Working With Human Subjects

A Questionnaire-Based Study H-100 Form

Application for Human Research Review H-100

Colorado State University

 

 

This information will assist you in applying for approval to use human participants for research under Colorado State University’s auspices. All of the information is available on the Regulatory Compliance Web page, http://www.research.colostate.edu/rcoweb.

1.      Instructions

Under the Federal Policy for the Protection of Human Subjects, Federal Register, V. 56, No. 117, June 18, 1991, and later amendments, Colorado State University’s Human Research Committee (HRC) is required to review and approve all proposed research involving humans that is conducted under the University’s auspices. Approval is required regardless of funding status or sponsorship. Our campus policies are affirmed to the federal government in a document titled “Federalwide Assurance of Compliance with DHHS Regulations for Protection of Human Research Subjects” (1996, copy available on the Web page or by request).

The main considerations and responsibilities of the HRC are to determine that

a.      the potential risks to research subjects are adequately addressed and their confidentiality is assured.

c.      the proposals are clearly planned and the risk/benefit ratio to the subjects is clearly articulated and acceptable.

Philosophically, the HRC believes that investigators who use humans in their studies have a fundamental ethical responsibility to inform the participants of the nature of the investigation and obtain informed consent for participation in the studies. The procedure for obtaining informed consent may differ from one study to another, but using a carefully considered procedure has the advantage that it will reduce problems for the investigator in the future. Participants who have a clear understanding of the extent and purpose of their role in a study are less likely to have complaints about the investigator and the study. The fundamental right of individuals to be informed of their role in research should not be violated by investigators, and should be of particular concern to all involved in conducting research involving human participation. Failure of even one researcher to abide by ethical guidelines could jeopardize the future right of everyone at the University to conduct research.

The Administrator for the HRC is a staff person (see below) with the Regulatory Compliance Office, located at 410 University Services Center. All inquiries, correspondence, and submissions should be directed there. 

 

A current copy of the curriculum vitae of the Principal Investigator must be on file in the Administrator’s office. If you have submitted a vitae since July 1 of this year, you do not need to include it with this application.

 

If this project is being conducted for a graduate degree, the student’s faculty advisory committee should approve it before it is submitted to the HRC. The faculty Principal Investigator will receive the original review and approval documentation; the student will receive copies through his/her campus department address. Renewal documents will be sent to the Principal Investigator only, since the student typically has graduated. It is the responsibility of the Principal Investigator to retain records and report the status of the project for renewal or close-out.

 Data from human subjects are not to be collected until approval is received from the Human Research Committee.

Training of the PI:

A protocol may be reviewed, but not approved, until the Principal Investigator has successfully completed one of CSU’s human research protection training options and met any continuing education requirements. This became a requirement with CSU’s 2001 Federalwide Assurance. Details about training are linked from the human research web site at www.research.colostate.edu/rcoweb.     

 

How to proceed:

1.       Become familiar with this packet. Consult other links on the Human Research web page (FAQ and tips especially).

2.       Complete Parts A, B, C & D. This must be done for all types of review. Include all necessary attachments.

3.       Preliminarily determine the type of review for which your project would qualify (the final determination rests with the HRC and any project may be referred to the HRC for full review at a regularly convened meeting). If you have questions about the type of review for which your project will qualify, call the HRC Administrator in the Regulatory Compliance Office (see below).

 

          Exempt Review:  See Exemption Criteria. Submit anytime. Submit the original application.  Keep a copy for yourself. Reviewed by one reviewer. Response in approximately 10 days.

 

          Expedite Review:  See Expedite Criteria. Submit anytime. Submit the original application and one entire copy (but only one copy of the proposal/prospectus and résumé). Keep a copy for yourself. Reviewed by two reviewers. Response in approximately 14 days.

 

          Full Review:  Every other type of activity.  Submit by noon on second Thursday of every month.  Submit the original application and 13 entire copies (but only one copy of the proposal/prospectus and résumé). Keep a copy for yourself. Reviewed by full HRC at regular monthly meeting on the third Thursday of every month.  Response is within 10 business days after committee meeting.

 

Remember:  Each application set represents your project to the HRC reviewer. It must be complete.

 

Submit application and copies to: 

                        HRC Administrator 

                        Regulatory Compliance

                        410 University Services Center

                        Campus 2011

 

After review, you will receive an e-mail or printed determination notice (copy to the student co-PI via campus mail to the department) outlining the reviewers' concerns.  Once the concerns have been satisfactorily addressed, a written approval notice will be sent to both the researcher and the student Co-PI.  Federal certification forms will be provided if the project is being submitted for funding to a federal agency requiring such forms (USDA, NIH).

 

Recognizing every situation has unique characteristics, please do not hesitate to call the Administrator if you have questions or concerns:  Janell Meldrem, HRC Administrator.  Telephone:  970-491-1655  FAX:  970-491-2293  E-mail:  janell.meldrem@colostate.edu.


 

2.   Forms to be completed:  Application to Use Human Subjects H-100

Part A:  Cover page.  

Part B:  Research Project Review Summary.

Part C:  Protocol information, to be typed on your word processor in Word.  Every question must be answered, even if "not applicable."

Part D:   Special requirements/attachments checklist. Don’t forget a copy of the entire proposal or prospectus.

 

3.      Helpful information All of these are available separately on the HRC Forms web site.

      a. Exempt criteria

b. Expedite criteria

c. Risks of common procedures (focus groups, blood draws, etc.)

d. Definitions

e. Elements of a consent form

f. Model consent form.  If your project will require a consent form, remove the italics, bracketed

         text from this model and add project-specific information to produce a consent form that is    

         typically suitable for a routine project.

 

For best results, save this as a file to your computer. If bullets or different formatting are needed, unprotect the file.

Office Use Only:  HRC Tracking number:  _____________

Type of Review:  ? Exempt   ? Expedite   ? Full     Category #_______        PI Trained  Y ?   N?

 

APPLICATION FOR Human subjects research review

COLORADO STATE UNIVERSITY

(Please type or electronically fill)

 

Complete the cover page, review summary, and sections A, B, C & D. For full review protocols, submit the ORIGINAL (with original signatures and copy of proposal/dissertation/thesis) and 13 copies (each with attachments except proposal/dissertation/thesis) to Regulatory Compliance Office (RCO), 410 University Services Center, Campus Delivery 2011. Assistance is available on the RCO web site at http://www.research.colostate.edu/rcoweb

 

H-100 COVER SHEET  Part A

Project Title (identical to proposal or thesis/dissertation): Community Based Writing Journals: Principles and Practices

OR

Grant Title if different from Project Title:      

 

Contact Information

 

Principal Investigator (PI):

Name: Dr. Tobi Jacobi

Department: English

 

Campus Mailing Address & Mail Code:   359 Eddy Hall

 

Phone #: (970) 491-3344

E-Mail Address: tobi.jacobi@colostate.edu

 

 

Co-Investigator (attach information if more than one Co-PI):

Name:  Renee Rallo

 Department: English

Campus Mailing Address & Mail Code:  359 Eddy Hall

 

Phone #: (970) 221-1521

E-Mail Address: rrallo@lamar.colostate.edu

 

 

Funding Source:  n/a

 

PASS #:

n/a

Proposed Start Date (may not precede approval date):       

OR

X  “Upon HRC approval”

If Co-PI is a student, is this project for a:

 X thesis    dissertation    other

 

I think this qualifies for the following type of review:

 Exempt    Category number          (submit original)

Expedite  Category number  7   (submit original & one copy)

 Full Review (submit original & 13 copies)

New Protocol                              YES X      NO

Resubmission                            YES      NO

Follow-up to 118 request         YES      NO  

 

 

                                                                                                                               

As the PI submitting this proposed research and signing below, I agree to conduct the research involving human subjects as presented in the protocol or modifications to it and as approved by the Department and the Human Research Committee;  to obtain and document informed consent and provide a copy of the consent form to each subject unless this is waived by the HRC; to present any proposed  modifications in the research to the HRC for review and approval prior to implementation; to retain records for the mandated lengths of time; and to report to the HRC any problems or injuries to subjects.

 

PI Signature:   _____________________________________________ Date:  __________________

 

 

My signature below confirms that I have read this protocol and approve of this research.

 

Department Chair/Head  or  Acting Signature

 

Signature:____________________________________________           Date:  ___________________

(If PI is Department Head, please have alternate/designee sign)


 PART B.  RESEARCH PROJECT REVIEW SUMMARY  Your completion of the following checklist will facilitate the review process.

 

1.     SUBJECT POPULATION:  (Check all appropriate boxes.)

 Healthy adults  X                                                       Children or minors (<18)

 Institutional residents                                             Cognitively or psychologically impaired

 Elderly                                                                      Pregnant women or fetuses           

 Prisoners or parolees                                            Non-English speaking

 

2.     If the research involves any of the following, check the appropriate boxeS:

 Interview                                                                  Survey/questionnaire      

 Clinical studies                                                       Behavioral observation   

 Investigational drugs                                             Investigational devices

 Deception                                                                Waiver of consent            

 Study of existing data                                            Controlled substances

 Study of human biological specimens              Microorganisms or recombinant DNA

 Venipuncture                                                           Genetic research              

 PI or Co-PI is the treating physician

 

3.     LOCATION(S) OF RESEARCH TO BE CONDUCTED AT:

         CSU campus                                                           Other locations, specify: Questionnaires will be mailed and will be completed by respondents and mailed back.

 

4.       INFORMED CONSENT OF SUBJECTS:  Your study protocol must clearly address one of the following areas:  (justification for #2 & #3 must be included in your application) Discuss details in purpose section, (question If).

 

  INFORMED CONSENT:  Signed informed consent is the default. A model consent is available on the HRC website and should be used as a basis for developing your informed consent document.  If applicable, the proposed consent must be submitted with the study protocol.  http://www.research.colostate.edu/rcoweb/hr/hr_forms.htm

 

  COVER LETTER:  You may request a waiver of documented informed consent under the following conditions: (1) That the only recording linking the subject and the research would be the consent document and the principle risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; (45CFR46.117c1), OR (2)That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent if normally required outside of the research context. (45CFR46117c2).

 

It is the responsibility of the investigator to:  a) provide clear justification for how a

project meets the criteria for waiver of documented informed consent under one of the

two previous categories, and b) provide what will be used to inform the subjects about research activities.  It may be a telephone or verbal script, a cover letter, or some other means.

 

The cover letter needs to be sent to the subjects and to the HRC on CSU departmental letterhead.

 

  NO INFORMED CONSENT: You may request a waiver of informed consent under the following conditions: (1) The research involves no more than minimal risk to the subjects; (2) the waiver or alteration will not adversely affect the rights and welfare of the subjects; (3) the research could not practicably be carried out without the waiver or alteration; and (4) when appropriate, the subjects will be provided with additional pertinent information after participation (45CFR46.116d).

 

      It is the responsibility of the investigator to:  a) explain how a project meets all four of the criteria for waiver of informed consent and b) where applicable, provide an alternate form of sharing study information with prospective subjects (i.e., a public service announcement, or a modified version of a consent to be used in research that by design requires deception – this type of research requires an accompanying debriefing form that completes the informed consent process).

 


PART C.  RESEARCH PROTOCOL:   

 

I.     PURPOSE, METHODS, AND PROCEDURES:  Describe the following:

a.       Purpose (will be used in assessing the risk/benefit ratio for subjects. The hypothesis to be tested may be listed.)      

b.      Research methods and procedures of the study. (It is OK to diagram complex designs.  Please include information on the time commitment required for each activity.)      

c.       Variables to be studied (what is being measured or examined).      

d.      Describe equipment used with subjects, if any.      

e.       How will subject confidentiality or anonymity be maintained? If a linked list is used, list when it will be destroyed. Provide a sample of the code that will be used.      

f.        Describe the consent process and method of consent to be used. (signed consent, cover letter, other)      

g.      How will research records be maintained during and upon completion of the project? (This may include audio or videotapes). Indicate when the records and/or tapes will be destroyed. Federal Regulations require that study data and consent documents be kept for a minimum of 3 years after the completion of the study by the PI; for longitudinal projects, a longer period may be needed.

     

h.      Address how you will monitor this study to ensure that the study is being conducted according to the protocol.       

i.        Is a Data Safety Monitoring Board required to conduct such monitoring?    YES       NO 

If yes, the HRC may request copies of the reports.

 

II.      SUBJECT SELECTION:  Indicate the following (this section must also be completed for secondary data analysis):

a.       How will subjects be recruited and where will the recruitment take place? (submit recruitment material)      

b.      If secondary data analysis is being conducted, please describe the original consent procedures.      

c.       What are the characteristics of the subject population? (age, gender, student, disease conditions, behavioral abnormalities; affiliations or memberships)      

d.      How many subjects do you plan to study?       

e.       Address the inclusion and exclusion criteria. Federal regulations consider minors, pregnant women and prisoners vulnerable populations that require added protection. When vulnerable populations are involved, describe why they are necessary. Excluding any group, i.e., minors, elderly, gender, ethnic minorities, must be clearly justified and inconvenience can’t be the reason. For example, if minors are in a classroom where recruitment will take place, parental permission must be obtained or justification must be made to exclude the minors.       

f.        Will subjects be compensated for participation?  If so, please describe the proposed compensation.      

g.      Criteria for excluding participants involuntarily (such as “failed to keep food diary as required”)      

h.      Letters of agreement/approval from the organizations that will be recruiting subjects for the project will be needed. Such letters need to be initiated by the organization, on organization letterhead, and signed by a person authorized to do so. The letters need to include statements a) that the organization is familiar with the scope of the project, b) that it is satisfied the individuals it is involving are adequately protected as human research subjects, c) that the subjects’ participation is completely voluntary, and d) identify what the organization’s involvement will entail.

 

III.    RISKS AND DISCOMFORTS:

a.       Describe any potential risks to subjects and assess the likelihood and seriousness of those risks. (If there are no known risks, state as such, but do NOT respond “NA”.) These could include:  physical, psychological trauma or stress, legal, social, economic, loss of confidentiality.      

b.      Please describe the proposed methods to minimize the risks and discomforts associated with the research. For example, document how potential psychological distress will be addressed, by whom, and with what credentials (provide letter of agreement from counselor explaining their role – this must be someone other than the researchers on the project) Specify what factors will lead to stopping procedures causing physical or emotional stress.      

c.       If the methods of research create potential risks, describe other methods, if any, that were considered and why they will not be used.      

d.      Address procedures for maintaining confidentiality if a breach of confidentiality represents a risk.      

 

IV.  ADVERSE EVENTS:  Explain your reporting mechanism for reporting adverse and serious adverse events to the HRC.      

 

V.  BENEFITS:  Describe the anticipated benefits of the research to the individual subjects, to the particular group or class from which the subject population is drawn. The benefits must be realistic and not overly stated of what each person is likely to gain from the research. If there is no direct benefit to the subject, state so. For example: “There is no known benefit in participating in this study, but we hope you will gain more knowledge on…”  Compensation, payment for participation, gifts, etc., are NOT benefits.      

 

VI. Other matters pertinent to the human participant.      

 

 

 

Part D.   SPECIAL REQUIREMENTS/ATTACHMENTS CHECKLIST: For the items below, check where applicable and include with your protocol submission. Items marked “required” must accompany an HRC protocol application or the project can not be approved.

 

Research Proposal Materials

  Grant proposal (if this is a funded project, this is required)

 X Thesis/dissertation methods (if the project is a thesis or dissertation, this is required)

  CV  (If this is a first time submission as PI, this is required. A current copy of the curriculum vitae of the PI must be on file in the Administrator’s office. If the PI has submitted a vitae since July 1 of the current year, the PI does not need to include it with this application).

 

Research Instruments/Tools

  X Informed Consent, or

  X Cover letter (with justification for waiver), or

  Justification for waiving informed consent

  Interviews (phone or in person) - attach script if applicable and questions to be asked. 

  X Surveys/questionnaires - attach surveys and questionnaires if applicable.  Provide permission use for instruments (whether copyrighted or public domain)

  Focus Groups: attach introductory script to the group and sample questions. (describe in consent form what a focus group is)

  X Recruitment materials:  Advertisements, press releases, in-class announcements, posted flyers, e-mail announcements, phone script, or other forms of recruitment.

  X Debriefing Materials

 

Research Collaboration/Support Materials

  IRB approval from other institutions involved in research (collaborating university, hospital, etc.)

  Letters of cooperation from participating sites that do not have an IRB.

  Letters of agreement  (i.e., from a site that is allowing you access, but is not directly involved in research, or a colleague allowing you to recruit from a class, a clinic or business allowing recruitment, etc.)

  Letter of collaboration from a counselor if needed.

Secondary Data Analysis (for research involving secondary data analysis, include original IRB approval and informed consent)

  IRB approval from collaborating organization

  Consent form from original data analysis

 

 

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