ATTACH 5_Memo from NIH OHSR

ATTACHMENT 5: Memo from NIH Office of Human Subjects Research

OHSR RES~ONSE
TO REQUEST FOR REVIEW OF RESEARCH ACTIVITY
INVOLVING HUMAN SUBJECTS

FAX:
To:

Exempt: #:

301-480-3441
Massett, Holly
NCI
6116 Executive Blvd.

From:

Office of Human Subjects Research (OHSR)

Nature of Research Activity:
NCI proposes using focus groups to conduct qualitative research with members of the general public. NCI
will convene 12 consumer focus groups using standard focus group methodologies to elicit formative
information and gain an understanding of consumer knowledge, attitudes, perceptions, opinions, and interest
in genetic testing, with specific interest in the newly emerging area of direct-toconsumer (DTC) genetic
testing. The focus groups will also ask questions related to the public's information needs in regard to an
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Original Request Received in OHSR on:

1011612008

Responsible NIH Research Investigator(s):

Holly Massett, PhD NCI

.I11

1

OHSR review of your request dated Fri, Sep 26,2008 has determined that:

q Federal regulations for the protection of human subjects do not apply to above named
activity. No further action is necessary.
The activity is designated EXEMPT, and has been entered in the OHSR database.
PLEASE NOTIFY OHSR OF ANY SIGNIFICANT CHANGES THAT MAY ALTER THE
EXEMPT STATUS OF THIS RESEARCH ACTIVITY.

q NOT EXEMPT. OHSR recommends IRB review. Please forward your request to the
Chair of your IRB, who may ask you to provide additional information in order to determine
whether expedited or full review is appropriate.
Confidentiality Agreement

q Reliance
q Amendment
Other
Note:

Office Person

Admin Asst.

T I

Date

1

Domestic/lnternationaI:
Domestic
OHSR Use Only
Human Subjects Data: Yes
Biologic Material:

Yes

0 1 H 2 0 3 0 4 0 5 0 6

ATTACHMENT 5: Memo from NIH Office of Human Subjects Research

REOUEST FOR REVIEW OF RESEARCH A C T M T Y INVOLVING HUMAN
k
SUBJECTS
INSTRUCTIONS: Please type directly on this form. You can expand the document if
you need more space. If your research involves a survey or questionnaire, please attach it
to this completed form.
Completed forms (with all required signatures) may be sent to OHSR by FAX (301-4023443) or by mail (2C146). If you have any questions, call OHSR at (301) 402-3444.
Date: Sept 26,2008
To:

OFFICE OF

SUBJECTS RESEARCH, Building 10, Room 2C-146

From:
(

From:

-

h/W

I

q

A

Name of OMRE NIH Principal Investigator(s): Holly Massett, PhD
IC
LaboratoryiBranch Office of Communications and Education
Building & Room No: 61 161400 Tel. No: 301-594-8 193 FAX No: 301-4803441
Name of OMRE NlH Co-Principal Investigator(s): Nina Goodman. MHS
IC
NCI
Laboratorykiranch Office of Market Research & Evaluation
Tel. No: 301-435-7789 FAX No: 301Building & Room No: 6 1161400
480-3441
Is the Principal investigator an NIH employee? -X-Yes

No

If no, please explain:

1.What is the proposed research activity that you intend to perform a t NIH (please
use lay terms):
NCI proposes using focus groups to conduct qualitative research with members of the
general public. NCI will convene 12 consumer focus groups using standard focus group
methodologies to elicit formative information and gain an understanding of consumer
knowledge, attitudes, perceptions, opinions, and interest in genetic testing, with specific
interest in the newly emerging area of direct-to-consumer (DTC) genetic testing. The
focus groups will also ask questions related to the public's information needs in regards
to an informational Web site about DTC genetic testing that is being developed by the

Last revised 11/7/05

ATTACHMENT 5: Memo from NIH Office of Human Subjects Research

NM. Focus group participants will be asked for feedback about the extent to which the
information is comprehendible,~credible,relevant, and useful. Recommendations for
content improvement will also be obtained.
2. If applicable, list your non-NIH Collaborating Investtgator(s).

Name
Tom Lehman

Institution

I AED

Address Tel. # FAX #

1 1825 Connecticut Avenue, N W . I
Washington, DC 20009
(202) 884-8863

3. Proposed start date of your research upon IRB approval
Proposed completion date December 30,2008

4, Will you be

these samples or data?

Collecting w o
Receiving ~ e s m
Sending
m
o
5. Do the samples or data:
(a) Already exist?-Yes

-XNo

(b) Or are they being collected for the express purpose of this study? -X-Yes N
If "yes," please describe:
The proposed study will gather information through focus groups on the general
public's opinions and perceptions of genetic testing.

o

(c) Or a combination of (a) and (b)?

6. What role will you have in this research project? (Check all that apply)

X Analyze samplesfdata only.
X Consultant~advisorto collaborator(s) listed above.
X Author of the protocol that is being implemented by your collaborating investigator
(identified in question #2).
X Co-authorship on publication(s)/manuscript(s) pertaining to this research.
-

-You or NIH hold an IND for this research.
X Decisional authority over the design or implementation of the research at the IRB
approved site? If so, please explain.

Last revised 1 1/7/05

ATTACHMENT 5: Memo from NIH Office of Human Subjects Research

NCI will serve as the decisional authority over the design and implementation of the
research that will be taking plaEe.
Other (If necessary, use this space to describe your role in this research).

7. Where are the subjects of this research activity located?
A maximum of 108 respondents (12 groups with maximum of 9 individuals per group)
will participate in the focus groups. The participants will be recruited through a recruiting
firm using lists of laypersons who have chosen to opt-in for participation in such surveys,
The participants will be recruited using a screener (attached here).
The participants in these consumer focus groups will be members of the general
population ages 18 and older. Potential participants will include both men and women,
and represent all racial, ethnic, and educational backgrounds. All groups will be recruited
to attempt to include a mix of income and education levels.
The subjects will be lo'cated in the Washington, DC metropolitan area as well as in two
other locations that are to be determined.
8. If human subjects are located elsewhere (not at NIH), will you have direct
contact or intervention with them? (Examples: as subject's physician; in obtaining
o
samples directly from the subject; by interviewing the subject?) X _ Yes N
9. What kind of human samples (e.g., tissue, blood) or data (e.g., private
information, responses to questionnaires) will be involved in your research?
Using a moderator guide (attached), a trained facilitator will lead all discussions. During
the discussions respondents will be asked about their thoughts, opinions and perceptions
of genetic testing as well as the relatively new and rapidly growing area of "direct-toconsumer'' (DTC) genetic testing. The information gathered from the focus groups will
aid in the development of formative communication resources that will help the public
understand the language, issues, and complexities inherent in the area of genetic testing.

The moderator for the group discussions will be:
o Trained in focus group moderation
o Experienced in facilitating discussions on sensitive topics
o Educated in the Human Participants Protection Education for Research Teams
online course, sponsored by NIH
o Skilled at diffusing conflict
o Skilled at discouraging and immediately redirecting a group discussion back
to the moderator guide if a participant begins to disclose unsolicited,
inappropriate, and potentialIy damaging personal information
Individual respondents will not be identified and participation will be strictly voluntary.
Names or images will not be recorded, nor will personal identifying data be maintained
in the focus group data records. Respondents will be assured that neither their

Last revised 11/7/05

ATTACHMENT 5: Memo from NIH Office of Human Subjects Research

participationlnon-participation nor any responses to items will have any effect on their
eligibility for, or receipt of, seGices. All data will be collected by the contractor, the
Academy for Educational Development (AED), and all personal identifiers will be
excluded from the data records.
The interviews will be audiotaped. The researcher will not have access to identifying
information (such as consent agreements) that would link the data on the audiotapes to a
participant's identity. Audiotapes will be used to aid report writing, and will be secured in
a locked area. Audiotapes will be destroyed by December 3 1,2013. No names will be
used when reporting findings.
Consent agreements will be collected by the recruiting facility and provided AED. Upon
receipt AED will forward these consent forms to an NCI researcher. Consent agreements
with the participants' full names and signatures will be kept by NCI staff and stored in a
secure, locked area. They will be kept separate from any discussion data associated with
the study.

10. If the samples, ddta do not come from an IRB approved protocol, do they come
from:
(a) Repository Y e s X

No

(b) Pathological waste -Yes
(c) Autopsy material -Yes X

X No
No

(d) Publicly available source Y e s X

No

(e) Other
11. Please check the box(es) that apply(ies) to the samples/dah that you will receive.
(a) X Samples andlor data will be anonymizedunlinked. (The sampleddata
cannot be linked to individual subjects by you or your collaborators at other sites.)
(b)

-Samples andor data will be coded, however that code cannot be used by
either the sender or the receiver to identify specific individuals.

(c) -Samples andlor data will be coded so that the provider of the samplesldata
can link them to specific individuals but the receiver will not be able to do so.
12. Will you send results back to the provider(s) (listed in question 2 of this form)?

(a)

X No, I will not send results back to the provider(s).

Last revised 1 1/7/05

ATTACHMENT 5: Memo from NIH Office of Human Subjects Research

(b) -Yes, I will send aggregate results to the provider(@.
(c) -Yes, I will send results to the provider(s) that are linked to identifiable
individuals.
If yes, does the provider intend to link your data to identifiable individuals?
Yes
No

13. Has the research activity that vou are proposinp in this form been approved by
an Institutional Review Board (IRB)elsewhere?

X Yes, the NIH research activity has been reviewed by the following LRB (s)
(Please provide the following information for each IRB):
Academy for Educational Development
1825 Connecticut Ave, N W
Washington, DC 20009-572 1
Thomas Lelunan
Focus Groups to Assess Consumers'
Perceptions of Direct-to-Consumer
Genetic Testing (AED protocol # 3721I 03-001

1

#0000750 1

Name of institution that
Address of reviewing institution
Name of PI for the IRB approved protocol
Title of IRB approved protocol and protocol #

Federal Wide Assurance (FWA) number*"
- --

-- - .

No IRB review of the research activity described in question #I above has
taken place
(**An FWA is a contract between the U.S.Department of Health and Human Services
(DHHS) and an entity receiving DHHS funds to conduct clinical research that the latter
will follow ethical guidelines and federal regulations for the protection of human
subjects. For a list of domestic and international institutions go to

htb://ohr~.cit.nih.~ovlsearchlasearch.asa#ASUR
14. Per NIH guidance***, have conflicts of interest by NIH employees, if any, been
resolved?
X Yes
No

-

If your answer is no, please see your Clinical Director about this matter before
proceeding ~ i t this
h research.
***The January 5,2005 NIH Guide to Preventing Conflict of Interest applies to all
docs.html
research conducted at NIH, htto://ohsr.od.~~ih.aov/New/mr>afwa

Lost revised 1 1/7/05

ATTACHMENT 5: Memo from NIH Office of Human Subjects Research

Genetics and Common Disease - Focus Group Discussion
Consent Form
About the Project

We have asked you to join a focus group discussion with up to eight other people.
You will be asked about your thoughts and opinions related to genetic testing for
common diseases. The information collected as part of these research efforts will
allow the government to better understand the public's perceptions of this
relatively new and rapidly growing area. The talk will last about 2 hours. A trained
leader will conduct it.
Researchers will watch the discussion through a one-way mirror. We will record
this talk by audiotape. We will listen to the tapes and write down what is said. We
do all this to write a report. We will not allow anyone outside this research project
to listen to anything r~corded.All that you say will be kept private as required by
law. We kill not put your name in the report or on the tapes. The tapes will be
kept in a locked cabinet. The tapes will be destroyed by December 31,2013.
There will be no risk to you. You do not have to answer anything. You may stop at
any time.
This project is sponsored by the National Cancer Institute. The Academy for
Educational Development is helping to do this research. If you have any questions
about this project, please call Holly Massett, Ph.D. at 301-594-8 193. You may
call this number if you have questions about your rights as a participant in this
project or if you think you have been harmed. Leave a message with your name
and phone number, and someone will call you back as soon as possible.
We thank you for your time.

ATTACHMENT 5: Memo from NIH Office of Human Subjects Research

Participant Consent

My signature verifies that I have read the About the Project and understand my
rights as a participant. I agree to participate in today's discussion. I understand that
the group will discuss thoughts and opinions related to genetic testing for common
disease. I agree to be audio-taped only and observed through a one-way mirror. I
understand that only the people working on this project will be able to hear the
tapes or observe this group. I understand that neither my name nor any other
identifying characteristics will be used in any report or other products that may
result from this project.
Name (Pleaseprint):

Signature:
I

Date:

ATTACHMENT 5: Memo from NIH Office of Human Subjects Research

OMB#O925-0046-1 1

Exp. Dale: 113 1 1201 0

Genetic Testing
Gonsumer Focus Groups
National Cancer Institute
9/25/08
Mode re tor's Guide (90-rninufe session)
Public reporting burden for this collection of illformation is estimated to average 90
millutes total, including the time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and reviewing the
collection of infoimation. An agency nlay not conduct or sponsor, and a persoil is not
required to respond to, a collection of information unless it displays a cui~entlyvalid
OMB control number. Send conunents regarding this burden estimate or any other aspect
of this collection of information, including suggestions for reducing this burden, to: NIH,
Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 208927974, A?TN; PRA (0925-0046). Do 11ot.retui-uthe conlpleted fonn to this address.

OVERARCHING RESEARCH QUESTIONS

I. What are consumers' levels of knowledge and awareness of genetic testing

2.
3.
4.

5.
6.

7.
8.

(in general and direct-to-consumer) that provides a person with their risk of
developing various common diseases?
What additional information do consumers want to know about genetic
testing for common diseases (in general and direct-to-consumer)?
Through wha4 channels and from what sources would consumers look for
additional information about genetic testing for common diseases (in general
and direct-to-consumer)?
What are the greatest benefits to consumers of genetic testing for common
diseases (in general and direct-to-consumer)?
What are the greatest barrierslconcems of consumers about genetic testing
for common diseases (in general and direct-to-consumer)?
What are consumers' expectations andlor experiences with the direct-toconsumer genetic testing for common diseases process and results?
What kind of inforrnation on geneUc testing for common diseases would
consumers like the government (NIH) to provide to the American public (in
general and direct-to-consumer)?
What are consumer reactions to drafl Web content on genetic testing for
common diseases (in general and dlrect-to-consumer)?

OPENING REMARKS AND INTRODUCTIONS [I0 min]
Introduction a n d Purpose
1.
Hello and welcome. My name is
and l
work for the Academy for Educational Development, or AED.

ATTACHMENT 5: Memo from NIH Office of Human Subjects Research

2.

3.

We're working with the National Cancer Institute, or NCI, on a
project, ahd talking to people in several cities to find out what you
think about genetic testing. We really want to hear about your
thoughts and experiences so we can create some useful
materials.
We appreciate you taking the time to talk with us today and share
your opinions. Thank you for being here.

ATTACHMENT 5: Memo from NIH Office of Human Subjects Research

Confidentiality and Process
1.

Before we get started, I'd like to tell you how groups like this
usually work. First, you'll notice that we're taking notes as well as
tape recording our conversation. The audio recording is to help us
remember what you said, and the note-taking is a back up in case
the recorders break.
None of the information that is written down and recorded will be
connected to you in any way.
After we have written a report about all the opinions we have
heard here and in other cities, the tapes and notes will be
destroyed.
When we have groups like this, we usually set ground rules
that we can all agree on. I'm going to show you some that may
be important to you. Let me know if you have others to add.
[POST LIST]
Can we agree on these ground rules? Are there any others
you would like to add?
GROUND RULES

I.There are no right or wrong answers.
2. It's okay to disagree.
3. Each person's comments are important and valued.
4. One person speaks at a time.
5. Speak loudly and clearly.
6. Don't have to answer every question.
7. Please be honest and tell us how you really feel.

Self-introductions
1.
First name, one of your favorite Web sites.

ATTACHMENT 5: Memo from NIH Office of Human Subjects Research

-

KNOWLEDGE AND AWARENESS OVERALL [20 min]
What do you think of when you read or hear the term "genetic testingn?
What questions come to mind when you think about genetic testing?
What do you think of when you read or hear about genetic testing that
can tell a person what their risk is of getting certain common diseases,
like different types of cancers, diabetes, or Alzheimer's Disease?
What have you heard others saying (such as Web sites, newspapers,
magazines, doctors, etc.) about genetic testing?
What would makelwhat has made you want to get a genetic test to learn
risk is of getting certain common diseases like these?
what
o What doldid you want to learn from this kind of test?
o What doldid you not want to learn?
o , What disease or diseases are you most interested in learning .
your level of risk?
o Are there some diseases that you don't want to know what your
risk is of getting them? Which ones?

What would make you not want to get this kind of genetic test to learn
what
risk is of getting certain diseases?
How wouldldid you go about making the decision to either get a genetic
test to learn m r risk of getting certain diseases or not?
What thoughts would behvere running through your mind?
o Wouldldid you talk to anyone about it? If so, why?
o Who wouldldid you talk to?
o What wouldldid you say to them?
o

If you did get a genetic test to learn your risk of getting certain diseases,
what would you belwere you worried or concerned about afterwards?
Do you ever hear any words or phrases with regard to genetic testing that
you don't understand? What are they?
PROBE: genome, DNA, phenotype, gene scan, etc.
If a person gets a genetic test to find out their risk for a disease, such as
cancer, diabetes or Alzheimer's Disease, how should a physician be
involved once that person gets their test results?

ATTACHMENT 5: Memo from NIH Office of Human Subjects Research

II.

.

KNOWLEDGE AND AWARENESS

- DIRECT-TO-CONSUMER [5 min]

Throughout the rest of our discussion, we're going to talk about genetic testing services
that are being offered by companies, usually through company Web sites, which people
can purchase and have tests done without going through their physician. For the
purposes of our discussion, we're going to refer to these kinds of genetic tests as "directto-consumer" tests, because the testing happens directly between the company and the
person. The person's physician is not involved.
[Note: Read "DTC" as "direct-to-consumer"]
What have you heard about DTC genetic testing services?
o

Has the topic of this kind of genetic testing ever come up in
conversations with your family, friends or coworkers? If so, what
do you talk about'?
PROBE: reasons for doing it, benefits, risks, process,
companies providing it

As sornAone who has looked intolparticipated in this kind of genetic
testing service, what is it that you most want(ed) to learn?
o

For what reasons?

What would causelcaused you to look into getting DTC genetic testing
and not go through your doctor'?

INFORMATION SOURCES AND TRUSTED SOURCES [5 mln]
Where did you first hear about DTC genetic testing services?
Has your physician ever mentioned DTC genetic testing? If so, what did
helshe say?
o
o

What was the conversation like?
Did you or your doctor start the conversation?

After you first heard about it, where did you get your information on DTC
genetic testing?
What makes you feel that the information you found or got about this kind
of genetic testing is accurate?
[For Early Adopters, information learned before purchasing test]
o

If you don't think it's accurate, where would you look or go to get
trusted Informationon this kind of genetic testing?
PROBE: physician, government Web site, medical orgs

ATTACHMENT 5: Memo from NIH Office of Human Subjects Research

BARRIERS AND BENEFITS [ I 0 mln]
As you werelare making the decision to either participate or not
participate in DTC genetic testing, what concerns or worries didldo you
have?
PROBE:
o Done by a company
o No physician input
o Effect on health insurance, future employment
o Fear
o Privacy
0 Cost
o Ability to handle results
o Compared to getting it through your doctor
o Impact onlreactions from family members
How much would you be willing to pay for this kind of test?
(out-of-pocket costs not covered by insurance)
What are the downsides of DTC genetic testing?
What are the benefits?
How wouldldid your test results affect your health decisions or life
planning?

ATTACHMENT 5: Memo from NIH Office of Human Subjects Research

[EARLY ADOPTERS ONLY] TESTING EXPERIENCE [ I 0 min]
As someone who has done a DTC genetic test, what would you tell others
about your experience?
PROBE: Process, test results, learning this information about yourself
o If yes, would you recommend it others?
o If you had the decision to make all over again, would you do it?
Why, why not?
o What, if anything, do you wish you had known before doing a
DTC genetic test?
Are you satisfied with your results?
o What parts of your results were hard to understand?
o Did you get your questions answered?
o Who did you share your results with?
PROBE: doctor, famlly, friends, children
[Need to add question about how they are interpreting their
results]
Do you h s t the results you received?
o What is it about the company you used that makes you feel like
you can trust your results?
o What do you wish the company would have done so you could
feel like you can trust your results?
How did you use, or plan to use, your results?
PROBE: share with doctor, family, change lifestyle, seek healthcare,
reproductive decisions
Tell me about any positive or negative outcomes that resulted from you
taking a DTC genetic test?
o Positives
o Negatives
o Unexpectedlunanticipated

ATTACHMENT 5: Memo from NIH Office of Human Subjects Research

VI.

INFORMATION NEEDS [5 min]
What information does a person need about DTC genetic testing to make
an informed decision to participate in the testing process?
PROBE: what they can find out, how it works, cost, how to intefpret
results, security/confidentiality
[Rejectors only]
What information about DTC genetic testing did you get that made you
decide not to participate in this kind of test?
o - Where did you get this information?

o What information might make you change your mind?
o What other factors might make you change your mind?
PROBE: reduced,cost,ADD OTHERS.. .

[Contemplators only]
What information about DTC genetic testing might help you make a
decision,to participate in this kind of test or not?
o What other information might help you make a decision?
o What other factors might help you make a decision?
PROBE: cost, confidentiality, security of Information
[Early Adopters only]
What information about DTC genetic testing did you learn that made you
decide to participate in this kind of test?
o Where did you get this information?
o What other information helped you make your decision?
o What other factors helped you make your decision?
PROBE: cost, what you wanted to learn (e.g., family history)
What types of information arelwere most helpful to you in making an
Informed decision about participating in DTC genetic testing?
PROBE: statisticslfacts, testimonials, visuaVgraphic depiction of
information
o What types of information do you think are still needed?
What questions do you stilihave about DTC genetic testing?

ATTACHMENT 5: Memo from NIH Office of Human Subjects Research

VII.

WEB CONTENT REACTIONS [I
0 min]
Now, I'd like to show you an example of information that is being considered for a
Web site about genetic testing services that are offered to people directly without
having to go through their physician.
What do you like about it?
o Layoutldesign
o Images
o Colors
o Types of information
What don't you like about it?
Of the information included, what is confusing or hard to understand?
Which information would be most useful to someone thinking about
getting DTC genetic testing?
What would you improve or do differently?
What is missing?
If you knew this Web site existed, would you go to it for information on
DTC genetic testing? Whylwhy not?

VIII.

ROLE OF GOVERNMENT [5 min]
What kinds of information about genetic testing in general would you
expect the government to provide?
What information would you want to find on a government Web site about
DTC genetic testing, specifically?
How can government agencies help people make informed decisions
about whether to participate in DTC genetic testing?

ATTACHMENT 5: Memo from NIH Office of Human Subjects Research

IX. CLOSING REMARKS [5 min]
A. Thank you for helping us to learn more about what you think about
genetic testing. We will be using your input to develop helpful information
about this topic.
B. Is there anything else you would like to tell us about anything we talked
about today?
C. Do you have any questions for me?

D. Each of you will receive your gift for participating today as you leave the
building.
THANK YOU!

ATTACHMENT 5: Memo from NIH Office of Human Subjects Research

TRANSMISSION VERIFICATION

REPORT
TIME : 1[1/15/2008 10: 33

...-.DATE, TIME
FAX NO. /NAME
WRATION
PAGE(S )
ESULT

mDE

18/15 10:28
3014023443
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STANDARD
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ATTACHMENT 5: Memo from NIH Office of Human Subjects Research

Office of Communications & Education
OfFice of Market Research & Evaluation
User-Centered Informatics Research Lab
6116 Executive Boulevard, Suite 400
Rockville, Maryland 20852
Phone: 301-451-4687 (main)
Fax: 301-480-3441

Date:

To:

MSL

Fax:

-

b-

From:
Phone:

31
4
1- Z [ f f
C

4

f-

5.

pages including coversheet

The attached information may be confidential. It is intended only for the addressee(s) identified above. If you
are not Ule addressee(s), or an employee or agent of the addressee(s), please note that any dissemination,
distribution or copying of this communication is strictly prohibited. If you have received this fax in error,
please destroy the document and notify the sender of the ermr. Thank you.

ATTACHMENT 5: Memo from NIH Office of Human Subjects Research

Page 1 of 1

OHSR (NIHIDDIR)
From:
Sent:
To:
Cc:

OHSR (NIHIDDIR)
Thursday, October 16, 2008 2: 16 PM
Massett, Holly (NIHINCI) [El
Goodman, Nina (NIHINCI) [El;Rienzo, Marie (NIHINCI) [C]

Subject: Requests for Review Rec'd-OHSR

Good afternoon Dr. Massett,
This email is to verify that OHSR has received your Requests for Review of Research and are currently being
processed as OHSR #398 and #4399. Please use these numbers in any future correspondence regarding these
studies.
We will contact you via email if any additional information is needed. If you have not heard from OHSR within 7
business days, please contact us.
#398-Genetics focus group-Physicians
#399-Genetics focus group-Consumers
OHSR:
Ph: 301.402.3444
Fax: 301.402.3443
Thank you.
Sincerely,

Chris Brentin

Administrative Assistant
OD/OHSR/NIH
10 Center Drive, Rm.2C-146

Bethesda, MD ,20892
30 1-402-863 1 (Direct)
301-402-3443 (Fax)