer a patient to
a CLIA certified laboratory which is the best thing one could do. I would rather endure that prosecution by
CLIA by CMS than to have an individual in whom I had, my researcher, had identified
a truly health actionable result, like BRCA gene and remain silent. Now this is shocking to compliance officer. But when one has to choose, I would rather
choose the safety of the patient and the research subject and their interest over the folks
that are the CMS enforcement people. SO it’s important to try and anticipate
this before you get into the soup. And think about it when you have a research
study that is going to genetic sequencing, that is going to do biomarker testing, when
it’s going to be done in a non-CLIA certified laboratory. Flag it before hand and send it back to the
investigator to think about what he or she is going to do with these results before you
get them. There was guidance that was issued by HHS
Office of Civil Rights about this HIPPA CLIA change that happened in 2014. But the guidance did not tell us what to do
about this. I think OCR would like to tell us what to
do about this, but they are hostage to the enforcement folks within CMS as well. So, what should you do as HIPAA covered entity? And again I’m not talking about the voluntary
disclosure, I’m talking about the individual at this point when he or she demands copy
of his or her designated record set which may include results from a non-CLIA certified
laboratory within a HIPPA covered entity. What do you do? Well one thing you need to do, I would suggest
you talk to your HIPPA privacy folks within your covered entity and come up with a definition
of designated record set. Because the DRS is often, which is often-
the individual has the right of access to the DRS. And so however a DRS is defined in your policies
is going to be somewhat determinative of how one response to that demand. Review your research studies as I said that
have genetic testing or biomarker comments. Review your practices of your researchers
in regard to whether they are returning results to patients. The last thing that you actually want is a
researcher spuriously to be disclosing things to subjects that the IRB even knowing about
it because that would be a violation of the protocol. Protocol didn’t have it and that’s an
important step in the research than doing it outside of the protocol is not a good idea
either. And educate your IRB staff and your research
team members including your investigators to spot these issues. And finally let me just say a couple of words
about the FDA. The FDA regulations also impact the return
of results. And in a way that is oblique but is quite
important especially in regard of genetic testing. Many biobanks studies involve the performance
of experimental and unvalidated laboratory test. And some biobanks to encourage participation
would like to return results to subjects. And by the way I can tell you there is another
current that I, not on the slides, that I want to mention to you. There are a number of Pharma companies and
biotech companies that have biobanks and are doing genetic testing on their biobanks that
are asking themselves the question right now as to whether they should return actionable
results. We’re going to be see developments on this. It’s too soon, I can’t disclose client
confidence because I advise both Pharma and Biotech on the one hand and also academic
medical centers on the other. But I can tell you that this issue is in ferment
in regard to the privately held industry held biobanks and the genetic sequencing that is
going in them in their secondary research. Some laboratory test may be categorized as
in vitro diagnostics subject to FDA jurisdiction. In fact, the FDA has taken the position that
an algorithm ad computerized algorithm which applies to it, which takes genetic sequences
and interprets them. That itself is an IVD, in vitro diagnostic
because it is taking data and using mechanical means to interpret the data and give a result
that would be feed back to the individual and his or her provider that would influence
health. That is regarded by the FDA potentially as
an in vitro diagnostic. And when it is an in vitro diagnostic, you
got to get IDE from the FDA to use it. Then you have to go – you have to go first,
of course if you decide it’s an IVD, as an IRB go through the issue of whether it
is a significant risk device, or whether it is not. If it is significant, and remember that significant
risk for these purposes includes the risk of misdiagnosis or error in treatment caused
by inaccurate test result if the harm is life-threatening or could result in permanent injury. So one has to as an IRB and as an investigator
have to decide if it’s an algorithm, if it’s an electronic algorithm that is interpreting
genetic test results or biomarkers then is it significant risk or not significant risk? If it’s significant risk, you actually have
to get IDE from the FDA before you can go forward with the research. If it’s a non-significant risk device, then
you have to meet a number of requirements. The investigator does not have to go to the
FDA but he or she has to get IRB approval, they got to get proper labeling got to monitor,
got to do informed consent, and they have to have proper record keeping in order to
keep themselves from the investigational device exemption requirement. This IDE, this extent of jurisdiction, this
interpretation of jurisdiction by FDA is not immediately understandable. There are some investigators and some companies
for that matter who have proceeded in my experience with these kinds of use of algorithms without
even considering the FDA potential here. But do consider the potential. So finally, in conclusion, if the results
are going to be returned, then I would suggest or if you think even if you don’t plan to
your research is going to generate results that the investigator would want to return
or may want to return. Think about the following questions. In what type of facility are the results generated? CLIA certified? Non-CLIA certified? Covered entity under HIPPA? Non-covered entity under HIPPA? Can the test be actually performed in a CLIA-certified
laboratory, so that at least you can use the result from a non-CLIA certified laboratory
to refer the individual or subject or his or her physician to a CLIA certified laboratory? If there is no analogous test that is possible
in a CLIA certified laboratory, then you’re back in the pickle cause you can’t even
use the result from a non-CLIA certified laboratory to refer the individual. You either have the choice; you can give them
the information or you could not if the information is actionable. Will the results be used to care of the patient
or influence the treatment decisions? Have the test results been validated by another
established procedure? Who will return the results? Should it be the investigator or should it
be a genetic counselor for example? What information will accompany the results
that will be returned. And with that I will stop and thank you for
your attention. [Applause]