Questions and Answers Table of Contents
How do I determine if I am conducting human
subjects research? |
Who can help me determine
if my study is considered to be human subjects research? |
Will
the scientific review officer and peer reviewers evaluate
my application's human subjects determination? |
Does
FDA's Interim Final Rule on Medical Devices; Exception From General
Requirements for Informed Consent affect my human subjects determination? |
Is it common
for NIAID research to be exempt from human subject requirements? |
How
can I find out if my research is
one of the rare studies at NIAID that may be exempt
from human subject requirements? |
Where
can I find guidance on research involving coded private information
or biological specimens? |
Does NIAID
have special procedures and instructions for human subjects applications? |
Where do I find information and advice on preparing
a human subjects application? |
Is
it necessary to list the name of the PI grantee on each of the
grant's protocols? |
For
fellowship and career awards, is it necessary to be covered by
an IRB approval? |
Do
I need an institutional assurance to conduct human
subjects research? |
Do I need to replace my Single Project
Assurance with a Federalwide Assurance? |
When should I start working on obtaining or renewing a Federalwide
Assurance? |
Can
I obtain, update, and renew a Federalwide Assurance, IRB or IEC
registration online? |
Is it ok if I do not yet
have my Federalwide Assurance number when I apply? |
When should I start getting IRB or
IEC approvals? |
Do I need
IRB approval for a clinical trial Web site? |
Where can I find information about
IRB and IEC requirements for foreign applications? |
Where can I find information about research
in foreign populations? |
Do all investigators on a human subjects
application have to show training in the protection of human subjects? |
Are human subjects applications reviewed differently? |
If my description of human
subjects protection is inadequate, how will this affect the
review of my application? |
Can a human subjects concern lead to a bar
to award? |
Can I get an award if I have a bar? |
Can I begin accruing subjects
before my start date? |
If I'm conducting a clinical trial, does
my Research Plan need to address expectations for the clinical
intervention? |
Are independent data and safety monitoring
boards required for all clinical trials? |
Am I
responsible for acquiring informed consent? |
What are informed consent
requirements for research involving in vitro diagnostic
devices? |
If I want to submit my clinical study
for publication, do I need to register early in the process? |
Could not registering affect
my ability to publish? |
Must I send NIAID the
IRB-approved protocol before accruing patients or enrolling participants? |
Do T32 grants need IRB approval before an award is made? |
Do I have to inform my program or project officer of my reports
to FDA? |
As an investigational new
drug sponsor, must I notify FDA and NIAID about adverse events? |
For a clinical trial, how often must I
send an Inclusion Enrollment Report form? |
Can NIH help me protect the confidentiality
of my research subjects? |
Does NIH have requirements for HIPAA? |
If I
can't complete a clinical trial within the performance period
of my current award, can I apply for an
extension? |
Do I need to register my clinical trial with ClinicalTrials.gov? |
If I have other questions about human subjects, is there another good source of information? |
What if my question wasn't answered here, or I'd like to suggest a question? |
How do I determine 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 for
definitions of these terms.
The Office
for Human Research Protections decision tree Is
an Activity Research Involving Human Subjects? is very helpful
for figuring this out. Also see our tutorial page Are
You Conducting Human Subjects Research? and Private
Information or Biological Specimens in Human Subjects Research questions
and answers.
For more help, 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.
Who can
help me determine if my study is considered to be human subjects research?
Take a look at Who
determines if research that involves coded data or specimens is human
subjects? and Can my institution
provide guidance about whether my research is considered human subjects,
or should I contact someone at NIAID? in our Private
Information or Biological Specimens in Human Subjects Research questions
and answers.
Will the
scientific review officer and peer reviewers evaluate my application's
human subjects determination?
Yes. See How
Human Subjects Applications are Reviewed in NIAID's human subjects
tutorial.
Does FDA's
Interim Final Rule on Medical Devices; Exception From General Requirements
for Informed Consent affect my human
subjects determination?
See the following:
Is it common for NIAID research to be exempt
from human subject requirements?
No. Since NIH clarified what it considers
to be human
subjects research,
the six
human subjects exemptions rarely apply to
NIAID applicants. Most research at NIAID is now either "human
subjects"
or "not human subjects." For more details, see NIAID's Is
Your Research Exempt? tutorial page.
To learn how NIH clarified
its policy on human subjects research, see the December
30, 2004 Guide notice, which was based on OHRP's Guidance
on Research Involving Coded Private Information or Biological Specimens.
How
can I find out if my research is
one of the rare studies at NIAID that may be exempt from human
subject requirements?
Remember, exemptions usually won't apply
to NIAID research. However, if you have used the Human
Subject Regulations Decision Charts, reviewed both NIH and NIAID
guidance, and still believe your study may be exempt:
- Consult with your institution: 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.
- Contact your program or project
officer for additional assistance.
For more information, read What
is a human subjects exemption? in NIAID's Private
Information or Biological Specimens in Human Subjects Research questions
and answers.
Where
can I find guidance on research involving coded private information
or biological specimens?
See the December
30, 2004, Guide notice, which was based on OHRP
Guidance on Research Involving Coded Private Information or Biological
Specimens.
Also, visit our Private
Information or Biological Specimens in Human Subjects Research questions and answers.
Does NIAID have special
procedures and instructions for
human subjects applications?
Yes. All human subjects applications must also comply with the NIAID Clinical Terms of Award. Investigators should read this document to
see what NIAID expects in the application and after award. These instructions
are in addition to, not in lieu of, those in the PHS
398 or funding opportunity
announcement.
Additionally, for research in China, follow the
instructions in NIAID
Clinical Terms of Award Restriction for China.
For further details,
see the Human Subjects SOPs.
Also, in May 2005 NIAID launched a mandatory, two-step approach to
funding
investigator-initiated clinical
trials: a Clinical Trial Planning Grant (R34) followed by a Clinical
Trial Implementation Cooperative Agreement (U01). Only PIs who have
completed the R34 can apply for a U01.
For more information, go to Investigator-Initiated
Clinical Trial Planning and Implementation Grants.
Where do I find information and advice on preparing
a human subjects application?
You must read and follow the instructions in either the funding
opportunity announcement (for electronic applications)
or the PHS
398 (for paper applications) and RFA,
RFP, and PA notices,
in addition to the NIAID
Clinical Terms of Award.
For more help and advice, visit our How
to Write a Human Subjects Application tutorial on our Human
Subjects, Clinical Research page.
Is
it necessary to list the name of the PI grantee on each of the grant's
protocols?
No, it's not essential. If, for example, the grantee
has subcontracted out their human subjects research, the project
leader overseeing the work done at the subcontractor
site might
be
the one
listed on the related protocols, rather than the PI of the grant. The
subcontracted project leader is not required to list the PI's
name on the protocol.
When you submit the protocol for IRB or IEC review,
it's more important for the subcontractor to provide other identifying
information about the grant itself (i.e., title, grant number).
If
the
IRB approval
document
submitted
to
the grants management specialist does
not reflect
the PI's
name, we will
request written confirmation that the protocol's IRB
approval belongs
with the application to be funded. (This also applies to IACUC approvals.)
So the name on the protocol can be different
than the name listed on the grant. We will verify at
the time of award that the approval covers
the
application being funded.
For fellowship and career awards, is it necessary to be covered by an
IRB approval?
If you are involved in human
subjects research with your sponsor, you
must be covered by their IRB approval.
Do
I need an institutional assurance to conduct human subjects
research?
Yes. Visit the Human Subjects SOPs.
Do I need to replace
my Single Project Assurance with a Federalwide Assurance?
On December 31, 2005, the Federalwide Assurance became the only
valid human subjects assurance. However, if you obtained a Single Project Assurance before that
date, it is effective until the end of your project.
Your institution
will still need a Federalwide Assurance for new projects. See the Human Subjects SOPs for more information.
When should I start working on obtaining or renewing a Federalwide Assurance?
See Is it ok if I do not yet have
my Federalwide Assurance number when I apply?
Can I
obtain, update, and renew a Federalwide Assurance, IRB or IEC registration
online? Yes you can. The Office
for Human Research Protections provides these features on its Electronic
Submission System.
To register, go to Filing
of a New FWA or Filing
a New IORG-IRB/IEC(s) Registration. To update, go to Update
and Renewal of Domestic
(U.S.) or International (non-U.S.) Federalwide Assurances or Update
and Renewal of an IORG-IRB/IEC Registration. If
you have any questions, email your regional or country coordinator
listed
on Contact
Information/Staff Assignments.
Is it ok if I do not yet have
my Federalwide Assurance number when I apply?
Yes, because it's not necessary for peer review;
the official due
date for your Federalwide
assurance (FWA) is "just-in-time," which
means just before NIAID is
ready
to
issue
an
award. To make sure you
can obtain it in
time for award,
keep this in mind: Typically, it takes the Office
for Human Research Protections (OHRP) two weeks
or less to approve your FWA application. However, if OHRP spots a
problem with your FWA application,
it will
probably take longer. See OHRP for more information.
When should I start getting IRB or IEC approvals?
Though your certification of IRB or IEC approval
is due "just-in-time," i.e.,
just before we are ready to issue an award, you should
start the approval process well before the application's
due date because revisions and final
approval can take time. If the certification is ready, include it in
the application. Read more in Plan
for IRB or IEC Approval. Also see the Human
Subjects Certifications: IRB or IEC SOP.
Do I need IRB
approval for a clinical trial Web site?
Yes, if you're planning to use it to advertise for subjects. When a
site goes beyond listing basic descriptive information, IRB approval
is usually required. For details, read OHRP
Guidance on Institutional Review Board Review of Clinical Trial Web sites.
Where can I find information about IRB and IEC requirements for foreign
applications?
See IRB, IEC, and FWA Requirements for Foreign Countries. For more information,
see the Human Subjects
Certifications: IRB or IEC SOP. Also, see the Investigator
Responsibilities section of Human
Research Questions and Answers on the Office
for Human Research Protections' Web site.
Where can I
find information about research in foreign populations?
See Investigating
Foreign Populations.
Do all investigators
on a human subjects application have to show training in the protection
of human subjects?
Yes. Your application must show
mandatory training in the responsible conduct of research for all key
personnel on the grant. Follow instructions in the September
5, 2001, Guide notice and consult NIH's
Frequently Asked Questions.
Also see our Document
Training in Research Conduct, Sample
Letter to Document Training in the Protection of Human Subjects,
and Human Subjects Certifications:
Training SOP.
For more information, see the Investigator
Responsibilities section of Human
Research Questions and Answers on the Office
for Human Research Protections' Web site.
Are human subjects
applications reviewed differently?
Yes. In addition to the regular review
criteria, reviewers use
four other criteria to judge human subjects research applications. Read
more in How
Human Subjects Applications are Reviewed.
If my description of
human subjects protection is inadequate, how will this affect the
review of my application?
During peer
review,
the panel will discuss whether the human subjects protection
described in your application is adequate. That information
will be reflected in your summary
statement and may affect the priority
score, depending on the nature and severity of inadequacies, e.g.,
information missing from your application.
See After Peer Review questions and
answers. In addition, your application will be coded to reflect the inadequacy,
which must be addressed before an award is made.
Can a human subjects
concern lead to a bar to award?
Yes. During peer
review,
the scientific
review group will assess the
human subjects section of your application. Based on the concerns
expressed by the scientific review group, codes will
be
given to
your application
that may bar or
restrict your award. A code 44 indicates a bar to award due
to a human subjects issue. Codes typically appear with a brief explanation.
Under normal circumstances, you will not be funded until you address
the issues; contact your program
officer for advice.
Can I get an award if I have a bar?
You may receive an award, but a restriction
on the terms of the award prevents you from spending funds on the
parts of your project that are barred. Check your Notice
of Award for specifics, and see Read Your Notice of Award, Know Your Terms in the NIH Grant Cycle: Application to Renewal. Also see Human Subjects SOPs.
Can I begin accruing
subjects before my start date?
No. Before you enroll any subjects, NIAID staff must
approve your protocol and have your IRB approval and other documents
on file.
Read Before
You Enroll Participants in our human subjects tutorial, and see Must I send NIAID the
IRB-approved protocol before accruing patients or enrolling participants? on this page.
For more information, see the Investigator
Responsibilities section of Human
Research Questions and Answers on the Office
for Human Research Protections' Web site.
If I'm conducting a
clinical trial, does my Research Plan need to address expectations
for the clinical intervention?
Yes, for phase
III clinical trials. In addition
to providing a Data and Safety Monitoring Plan, you should address
whether you
expect to find clinically important
gender, race, or ethnicity differences in the intervention effect.
For more information,
see "Question
5: Does your proposed research meet criteria for an NIH-Defined
Phase III Clinical Trial?" in the PHS
398 or the instructions in the funding
opportunity announcement (for grants that have moved
to electronic application).
Also, see Create
a Data and Safety Monitoring Plan in our human subjects
tutorial.
Are independent data and safety monitoring boards required
for all clinical trials?
It depends on the type of clinical
trial you're
doing. Phase
III clinical trials must be reviewed by an independent
data
and safety monitoring board (DSMB). Others
may require DSMB oversight. For details, see NIAID
Clinical Terms of Award, Create
a Data and Safety Monitoring Plan, and
Human Subjects Certifications: IRB
or IEC SOP at NIAID
Research Funding.
Am
I responsible for acquiring informed consent?
See Plan
for IRB or IEC Approval and We
Must Have Approval from All IRBs or IECs in our human
subjects tutorial. Also see the Informed
Consent and Investigator
Responsibilities sections of Human
Research Questions and Answers on the Office
for Human Research Protections' Web site.
What are informed
consent requirements for research involving in vitro diagnostic
devices?
Take a look at If I use
leftover human specimens to conduct an in vitro diagnostic
device study, do I need to get informed consent? in our Private
Information or Biological Specimens in Human Subjects Research questions
and answers.
For additional information,
see the Informed
Consent section of Human
Research Questions and Answers on the Office
for Human Research Protections' Web site.
If I want to submit my
clinical study for publication, do I need to register
early in the process?
Registering early with ClinicalTrials.gov may
be necessary if you want your study to be considered for publication
in
a journal
governed
by the International Committee
of Medical Journal Editors (ICMJE).
For phase
III clinical trials,
ICMJE's publication policy requires registration before you enroll your first
patient. This may also be required for other types
of clinical
trials.
For details, read "Is
This Clinical Trial Fully Registered?"
Could not registering affect
my ability to publish?
Yes. If you want your study results to be published in a journal
governed by the International Committee of Medical Journal Editors,
make sure you understand its registration policy.
That policy may require that you register
your clinical trial before you enroll your first patient. To
see how it applies to
your research, read "Is
This Clinical Trial Fully Registered?"
Must I send NIAID
the IRB-approved protocol before accruing patients or enrolling
participants?
Yes. See NIAID Clinical Terms of
Award, page 3. Also, see Can I begin accruing subjects
before my start date? on this page.
Do T32 grants need IRB approval before an award is made?
No. T32 grants are one exception to the rule, though they still must
show approval before you start the research that involves human subjects.
Do I have to inform my program or project officer of my reports to
FDA?
Yes. See Ongoing Reporting Requirements in Guidance
for Compliance with NIAID Clinical Terms of Award, page 5.
As an investigational new
drug sponsor, must I notify FDA and NIAID about adverse events?
Yes. See Guidance
for Compliance with NIAID Clinical Terms of Award, page 7.
Also take a look at Report Adverse Events Promptly
in our human subjects tutorial.
For a clinical trial,
how often must I send an Inclusion Enrollment Report form?
Send an Inclusion
Enrollment Report form annually. See Guidance
for Compliance with NIAID Clinical Terms of Award, page 7. For
more information, see Send
the Inclusion Enrollment Form With Your Progress Report in our
human subjects tutorial.
Can NIH help me protect the confidentiality of my research subjects?
Yes, with a certificate of confidentiality. See NIH's
Certificates of Confidentiality Kiosk for details and follow instructions on
applying for the certificate. Since the advent
of the NIH site,
NIAID no longer maintains an NIAID site
for this topic.
Does NIH have requirements for HIPAA?
No. NIH doesn't ask applicants to address the Health Insurance
Portability and Accountability Act because NIH is not a covered entity.
You can read
the HIPAA
Privacy Rule to see if the requirements apply to you.
If I
can't complete a clinical trial within the performance period
of my current award, can I apply for an
extension?
You may be able to apply for an extension. To
learn more, read the NIAID
Policy for Extension of Investigator-Initiated Clinical Trials Guide notice. Also see our Investigator-Initiated Clinical Trial Administrative Extensions SOP and Investigator-Initiated Clinical Trial Administrative Extensions questions and answers.
Do I need to register my clinical trial with ClinicalTrials.gov?
If you are conducting an applicable clinical trial, you must register with ClinicalTrials.gov. For more information, see Before You Enroll Participants.
If I have other questions about human subjects, is there another good source of information?
Yes. See Human Research Questions and Answers on the Office for
Human Research Protections' Web site and 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. |