New Guidance Issued by OHRP:
Subject Withdrawal, Data Retention and Other Related Issues
NOVEMBER, 2010
HHS Office of Human Research Protections (OHRP) recently finalized
a new seven-page guidance issued on the topic of "Withdrawal of
Subjects from Research". Specifically, details regarding the right of
researchers to use data after the subject chooses to withdraw or
investigator termination (including the use of identifiable private
information) is discussed. It is noted that both DHHS and FDA remain
silent on issues specific to biospecimens for research purposes for
subjects who subsequently withdraw. Any specific questions related
to the handling of biospecimens obtained from subjects who
withdraw during the course of study participation should be
directed to dlayton@usouthal.edu for DHHS/FDA guidance.
Inside This Issue
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Human Subjects:
New Guidance: Subject Withdrawal and
Data Retention
Involving Children
Engagement in Research
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3
Announcements:
The guidance answers the following questions:
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2
Export Controls:
International Travel
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1
Revised Guidelines for Research
What does it mean when a subject withdraws from a
research study?
May an investigator retain and analyze already collected
data about a subject who withdraws from the research or
whose participation is terminated by the investigator?
Can investigators honor subjects’ requests to have their data
destroyed or excluded from any analysis?
Should the withdrawal of a subject from a research study be
documented?
What is the relationship of this guidance to FDA’s guidance
on this issue and to the HIPAA Privacy Rule?
When seeking the informed consent of subjects, what should
investigators tell subjects about data retention in the event
the subjects withdraw?
“The Guide” –Revised
4
IBC Annual Inspections
4
Welcome Shaun Kaulfers
4
RCR Workshop
4
Animal Care and Use:
When to Notify NIH of Change
in Animal Activities
Items of Interest:
Contact us at:
This guidance serves as recommendations from OHRP unless
specific regulatory requirements are cited. The new document is
posted at: http://www.hhs.gov/ohrp/policy/subjectwithdrawal.html
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Office of Research Compliance
CSAB 120
251-460-6625
dlayton@usouthal.edu
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Revised Guidelines for Research Involving Children in Clinical Investigations
The American Academy of Pediatrics (AAP) issued new guidelines designed to better protect
children as research subjects. The new document focuses on the necessity of a safety plan during
all phases of clinical trial and emphasizes the importance of an independent data and safety
monitoring committee for all phase 3 trials. Data-monitoring mechanisms help ensure that a study
can be terminated in a timely manner should an unexpected hazard be identified. The Office of
Research Compliance and the IRB has approved to make revisions to the Investigator Checklist for
Research Involving Children regarding standards for monitoring safety during a study. These
changes call for PI’s to adopt a data safety monitoring plan for phase 1 and 2 drug trials without a
Data Safety Monitoring Board (DSMB) in place. For phase 3 trials, if a DSMB is not required by the
FDA, the IRB strongly recommends initiation of such a group. For more information on the AAP
guidelines go to: http://pediatrics.aappublications.org/cgi/reprint/125/4/850
When is an Institution Considered to Be
Engaged in Research?
REMINDER: If the PI of a project is unavailable to
conduct research, as when on extended leave, there is
a responsibility to make arrangements for another
investigator to assume all responsibilities for the study.
These modifications must be submitted as a change in
PI of the project and approved prior to implementation
The DHHS Office of Human Research
Protections (OHRP) has clarified in a revision to
the frequently asked question regarding
“engagement in research”. Any institution
which receives a direct award from the DHHS
to carry out non-exempt human research is
automatically considered to be "engaged". This
applies even where all activities involving
human subjects are carried out by a
subcontractor or collaborator. In general, an
institution is considered to be engaged in human subject’s research when its employees or agents:
•
•
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obtain data about living individuals for research purposes through intervention or interaction with
them,
obtain individually identifiable private information for research purposes (45 CFR 46.102(d),(f))
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.102; or
obtain the informed consent of human subjects.
Employees and agents, including students, are individuals performing institutionally designated activities
and acting on behalf of the institution or exercising institutional authority or responsibility.
In general, simply informing potential subjects about a research study is not considered engagement in
research. Also, providing written information about a research study, including how to contact the
investigators for information and enrollment, and seeking and obtaining prospective subjects' permission
for investigators to contact them are not considered engagement in research. On the other hand, if one
is seeking informed consent from a research participant then this activity would be considered
engagement in research. For specific details, go to DHHS OHRP’s guidance on this topic at:
http://www.hhs.gov/ohrp/humansubjects/guidance/engage08.html
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QUESTIONS, QUESTIONS, QUESTIONS! LET ME GET ON WITH MY TRIP!
The international travel policy and processes is a bit different than in years past, in particular with
questions pertaining to export controls that may not seem to make a lot of sense. The majority of the
International Travel Review Form is fairly straight forward listing out your basic information, where you are
going, what you will be attending, etc. At the top of the second page are a series of questions that
pertain to federal export controls that may have a potential bearing on your business trip. For a closer
look….
Will you be working with, faculty or students, educational institutions or businesses while traveling for your
project?
First of all, realize that any sort of communication that you have with any person that is not a United
States citizen is considered to be exporting information to their country of origin. This includes those
physically in the US, so it stands to reason it would apply if you are actually abroad. So, if you are
travelling to present a paper or will be potentially discussing research it becomes important if what you
are discussing is not covered by the fundamental research exemption. Even more slippery, what if
someone you are meeting is listed on a Restricted Parties List by any one of numerous government
agencies? It might seem farfetched, but there are thousands of people and businesses in the world with
which it is illegal to contact or conduct business. These internal controls are implemented as measures
for complying with export control laws.
Will you be transporting any encrypted software /technology/items/data to or from a foreign country?
Your smart phone is encrypted, Microsoft Office is encrypted, your iToys are encrypted, and so can you
not carry them? Of course you can. Items that are available on the mass market generally have
exemptions even if they happen have characteristics that would put them in the purview of export
controls. But, what about the engineering software you use for your research? What about the new
program you wrote? What about the software that you use to keep track of temperature readings on
buoys that you placed in the Bay? What about???? If there is proprietary software on a computer or
device that you are carrying with you there could be issues with taking the technology to another
country, especially if you have technical information regarding it that you are carrying with you. Listing
out software that you know to be encrypted, can allow us to research it for you to make sure you are
allowed to take it with you.
Will you be transporting any equipment/biological samples to or from a foreign country?
As mentioned above, you would be amazed at the everyday items you own that are included in
descriptions on the Commerce Control List and have an “Export Control Classification Number” or
“ECCN.” It is the number used to identify an item as controlled and what is used in obtaining license for
exporting it. Many times, the manufacturer has found the ECCN number even if the product is on the
mass market and exempted. If not, we can help do it for you. Providing a list of samples or, as
mentioned above, equipment that you intend to take on your trip helps us aid you in compliance with
export control laws. The last place that you want to discover that the items you are transporting are in
violation of the law is from a Customs agent at an airport.
So, yes, the questions on the form may seem odd, but they provide for a screening mechanism in
advance of your travels and potential protect you from unexpected hassles. We don’t want you, in any
capacity, to get “caught” running up against these rules. Any questions? Contact Alison Henry at
ahenry@usouthal.edu or 460-6509.
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♦ ♦ ANNOUNCEMENTS ♦ ♦
The Guide for the Care and
Use of Laboratory Animals
Revised
The ILAR (Institute for
Laboratory Animal Research)
“Guide for the Care and Use
of Laboratory Animals” has
been revised and will be
published in the near future.
Once it is published, the
IACUC will use it, in
conjunction with other
publications, to evaluate the
Animal Care and Use
Program at USA.
Research Compliance
Welcomes New Staff
We are pleased to welcome
Mr. Shaun Kaulfers as our
IACUC Compliance
Specialist. Shaun is available
to assist you with your
protocol submissions, training
requirements, protocol
approvals and general
IACUC questions or concerns.
He can be reached at 4606863 or
skaulfers@usouthal.edu Stop
by and welcome him to our
Research Compliance team.
IBC Inspection Dates
Investigators who have active
registrations with the
Institutional Bio-safety
Committee need to be
aware that on December 13
and 14 the annual laboratory
inspections will commence.
Your designated date and
time will be communicated
to you after the Thanksgiving
holiday. Please take a
moment to look at your
registrations and ensure that
all personnel are updated
and have completed biosafety training in the last year.
A link to the training can be
found here:
http://www.southalabama.edu/rese
archcompliance/biosafety.html
When should you notify NIH of a change in an animal activity supported by PHS funds?
All changes in animal activities requires the review and approval of the IACUC, however, keep in mind
they may also required approval by NIH. Any significant change or change in scope would require
notification to the NIH funding component. As defined by the NIH Grants Policy Statement, a change in
scope refers to a change in direction, type of research or training from the objectives, purposes, or aims
of the approved work. Examples includes in the Grants Policy Statement include change in specific
aims, shift of research emphasis, substation of animal models, application of a new technology such as
changing assay methods. Ultimately, consultation with NIH grants management personnel may need to
be sought since not every change in animal model or
RCR Training Workshop:
use represents a change in scope. Please be aware
that the IACUC is not responsible for notifying NIH of any
changes. The request should be made in writing to the
Ownership of the Results of Research
funding component no less than 30 days before
Presented by: Russ Lea, Ph.D., VP for Research
the proposed change. The NIH Office of Laboratory
Animal Welfare addresses this question at:
December 14th 1:00-2:30 pm
http://grants.nih.gov/grants/olaw/faqs.htm#b13
WHERE: University Main Library, rm 181
To register go to https://jagmail.usouthal.edu/cgibin/CA/seminar/semrca.cgi
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*
* * Items of Interest * * *
What to tell the patient after a trial goes awry
http://www.nytimes.com/2010/08/24/health/24alzheimers.html?_r=3&ref=the_vanishing_mind
Promoting an ethical compass for the information age
One researcher discusses the ethics of using social networking sites for research.
Jeffrey M. Drazen, M.D., and Alastair J.J. Wood, M.D. “Don't Mess with the DSMB” N Engl J Med
2010; 363:477-478, July 29, 2010. http://www.nejm.org/doi/full/10.1056/NEJMe1007445
Gaps in Medical Research Ethics
Laura Stark discusses what she believes are problems in the history of research ethics
First Clinical Trial Begins for Stem Cell Therapy
The first clinical trial of a therapy derived from human embryonic stem cells has begun. Researchers
are testing a treatment for patients with spinal cord injuries for safety.
Have a Question or a Comment?
Dusty Layton
Director, Research Compliance
460-6625
dlayton@usouthal.edu
Alison Henry
Assistant Director, Research Compliance
460-6509
ahenry@usouthal.edu
SuzAnne Robbins
IRB Compliance Specialist
460-6308
srobbins@usouthal.edu
Shaun Kaulfers
IACUC Compliance Specialist
460-6863
skaulfers@usouthal.edu
Newsletter archives are posted on the Office of Research Compliance website at:
http://www.southalabama.edu/com/research/
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