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Wa Doc Policy on Prisoner Medical Research Approval 2006 Attachment

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WASHINGTON STATE
DEPARTMENT OF CORRECTIONS

APPLICATION
TO SEEK APPROVAL OF A
RESEARCH PROJECT
Harold W. Clarke, Secretary

Rev. (12/06)

DOC 260.050 Attachment 1

TABLE OF CONTENTS

PAGE
General Application Format Requirements...................................................................... 1
Level 1 – Research Project – Flow Chart ........................................................................ 2
Level II – Research Project – Flow Chart ........................................................................ 3
Form Instructions............................................................................................................. 4
Form A – Project Application Summary......................................................................... 11
Form B – Administrative Information Summary ............................................................. 12
Form C – Biographical Information................................................................................ 13
Form D – Approval Human Subject Review .................................................................. 14
Form E – Project Budget ............................................................................................... 15
Form E1 – Cooperative Project Contributions ............................................................... 16
Requested from Department of Corrections
Form E2 – Cooperative Project Contributions Requested from..................................... 17
Department of Corrections Administrators/Superintendent/Supervisor
Form F – Project Description......................................................................................... 18
Form G – Description of Risks and Safeguards for Subjects in this Research Project.. 19
Form H – Informed Consent Documents ....................................................................... 21
Attachment H1 – Sample of Consent Format ................................................................ 22
Form I – Waiver of Informed Consent ........................................................................... 24
Form J – Review of ongoing Research Projects(s) and Project Completion ................. 25

Rev. (12/06)

i.

DOC 260.050 Attachment 1

STATE OF WASHINGTON
DEPARTMENT OF CORRECTIONS
RESEARCH APPLICATION FORMS
GENERAL APPLICATION FORMAT REQUIREMENTS
The Department of Corrections welcomes research proposals and we thank you for your
interest. When your application for research is received, we will process this application in
a timely manner.
1.

Please notify the Department of Corrections Research Review Committee of your
intent to submit a proposal prior to completing this application. You may contact us
by phone at (360) 725-8690, by email at bjmanning@doc1.wa.gov, or by mail at:
Anmarie Aylward, Chair
Research Review Committee
P.O. Box 41127
Olympia, WA 98504-1127

2.

The application forms are not form-field protected or set up as text boxes. Type
your answers and information into each form and the forms will expand to
accommodate the amount of text entered. Forms are formatted for use with
Microsoft Word; formatting may change if edited in other word processing
applications.

3.

Submittal and formatting of your application:
‰

Use 12-point font.

‰

If foreign language materials are to be used, send them after receiving
approval for your study.

‰

Provide adequate detail, especially on all forms.

‰

Consent forms should be written at no more than an eighth grade reading level.

‰

Submit only the completed forms and attachments; instruction pages do not
need to be returned with the application.

‰

Submit one original application, with signatures, and 6 copies of your research
proposal.

4.

Please read through the entire packet before filling out the forms and carefully
follow the instructions for all the forms in this application kit. Submission of an
incomplete application is a common cause for delay in the review of proposals. If
you have questions about the information requested in this application, please
contact Barbara Manning at (360) 725-8690 or at bjmanning@doc1.wa.gov the
Research Review Committee Chair.

Rev. (12/06)

1

DOC 260.050 Attachment 1

LEVEL I — RESEARCH PROJECT
There are two types of research projects – Level I and Level II.
The Level I type of research is generally limited to the study and analysis of policies, procedures,
and statistical materials. This does not include the study or review of specific identifiable
individuals and/or individuals' records. Here are the steps you will take as you complete this
application and the process used by the Research Review Committee to evaluate your proposal.
Request Application Packet from Department
of Corrections

Complete Forms: A, B, C, D, E, F, I, J

Submit Application Packet to Department of Corrections’
Research Review Chair

Obtain
Approval

Request
Additional
Information

Denied

Recommend
Approval

Recommend
Approval

Denied

Letter of Approval / Denial from
Secretary of Department of
Corrections. There is no appeal
of the Secretary's decision.

Conduct Research
Research Review Committee
Establishes Time Frames for Project
Updates to be Submitted to the
Committee
Project
Updates as
Approved
SUBMIT your original application with 6
copies of your research project
proposal and all reports to:
Anmarie Aylward, Chair
Research Review Committee
Department of Corrections
P.O. Box 41127
Olympia, WA 98504-1127
Rev. (12/06)

Submit Final
Report to Chair of
Research

2

DOC 260.050 Attachment 1

LEVEL II — RESEARCH PROJECT
Level II is research typically sponsored or associated with some other organization. It may
or may not involve direct contact with identifiable individuals and/or individual's records.

Request Packet from Department of
Corrections

Complete Forms: A, B, C, D, E, F, G, H, I, J

Submit Packet to Department of Corrections’
Research Review Chair

Request
Additional
Information

Obtain
Approval
Denied

Recommend
Approval
Recommend
Approval

Denied

Letter of Approval / Denial from
Secretary of Department of
Corrections. There is no appeal
of the Secretary’s decision
Acquire ALL Consent Forms of Human
Subjects Where Applicable
Research Review Committee
Establishes Time Frames for Project
Updates to be Submitted to the
Committee

Conduct Research

Project
Updates, as
Approved

SUBMIT Original application with 6
copies of your research project
proposal and all reports to:
Anmarie Aylward, Chair
Research Review Committee
Department of Corrections
P.O. Box 41127
Olympia, WA 98504-1127

Rev. (12/06)

Submit Final
Report to Research
Review Committee
Chair

3

DOC 260.050 Attachment 1

INSTRUCTIONS
FORM A: PROJECT APPLICATION SUMMARY
Briefly describe the Objectives, Methods and Procedures, and Significance of this Project
on Form A. Do not complete this form by referencing pages in other attached material.
Please do not use continuation pages; Form A is intended to be a brief, one-page
summary.

FORM B: ADMINISTRATIVE INFORMATION SUMMARY
Principal Investigator/Researcher
Fill in the information requested in this section for the person who will conduct the
proposed research. Form B must be signed and dated by the Principal
Investigator/Researcher.

FORM C: BIOGRAPHICAL INFORMATION
Provide biographical information for project staff directly involved with your study on Form
C. Copies of resumes or curricula vitae will be accepted in lieu of Form C. Please do not
exceed five pages per person.

FORM D: HUMAN SUBJECT REVIEW
This section documents that the responsible officials at the researcher’s professional
organization are aware of the proposal, and have assumed responsibility for the
appropriate level of review of the proposed research.
1. Complete Section 1
- If you are a Researcher who is affiliated with an organization that has an
Institutional Review Board (IRB), you need to obtain the signature of the
appropriate Institutional Review Board (IRB) official or administrator.
2. Complete Section 2
- If you are a Researcher who is affiliated with an organization not having an
Institutional Review Board (IRB), you should obtain the signature of the
organizational official authorized to approve the research proposal.
2. Complete Section 3 AND either Section 1 or 2
- If you are a Researcher who is proposing to conduct research for graduate credit,
you should obtain the signature of your academic advisor or the chair of your
supervisory committee, in addition to obtaining the signature on either Section 1 or
2.

Rev. (12/06)

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DOC 260.050 Attachment 1

FORM E: PROJECT BUDGET
Proposals supported by formal budgets (grants, contracts, state funds)
Summarize the major budget categories for the proposed research on Form E. If this is a
multi-state or agency study, include only the amount of the budget allocated to the
Department of Corrections' study site described in this proposal. Indicate whether budget
amounts are for one year or for the total study period.
Proposals not supported by formal budgets
Provide enough information on Form E to explain how the proposed research will be
funded or otherwise supported.
Significant Financial Interest:
If any member of the research team has a significant financial interest in the research, or in
its products, or in the study sponsor, please explain the nature of this financial interest and
describe the monetary value of the financial interest.

FORMS E1 and E2: COOPERATIVE PROJECT CONTRIBUTIONS REQUESTED
FROM THE DEPARTMENT OF CORRECTIONS
This two-part form demonstrates that the researcher(s) have discussed project plans with
staff in the applicable state agency or agencies and have obtained preliminary agreements
from them to provide the resources needed for the proposed research to be conducted.
INSTRUCTION FOR RESEARCHERS:
If the project requires resource contributions from Department of Corrections, you must
discuss your plans with the administrator(s) of the immediate Department of Corrections
unit(s). On the basis of your plans and your discussions with Department of Corrections,
complete and sign Form E1 and send a copy of Forms E1 and E2, along with a copy of the
proposal, to each person from whom resource contributions are requested.
WHO RESEARCHERS SHOULD CONTACT:
If the research requires access to case records maintained in a local Department of
Corrections facility/site, or if the research involves other activities conducted in a local
office, you should contact the Department of Corrections Superintendent/Supervisor.
If the research requires access to computerized data maintained by Department of
Corrections, you should contact the Department of Corrections Budget Resource
Management Section at (360) 725-8270.
If the research involves interviews or interventions with persons in Department of
Corrections institutions or facilities, and/or access to offender or staff records maintained in
the institution, you should contact the Superintendent of the institution.
IF THE PROPOSED RESEARCH REQUIRES ACCESS TO DEPARTMENT OF
CORRECTIONS FACILITIES FOR SUBJECT RECRUITMENT PURPOSES, STATE
AGENCY STAFF MUST BE INVOLVED IN MAKING INITIAL CONTACT WITH
POTENTIAL SUBJECTS. Agency assistance in recruiting research subjects must be
negotiated with appropriate administrators and documented on Form E1.
Rev. (12/06)

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DOC 260.050 Attachment 1

FORM F: PROJECT DESCRIPTION
The expected level of detail in the project description depends upon the nature and
purpose of the proposed activity. Minimal risk projects involving only access to existing
records or administration of anonymous surveys require the least level of detail. Projects
involving direct interventions or contacts with human subjects must provide more detailed
information. Clearly label and attach data collection instruments, flow charts, and other
supporting documentation relevant to the proposed research. The Project Description
should provide all the following information that is relevant to the proposed research:
Conceptual Introduction
1)

Provide a clear conceptual rationale for conducting the proposed research.

2)

Specify the research questions and the reasons for asking them.

3)

Clearly state the project purposes, objectives, and hypotheses, and relate them to
findings by others.

4)

For program evaluations, describe the program in sufficient detail to provide a context
for the evaluation design.

5)

Include a summary of the pertinent literature, with citations, if relevant.

Project Methods
Sampling and Subject Selection
6)

Describe the sampling rationale and procedures.

7)

Specify the proposed sample size, the age range of subjects, the subject inclusion
and exclusion criteria, and the power of the planned statistical tests.

8)

Identify the population from which subjects will be drawn, the source of subjects, and
the location where study procedures will be carried out.

9)

Indicate whether subjects will be recruited from non-English speaking populations,
and if so, identify which non-English speaking groups will be included.

10) Indicate whether subjects will be compensated for study participation, and if so, how
much.
11) Specify how subjects will be identified, contacted, and recruited in Form F.
Study Design
12) Describe the design of the proposed research. Study designs may vary from simple
descriptive survey research with no comparison groups to quasi-experimental or
experimental designs.
13) Specify the independent, dependent and extraneous variables, and discuss possible
threats to internal and/or external validity (e.g., effects of uncontrolled factors) that are
implicit in the proposed design.
14) Indicate if the design requires deception or withholding complete information about
study purposes, and if so, provide justification.
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DOC 260.050 Attachment 1

Measurement and Data Production
15) Describe how study variables will be defined and operationalized, and how the data
will be obtained.
16) Identify and attach a copy of the research instruments, (e.g., questionnaires,
structured interviews, observational methods, psychological tests, medical tests, etc.)
you plan to use to collect the data.
17) Provide evidence for the reliability and validity of the research instruments. Attach
copies of data collection instruments to the application.
Data Analysis
18) Specify any planned statistical tests or comparisons, and describe the relationship
between the expected outcome of such tests and the project’s purposes and/or
hypotheses.
Project Logistics
19) Describe the timetable and specific working arrangements for conducting the
research.
Significance of Proposed Project
Professional Proposals
20) Provide a realistic estimate of the relevance of expected study results, both in terms
of applied and basic knowledge. The implications of the research for programs
administered by the relevant state agencies are of particular interest.
Student Proposals
21) Student research projects, up to and including Master’s thesis research, are
considered professional learning experiences and are reviewed as student proposals.
Students and their academic advisors are strongly urged to tailor their
proposals carefully to what the student may realistically hope to accomplish in
light of likely limitations in time, funds, and experience.

FORM G: DESCRIPTION OF RISKS AND SAFEGUARDS FOR SUBJECTS IN THIS
RESEARCH PROJECT
NOTE: If the research involves only use of records, indicate “Not Applicable” for #2,
Subject Recruitment. All other sections must be completed for record research.
1.

Risks to Subjects: All possible physical, psychological, social, and economic risks
to the rights and welfare of the subjects who are asked to participate in the research
(including threats to the right of privacy and freedom from undue harassment).
Describe the provisions made to minimize the risks of harm and to protect subjects’
rights and welfare.

Rev. (12/06)

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DOC 260.050 Attachment 1

2.

Subject Recruitment: Describe the methods you will use to identify, contact, and
recruit potential subjects, and to obtain their informed consent, with special
emphasis on the appropriateness of these methods to the class of subjects being
recruited (e.g., children, hospitalized mentally ill). If the proposed research requires
access to Department of Corrections facilities, for subject recruitment purposes, the
agency must be involved in making initial contact with potential subjects.

3.

Targeted Population: Explain why the research must be conducted with offender
population rather than with a less vulnerable population.

4.

Confidentiality: Describe the methods proposed to ensure the confidentiality of
identified research data and documents. Please specify the point in time when all
identifiers and codes linked to identifiers will be permanently removed from all study
records, thus rendering all study records unidentifiable.

By signing Form G, the Investigator/Researcher agrees to on-site inspection of agreedupon safeguards so the Department can be sure the information is used only for research
or statistical purposes and is not re-disclosed without prior permission.
Disclosure of Identified Record Information
Research or statistical proposals requesting direct access to offender or employee records
or requiring that the Department provide identified information extracted from such records
will only be approved if all of the following conditions are satisfied:
1. Disclosure of the identified information is compatible with state and federal laws and
regulations.
2. The information requested in an identifiable form for the use of a statistical or research
activity will not be used to contact, in any way, any person identified in that information.
3. The requested information or activity does not place an unacceptable burden on
ongoing departmental operations.
4. A mutually acceptable Confidentiality Contract with the outside Investigator/Researcher
is provided.

FORM H: INFORMED CONSENT
CONSENT DOCUMENTS and ATTACHMENT H1
Attach the consent and assent forms in exactly the format that they would be used in the
proposed research. Also, attach copies of contact letters, recruitment scripts, telephone
scripts, and posters or advertisements that will be used for study recruitment. If you will
direct participants to a website, please provide the web address and copies of all web
materials. Please identify all types of consent documents proposed for this study on
Form H.
The consent documents should be written in clear, short, declarative sentences, using lay
language that prospective subjects can readily understand. Avoid the use of technical
terms, and define such terms if their use cannot be avoided. Font size should be at least
12 point and margins at least one inch. All consent documents must be printed one-sided.
Rev. (12/06)

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DOC 260.050 Attachment 1

Use the Flesch-Kincaid test in Word (or other comparable measure) to assess the
readability of the consent documents, and report the results on Form H. Please submit
copies of all proposed consent documents with your application.
If subjects will be recruited from populations in which English is not the primary spoken
language, please describe on Form H the provisions that are planned for communicating
with potential subjects in their native language and for translating consent documents.
NOTE: Do not submit translations until all consent documents have been approved
by the Research Review Committee.
Attachment H1: A sample consent form in Attachment H1. Please follow the format in
this sample when writing consent forms for your research. The sample consent form
specifies the information, which typically should be included in each section of the form.
Please ensure that your consent form includes all information necessary to obtain informed
consent for study participation.

FORM I: WAIVER OF INFORMED CONSENT
Complete this form ONLY IF you are requesting Unidentified Record Information
(information stripped of identifiers) for your project.
DISCLOSURE OF DEPARTMENT RECORD INFORMATION FOR RESEARCH AND
STATISTICAL PURPOSES
The Secretary of Department of Corrections may approve proposals by outside
Investigator/Researchers requiring the release of information from individual offender and
employee records without the consent of the persons to whom the records pertain under
the following disclosure conditions:
Disclosure of Unidentified Record Information (Information stripped of identifiers)
Many statistical and research activities do not require information in a format that identifies
specific offenders or employees. Therefore, whenever possible, the Department will
release record information for statistical or research purposes only in a form that cannot be
associated with particular individuals.

FORM J: REVIEW OF ONGOING RESEARCH PROJECT(S) AND PROJECT
COMPLETION
Once your research project is approved by the Department’s Secretary, you will receive an
approval letter listing dates that periodic status reports are due.
THE DEPARTMENT’S PUBLICATION RIGHTS
A.

The Investigator/Researcher or project director shall furnish four (4) copies of your
final publication to the Department.

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DOC 260.050 Attachment 1

B.

Manuscripts by students to be submitted for publication in a professional journal or a
non-professional publication must be reviewed and approved by the Department prior
to their submission to the publication source.

C.

Unless otherwise mutually agreed to, the outside professional
Investigator/Researcher or project director may not copyright the results of the project
without the written consent of the Department.

Rev. (12/06)

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DOC 260.050 Attachment 1

FORM A
STATE OF WASHINGTON
DEPARTMENT OF CORRECTIONS
PROJECT APPLICATION SUMMARY
Project Title:

Principal Investigator/Researcher:

Organizational Affiliation:

Objectives:

Methods and Procedures:

Significance of this Project:

Rev. (12/06)

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DOC 260.050 Attachment 1

FORM B
STATE OF WASHINGTON
DEPARTMENT OF CORRECTIONS
ADMINISTRATIVE INFORMATION SUMMARY
TITLE OF PROPOSAL:

PRINCIPAL INVESTIGATOR/RESEARCHER:
Performance Site:

Name:

TITLE/POSITION:

MAILING ADDRESS:

PROPOSED PROJECT DATES:
FROM:

TO

FUNDING SOURCE:

DAY TIME TELEPHONE:

AFFILIATED WITH DEPARTMENT OF
CORRECTIONS?
Yes _______

Rev. (12/06)

12

No ________

DOC 260.050 Attachment 1

FORM C
STATE OF WASHINGTON
DEPARTMENT OF CORRECTIONS
BIOGRAPHICAL INFORMATION
Use one sheet for each of the personnel involved in the proposed project; number sheets consecutively.

NAME:

TITLE:

Affiliated with
Department of
Corrections?
Yes ____
No ____

NAME AND ADDRESS OF EMPLOYING AGENCY OR ORGANIZATION

EDUCATIONAL BACKGROUND (Degree(s) and institutions)

PROFESSIONAL BACKGROUND (positions and appointments)

SCIENTIFIC BACKGROUND (description of research activities and interests)

Bibliography: list not more than five publications relevant to the proposed project showing you as
author or co-author. If less than two publications have been produced, list graduate theses,
papers read at conferences, or project reports.

Rev. (12/06)

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DOC 260.050 Attachment 1

FORM D
STATE OF WASHINGTON
DEPARTMENT OF CORRECTIONS
APPROVAL HUMAN SUBJECT REVIEW
To be completed by sponsoring agency or organization. (University, Professional Organization, Public
Agency, Commercial Research Firm, etc.)

SECTION 1:
Approval by Institutions or Organization with an Accredited Human Subject Review Board(s)
NAME:
TITLE/POSITION:
MAILING ADDRESS:
I have reviewed the proposed methodology and feasibility of the research project and recommend approval.

Signature

Date

SECTION 2:
Approval by Institutions or Organization without an Accredited Human Subject Review Board
NAME:
TITLE/POSITION:
MAILING ADDRESS:
I have reviewed the proposed methodology and feasibility of the research project and recommend approval.

Signature

Date

SECTION 3:
Approval by academic advisor or Chair of Advisory Committee of Research for graduate credit.
NAME:
TITLE/POSITION:
MAILING ADDRESS:

Signature
Rev. (12/06)

Date
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DOC 260.050 Attachment 1

FORM E
STATE OF WASHINGTON
DEPARTMENT OF CORRECTIONS
PROJECT BUDGET
Use as many continuation pages as needed. Please number pages consecutively.

Formal Budget – Provide Summary:

No Formal Budget - Explain how the proposed research will be supported:

Significant Financial Interest:
Does any member of the research team have a significant financial interest in the research, or in its products,
YES
NO
or in its sponsor?
If Yes, please explain the nature of this financial interest and describe the monetary value of the financial
interest:

Rev. (12/06)

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DOC 260.050 Attachment 1

FORM E1
STATE OF WASHINGTON
COOPERATIVE PROJECT CONTRIBUTIONS REQUESTED FROM
DEPARTMENT OF CORRECTION
Project Title:

TO BE COMPLETED BY THE PRINCIPAL INVESTIGATOR/RESEARCHER: On the basis of your plans and your
discussions with Department of Corrections administrators, please complete and sign Form E1 and send a copy
of Forms E1 and E2, along with a copy of the proposal, to each administrator or data coordinator from
whom resource contributions are requested.
Department of Corrections Contributions Requested:
YES

NO

1. Department of Corrections Clerical Services
2. Department of Corrections Facilities/Equipment
3. Department of Corrections Case Records (Specify below)

4. Department of Corrections Computerized Records (Specify below)

5. Department of Corrections Assistance in recruiting Research Subjects (Specify below)

6. Other (Specify below)

For each category checked above, please describe the specific contributions requested. For case records or
computerized records, please describe the parameters of the data request (i.e., study group, time periods,
geographic areas, data elements, etc.)

(Attach additional pages if necessary)
I certify that I have discussed this proposal with Department of Corrections administrators and that, to the best of
my knowledge, this form accurately describes the contributions requested for this research project.
Principal Investigator/Researcher (Type Name)

Signature_______________________________________________

Telephone

Administrator or Data Coordinator to whom page E2 will be sent

Telephone

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DOC 260.050 Attachment 1

FORM E2
STATE OF WASHINGTON
COOPERATIVE PROJECT CONTRIBUTIONS REQUESTED FROM
DEPARTMENT OF CORRECTIONS ADMINISTRATORS/SUPERINTENDENT/SUPERVISOR

Project Title:

TO BE COMPLETED BY THE DEPARTMENT OF CORRECTIONS ADMINISTRATOR : On the basis of
your plans and your discussions with the researcher and the information provided on Form E1, please
estimate the costs of supporting this research project. If the contributions being requested are unclear, or if
additional information is needed, please contact the Research Review Committee Chair. Please complete
and sign Form E2. Send to Department of Corrections Research Review Committee, Chair.

Estimated Costs of Department of Corrections Contributions:
1. Professional Services

2. Clerical Services

3. Computer Services (including staff-time)

4. Consumable Supplies

5. Other (Specify):

Type Name:

Signature _________________________________________________________
Department of Corrections Administrator/Superintendent/Supervisor

Telephone

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DOC 260.050 Attachment 1

FORM F
PROJECT DESCRIPTION
1. Use as many continuation pages as needed. Please number pages consecutively.
OR
2. Attach materials that you have submitted to your funding agency, institutional review board, or a
copy of your thesis if this information will provide clear responses to the 20 questions being asked in
the Form F Instructions (see page 6-7).
Note:
ƒ
ƒ

Identify the section/page in your document where each piece of requested information can be
found.
Identify any questions that are N/A.

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DOC 260.050 Attachment 1

FORM G
STATE OF WASHINGTON
DEPARTMENT CORRECTIONS
DESCRIPTION OF RISKS AND SAFEGUARDS
FOR SUBJECTS IN THIS RESEARCH PROJECT
Use as many continuation pages as needed. Please number pages consecutively.
Risks to Subjects:

Subject Recruitment:

Targeted Population:

Confidentiality:

___________________________________________________________
Signature of Principal Investigator/Researcher
Date

__________

___________________________________________________
Print or Type Name

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DOC 260.050 Attachment 1

FORM G (additional signature page)
Signature of All Investigator/Researchers:

___________________________
Investigator/Researcher
(Please Type Name)

___________________________ _________
Signature

_____________
Date

___________________________
Investigator/Researcher
(Please Type Name)

___________________________ _________
Signature

_____________
Date

___________________________
Investigator/Researcher
(Please Type Name)

___________________________ _________
Signature

_____________
Date

___________________________
Investigator/Researcher
(Please Type Name)

___________________________ _________
Signature

_____________
Date

___________________________
Investigator/Researcher
(Please Type Name)

___________________________ _________
Signature

_____________
Date

___________________________
Investigator/Researcher
(Please Type Name)

___________________________ _________
Signature

_____________
Date

___________________________
Investigator/Researcher
(Please Type Name)

___________________________ _________
Signature

_____________
Date

___________________________
Investigator/Researcher
(Please Type Name)

___________________________ _________
Signature

_____________
Date

___________________________
Investigator/Researcher
(Please Type Name)

___________________________ _________
Signature

_____________
Date

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DOC 260.050 Attachment 1

FORM H
STATE OF WASHINGTON
DEPARTMENT OF CORRECTIONS
INFORMED CONSENT DOCUMENTS
Use as many continuation pages as needed. Please number pages consecutively.
Consent Documents – Check all recruitment and consent documents proposed for this research; indicate
readability level using Flesch-Kincaid test in Microsoft Word or equivalent measure; attach copies of all
consent documents and all documents to this form.
Flesch-Kincaid Reading Level
Consent Form(s)

______________________

Contact Letter(s)

________________________

Recruitment Script(s)

________________________

Telephone Script(s)

________________________

Advertisement(s)

________________________

Web Page(s)

________________________

Other: ________________

________________________

Non-English Speaking Subjects:
If subjects will be recruited from non-English speaking populations, describe your plans for
communicating with potential subjects and for translating consent documents into their native language:

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DOC 260.050 Attachment 1

ATTACHMENT H1
SAMPLE – CONSENT FORMAT
(Use simple direct language appropriate for the intended readers)
CONSENT FORM
TITLE OF RESEARCH PROJECT
Investigator/Researchers: (List names, academic/staff positions, university/agency affiliation, complete
address and telephone numbers of Investigator/Researchers and co-Investigator/Researchers)
Investigator/Researcher's Statement:
PURPOSE AND BENEFITS
State that this is a research activity. Identify the sponsor of the study. Describe the purpose of the research
and the questions the study is intended to answer. Describe the expected benefits to individual subjects
and/or society.
PROCEDURES
Describe the procedures involved. Identify any procedures that are experimental. Describe the time
involved for each procedure, the total amount of time involved, and the duration of the subjects’ involvement
in the research. If random assignment is involved, state that subjects will be assigned by chance to one of a
number of groups, and describe the differences between the groups. Identify where the study procedures
will take place, and who will administer the procedures. As appropriate, list and/or describe the specimens
to be taken and the names and doses of substances to be given. Describe questionnaires and interviews to
be administered, and provide examples of the most personal and sensitive questions to be asked. State
that subjects may refuse to answer any question or item. Describe any medical, social service or
computerized records needed, and specify any plans to video or audio tape subjects.
RISKS, STRESS, AND DISCOMFORT
Describe the physical, psychological, social, and/or economic risks of the research in terms of type,
probability, magnitude and duration. Include a description of possible stress, discomforts or the invasion of
privacy that might result.
OTHER INFORMATION
If applicable, describe the alternative procedures or standard of care that might benefit the subject. State
whether study data will be confidential (linked to identifiers) or anonymous (no links). Indicate who will have
access to identifiable data and how long identifiable data will be retained until destroyed. Describe
procedures for protecting confidentiality of study data. As appropriate, state that while study data will remain
confidential, the law requires that information about suspected abuse of children or dependent adults must
be reported. State that study participation is voluntary, and that subjects may refuse to participate or may
withdraw from the study at any time without penalty or loss of benefits to which they are otherwise entitled.
Include a description of any payments subjects may receive for participation. Indicate any costs subjects
may immediately or ultimately have to bear. If appropriate, explain whether any medical treatments are
available if injury occurs, and if so, what they consist of and whether their cost will be borne by the
researcher or the subject. Indicate that the subject may contact the Investigator/Researchers toll-free or by
collect call if they have any questions about the research.
____________________________________________
Signature of Investigator/Researcher

Rev. (12/06)

22

___________
Date

DOC 260.050 Attachment 1

Participant’s Statement:
"The study described above has been explained to me. I voluntarily consent to participate in this activity. I
have been told that I can refuse to answer any question or withdraw from the study at any time without
penalty. I have had an opportunity to ask questions. I have been told that future questions I may have about
the research or about my rights as a participant will be answered by one of the Investigator/Researchers
listed above."
_____________________________________________
Signature of Participant

___________
Date

_____________________________________________
Witness Signature (if appropriate)

___________
Date

Copies to:

Rev. (12/06)

Participant
Investigator/Researcher's file

23

DOC 260.050 Attachment 1

FORM I
STATE OF WASHINGTON
DEPARTMENT OF CORRECTIONS
WAIVER OF INFORMED CONSENT

Research Involving Records Only – No Contacts with Human Subjects:
Waiver of consent for disclosure of state agency records.

Information Supporting Request for Waiver:

Rev. (12/06)

24

DOC 260.050 Attachment 1

FORM J
Approval Expiration Date __________
STATE OF WASHINGTON
DEPARTMENT OF CORRECTIONS
REVIEW OF ONGOING RESEARCH PROJECT(S) AND PROJECT COMPLETION
Project Title:
Principal Investigator/Researcher:
Address:

Telephone:

FAX:

Email:

Investigator/Researchers must provide documentation of completion of appropriate
education and training in the protection of human subjects with their progress reports
for continuing review.
1. Status of Project: Include major accomplishments, significant events or study findings,
dissertation activities, etc. Use additional sheets as necessary.
2. Summarize Study Amendments During this Past Year: Describe any revisions in the
study design and/or study procedures, such as the number and/or size of study groups,
changes in recruitment procedures, materials and/or consent forms, revisions to
instruments, requests for additional data, etc. Use additional sheets as necessary.
3. Anticipated Completion Date for your project:

INVESTIGATOR/RESEARCHER’S STATEMENT:
As Principal Investigator/Researcher, I acknowledge that I am responsible for reporting any
emergent problems, serious adverse events or reactions, or proposed study modifications, and
that no modifications will be put into effect without prior Research Review Committee approval.
I affirm that this research is being conducted in compliance with all Departmental-approved
procedures and requirements, and that this research will not proceed beyond the expiration date
of study approval unless continuation approval is extended. I affirm that this progress report is
an accurate and complete description of my research.

Signature of Principal Investigator/Researcher

Date

Return entire packet to: Anmarie Aylward, Chair
Department of Corrections Research Review Committee
P.O. Box 41127
Olympia, WA 98504-1127
Rev. (12/06)

25

DOC 260.050 Attachment 1

STATE OF WASHINGTON
DEPARTMENT OF CORRECTIONS

CONFIDENTIALITY CONTRACT

I,

, understand and agree that,
PRINT NAME

in the performance of my research project as a Principal Investigator/Researcher, I am obligated
to treat any and all offender or employee records to which I have access or might have access,
through whatever means, as confidential and privileged. Furthermore:
™ I understand that disclosure of the identified information will only be approved if disclosure is
compatible with state and federal laws and regulations.
™ I understand that any violation of confidentiality of offender or employee records or
information may result in termination of the research project and that action may be taken by
a prosecuting attorney if the breach of confidentiality violates state laws and regulations.
™ I agree that information requested in an identifiable form for use of a statistical or research
activity will not be used to contact, in any way, any person identified in that information
outside of the parameters of the project.

SIGNATURE

Rev. (12/06)

DATE

26

DOC 260.050 Attachment 1

 

 

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