Hello, I’m Yvonne Lau from the HHS Office for Human Research Protections.
I’m going to talk about regulatory options for secondary research with private information
and biospecimens.
Note that this is the second webinar of a two-part series.
We advise you to watch part 1 first, to get familiarized with important basic concepts
on this topic, before watching this part 2.
In this part 2 webinar, I’m going to concentrate on talking about the options for investigators
planning to do secondary research.
In part 1, we covered basic concepts on what secondary research is, what identifiability
means, and we talked about the options for doing research—secondary research—with
nonidentifiable materials, as well as doing secondary research with identifiable private
information, and identifiable biospecimens.
In this particular webinar, we’ll concentrate on looking at these options from the investigator’s
perspective.
Investigators who intend to reuse information or biospecimens collected from their own primary
research in future secondary research.
In other words, if you are an investigator, you are going to be doing a primary research
where you interact and intervene with living individuals to collect their information for
a proposed research.
Now, you are thinking that, you know what, for this material that I’m collecting now,
I might actually contemplate on doing future secondary research that may be beyond the
scope of this current research.
So what do I do?
So for this first one, we are talking about planning to use or share nonidentifiable materials
with researchers to do secondary research.
Please note that when you are doing your initial informed consent process at the point of the
primary research, there is a new requirement in that informed consent under 116(b) in the
revised Common Rule.
And this requirement is a notification that needs to be included, to tell your research
subjects whether or not you will be using their nonidentifiable materials potentially,
in future secondary research.
So this is a notification.
If you think that you absolutely not going to be using that material for future research,
your notification would tell them that you’re not, but in this particular situation, since
we are contemplating on re-using, recycling, so to speak, this material, the notification
will have to be telling your research subjects that this is something that you contemplate
on doing in the future.
Other than that, that you need to pay attention to -- the next thing we realize is, in fact,
secondary research with nonidentifiable materials is not human subjects research and therefore
does not need IRB review.
I just want to repeat here: Secondary research refers to research where you are using materials
that are either collected for non-research purposes, or for research other than the one
that you’re proposing.
All right?
This is secondary research.
And when you do that with no identifiable materials, in other words, information or
biospecimens, you cannot link back to living individuals, right?
Then this is not human subjects research, and it does not require IRB review.
What if you plan to use or share materials with identifiers retained?
Because in your future secondary research, if for some reason, you think that retaining
the identifiers would be important for you.
So what if you want to do that?
Well, the important thing is to anticipate and plan ahead.
So now that you’re planning to go about doing your interaction and intervention primary
research, you want to start anticipating that this is something that you want to do in the
future.
Secondary research with identifiers retained.
In the informed consent form that you are giving to your subjects, you know, the study
that you’re doing now, you should actually consider how to appropriately describe, in
this informed consent, the extent to which confidentiality of records, identifying subjects,
will be maintained.
You should do this when you’re actually getting your informed consent for this first
initial, original study.
So this is so that subjects will have a clear idea as to how this protection of their information
will be undertaken, and you know, especially in the case when you plan to use some of the
materials with identifiers in the future.
So this is just the baseline, right?
Once you’ve done that, then here are the options that you can consider.
So options for using or sharing information or biospecimens with identifiers retained
for secondary research.
Because this secondary research involves identifiable materials, any time you have identifiable
materials, it’s called human subjects research, and then your options will be either, there
maybe exemptions that could work to your favor, or that it will have to be considered under
nonexempt human subjects research, requiring IRB review.
So I’m going to go through these options.
For certain data research, exemption 4, with a new expanded provision, the so-called HIPAA
provision, may apply to you.
So you could, under this, if you were investigators under a HIPAA-regulated entity, and you propose
to use this material with identifiers, you could potentially do this under exemption
4, noting of course, that HIPAA does not cover biospecimens.
I want to point out also that exemption 4, provision 1, which involves the use of publicly
available identifiable material, you can do that too, since it’s publicly available.
There is no additional worry about privacy and confidentiality.
Or the new fourth provision, and the exemption 4, which really is not so commonly used in
the general research community, because it really involves just government work, using
information that is collected by the government.
So I’m not going to go into that.
So the most relevant one for you is the exemption 4, provision 3, the so-called HIPAA provision.
Another option is to obtain broad consent under the revised Common Rule, for future
secondary use, when obtaining the initial standard informed consent.
So here, I just want to say, broad consent, when we refer to broad consent under the revised
Common Rule, it’s a new specific, unique term of art.
And to understand what it is, you should refer to our webinars or other resources that talk
about broad consent.
The anticipation is that many people, when they are doing their initial study and trial
where they are interacting with subjects and getting their standard informed consent, that
they would at the same time, potentially obtain their broad consent that would cover broad
future secondary use.
Your third option is to just obtain what we refer to as the standard informed consent,
fulfilling all the requirements that are indicated in 46.116.
Now we kind of think that -- could you actually get the standard informed consent for secondary,
future secondary use at the time of the initial research?
Potentially, you could, but you need enough specifics.
You need to know enough specificity about your future secondary research to possibly
be able to satisfy the requirements that are required to be included in the standard informed
consent form.
One of the other opportunities is actually researchers in the future, because they never
really thought about using the materials with identifiers, but at some point in the future
when they are actually really planning their secondary research, at that moment in time,
and they realize, “Oh, you know what?
We would really like to be able to use this material with identifiers.”
So it could be, at that point in time that they choose to go back and ask subjects through
the standard informed consent process, and ask them for the informed consent for the
use of this material.
And the fourth option, which is commonly used in research community at the moment, is for
researchers to go to their IRB to obtain a waiver of informed consent, so that the materials
can be used.
And of course, all of the conditions for waiver alteration informed consent, need to be satisfied.
And I just want to point out at this point here, is that under the revised rule, for
the waiver of informed consent, the IRB needs to make an additional verification, and that
is that identifiers are necessary for the research.
The IRB needs to verify that, really, the researchers cannot do their research without
the identifiers.
So this is an additional condition that needs to be satisfied in the waiver of consent,
under the revised Common Rule.
So, let’s turn to the other side.
You know, out there in the research community, there are many investigators who actually
never really do the initial interaction and intervention with subjects to get their materials
for research, so they never really do primary research, and all they actually do most of
the time anyway, is secondary research.
By this, it means that their entire research project only involves materials that are collected
for the purpose of research that is not the current one, or collected through non-research
processes.
So just looking at clinical data, or tests, samples that remain after a clinical diagnostic
test, or treatment, and so on, so forth, or information that are generally being collected
for other purposes already.
So there is a whole lot of researchers who actually are only involved in conducting secondary
research.
So from their perspective, what do they need to know?
If they are seeking only non-identifiable materials, in other words that the material
could be coded, but as long as they cannot link back to living individuals who donated
those materials, then we are saying that this is not human subject research, and the Common
Rule doesn’t really apply to them.
So this is what it is currently, and is not changed under the new revised Common Rule.
What happens if these researchers are seeking identifiable materials to work with for their
secondary research?
First of all, see if one of the exemptions can be used.
I’ve talked about exemption 4 already.
So again, a reminder, there are four provisions in the exemption 4 under the revised rule.
If you want to go through them, review part 1 of this set of webinars.
Exemption 4, if it’s applicable, there is no IRB review needed.
Then there is potential for using exemption 8.
Exemption 8 is a new exemption.
It would require having had broad consent obtained at some point in time.
So there is broad consent from subjects.
And again, broad consent is this new concept under the revised Common Rule.
Its use will require something called limited IRB review, where the IRB has verified and
confirmed that specific conditions for this exemption have all been met.
And just one last reminder, if investigators choose to use this exemption 8 and they satisfy
the conditions, they also need to make sure that there is not a plan to return research
results in the plan of this research.
So, what about if none of the exemptions that we just talked about, can be used?
What can these investigators do?
If none of the exemptions work, then it will have to be done under non-exempt human subjects
research situation, which means that it will require IRB review of some sort, and also
that they will need to obtain a standard informed consent to do that--go back to subjects and
ask for informed consent in order to be able to retain the identifiers.
Or they can go back to the IRB and request a waiver of informed consent.
Again, I mentioned that under the revised Common Rule, there is a new condition that
the IRB needs to make sure that is satisfied, and that new requirement is that the research
requires the use of the identifiers.
So identifiers are necessary for this research.
They need to be able to show that.
So, this ends part 2 of this set of webinars on secondary research use of identifiable
private information and biospecimens.
Please refer to the text of the revised Common Rule available on OHRP’s website for a complete
and accurate description of the regulatory requirements.
For this particular presentation, please review the regulations at sections 46.102(e), which
talks about identifiability, 46.104(d), which talks about the exemptions, and 46.116, which
talks about informed consent including broad consent.
So if you have any questions, do not hesitate to submit your questions by email to OHRP@hhs.gov.
Please also check out the OHRP website at www.hhs.gov/ohrp for resources on the revised
Common Rule.
Thank you for your attention, and we invite you to review other webinars on the revised
Common Rule that OHRP has created to inform the research community.
Thank you very much.