Human Subjects Review Council
Application HELP Manual
PLEASE DO NOT USE THIS APPLICATION MANUAL TO
SUBMIT YOUR MATERIALS FOR HSRC REVIEW.
Obtain the most current blank application form from the website.
THIS MANUAL IS DESIGNED TO PROVIDE MORE SPECIFIC INSTRUCTIONS
AND RESOURCES TO INVESTIGATORS WHO ARE COMPLETING THE
HUMAN SUBJECTS REVIEW COUNCIL (HSRC) APPLICATION.
ADDITIONAL INSTRUCTIONS FOR COMPLETING THE APPLICATION APPEAR
IN BOXED TEXT FOLLOWING EACH OF THE QUESTIONS OR ITEMS.
BOLDFACED COMMENTS IN RED: These comments are intended to clarify the
purpose of each section or question contained in the HSRC application. In some
cases, these comments will provide examples of the kinds of information the Human
Subjects Review Council would like to see in response to a particular question or
section.
ITALICIZED COMMENTS IN RED: These comments provide relevant information
that should be included in the informed consent documents provided to subjects or
their legally authorized representatives (i.e., parents, guardians).
UNDERLINED COMMENTS IN GRAY: The underlined gray text represents
hyperlinks to other on-line resources that may be helpful to researchers as they
prepare responses to specific items on the HSRC application.
These instructions generally represent the minimum standards. Provide as
much additional information as necessary to clearly present all aspects of
your study.
To check boxes on your application, double click on the box. A dialogue box should
appear allowing you to check/uncheck the box.
HSRC 17Sept2012
Page 1 of 15
CENTRAL WASHINGTON UNIVERSITY
HUMAN SUBJECTS REVIEW COUNCIL (HSRC) APPLICATION
HSRC Office
Black Hall, Room 225-17
400 East University Way
Mail Stop 7401
Ellensburg WA 98926-7401
(509) 963-3115
Fax: (509) 963-1064
BOX FOR COUNCIL USE ONLY

MASTER

REVIEWER
HSRC APPLICATION NUMBER:
_____________________________________________________
______________________
HUMAN SUBJECTS REVIEW COUNCIL SIGNATURE
DATE

APPROVE

DISAPPROVE
Subject to the following conditions:
Period of approval is no more than one year. Approved from _____________________________ through __________________________.
THIS APPROVAL IS VALID ONLY AS LONG AS APPROVED PROCEDURES ARE FOLLOWED
Instructions:


DO NOT LEAVE ANY BLANKS; if the item is not applicable to your study, please mark “N/A” in the designated space.
Send this completed application form with inked signatures and all attachments (e.g., consent forms, questionnaires, instruments, data
collection forms, debriefing statements, recruitment advertisements) to the HSRC Office. In addition, send an electronic copy of
application and all attachments to hsrc@cwu.edu.

If this is funded research, please provide one copy of the complete grant proposal with this application.

If this is thesis research, please provide one copy of the introduction and methods sections with this application.
For assistance in completing this form, refer to the HSRC Application Help Manual or call the HSRC Office.
The contents of this application and attachments will be kept confidential within the limits of state and federal law.
Check here if your project falls into one or more of the Minimal Risk (or “Expedited”) categories of research (see Expedited
Categories for listing of categories). If this project is determined to require full council review, the principal investigator will be
contacted and eight additional copies will be requested.
I.
PRINCIPAL INVESTIGATOR. (Provide all the information requested. All correspondence from the HSRC will be directed to this
person.)
This is the person with ultimate responsibility for the research project.
Name:
Title: CWU title such as Graduate Student, Assoc. Professor, etc.
Department/Division:
Mail Stop
Address to mail correspondence to:
Contact Phone Number:
Fax:
Contact E-mail:
II. TITLE OF RESEARCH PROJECT:
Anticipated start date:
Anticipated completion date:
III. SIGNATURES. The undersigned acknowledges that: (1) this application represents an accurate and complete description of the
proposed research; (2) the research will be conducted in compliance with and only after approval has been received from the Human
Subjects Review Council (HSRC). The principal investigator understands that he or she is responsible for immediately reporting any
unanticipated problems to the HSRC, for requesting prior HSRC approval for modifications in study documents or procedures, and for
requesting continuing review and approval of the study before its approval expires.
A. Investigator:
HSRC 17Sept2012
Typed Name
Typed Title
Investigator Signature
Date
Page 2 of 15
III. SIGNATURES (continued):
B.
Faculty Sponsor (if principal investigator is a student):
Undergraduate and graduate students must have the faculty sponsor (e.g., course instructor, thesis
chairperson) sign and date the application here.
Typed Name
Typed Title
Department
Sponsor’s Phone Number
Mail Stop
Faculty Sponsor’s Signature
C.
Date
The Chair, Dean, or Director signing below acknowledges that this proposed activity has received local review and approval of
scientific merit. Note: All investigators must have the signature of their chair, dean, or director.
D.
The Department Chair or supervisor must sign and date the application here.
Typed Name
Typed Title
Department/College/Division
Mail Stop
Chair/Dean/Director Signature
Date
Campus Phone
IV. CO-INVESTIGATORS (Provide all the information requested for each co-investigator. Co-investigators are those individuals
you expect to have contact with prospective subjects and/or the research data. (Thesis Committee members are not co-investigators
unless they are actively involved in the procedures.) Copy and paste additional lines if necessary.
List only individuals who will be actively involved in data collection, etc. Do not list Thesis Council
members with no active role in the study.
Name:
Title:
Department/Division:
Local Telephone Number:
E-mail:
Campus Mail Stop or Local Address:
Name:
Title:
Department/Division:
Local Telephone Number:
E-mail:
Campus Mail Stop or Local Address:
V.
FUNDING SOURCES. List each proposed and funded non-CWU grant or contract relevant to this application.
IF NONE, please check here.
A. Type of Proposal:
Research
Contract
Grant
Subcontract
B. Name of Principal Investigator on Grant or Contract:
C. Name of Funding Agency:
HSRC 17Sept2012
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D. Title of Proposal Submitted to Funding Agency:
E. Funding Dates: From
through
F. Has this grant proposal been submitted to the CWU Office of Grants and Contracts for review?
Yes
VI.
No
If No, please attach a letter of explanation..
SUMMARY OF RESEARCH ACTIVITY. INSTRUCTIONS: Answer in the spaces provided. (Do not merely refer to an
accompanying grant or thesis proposal; rather, answer each question on this human subjects application form.) The space for each
answer will expand as you type. If necessary, attach additional information on separate sheets at the end of this document, labeling
each addition with the corresponding question number and/or letter.
A.
PURPOSE OF THIS RESEARCH. Provide a brief description of the purpose(s) of the proposed research, including relevant
background information (i.e., previous research findings) and the specific research questions or hypotheses this study is designed
to address. Note that the Council includes members with both scientific and non-scientific background. For a faster and more
thorough review, we ask that you use lay language throughout the application.
Include a short description of your research goals and their significance to the discipline (i.e., area of study).
Avoid technical terms or jargon since some members of the HSRC are not scientists.
B.
RESEARCH PROCEDURES INVOLVED:
1. Using lay language, provide a complete description of:

The study design

Sequence and timing of all steps of the study from recruitment to data analysis in enough detail that reviewers can
flowchart the entire process. Be sure to include such things as names of instruments to be used, anticipated time
required to complete each procedure, approximate total time subjects might anticipate being involved, etc.

List and attach copies of all data collection instruments (include documentation as detailed in Guidelines on use of
non-original instruments.)

If your study involves multiple phases (e.g., pilot testing, screening, delivery of intervention), please provide requested
information for each phase of the study.
Provide the HSRC reviewers with complete information on your research procedures. Again, please avoid
the use of technical terms and jargon.
This information should be specific and include:

a description of the research design (e.g., type of experimental design, qualitative method);

the number of subjects in each experimental condition or group;

size(s) of sample(s) (e.g., blood) to be collected (where applicable);

names of all questionnaires, measures, or devices to be used;

a description of instruments, interview questions, and other research methods.
If your study compares different types of treatment or interventions, describe specifically the nature of the
interventions to be used.
If the study is complex or has multiple phases, it may be helpful to provide a flow chart of the procedures.
2.
Would subjects undergo these or similar procedures (psychological, educational, etc.) if they were not taking part in this
research?
Yes
No
Please Explain:
Members of the HSRC need to know how your research procedures compare with what would usually
happen to a subject. For example, if study procedures are conducted in a classroom (educational) setting,
how do your research procedures compare with what ordinarily happens in that classroom? To what extent
does the subject’s experience in the classroom change because of the type of procedures used in this
study?
Describe any procedures that are experimental (not standard) in nature.
HSRC 17Sept2012
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Describe procedures that are conducted in addition to what the client or student would undergo routinely in
this setting if they were not participating in this study. For example, if you are conducting a study in a
psychotherapy clinic, you should identify the research-related tasks that occur in addition to what a
counseling client would ordinarily receive as part of their counseling experience at this clinic.
C.
DECEPTION.
1. Is the use of deception or withholding of complete information from subjects required for this research activity?
Yes If Yes, please explain why this is necessary.
No If No, skip to Section D.
Provide a specific explanation of why deception is a necessary part of your study. Include a discussion
of what information will be withheld and what effect it will have on the subjects.
2. Attach a copy of the script or handout that will be used in debriefing subjects upon completion of their participation. Explain
when, how, and by whom subjects will be debriefed:
Explain:
 who will debrief the subjects;
 when subjects will be debriefed; and
 what information you will provide in order to explain the deception to subjects, including why it was
necessary to use deception in this study.
Attach a copy of the debriefing script or statement, and any handouts you intend to use with subjects in
this study.
D. SUBJECTS: (Please refer to the following guidance documents before completing this section: Non-discriminatory Subject
Recruitment and Subject Recruitment and Extra Credit)
1. Will you involve minors (those under 18) as subjects in your study?
Yes
2.
If Yes, please read assent/permission and follow instructions
How many subjects will you need to complete this study? Number:
No
Age range:
Include the total number of subjects (in all conditions) needed to meet your study objectives.
This should be a realistic estimate: it will help the HSRC evaluate risks and benefits; you will not be
required to limit your recruitment to this number of subjects.
3.
Explain how you will achieve equitable subject representation in the following categories. (If this is not applicable to your
study, justify your exclusions.)
The HSRC must consider subjects’ age, gender, and minority status when evaluating the risks and benefits
associated with your research. The HSRC also uses the information you provide about inclusion and
exclusion criteria to assess both the safety and equitability of your subject selection procedures.
Please describe the steps you will take to include an equitable representation of ages, genders, and minority
groups in your study.
If age, gender, and ethnicity are irrelevant to your study purposes or objectives, please explain why this Is
so.
4.
a.
Age (minors, elderly):
b.
Gender (male, female):
c.
Ethnic and racial minority populations:
What characteristics must subjects have to be in this study? (Answer for each subject group, if different.)
HSRC 17Sept2012
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Provide a description of the criteria you will use to select subjects for your study. (For example, “must be
undergraduate males and females within the ages of 18 and 35.”)
5.
What characteristics would exclude subjects who are otherwise eligible for your study? (Answer for each subject group, if
different.)
Describe the criteria you will use to exclude potential subjects from participation in your research. (For
example, “under age 18,” “allergic to specific substances,” “pregnant,” “currently receiving counseling
elsewhere.”)
6.
How will you identify potential subjects? Describe the subject recruitment strategies you will use for each group of
subjects. (Attach all copies of advertisements, flyers, contact letters, telephone contact protocols, web site information you
will use for recruiting study participants.)
Identifying potential subjects may be as simple as “all teachers in the Regency School District” or as
complex as reviewing school records to find individuals in a certain discipline.
Explain how you will recruit each group of subjects in your study. (For example, will you recruit from
particular CWU classes, from specific organizations, or mental health facilities?)
Attach to the application examples of the flyers, recruitment letters, email, advertisements, or telephone
scripts you will use to recruit subjects.
7.
Explain who will approach potential subjects to take part in the study and how this will be done to protect subjects’ privacy.
(Attach original letters of cooperation from those agencies, institutions, or others that will be involved in subject
recruitment.)
Explain who will be directly recruiting each group of subjects or how subjects will be approached to
participate in your study. (For example, will a member of the research team contact the parents of first
graders to obtain permission for their child’s participation in the study, or will the first grade teacher be
asked to approach parents on behalf of the researcher?)
If you are recruiting participants from non-CWU agencies or organizations, please attach a copy of a letter of
support indicating that organization’s approval of your recruitment of subjects from their population. This is
called a letter of cooperation and samples are available on the HSRC website forms page.
8.
Explain what steps you will take during the recruitment process to minimize potential coercion or undue influence.
Explain the steps that members of your research team will take to insure that potential subjects feel free to
decline to participate in your research. What steps will you take to avoid undue influence or coercion
(threat)?
This is especially important if you have a non-research relationship with potential subjects. If you are their
teacher, supervisor, friend or are in any kind of position of authority over them, you must have a plan to
make sure the relationship does not interfere with the subjects’ freedom of choice.
9. Briefly detail any previous experience or background you may have had with your target population.
10. Will you give subjects gifts, payments, services without charge, or will extra course credit be made available?
Yes
If Yes, please explain.
No
If subjects are to receive payments (i.e., money), services (e.g., counseling), extra course credit, or any other
inducement for participating in your research, please explain: (a) why the inducement is both necessary and
not coercive; and (b) how it will be delivered to the subjects. (For example, will it be prorated by length of
participation, given at the end of the study, or given to subjects upon their initial arrival?)
Please note: Things like course credit and money are considered “compensation” for subjects’ time and
inconvenience, and should not be described as “benefits” of participation.
HSRC 17Sept2012
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Consent Form: A clear description of the inducements for participation and contingencies for receiving
compensation should be explicitly stated in the written consent form.
11. Will any of the subjects or their third-party payers (e.g., health insurance company) be charged for any of your study
procedures?
Yes
If Yes, please explain
No
No cost to clients
Explain what charges, if any, subjects will be asked to pay as part of their participation in your study. (For
example, will subjects be asked to pay for the costs of tests or for materials?)
Include a justification for why subjects should be asked to bear these costs, particularly if participating in
your study is not of direct benefit to the subjects themselves.
12. Where will your study procedures be carried out? (Attach copies of IRB approvals or letters of cooperation, on letterhead,
from non-CWU sites)
Include a description of the site(s) at which your subjects will be recruited and study procedures will be
implemented (e.g., elementary school classroom, computer lab in Psychology Building, description of
clinic).
The HSRC will consider the safety and appropriateness of the sites to be used and determine whether
additional approvals are necessary prior to initiating study procedures.
If the data are to be collected at or from institutions, organizations, or agencies other than CWU, you must
attach copies of letters of approval or cooperation from those sites.
E.
RISKS AND BENEFITS
1a. Describe the nature and degree of risk of possible injury, stress, discomfort, disgrace, invasion of privacy, and other side
effects associated with each of your study procedures. Describe these risks in detail in this portion of the HSRC
application; do not simply refer to your consent form.
Describe the risks, stress, physical or psychological discomfort, or invasion of privacy that may occur to the
subject as a result of choosing to participate in your study. For example, describe the potential stress
associated with responding to intimate questions, the risk that sensitive information will be disclosed, or the
potential for discomfort associated with specific physical or psychological research procedures.
Consent Form: A clear, specific description of the potential risks, stresses, or discomforts involved in the
study must be included in the consent form. “Potential” does not necessarily mean “every possible risk.”
You should include risks that are reasonably foreseeable and probable, and those that may have serious
consequences even if they are less probable.
1b. Explain whether the procedures themselves could have an adverse effect on subjects, e.g., by focusing on negative feelings
or leading subjects to see themselves in a negative light. If so, describe the steps you will take to minimize these risks.
The HSRC is charged with the responsibility of insuring that the researcher has minimized the risks of harm
(e.g., physical, psychological, social, economic) to subjects.
For 1b through 1e, please describe the specific steps you will undertake to protect the rights and welfare of
your participants.
For vulnerable groups of subjects (e.g., minors, prisoners, decisionally-impaired individuals), the HSRC is
also looking for evidence that the researcher recognizes the special needs of these groups and has specific
plans for reducing the possibility of threats or harm to the rights and welfare of these subjects.
1c. Explain whether disclosure of the data could place the subjects, or groups to which they belong, at risk of criminal or civil
prosecution. If so, describe the steps you will take to minimize these risks.
HSRC 17Sept2012
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1d. Explain whether disclosure of the data could place the subjects, or groups to which they belong, at risk of emotional
discomfort, embarrassment or humiliation. If so, describe the steps you will take to minimize these risks.
1e. Explain whether disclosure of the data could place the subjects, or groups to which they belong, at risk of losing their jobs,
insurance, personal relationships, eligibility for benefit or other programs, or otherwise harm their rights and welfare. If so,
describe the steps you will take to minimize these risks.
2.
Is there any possibility that subjects might suffer physical injuries as a result of your study?
Yes
No
If Yes, state what those injuries may be and check the appropriate box below indicating who will be financially
responsible for the treatment of these injuries.
Subject or subject’s insurer
Other
3.
Study sponsor (if funded research)
CWU (attach letter of authorization)
Please specify:
Is it possible that you will discover a subject’s previously unknown condition (e.g., disease, suicidal ideation, genetic
predisposition) as a result of your study procedures?
Yes
If Yes, please explain how you will handle these situations.
No
If you intend to perform tests or administer instruments that might reveal a serious or previously unknown
condition (e.g., hypertension, suicidal ideation), please explain to the HSRC the nature of these testing
procedures and the specific conditions that might be revealed by your tests or measures.
Describe the qualifications of the person(s) who will provide information about the testing and test results to
the subjects.
If your measures might reveal subjects’ intentions to harm themselves or others, or would indicate that
some subjects are severely distressed, please explain whether you will provide additional assistance to
these subjects or whether you will refer them to other agencies for help. (If other agencies are involved, you
must attach copies of letters from those sites agreeing to accept your referrals. See next question.)
If members of your research team will provide follow-up care to these subjects, please provide information
regarding their qualifications to do so, and explain the steps you will take to protect the subjects or others
from harm.
Consent Form: The consent form should indicate the limits to which information shared by subjects is
confidential as well as the kinds of information (e.g., suicidal or homicidal ideation, child abuse) for which
the researcher may not be able to guarantee the confidentiality of the participants.
4. Who will handle unanticipated
problems?
Investigator(s)
Faculty
sponsor
Referral agencies (Attach a letter from
the agency stating they are aware of
your study and are willing to accept
referrals.)
Other
Please identify:
If you will handle unanticipated problems, please describe the training and experience you have had in handling the most
likely unanticipated events.
Describe how the researcher(s) will deal with adverse or unanticipated events (i.e., injuries to subjects,
breaches of confidentiality) that might result from the study procedures, both immediately and in the future
(if applicable).
If you intend to handle the unanticipated problems, please describe for the HSRC, your qualifications to do
so. If members of the research team will handle some of these events, but refer some types of problems,
these procedures should be described in detail for the HSRC.
If you plan to refer subjects to the Student Health and Counseling Center (or other agency), attach a letter
from them indicating they are willing to accept referrals from your study.
HSRC 17Sept2012
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Consent Form: Information about procedures for handling any likely adverse events should be provided in
the written consent form. It may also be appropriate, in some cases, for the investigator to include a 24-hour
emergency contact phone number on the consent form.
On the other hand, if adverse events are truly unlikely to occur in your study, there is no point in unduly
alarming subjects by mentioning them in the consent form.
5.
Are your research facilities and equipment adequate to handle possible unexpected events?
Yes
No
Please explain your answer.
This may be as simple as having access to a telephone in case of emergency in a survey study or as
complex as having a trained lifeguard and resuscitation equipment for a swimming study. If the
researcher’s facilities are not sufficient to handle unanticipated problems, please explain the specific steps
researchers will take should such an event occur.
Consent Form: If the researcher intends to refer participants to other sources for assistance, the nature of
these arrangements should be described in the consent form.
6.
Do you anticipate that individual subjects in each subject group can reliably expect a direct benefit from study procedures?
(Please note that receiving financial payment or extra course credit is not considered a benefit of study participation.)
No
Yes If Yes, please describe the direct benefits.
Describe the realistically anticipated benefits of participation for subjects. If there are none, this should be
stated explicitly both in this HSRC application and in the consent form.
Being exposed to a procedure (e.g. a psychological test) or being in an “experiment” in itself is not a benefit
to a subject. To be a benefit, the subject would have to receive feedback and/or some educational
information related to the experience (e.g. in debriefing).
Consent Form: The consent form should explicitly describe the anticipated benefits, if any, to subjects in
this study.
7.
Describe the anticipated benefits of this research for society.
Concisely describe the realistically anticipated benefits of your research for society.
Consent Form: The consent form should describe explicitly the anticipated benefits, if any, for society.
8. Explain how the anticipated benefits of this research project outweigh the anticipated risks associated with your study
procedures.
Members of the HSRC are responsible for determining that the risk of harm to subjects is outweighed by the
potential benefit(s) of the research for society. This is a particularly important consideration in cases where
there is little or no anticipated benefit to the subjects themselves.
Clearly state how benefits outweigh risks.
Consent Form: This information about risks relative to benefits should also be discussed in the subjects’
consent form(s).
9. Will subjects be able to receive the results of your study?
Yes If Yes, please explain how this will happen.
No
If No, explain why.
For example, “The PI will meet individually with each subject one week after their participation is complete
and will thoroughly describe all test results.” OR, “All data will be recorded anonymously and the consent
form will state that individual results will not be available, but participants may request the study results by
emailing the PI.”
HSRC 17Sept2012
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Consent Form: This information should be clearly stated in the consent form.
F.
CONFIDENTIALITY OF RESEARCH DATA
1.
Will you collect and use any direct individual identifiers (e.g., subjects’ names, student IDs, Social Security numbers,
addresses, telephone numbers)?
Yes If Yes, please explain what identifiers will be
collected and why this is necessary. Also, describe
any coding system you will use to protect against
disclosure.
No
Data will be collected via Internet
Answer 2b below as described in the
HSRC Application Help Manual,
section F.
List the identifiers to be collected. Describe how you will use them. Include information about how long you
will need to keep the identifiers.
Ideally, the researcher will not retain any direct subject identifiers (i.e., information that could be used to
identify specific subjects) after all the data are collected. If it is necessary for the researcher to retain these
identifiers in order to conduct follow-up studies or to compare different data sets, please provide the HSRC
with a rationale for the use of such identifiers in #2 below.
Consent Form: Information about the type of identifier(s) to be retained by the investigator must be
described in the consent form.
2.
Will you retain subjects’ direct identifiers or a link between identifiers and study code numbers after the data collection is
complete?
Yes If Yes, answer a-c below.
No
a.
Explain why this is necessary.
b.
Describe how you will protect study data against disclosure to the public or to other researchers or non-researchers
(e.g., coded master list stored separate from data, locked cabinet or office, restricted computer, etc.)
Describe in detail your procedures for collecting, analyzing, and storing your research data in such a
way as to guard against breaches of confidentiality. Explain who will have access to your data.
Explain your procedures for the secure storage of confidential data (e.g., password protected files,
locked file cabinets, encrypted files).
If members of the research team, including transcribers, will be required to sign a Confidentiality
Agreement, please attach to this application a copy of your confidential agreement form. (In most
cases, you will not have to get signatures on the form until after the study is approved.)
INTERNET DATA COLLECTION
For those using an Internet survey service for data collection, please complete the Internet Survey
Security Form or Security for SurveyMonkey Form, whichever is applicable.
For those using a non-survey method of Internet data collection (e.g., chat rooms, social networking
website), include where applicable:
 Information about the security and privacy measures in place by the web service you are using
(usually available at their website);
 The website’s policy on investigators using data from the site for research purposes (usually
available at their website).
On the HSRC application, section H on Informed Consent (items 4b and 4c), you will need to request a
waiver of informed consent and a waiver of documentation of consent since, in most cases, it is not
possible to get a true informed consent on-line. However, you will be expected to provide to subjects an
introductory information page that contains most of the elements of an informed consent document.
See guidance on Internet Research Issues.
HSRC 17Sept2012
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Consent Form: Please describe in the consent form(s) your procedures for safeguarding the
confidentiality of subjects’ identities and the research data.
The consent form should also describe who has access, legally, to their study-related data (see 3
below). (No separate statement is needed in the body of the consent form for faculty sponsor if s/he is
listed in the heading of the form.)
For those using the Internet for data collection, see the guidance on Internet Research Issues.
c.
Provide the estimated month/year you plan to de-link the study data from direct subject identifiers. If there is no plan
to do so, explain why.
3.
Explain who—other than members of the research team—will have access to your data (e.g., study sponsors (if funded
research), faculty sponsor, government agencies, Internet Survey sites like SurveyMonkey). In each case, specify whether
they will have access to study data with identifiers or only to coded data with no access to the identifying study code.
4.
Do you anticipate any circumstances under which you might be obliged or compelled to disclose data that could be linked
with an individual or group?
Yes If Yes, explain these circumstances and confirm that you have included
No
information about these exceptions to confidentiality in the consent process.
5.
Will you place a copy of the consent form or other study information in the subject’s medical, counseling, educational, or
other personal record?
Yes If Yes, please explain where you intend to place a copy of the consent form;
No
confirm that you have included information about the storage in the consent process.
6.
Do you anticipate using the raw data from this study for other studies in the future?
Yes If Yes, please explain, including whether data will be retained in identifiable
form and confirm that you have included information about the future use of data in the
consent process.
No
Consent Form: If you think it is possible that you will want to use data from the current study in future
research, a description of potential future uses should be included in the current consent form.
G. ADDITIONAL INFORMATION
1.
Will you need access to subjects’ medical, academic, or other personal records for screening or data collection purposes?
Yes If Yes, please specify the types of records, what information you will take from
No
the records, and how you intend to use this information.
Washington state law requires explicit written consent for research access to health care information,
therefore this information must be included on the research consent form (i.e., “We would like to review your
medical record for information regarding your health history and treatment.”) or as a separate release of
medical information form attached to the research consent form.
If you wish to inspect these records prior to obtaining subjects’ consent, you must request a “waiver of
consent” from the HSRC and, upon approval, require all members of your research team to sign a
“confidentiality agreement.”
If you are accessing “Personal Health Information” you may be subject to the requirements of the
Health Insurance Portability and Accountability Act (HIPAA).
Consent Form: If medical, counseling, or academic records will be examined in order to screen subjects,
recruit subjects, or collect study data, this information should be included on the research consent form.
HSRC 17Sept2012
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2.
Will you make audio-visual or tape recordings or photographs of subjects?
Yes
If Yes, explain (a) what type of recordings you will make, (b) how long you
will keep them, (c) what procedures you intend to use for storing them, and
(d) who, if anyone, other than members of the research team, will be able to
see or hear them.
No
If the recordings or their transcripts will be shared in any way (i.e., through publications, presentations,
classroom use) with anyone who is not a member of the research team, subjects should be offered the
opportunity to review the recording or transcript and to delete any portion they wish.
Wherever possible, subjects in recordings should not be identifiable.
Please describe your procedures for recording, transporting (if applicable), and storing these audio-visual or
taped recordings. Also report the length of time the recordings will be stored and describe your procedures
for destroying these materials at the conclusion of your study.
Consent Form: If your study procedures include audio-visual or tape records, provide this information to
subjects on the consent form. In some situations you may want to have separate consent statements for
willingness to be recorded and for willingness to allow the recording to be used in public presentations.
3.
Will your study involve use of equipment involving energy input to subjects (e.g., ultrasound, muscle stimulation unit,
etc.)?
Yes If Yes, attach documentation specifying that all equipment will be regularly tested
No
for safety and state who will test it.
If “yes,” properly trained technicians must routinely inspect all study instruments that use electricity.
Please describe the safety testing procedures you will use or the testing schedule and qualifications of the
technicians who will do this safety monitoring for you.
4.
Does any member of the research team have a financial interest in the research or its products or in the study sponsor (i.e.,
funding source)?
Yes If Yes, please include documentation that conflicts of interest have been reviewed
No
by the Office of Grants and Contracts.
Researchers with a financial interest in their projects must engage in a disclosure procedure with the
University. If you or any member of the research team has a financial interest in this investigation, please
contact the Human Subjects Review Council office for more information regarding the process for
documenting that the University has reviewed and cleared all financial conflicts of interest.
5.
Does any member of the research team have a potential non-financial conflict of interest with potential study participants
(e.g., teacher of participants or relative of participant )?
Yes
If Yes, please describe how these potential conflicts of interest will be
No
managed in order to minimize risks to subjects.
Please describe the nature of the non-financial conflict of interest (e.g., being both the classroom instructor
and researcher). Next, describe your specific procedures (e.g., using intermediaries, not looking at the data
until the quarter has ended and grades are posted) for reducing associated risks (e.g., undue influence,
coercion) to subjects.
H. INFORMED CONSENT
Informed consent is an ongoing process, not a piece of paper or a discrete moment in time. Informed consent assures that
prospective human subjects will understand the nature of the research and can knowledgeably and voluntarily decide whether
to participate. If some or all subjects are minors, see guidance on completing this section. If using the Internet for data
collection, see guidance on Internet Research Issues.
Standard HSRC procedure is that subjects will provide documentation of informed consent by signing a
written consent form.
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If there is a good reason why a different approach should be used in your study, please provide a
description of your method(s) for obtaining subjects’ consent as well as your justification for using this
procedure. For example, if you are requesting permission to use an “oral consent” procedure, you should
provide an explanation for why an oral consent process is the most appropriate course of action in your
study. In addition, you must include a copy of the oral consent statement that will be read to prospective
research participants.
In research with children, you should obtain the assent of minors after obtaining permission from their
parents or legal guardian. Assent documents should be tailored to the developmental level of the
participants in your study. Sample consent, permission and assent forms, as well as guidelines for writing
consent forms, are available on the HSRC website forms page (HSRC Forms).
Consent Forms: Consent documents should be prepared for each group in your study.
For those using the Internet for data collection: In this section, the investigator will need to request a waiver
of the entire consent document (in 4a and b) and a waiver of documentation of consent (in 4c) since, in most
cases, it is not possible to get a true informed consent online.
See Internet Research Issues for further guidance. Attach a copy of the information page that will take
the place of a consent document.
1.
Please explain how you will make sure that your subjects are legally and mentally competent to provide informed consent to
be in your study:
2.
Please explain how you will assess whether the subjects understand what you have told them about being in the study
before you accept their consent:
3.
Will all subjects in your study understand and read English?
Yes
No
If No, please list all documents that will need to be translated (e.g., consent form, recruitment materials, surveys, debriefing,
etc.). (At time of application, include the English versions of documents; HSRC will contact you for translated documents
before final approval.)
If subjects do not read, explain how you will obtain consent:
4a. Consent Materials and Procedures. An informed consent or permission process includes all the elements listed below.
Carefully review your consent document(s) for these elements. If there is a compelling reason, you may request that use of
a consent document be waived.
Request entire consent document be waived
OR
Check all elements below that are NOT included in your consent document:
A statement that the study involves research
An explanation of the purposes of the research
The expected duration of the subject’s participation
A description of the procedures to be followed
Identification of any procedures which are experimental
A description of any reasonably foreseeable risks or discomforts to the subject
A description of any benefits to the subject or to others which may reasonably be expected from the research
A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
For research involving more than minimal risk, an explanation as to whether any compensation and/or medical treatments
are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
HSRC 17Sept2012
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An explanation of whom to contact for answers to pertinent questions about
the research,
the research subject’s rights, and
whom to contact in the event of a research-related injury to the subject
A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the
subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to
which the subject is otherwise entitled
Under certain circumstances, additional elements may be required per 45 CFR 46.116
4b. If you have left out of your consent document any of the elements listed in 4a above, please answer each of the following.
All four regulatory requirements [per 45 CFR 46.116(d)] must be met in order for any element(s) to be waived.
(1.) The research in its entirety involves no more than minimal risk.
Yes
No
(2.) The waiver of informed consent will not adversely affect the rights and
welfare of the subjects.
Yes
No
(3.) It is not practicable to conduct the research without the waiver/alteration.
Yes
No
(4.) Whenever appropriate, subjects will be provided with additional
pertinent information after their participation (e.g., debriefing).
Yes
Not
Appropriate
These four questions must be answered affirmatively for consideration of a waiver of parental permission if
your study deals with individuals under the age of 18 and such a waiver is desired. Additional requirements
may be in place. Please call the HSRC office for further advice.
4c. Will you ask subjects to sign consent, assent, or permission documents?
Yes
No
If Yes, attach a copy of each consent, assent and permission form you will use for each subject group in this study.
Note: Sample consent, parent permission and assent forms, as well as guidelines for writing consent
forms, are available on the HSRC website forms page (HSRC Forms).
If No, select from below the reason(s) for requesting a waiver of signed written consent. Attach a copy of the consent form
(without signature line), information statement, script, or verbal process you will use for each subject in this study.
The research presents no more than minimal risk of harm to subjects and involves no procedures for which written
consent is normally required outside of the research context.
The only record linking the subject and the research would be the consent document, and the principal risk would be
potential harm resulting from a breach of confidentiality.
Be sure to attach all consent documents. When developing your consent documents, be sure they are
consistent and agree with what your actual procedures will be. The format of the form is less important
than the content: it can be as formal or informal as appropriate for your study. Readability level should be
appropriate to the age and education of the participants.
In research with children, appropriately label your forms as Parent Permission or Assent documents.
Please call the HSRC office for further advice if you have a complex situation.
HSRC 17Sept2012
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HSRC APPLICATION CHECKLIST
Before submitting your human subjects application to the HSRC, please review it carefully. Complete the following checklist to
ensure that you have included all necessary attachments to the HSRC application. To be complete, you must provide the original
application with signatures and all attachments. Also, you must send an electronic version of the entire application with attachments
to hsrc@cwu.edu
Required RCR Training has been completed by all investigators. Study will not be approved until all
investigators complete RCR Training.
Attach certificate if training was not completed through CWU HSRC tutorial or in class presentation.
Yes
No
Yes
No
NA
For funded research projects, provide one complete copy of the funding/grant proposal
Yes
No
NA
For thesis research, provide one copy of the introduction and methods sections
Yes
No
NA
For all projects, attach copies of written consent, permission and assent forms
Yes
No
NA
For all projects, attach copies of research materials (e.g., questionnaires, data forms). See Guidelines for
Use of Copyrighted, Licensed or Other Non-original Instruments
Yes
No
NA
For all projects, attach copies of recruitment materials (e.g., scripts, advertisements)
Yes
No
Yes
No
NA
Yes
No
NA
If grant proposal has not been reviewed and cleared by CWU Office of Grants and Contracts, attach a brief
letter of explanation
Yes
No
NA
For projects involving multiple phases or complex designs, attach flow chart(s) describing the sequence of
study procedures
Yes
No
NA
Yes
No
NA
If equitable selection of subjects will not be used, there is written justification for your exclusions.
Yes
No
NA
If other agencies or institutions will participate in recruitment or data collection activities, attach originals
of letters of cooperation from those organizations.
Yes
No
NA
If study procedures will be carried out at other institutions, attach copies of IRB approvals or the original
letters of cooperation from those institutions.
Yes
No
NA
If equipment involving energy input to subjects (e.g., ultrasound, muscle stimulation unit, etc.) will be
used, attach documentation specifying procedures for regular testing of equipment safety.
Yes
No
NA
Yes
No
All required inked signatures from Section III have been obtained
For Internet-based data collection, attach Internet Survey Security Form or other security information as
appropriate.
For projects involving deception, provide debriefing script.
If any member(s) of the research team has a financial interest in the research, its products, or the funding
source, attach documentation that these financial conflicts of interest have been reviewed by the Office of
Grants and Contracts.
Send an electronic version of the entire application with attachments to hsrc@cwu.edu
HSRC is providing a list of names of principal investigators, research titles, and approval dates via the HSRC website in the belief that the
university community benefits from the availability of this information.
I give permission to post my name, study title, and approval date on a list which is linked to the HSRC website.
I prefer not to have my name, study title, and approval date listed on the HSRC website.
If neither box is checked, your study will not be listed.
HSRC 17Sept2012
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