Questions and Answers Table of Contents
How do I know if I am conducting
human subjects research? |
What is a human
subjects exemption? |
Am I conducting human
subjects research if I'm using samples from unidentified people? |
What is coded private information? |
If I receive coded information
derived from human subjects, and the person who collected the specimens
is also collaborating on the study, am I
conducting
human
subjects
research? |
If I receive discarded surgical
specimens that are not coded, with no identifying information
or way to trace it back to the subject, am I doing human subjects
research? |
If I obtain surgical specimens
from a colleague, enter into an agreement prohibiting my access
to any identifying information, and do not involve the colleague
in my study, am I conducting human subjects research? |
If I receive coded surgical
specimens from a colleague who obtained the specimens from
living people but has no role in my my research, and we make an
agreement
prohibiting my access to the key to the code, am I conducting human
subjects research? |
If I
use leftover human specimens to conduct an in vitro diagnostic
device study, do I need to get informed consent? |
What are some
examples of situations that are and are not human subjects research? |
Is research on any tissues,
cells, or fluids considered human subjects research? |
What are the best approaches
for restricting access to human subjects information and ensuring
that it's unidentifiable? |
If I am the principal investigator,
do I need a written agreement prohibiting my access to the key
to the code? |
Who determines if research that involves coded
data or specimens is human subjects? |
Can my institution provide
guidance about whether my research is considered human subjects,
or should I contact
someone at NIAID? |
What are the requirements
for the Health Insurance Portability and Accountability Act? |
Where
can I find more guidance on research involving coded information? |
Where can I find more NIH information
about human subjects research? |
What if my question wasn't answered here, or I'd like to suggest a question? |
How do I know if I am conducting
human subjects research?
Investigators
conduct human
subjects research if
they obtain data
by intervention
or interaction with
a living person or obtain individually
identifiable private
information about a living person. Click on the glossary links
in blue for definitions of these terms.
For more help, see Are
You Conducting Human Subjects Research? and the Office
for Human Research Protections decision chart Is
an Activity Research Involving Human Subjects? Also see FAQs
from Applicants Human Subjects Research and FAQs
About Research Using Human Specimens, Cell Lines or Data on the Office
of Extramural Research's Web site.
What is
a human subjects exemption?
A human
subjects exemption removes
the need to comply with some or all of the human
subjects reporting requirements in 45
CFR Part 46, even though the research is considered to be human
subjects.
Usually, exemptions don't apply to research
funded by NIAID. In other words, most NIAID-funded research is either
"human subjects"
or "not human subjects" and is
not
exempt.
To learn more about exemptions, see Chart
2: Is the Research Involving Human Subjects Eligible for Exemption
Under 45 CFR 46.101 (b)? on the Office
for Human Research Protections' Web site. Also
visit NIAID's tutorial pages Is
Your Research Exempt? and Key
Points to Remember About Human Subjects Exemptions.
If you've
looked through NIH and NIAID guidance and still think your research
may be exempt, work
with your institution. Contact
your program or project officer if
you need additional assistance.
If your research is exempt, you still check "yes" for
human subjects research in the box on the application face page or cover
component of the PHS 398 or SF 424.
If you are not conducting human subjects research,
exemptions do not apply to you.
Am I conducting human
subjects research if I'm using samples from unidentified people?
Generally, if you are not collecting specimens from living people and
do not have access to identifiers for the specimens, you
are not conducting human
subjects research. See the December
30, 2004, Guide notice for
details. Also see FAQs
About Research Using Human Specimens, Cell Lines or Data on
the Office
of Extramural Research's Web site.
What is coded private information?
Coded
private information is a person's name,
social security number, or other identifiable private
information that is replaced with a code, e.g., number, letter,
or symbol. Investigators are generally considered to be conducting
human subjects research if they interact or intervene with living people
and can individually identify them directly or through a coding system.
For more information, read the Are
You Conducting Human Subjects Research? tutorial page and Human
Subjects questions and answers page on our Web site.
To learn more about privacy information, see
our Privacy,
Conduct, Conflict of Interest, and Clinical Research Ethics questions
and answers.
If I receive coded information
derived from human subjects, and the person who collected the specimens
is
also collaborating on the study, am I conducting human subjects research?
Yes.
If I receive discarded surgical
specimens that are not coded, with no identifying information
or way to trace it back to the subject, am I doing human subjects research?
No.
If I obtain surgical specimens
from a colleague, enter into an agreement
prohibiting my access to any identifying information, and do not involve
the colleague in my
study, am I conducting human subjects research?
No.
If I receive coded surgical
specimens from a colleague who obtained the specimens from living
people but has no role in my research, and we make an agreement prohibiting
my access to the key to the code, am I
conducting human subjects research?
No.
If I use leftover
human specimens to conduct an in vitro diagnostic device study, do
I need to get informed consent?
It depends on whether they are individually identifiable.
See the FDA Guidance
on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover
Human Specimens that are Not Individually Identifiable.
What are
some examples of situations that are and are not human subjects research?
1. Dr. Smith is working with unidentified human specimens provided
by a colleague.
Most likely, Dr. Smith's research would not be considered
human
subjects because he did not collect the specimens for his
study, no identifiers existed when he received the specimens, and
the colleague is not involved.
2. Dr. Jones obtained publically available
human specimens to conduct her research.
The study is not considered human subjects research
because the specimens were publically available.
3. Dr. Maple
collected specimens from patients, coded the data, and locked
away his key to the code.
a) If he is using the specimens to conduct research, is Dr.
Maple doing human subjects research?
Yes. He would
be considered doing human subjects research since he interacted
with the patients and collected the specimens. No one on
the application, including Dr. Maple, can know the identities
of the patients.
b) If Dr. Maple provides the coded data to Dr. Oaks, along
with an agreement stating that Dr. Oaks will never have access
to the code's key, and Dr. Maple does not collaborate
on the study, is
Dr.
Oaks doing human subjects research?
No, because Dr. Oaks did not interact with
the patients and has no
key to the code or access to identifying information.
Is research on any tissues, cells,
or fluids considered human subjects research?
All research involving samples obtained from human
subjects, including tissues, cells, or fluids can
be considered human subjects research if the samples are identifiable.
What are the best approaches
for restricting access to human subjects information and ensuring
that it's unidentifiable?
Some examples are:
- Ensuring the key to the code is destroyed before research begins.
- Having a nondisclosure
agreement between the provider and investigator.
- Setting up IRB policies that prohibit release of the
key to the code.
- Having other legal requirements that prohibit release
of the key.
If I am the principal investigator,
do I need a written agreement prohibiting my access to the key to the
code?
Though it's a good idea to have a written agreement, the Office
for Human Research Protections just requires that
an agreement exists. It does not mandate that the agreement
is in writing.
Who determines if research that
involves coded data or specimens is human subjects?
Applicant institutions designate a group, typically the institutional
review board, to make that determination.
NIH recommends that investigators are not given this
authority. It is difficult to determine if research is considered human
subjects because of the many variables involved. Even slight
variations in the way data and specimens are collected can change the
answer.
Can my institution provide
guidance about whether my research is considered human subjects, or
should I contact someone at NIAID?
It's up to institutions to create policies that will instruct applicants
on how to follow the Office
for Human Research Protections' Guidance
on Research Involving Coded Private Information or Biological Specimens and
obtain approval.
So work with your institution to resolve your
questions. Additionally, you may contact your NIAID program or project
officer.
What are the requirements
for the Health Insurance Portability and Accountability Act?
See Does NIH have requirements for
HIPAA? in the Human
Subjects questions and answers.
Where can I find more guidance on research
involving coded information?
See Office for Human Research
Protections' (OHRP) Guidance
on Research Involving Coded Private Information or Biological Specimens.
To help determine how this applies to your research, go to OHRP's
decision
chart Does
Exemption 45 CFR 46.101(b)(4) (for Existing Data Documents
and Specimens) Apply?
For more help, see Are
You Conducting Human Subjects Research? and the decision tree
for Research Involving Private Information or Biological Specimens.
Where can I find more NIH information
about human subjects research?
Visit the Frequently Asked Questions section of Research
Involving Human Subjects on the Office
of Extramural Research's Web site.
What if my question wasn't answered here, or I'd like to suggest a question?
Email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. We answer questions by email and post them here. Thanks for helping us clarify and expand our knowledge base. |