Download:
pdf |
pdf Bridge, Heather (NIH/OD) [E]
From:
To:
Cc:
Subject:
OHSR (NIH/DDIR)
Horovitch-Kelley, Vivian (NIH/NCI) [E]; Rabiner, Chana (NIH/NCI) [E]
Grant, Nicole (NIH/NCI) [E]
AM Determination OHSRP #11633
Good Afternoon Chana and Vivian,
Attached is the Amendment Determination of Exempt from IRB Review under 45 CFR 46.102 for the new survey
regarding Financial Sustainability of Human Tissue Biobanking for your project: International Focus Group to Inform
Economic Barriers and Challenges to Biobankers
Please retain this revised documentation as you would other research records. Please refer to OHSRP #11633 for future
amendments to this activity. To request other future amendments, please use the attached email template modified to
meet the specific changes needed for your project.
Best,
Heather Bridge
Office of Human Subjects Research Protections
Office of Intramural Research
National Institutes of Health
10 Center Drive,
Bldg. 10, Room 2C146
Bethesda, MD 20892
Direct line: 301‐402‐4504
BB: 240‐281‐9015
Office Main: 301‐402‐3444
Fax: 301‐402‐3443
E‐mail: [email protected]
OHSRP website: https://federation.nih.gov/ohsr/nih/index.php (NIH login required)
From: Horovitch-Kelley, Vivian (NIH/NCI) [E]
Sent: Wednesday, April 24, 2013 5:01 PM
To: Bridge, Heather (NIH/OD) [E]
Cc: Rabiner, Chana (NIH/NCI) [E]
Subject: RE: OHSR new forms for survey- Introductions
Hi Heather – quick question – does this program staff need to submit another OHSRP review to conduct a survey, when
the focus group was approved. It is on the same topic and in the same branch.
I have attached the OHSRP review approval that was done in 2012 for the focus groups – now this group is going to be
conducting a survey (see detail in the memo and the attached screenshots) and we are wondering whether Chana
should submit another OHSRP review – or whether the current review for the focus groups can be used?
Thanks.
Vivian Horovitch-Kelley
(Office Number) 301-480-0541
(Fax) TBD
[email protected]
1
Office of Management Policy and Compliance (OMPC)
PRA/OMB Liaison/Program Analyst
PRA-OMB Clearance Program
National Cancer Institute (NCI)/National Institutes of Health (NIH)
Office of Management Policy and Compliance
11400 Rockville Pike, Room 707, MSC 9162
Rockville, MD 20852
For more information about PRA/OMB clearance:
http://ompc.cancer.gov/about/omb-clearance
This email, including attachments, may contain privileged and confidential information intended only for the use of the individuals(s)
names above. Dissemination, distribution, or copying of this message or its content is subject to authorization by the sender. If you have
received this message in error, please notify the sender and delete immediately. Thank you.
2
Date:
April 24, 2013
TO:
Office of Management and Budget (OMB)
Through:
Keith Tucker, Reports Clearance Officer, HHS
Seleda Perryman, Program Clearance Officer, NIH
Vivian Horovitch-Kelley, PRA OMB Clearance Liaison, NCI
FROM:
Chana Rabiner, PhD
Biorepositories and Biospecimen Research Branch
Cancer Diagnosis Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute (NCI)/NIH
SUBJECT:
Financial Sustainability of Human Tissue Biobanking
This is a request for OMB to approve the new submission titled, “Financial Sustainability of
Human Tissue Biobanking” for 1 year. The supporting statements and various attachments
accompany this memorandum.
The purpose of this web-based survey is to collect information regarding the challenges that
human tissue biobanks encounter in achieving financially sustainable operations. The
information will be used to assist the National Cancer Institute (NCI) in strategizing program
plans to provide increased and tailored support for national and international biobanks.
The survey will collect a combination of structured, quantitative, and free-text descriptive data
that characterize the type and maturity of respondent biobanks, their sources of funding, and
their usage of funding in conducting operations. The survey will also collect information
describing the difficulties in maintaining funding sources and establishing new ones. Finally, the
survey will elicit descriptions of techniques used to overcome the difficulties.
The intent of the survey is to answer the following research question “What is the financial
burden (to the host institution) of the startup, maintenance and long-term sustainability of a
human biospecimen resource used for biomedical research, given the host institution’s
geographic and socioeconomic environment and organizational structure?”
A combination of domestic and international biobanks will be asked to participate in the survey,
totaling approximately 548 respondents. The annualized burden for the survey by all
participants is estimated to be 822 hours.
Screen Shots for
Financial Sustainability of Human Tissue Biobanking Survey Site
Main Landing Page
1
Self‐registration Screen
2
Burden Statement and List of Available Survey Sections
3
4
5
6
7
8
9
Bridge, Heather (NIH/OD) [E]
From:
To:
Cc:
Subject:
OHSR (NIH/DDIR)
Rabiner, Chana (NIH/NCI) [E]
Grant, Nicole (NIH/NCI) [E]
Determination for OHSRP #11633
Good Morning Dr. Rabiner,
Attached is the OHSRP determination of Exempt from IRB Review under 45 CFR 45.101(b)(2) for the survey and
interview procedures for your project: International Focus Group to Inform Economic Barriers and Challenges to
Biobankers
Please retain these records as you would other research records. Please refer to OHSRP #11626 for future amendment
requests for this activity.
Best of luck with your research,
Heather Bridge
Office of Human Subjects Research Protections
Office of Intramural Research
National Institutes of Health
10 Center Drive,
Bldg. 10, Room 2C146
Bethesda, MD 20892
During renovation, please use BB to reach me directly: 240‐281‐9015
Office Main: 301‐402‐3444
Use Direct line for voicemail only: 301‐402‐4504
Fax: 301‐402‐3443
E‐mail: [email protected]
From: OHSR (NIH/DDIR)
Sent: Tuesday, October 16, 2012 12:11 PM
To: Rabiner, Chana (NIH/NCI) [E]
Subject: Req for Determination Rec'd_OHSRP 11633
Good afternoon Dr. Rabiner,
This email is to verify that OHSR has received your Request for Review of Research and it is currently
being processed as OHSRP #11633. Please use this number in any future correspondence regarding this
study. 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.
Protocol Title: International Focus Group to Inform Economic Barriers and Challenges to Biobankers
Thank you.
Sincerely,
OHSRP - National Institutes of Health
Bldg 10, Suite 2C146
Bethesda, MD 20892
Office Telephone: 301-402-3444
Office Fax: 301-402-3443
1
OHSRP #11633
REQUEST FORM: OHSRP DETERMINATION FORSURVEYS, INTERVIEW PROCEDURES,
PROGRAM EVALUATION, EDUCATIONAL TESTING AND RESEARCH
Date of Request:
_October 8, 2012
Requestor’s name: _Chana Rabiner
[email protected]
e-mail:
Role: _Administrative support Xlnvestigator _Other, explain:
Name of NIH Senior Investigator: _Chana Rabiner__________________
(The investigator must be an NIH employee)
IC _NCL_ Laboratory/Branch ____DCTD/CDP/BBRB
Building & Room No. Rockwall_ Tel. No. _301-827-4319_ FAX No.
Is the NIH Senior Investigator an NIHipIoypeflE)? )X Yes
No
/
’,-i
Senior Investigator Signature:
Supervisor Signature:
estig6 who will conduct research)
(Siiat//re Qf
L/z.__,
C-t-_
(Sign gt"ure of officialfor IC, e.g., Lab/Branch Chief)
Name of NIH investigator conducting research if not the NIH Senior Investigator:
junior investigator, contractor investigator, fellow, student)
(i.e,
Please provide the name and e-mail of any others who should receive a copy of the
OHSRP determination:
1.
What role will the NIH investigator(s) have in this research project?
apply)
- Conduct research activity
Analyze samples/data only
X Consultant/advisor to collaborator(s)
X Author on publication(s)/manuscript(s) pertaining to this research
X_ Other, please describe: _project
manager
(check all that
-
Title: International Focus Group to Inform Economic Barriers and Challenges to
Biobankers
(Provide a short title to distinguish this activity from other projects that you may have)
2.
3. Describe in lay terms the research activity that will be performed:
Page 1 of
REQUEST FORM: OHSRP DETERMINATION FORSURVEYS, INTERVIEW PROCEDURES,
PROGRAM EVALUATION, EDUCATIONAL TESTING AND RESEARCH
The National Cancer Institute’s (NCI) Biorepositories and Biospecimen Research
Branch (BBRB) is involved in on-going studies of the economics of biobanking, which
include cost-recovery modeling and the qualification and quantification of the economic
impact of standardization of practice and centralization of resources. The first step in
accomplishing this goal is to gain a clearer understanding of the specific challenges
being faced, from the point of view of those directly impacted, through techniques such
as this focus group. The focus group will provide impressions and comments regarding a
survey to occur in the future (a separate request will be submitted to OHSRP when the
survey is finalized
4. Proposed start date _11_/7_/_2012_
Proposed completion date
11_/_9_/_2012_
S. Specify the nature of the data: (select all that apply)
X Interview procedure
- Survey
- Educational Testing
- Educational Research
- Research on public benefit or service programs
- Other, describe:
6. What kind of human data (e.g., private information, responses to questionnaires,
test results, recordings) will be collected in your research?
_responses to proposed survey
questions
7. Will human data be? (select all that apply)
Collected YesX No_
Received Yes_ N0X
Sent
Yes_ N0X
8. If receiving or sending, list the collaborating investigator(s):
Institution/IC
Address/e-mail
Name
FWA num b er*
9. Where are the subjects of this research activity located? (Provide a general
description or complete the institutional information below)
They will be attending the European, Middle, and African Society for Biobanking and
Biopreservation in Granada, Spain November 7-10
Institution:
Contact Name:
Phone:
Address:
Page 2 of 3
REQUEST FORM: OHSRP DETERMINATION FORSURVEYS, INTERVIEW PROCEDURES,
PROGRAM EVALUATION, EDUCATIONAL TESTING AND RESEARCH
10. Will NIH investigator(s) have direct contact or intervention with the subjects of
the study? (For example, by interviewing, surveying or recording the subjects?)
Yes_ NoX
If yes, what is the age range of subjects involved in the research?
Children aged <18 years
Adults aged > 18 years
11. Who will collect the data or information?
NIH Investigator
(a)
non-NIH Collaborator
(b)
(c) _X_ NIH Contractor
Other, specify_______
(d)
If b or c, will an Honest Broker or data use agreement be used? Yes NoX
If yes, complete and attach the Honest Broker Assurance or data-use agreement to
this submission; e-mail ohsr nih ddirod.nih.qp to request a form.
12. Select the best description that applies to the human data or information:
X Data or information will not contain any identifiable information, nor can it be
linked to individual subjects by you or your collaborators.
- Data or information will be recorded in such a manner that subjects can be
identified directly or through identifiers linked to the subjects
13. Per NIH guidance, are all conflicts of interest by NIH employees (sender or
No**
receiver), if any, resolved? - X-Yes
*A Federaiwide Assurance (FWA) is issued by the U.S. Department of Health and Human
Services (DHHS)/ Office of Human Research Protections (OHRP) to institutions which
receive Federaifunds/support to conduct human subjects research. To search for the
FWA# for domestic or international institutions go to
http://ohrp. cit. nih. gov/search/fwasearch . aspx?styp-bsc
**Jf the answer is "No", note that OHSRP will be unable to make a determination and
research may not proceed until all conflicts are resolved. For more information, see the
October 2011, A Guide to Preventing Financial and Non-Financial Conflict of Interest in
Human Subjects Research at NIH. For assistance review the list of Ethics Coordinators
and find the contact for your IC: http://ethics.od.nih.gov/coord.pdf
Page 3 of 3
Questions for BBRB Study
ESBB Conference
Sections
1
Organizational structure (network / stand-alone)
Current funding sources
Scale of operations
Coverage of current and projected growth
Feedback on new potential funding sources
Current challenges
Copyright © HealthCare IT, Inc. 2012
All rights reserved
Organizational structure and governance
(network / stand-alone)
2
Is your biobank part of a:
What internal governance model oversees your biobank?
Healthcare provider
Clinical research organization
Drug or device developer
Commercial biobank
Other: ___________
Permanent steering committee
Ad-hoc steering committee
Scientific/pathologist oversight team
Other: ___________
Is your biobank part of a network?
If yes, does the network have a steering committee
Do you exchange samples within your network?
Does your institution receive funding from the network?
Copyright © HealthCare IT, Inc. 2012
All rights reserved
Feedback on new potential funding sources
3
How likely are you to initiate/increase each of the
following new/current sources:
New/Current; Highly likely, maybe, we will not pursue
Charitable donations: ____
Support from our host enterprise: ____
Support from our network: ____
Grants: ____
Specimen sales: ____
Other: ____
Copyright © HealthCare IT, Inc. 2012
All rights reserved
Current funding sources
4
What is your biobanks total annual budget?
What percentage of your budget comes from:
Charitable donations: ____
Support from our host enterprise: ____
Support from our network: ____
Grants: ____
Specimen sales: ____
Other: ____
What percentage is used for:
Labor/staffing: ____
Capital equipment: ____
Other operational expenses: ____
Copyright © HealthCare IT, Inc. 2012
All rights reserved
Scale of operations
5
How many full time staff? _____
How many FTE’s in part-time staff? _____
How many researchers do your support?
How many grants do you support?
What portion of grant funding goes to your bank?
How many samples in your bank?
How many samples do you add monthly?
What is the annual sample turn-over rate?
Copyright © HealthCare IT, Inc. 2012
All rights reserved
Coverage of current and projected growth
6
At what rate are your total costs increasing per year? ____ What is
the breakdown:
Labor: ____
Capital: ____
Other operational expenses: ____
(need clarifying instructions for these percentages)
At what rate are your funding sources changing (+/- percentage)
Charitable donations: ____
Support from our host enterprise: ____
Support from our network: ____
Grants: ____
Specimen sales: ____
Other: ____
Copyright © HealthCare IT, Inc. 2012
All rights reserved
Coverage of current and projected growth
7
At what rate are your total costs increasing per year? ____ What is
the breakdown:
Labor: ____
Capital: ____
Other operational expenses: ____
(need clarifying instructions for these percentages)
At what rate are your funding sources changing (+/- percentage)
Charitable donations: ____
Support from our host enterprise: ____
Support from our network: ____
Grants: ____
Specimen sales: ____
Other: ____
Copyright © HealthCare IT, Inc. 2012
All rights reserved
Current challenges
8
Please list the top three challenges that you are currently facing and/or anticipate
in the next 12 months:
1.
2.
3.
Sustaining current growth
Acquiring new specimens
Replacing declining funding sources
Keeping pace with quality standards
Labor attrition
Managing changing consent
Data security
Keeping pace with new informatics
Integrating our information systems
Centralizing biobank operations in my enterprise
Establishing a competitive pricing strategy/policy
____________
____________
____________
Copyright © HealthCare IT, Inc. 2012
All rights reserved
Attachment # 2
Financial Sustainability Study
Focus Group Moderator Guide
Assessing Biobank Feedback regarding:
Financial Survey Instrument
October/November 2012
Focus Group Moderator Guide
BBRB Assessing Biobank Feedback Regarding: Financial Survey Instrument
OMB No.: 0925‐0642
Expiration Date: 9/30/2014
NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN
Public reporting burden for this collection of information is estimated to average 90 minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of
information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it
displays a currently valid OMB control number. Send comments 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
20892‐7974, ATTN: PRA (0925‐0642). Do not return the completed form to this address.
1.
WELCOME (1 minute)
a. Good morning/afternoon, my name is [Moderator Name]. I am the BBRB Biobank Financial
Sustainability Study Advisor and will be the moderator for today. Welcome and thank you for
participating in the Biobank Financial Sustainability Survey Focus Group Discussion.
b. Many of you may have participated in a focus group previously. A focus group is a small group
discussion that focuses on a particular topic in depth. The purpose of this focus group is to discuss the
Financial Sustainability Study Survey, specifically to understand your impressions, comments and
suggestions regarding the survey. I will be asking your opinions informed by your experiences in
biobanking. The information obtained will be used to refine and improve the Survey before we deploy in
the coming months.
2.
GROUND RULES (4 minutes)
Before we begin, I would like to review a few things about how the discussion will work.
a. In a focus group, there is no right or wrong answers, only opinions, and I’d like to hear from all of you
about your perspectives equally. It’s important that I hear what each of you thinks. Please talk one at a
time and in a clear voice. Because we are taking notes and taping the discussions, I may occasionally
interrupt you if two or more people are talking at once to be sure everyone gets a chance to talk and that
responses are recorded clearly.
b. Everyone needs to talk but each person doesn’t have to answer each question. If I haven’t heard from you
I may call on you occasionally. You don’t need to address all answers to me; I encourage you to
exchange points of view with each other. Also, please feel free to speak up even if you disagree with
someone else here. It’s OK to disagree, because it’s helpful to hear different points of view. I’m also
interested in any questions you may have as we go along.
c. This focus group will last approximately 1½ hours. To ensure that we stay within the allotted time, I may
jump ahead to the next topic from time to time to move us along, but please stop me if you want to add
anything.
2
d. This focus group will be audio-taped so that we can capture all of the relevant quotes and comments.
Everything you say is important to us, and we want to make sure we don’t miss any comments. Later,
we’ll go through all of your comments and use them to prepare a report of our discussion. I want to
assure you, however, that all of your comments are secure to the extent provided by law, and will be used
only for research purposes. Nothing you say will be connected with your name. As well, we would like
focus group participants to respect the confidentiality of all responses provided as well. Also, if there are
any questions you would prefer not to answer, please feel free not to respond to them.
Does anyone have any questions before we begin?
3.
INTRODUCTIONS (10 minutes)
a. I’m going to ask each of you to introduce yourself to the group. I’d like to ask that you tell us: current
position, years in your current position, years of experience in biobanking, the name of the biobank that
you represent, and the number of years it has been in operation.
4.
PERCEPTIONS AND FEEDBACK ON THE SURVEY
Relevance (20 minutes)
This survey captures the most important aspects of financial sustainability, funding, and related issues. As
you respond, please state whether you agree with this statement and for each of the first five sections of the
survey and please rate each section including:
a. Organizational structure (network / stand-alone)
i. Highly relevant to understand biobanking financial sustainability
ii. Somewhat related to understand biobanking financial sustainability
iii. Not needed to understand biobanking financial sustainability
b. Current funding sources
i. Highly relevant to understand biobanking financial sustainability
ii. Somewhat related to understand biobanking financial sustainability
iii. Not needed to understand biobanking financial sustainability
c. Scale of operations
i. Highly relevant to understand biobanking financial sustainability
ii. Somewhat related to understand biobanking financial sustainability
iii. Not needed to understand biobanking financial sustainability
d. Coverage of current and projected growth
i. Highly relevant to understand biobanking financial sustainability
ii. Somewhat related to understand biobanking financial sustainability
iii. Not needed to understand biobanking financial sustainability
e. Feedback on new potential funding sources
i. Highly relevant to understand biobanking financial sustainability
ii. Somewhat related to understand biobanking financial sustainability
iii. Not needed to understand biobanking financial sustainability
3
Complexity (20 minutes)
The Survey was easy to understand and to use. As you respond, please state whether you agree with this
statement and for each of the first five sections of the survey and please discuss and rate each section
including:
a. Organizational structure (network / stand-alone)
i. Very easy to understand
ii. Some questions were unclear (please let us know which ones need clarification)
iii. Most questions were unclear and need better explanation (be specific)
b. Current funding sources
i. Very easy to understand
ii. Some questions were unclear (please let us know which ones need clarification)
iii. Most questions were unclear and need better explanation (be specific)
c. Scale of operations
i. Very easy to understand
ii. Some questions were unclear (please let us know which ones need clarification)
iii. Most questions were unclear and need better explanation (be specific)
d. Coverage of current and projected growth
i. Very easy to understand
ii. Some questions were unclear (please let us know which ones need clarification)
iii. Most questions were unclear and need better explanation (be specific)
e. Feedback on new potential funding sources
i. Very easy to understand
ii. Some questions were unclear (please let us know which ones need clarification)
iii. Most questions were unclear and need better explanation (be specific)
Confidentiality (20 minutes)
The Survey asks for information that may be too confidential for your organization to disclose under certain
circumstances. As you respond, please state whether you agree with this statement and for each of the first
five sections of the survey and please discuss and rate each section including:
a. Organizational structure (network / stand-alone)
i. We would share this information publicly with attribution to our enterprise
ii. We would share this information provided our data were not attributed to our enterprise
iii. We would not share this information under any circumstance
b. Current funding sources
i. We would share this information publicly with attribution to our enterprise
ii. We would share this information provided our data were not attributed to our enterprise
iii. We would not share this information under any circumstance
c. Scale of operations
i. We would share this information publicly with attribution to our enterprise
ii. We would share this information provided our data were not attributed to our enterprise
iii. We would not share this information under any circumstance
d. Coverage of current and projected growth
i. We would share this information publicly with attribution to our enterprise
ii. We would share this information provided our data were not attributed to our enterprise
iii. We would not share this information under any circumstance
4
e. Feedback on new potential funding sources
i. We would share this information publicly with attribution to our enterprise
ii. We would share this information provided our data were not attributed to our enterprise
iii. We would not share this information under any circumstance
5. CHALLENGES (10 minutes)
The Survey requests your views on the challenges you now face anticipate in the near future. Please discuss
and rate this section by considering the following two statements:
The challenges listed include the most critical for my organization. Agree / disagree
Some important challenges are missing including . . .
6. CONCLUSION (2 minutes)
We’ve come to the end of our discussion. The BBRB team has worked hard to develop these questions so we
can improve the Survey for Financial Sustainability.
Do you have any additional comments you would like to make on our focus group topics?
On behalf of the BBRB, I want to thank you for your participation. This has been a valuable session. I want
to remind you that all of your comments are secure to the extent permitted by law, and will be used only for
research purposes. Thank you again for your comments and your time.
5
OHSR (NIH/DDIR)
From:
Sent:
To:
Subject:
Attachments:
Rabiner, Chana (NIH/NCI) [E]
Wednesday, October 10, 2012 11:52 AM
OHSR (NIH/DDIR)
Request form for international focus group
OHSRP BBRB SUBMISSION.pdf; BBRB Study Questions for Spain.pptx; #16_Attach_2
_BBRB_Moderator_Guide.docx
Please find the request for an international focus group. Thank you.
Chana
Chana Rabiner, PhD
Program Director
Biorepositories and Biospecimen Research Branch
Cancer Diagnosis Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
11400 Rockville Pike
Bethesda, MD 20892
Phone: +1.301.827.4319
[email protected]
1
OHSR (NIH/DDIR)
From:
Sent:
To:
Subject:
OHSR (NIH/DDIR)
Tuesday, October 16, 2012 12:11 PM
Rabiner, Chana (NIH/NCI) [E]
Req for Determination Rec'd_OHSRP 11633
Good afternoon Dr. Rabiner,
This email is to verify that OHSR has received your Request for Review of Research and it is currently
being processed as OHSRP #11633. Please use this number in any future correspondence regarding this
study. 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.
Protocol Title: International Focus Group to Inform Economic Barriers and Challenges to Biobankers
Thank you.
Sincerely,
OHSRP - National Institutes of Health
Bldg 10, Suite 2C146
Bethesda, MD 20892
Office Telephone: 301-402-3444
Office Fax: 301-402-3443
The NIH is committed to maintaining the highest standards for the protection of human
subjects.
Please consider the environment before printing this e-mail
1
| File Type | application/pdf |
| File Modified | 2013-04-26 |
| File Created | 2012-10-10 |