Attachment 11A.
Form
Approved OMB
No. 0923-0041
Exp.
Date xx/xx/201x
Type of request Research notification Data Biospecimens or
tissues (mark all that apply) Before
submitting your application, please attach a copy of the following
required materials in the web form on the application page. All
materials received by the Agency for Toxic Substances and Disease
Registry (ATSDR) have to be in pdf format.
Research Application Form.
Cover letter with a brief
overview of the project, highlighting the importance of the
research proposal.
PI CV or Biosketch.
Full study protocol, including
consent form if applicable.
Confirmation of IRB approval of
full protocol and informational materials.
Additional supporting documents.
For clinical notifications
include the recruitment letter and/or informational materials to be
sent to potential study participants and complete Part A. For specimens include completed
specimen request form(s) (Part B and/or Part C) including types and
number of specimens requested. For data only complete Part D.
Date (mm/dd/yyyy):
Title
of Study or Project:
Principal
Investigator (or Project Director):
Short
Title: Organization:
Co-Principal Investigator (if any): (if there are no Co-PI’s enter “None.”)
Name(s) |
Organization(s) |
Business Phone Number |
Business Email Address |
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CDC
estimates the average public reporting burden for this collection of
information as 30 minutes per response, including the time for
reviewing instructions, searching existing data/information sources,
gathering and maintaining the data/information 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 CDC/ATSDR Information
Collection Review Office, 1600 Clifton Road NE, MS D-74, Atlanta,
Georgia 30333; ATTN: PRA (0923-0041).
Funding source and any declared (to the IRB) financial conflicts of interest:
Funding source: List the source(s) of funding for the project and this sample, the amount of funding anticipated from each source, and indicate the type of support provided: i.e., grant, contract, cooperative agreement, interagency agreement, other (specify), and note if the funding is current or is pending.
Declared conflict of interest: For each investigator please list any financial conflicts of interest declared to the IRB.
Summary of Proposed Study Protocol or Project Activities:
Provide a brief summary of your proposed study or project activities. Provide sufficient detail to describe your study or project. If you are requesting data and/or biospecimens or tissues obtained from the National ALS Registry describe how they will be used. Include in this summary the ALS study population in which you are interested, describe the benefit of this study to the community or individuals involved, demonstrate an understanding of the scientific merit of your proposed study, include a description of the hypothesis to be tested and some background information to support why the study or project is being proposed, and include a brief description of your proposed methods and analytic plan. (The summary should be limited to 7000 characters.)
Background:
Specific Aims:
Methods:
Population:
Measures:
Analysis:
Institutional Review Board (IRB) for the Protection of Human Subjects:
(As defined by the U.S. Department of Health and Human Services in the Code of Federal Regulations, Title 45,
Part 46): Evidence of a current IRB approval is required prior to the ATSDR contacting ALS registrants.
Please provide the following information on the IRB to review this project outside of ATSDR:
Name and address of the IRB:
IRB Federal Wide Assurance (FWA) number:
If Yes, Date of the IRB approval (mm/dd/yyyy):
Please provide a lay summary of not more than 250 words that describes the purpose of your research, what information you hope to obtain, who can participate, number of participants, and what participants must do to take part including time commitment. Remember the average high school graduate reads at the 8th grade level so use simple declarative sentences and avoid scientific jargon.
Part A - Research Notification
Will any of the information (obtained from the National ALS Registry, or from the request for ATSDR to inform ALS registrants about the proposed study) be used as a basis for legal, administrative, or other actions which may directly affect particular individuals or establishments as a result of their specific identification in this project?
If Yes or Maybe, please explain:
Will any of the information (obtained from the National ALS Registry, or from the request for ATSDR to inform ALS registrants about the proposed study) be used as a basis for marketing purposes, including, but not limited to, marketing of pharmaceutical drugs?
If Yes or Maybe, please explain:
The following variables are available for all registrants and can be used to prescreen registrants for notification about your study. Please indicate which variables you would like us to use and specific criteria.
Specific Age Range at Diagnosis (e.g. 40-50, 50-60, 60-75):
Specific year/years of diagnosis (e.g. 2012 - current):
Specific Sex (e.g. female only, male only):
City and / or State(s) of residence or region of the United States (e.g. Los Angeles, CA, Dallas, TX, State of Arizona, State of Georgia and Florida):
*Additional variables are available on a subset of the population, such as registrants with a history of military service, smoking / alcohol consumption or specific ALSFRS score. If you wish to use these as eligibility requirements, please contact the ALS Research Notification System Administrator.
I do not want to prescreen for eligibility (e.g. I want to have research materials sent to all participants taking part in the notification process.).
* Requests to have ATSDR identify additional variables for eligible participant(s) may delay the distribution of research materials. If you have questions or concerns about the application process or status of your application, please contact the ALS Research Notification System Administrator at 877-442-9719 (Monday through Friday, 9am to 5pm ET). You may also send us an email at [email protected].
ATSDR kindly requests that researchers include the following acknowledgement in any publications deriving from the study:
“Recruitment for this study was in part made possible by ATSDR's National ALS Registry Research Notification Mechanism (http://wwwn.cdc.gov/ALS/ALSClinicalResearch.aspx)” and that they forward such publications to ATSDR ([email protected]).
Date of Request: |
SAMPLES |
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SAMPLE TYPE |
ALIQUOT SIZE |
PRICE/ALIQUOT |
NUMBER OF INDIVIDUALS REQUESTED |
REQUESTED NUMBER OF ALIQUOTS/INDIVIDUAL |
TOTAL ALIQUOTS |
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0.5 ml |
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1.0 ml |
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(metals free) |
1.8 ml |
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0.5 ml |
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2 ug |
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2 ug |
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1 ml |
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1 ml |
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Comments/Special Instructions:
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SURVEY DATA |
CONTACT INFORMATION _________________________________________________ Protocol # _________________________________________________ Title of Study or Project _________________________________________________ Principal Investigator or Project Director _________________________________________________ Organization _________________________________________________ Contact Phone Number _________________________________________________ Email Address
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*All specimen requests include demographics when available, including: age at diagnosis; age at first symptom; age at death; race; sex; family history of ALS; family history of other NGD; state of residence; ALSFRS closest to collection; and survival time.
Are you interested in additional Survey Data? Note, not all survey data may be available at this time. Yes No If yes, please select from the options below: Demographics Occupational History Military History Smoking/Alcohol History Physical Activity Disease Progression (ALSFRS) Family History of Neurological Diseases Clinical Data (e.g. devices used, body onset) Lifetime Residential History Lifetime Occupational History Residential Pesticide Use Hobbies with Toxicant Exposures Caffeine Consumption Reproductive History (women) Health Insurance Status Trauma History |
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SHIPPING INFORMATION |
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LAB CONTACT: |
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LAB TELEPHONE: |
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LAB CONTACT EMAIL: |
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LAB SHIPPING ADDRESS: |
Sample Request Form
Date of Request: |
Postmortem Sample Request Form
SAMPLES |
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SAMPLE TYPE |
PRICE/SAMPLE |
NUMBER OF INDIVIDUALS REQUESTED |
REQUESTED NUMBER OF SAMPLE/INDIVIDUAL |
TOTAL SAMPLES |
Frozen tissue (0.5-1g) |
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$80 |
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$100 |
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$100 |
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$100 |
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Other: |
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Parafin-embedded fixed tissue sections (5 sections at 5um) |
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$60 |
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$60 |
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peduncle |
$60 |
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(Brodmann area (BA) 4, 3, 2, 1) |
$40 |
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$40 |
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$40 |
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$40 |
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$40 |
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$40 |
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$40 |
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(CAP) |
$40 |
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$40 |
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$40 |
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$60 |
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substantia innominata |
$60 |
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$60 |
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body, tail of caudate |
$60 |
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$40 |
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$60 |
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$60 |
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$40 |
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$40 |
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$40 |
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$60 |
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$60 |
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$60 |
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$60 |
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$60 |
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$60 |
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$60 |
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$60 |
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$60 |
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$40 |
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Comments/Special Instructions:
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SURVEY DATA |
CONTACT INFORMATION _________________________________________________ Protocol # _________________________________________________ Title of Study or Project _________________________________________________ Principal Investigator or Project Director _________________________________________________ Organization _________________________________________________ Contact Phone Number _________________________________________________ Email Address
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*All specimen requests include demographics when available, including: age at diagnosis; age at first symptom; age at death; race; sex; family history of ALS; family history of other NGD; state of residence; ALSFRS closest to collection; and survival time.
Are you interested in additional Survey Data? Note, not all survey data may be available at this time. Yes No
If yes, please select from the options below: Demographics Occupational History Military History Smoking/Alcohol History Physical Activity Disease Progression (ALSFRS) Family History of Neurological Diseases Clinical Data (e.g. devices used, body onset) Lifetime Residential History Lifetime Occupational History Residential Pesticide Use Hobbies with Toxicant Exposures Caffeine Consumption Reproductive History (women) Health Insurance Status Trauma History |
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SHIPPING INFORMATION |
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LAB CONTACT: |
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LAB TELEPHONE: |
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LAB CONTACT EMAIL: |
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LAB SHIPPING ADDRESS: |
Part D – National ALS Registry Data only request
The National ALS Registry collects a variety of risk factor data.
Please select from the options below (mark all that apply):
Note that not all survey data may be available at this time.
Demographics
Occupational History
Military History
Smoking/Alcohol History
Physical Activity
Disease Progression (ALSFRS)
Family History of Neurological Diseases
Clinical Data (e.g. devices used, body onset)
Lifetime Residential History
Lifetime Occupational History
Residential Pesticide Use
Hobbies with Toxicant Exposures
Caffeine Consumption
Reproductive History (women)
Health Insurance Status
Trauma History
File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
File Modified | 0000-00-00 |
File Created | 2022-05-23 |