Teachers College_ Columbia University by yaofenji


									                                      Teachers College, Columbia University

                                           Human Subjects in Research

                          Request for Institutional        Review Board Approval

                          New Study Application 2011-2012

    1.   Please read the Quick Tips and Quick Reference Review Categories guides at the end of this application
         before completing the application. Please answer ALL questions on the application in the spaces below
         each question. You may expand to use more space as needed in answering each question.
    2.   Please submit one hard-copy (with original signatures) and email one electronic version of this application
         (no signatures required on the electronic version) as follows:
             o    Hard-Copy: One (1) paper-based application with original signatures and all supporting
                  documentation, assembled in the following order: (1) Application, (2) Informed Consent,
                  Participant’s Rights, Assent for Minors forms and translations, as applicable, (3) Interview scripts,
                  measurements/tools/instruments, as applicable, (4) Recruitment materials and permission letters,
                  as applicable. Please send or deliver to the IRB Office within the Office of Sponsored
                  Programs, Box 151, Room 422K Thompson Hall
             o    Electronic: One (1) PDF document [email to mbrooks@tc.edu] containing the application and
                  all of the above supporting documentation with the following exceptions:
                        NO translations of Informed Consent, Participant’s Rights and Assent for Minors Forms
                        NO permission letters from institutions or organizations
                        NO Certificates or proof of having taken Human Subjects Research training
    3.   The TC IRB now requires online training in Human Subjects Research provided by the Collaborative
         Institutional Training Initiative- CITI - for all first time applicants seeking IRB approval. Faculty, staff
         and students who have previously received approval on a study as the Principal Investigator [PI] from the
         TC IRB are exempt from the new training requirement. Please see our website www.tc.edu/irb for more

SECTION I: INVESTIGATOR: Check one: [ ] Doctoral Student [ ] Masters Student [ ] Faculty [ ] Staff [ ] Other
(Please explain) ________________________________________

Principal Investigator’s Name: (Last) ______________________________ (First) _______________________

Department: ________________________ (Students: Faculty Sponsor Name): ________________________

Address: (where you want notification sent) ________________________________________


Telephone #: Home: _____________________ Telephone #: Campus: ______________________

E-mail (preferred): _______________________________________2nd E-mail: _______________________

Date of Dissertation Proposal Hearing: _____/_____/____ (Required for doctoral dissertation research; if
you are a student doing research not related to dissertation, please explain the nature/purpose of this, such as: Pilot
Study, Pre-Dissertation/Preliminary Research, Masters Project/Independent Study Research, etc.)



Title: _____________________________________________________________________________________


        Anticipated Start & End Dates: FROM______/______/______ TO ______/______/______

Please note: No work with subjects may begin prior to approval by the IRB


Has this project been submitted for external funding? [ ] Yes [ ] No -- If yes, complete below:

What kind of funding will this project receive? [ ] None [ ] Grant/Contract [ ] Fellowship

Principal Investigator on Project: ________________________________________ Ext.________________

Funding source: __________________________________________TC Index # if applicable:___________

Project Title: ___________________________________________________________________

Are the contents of this protocol identical to those described in the funded proposal application? [ ] Yes [ ] No


Please see the Review Categories at the end of this Application (also located on our website: www.tc.edu/irb) and
indicate the type of review you are requesting: Exempt, Expedited or Full Committee. If you select either
Exempt or Expedited, circle the number of the review category that best fits your research. Final decisions about
the appropriate level of review rest with the IRB. Submit to the IRB One (1) ORIGINAL paper-based
Application + One (1) PDF version per Instructions at the beginning of this Application.

____ I am requesting an EXEMPT REVIEW under category: 1 2 3 4 5 6

____ I am requesting an EXPEDITED REVIEW under category: 4 5 6 7 8 9

____ I am requesting a FULL COMMITTEE REVIEW because my research does not precisely apply to any of
the categories specified in the EXEMPT or EXPEDITED review categories.

PLEASE NOTE: Applications that qualify for a FULL COMMITTEE review must be received at least 10
working days before the IRB Committee meeting date. Check the IRB web site for a listing of IRB Committee dates
and application receipt deadlines. Applications that qualify for Exempt or Expedited review are reviewed on a
rolling basis, in the order in which they are received.

SECTION V: SIGNATURES [Required for hard-copy submissions only]

INVESTIGATOR: I accept responsibility for the research protocol described herein. I am aware of all the
procedures to be followed & I will monitor the research & notify the IRB of any CHANGES or significant
problems. Further, I certify that I have undergone training in basic human subjects protections.

Principal Investigator’s Signature: _____________________________________ Date: ______/______/______

I have completed the required training in Human Subjects research: ____on-line ____workshop ____other
NOTE: Proof of completion must be attached to application.

FACULTY SPONSOR (Required for student research): I accept responsibility for the research protocol
described herein by the student/investigator working under my direction. I further attest that I am aware of all
procedures to be followed, will monitor research & will notify the IRB of any CHANGES or significant problems. I
certify that I have undergone training in basic human subjects protections.

Faculty Sponsor’s Signature: ________________________________________ Date: ______/______/______

Print Faculty Sponsor's Name: ____________________________________________


Fill out this section if additional investigators or research assistants will work on this project. Attach additional
pages if necessary.


[ ] Doctoral Student [ ] Masters Student [ ] Faculty [ ] Staff [ ] Other _______________

Name: (Last) ___________________________ (First) _____________________________

Department: ______________________________________________

Telephone#: ___________ E-mail: ________________

        Signature_________________________________ Date: ______/______/______

By signing above, I certify that I have undergone CITI or other training in basic human subjects research
protections, and will conduct my work on this project according to established ethical principals and the protocol
outlined in this application. Proof of training must be attached to application, if not done through TC’s CITI
program or affiliated with TC’;s CITI program (see our website www.tc.edu/irb for more information.).


[ ] Doctoral Student [ ] Masters Student [ ] Faculty [ ] Staff [ ] Other _______________

Name: (Last) ___________________________ (First) ____________________

Department: ________________________________________

Telephone#: ___________

E-mail: ________________

      Signature_____________________________________ Date: ______/______/______

   By signing above, I certify that I have undergone CITI or other training in basic human subjects research
   protections, and will conduct my work on this project according to established ethical principals and the
   protocol outlined in this application. Proof of training must be attached to application, if not done through
   TC’s CITI program or affiliated with TC’s CITI program (see our website www.tc.edu/irb for more

If you have more than 2 Additional Investigators, please cut and paste in order to add
sections or to attach additional pages


Please answer each question in the space below it


1. Who will your potential subjects be? Please check the subject population/s that
   will be involved in the research project:

[ ]Adults (competent to consent)

[ ]Adults (not competent to consent)

[ ]Minors (under 18 years old)

[ ]Prisoners

[ ]Pregnant Women

[ ]Developmentally Disabled [Please be specific about the population/s in the area below]

[ ]Non-English Speakers

2. Please describe their anticipated age range, gender, race/ethnicity (if applicable)
   and/or any important characteristics:

3. Please describe the purpose of your research. Provide relevant background
   information and scientific justification for your study. You may provide
   citations as necessary.

4. Federal guidelines state that research cannot exclude any classes of subjects
   without scientific justification. Will your study purposely exclude any classes
   of subjects (e.g. by gender, class, race or age)? If so, please justify.

5. Please state your research question (in one or two sentences, if possible).

6. Please describe the specific data you plan to collect and explain how data and
   the subjects you choose will help to answer your research question/s.


7. Please describe your recruitment methods. How and where will subjects be
   recruited (flyers, announcement/s, word-of-mouth, snowballing, etc.)?

8. Are you recruiting subjects from institutions other than Teachers College? If
   so, documentation of permission or pending IRB approval from the institution/s
   is required with this submission.

9. How many subjects are you planning to recruit?

10. Please describe what activities your subject will be engaging in (e.g. surveys,
   focus groups, interviews, diagnostic procedures, etc.). [PLEASE NOTE: If you
   are collecting any private medical information from your subjects, please see our website
   www.tc.edu/irb under Forms and Guidelines for the HIPAA consent document.]

11. How long will your subjects participate in this study (duration of activities and
   overall duration of study)? Please provide more detailed description, charts,
   etc. if needed for clarification, and indicate all that may apply:
            Single event lasting ____ # of minutes, hours, days (please circle)
            Multiple event participation over ____ # of (days, weeks, months)
              (please circle) If so, please describe activities briefly (e.g. pre-test,
              intervention, post-test, etc.)
            Expected total time participating in study _____( days, weeks,
              months) (please circle)
            Follow-up? Y/N __ If yes, after what period of time?

12. Where will your research take place specifically (e.g., in classroom, outside of
   classroom, waiting room, office, other location)?

13. Will subjects be remunerated for their participation? If, so please describe.
   [PLEASE NOTE: If using a lottery system, please remember to state odds of winning in
   consent form].

14. Will deception be used? If so, please provide a rationale for its use. How will
   subjects be debriefed afterward? Submit debriefing script. Scripts should
   include a statement that gives your subjects the opportunity to withdraw their
   participation at that time. [PLEASE NOTE: studies involving deception are given Full
   Board Review unless the deception is minor and risks are minimal].

15. Will you have a control group? Please describe your procedures and explain
   the purpose of using a control group.

16. Will you be videotaping your subjects? If so, please describe in detail.
   [PLEASE NOTE: The IRB will only approve videotaping when there is adequate scientific
   and ethical justification].


17. How will you ensure the subjects’ confidentiality? Describe in detail your
   plans for ensuring confidentiality of data regarding subjects. [PLEASE NOTE: If
   you will be remunerating subjects after their participation, please make it clear if and how
   you will link their names/contact information confidentially to their compensation].

18. If you will be audio/videotaping, please state how you will ensure that subjects
   have consented to being recorded, and if some subjects do not consent to being
   recorded, explain how you will protect their confidentiality. (This must also be
   clearly stated in your consent form/s).

19. Will data be collected anonymously? Will you be able to link the data? If
   data will not be collected anonymously, how will subjects’ identity/ information
   be protected? (e.g. codes, pseudonyms, masking of information, etc.)?

20. Where will coding and data materials be stored (e.g. ‘in a locked file cabinet in
   the Principal Investigator’s home or office’)?

21. Will you need bilingual interpreters or interviewers, and if so, what will you do
   to ensure confidentiality of the subjects? What are your procedures for
   recruiting interpreters/interviewers? Indicate the name of the
   interpreter/interviewer and for whom he/she works. Submit copies of all
   questionnaires or interview questions for each subject population.


22. What are the potential risks, if any, (physical, psychological, social, legal, or
   other) to your subjects? What is the likelihood of these risks occurring, and/or
   their seriousness? How will you work to minimize them? [PLEASE NOTE: The
   IRB regards no research involving human subjects as risk-free. You may describe minimal risks for
   your study (such as discomfort, boredom, fatigue, etc.), or state that the research will involve minimal
   risk, similar to an activity (named) like that which participants will perform as part of your study.]

23. What are your plans for ensuring necessary intervention in the event of a
   distressed subject and/or your referral sources if there is a need for
   psychological and/or physical treatment/assistance?

24. What are your qualifications/preparations that enable you to estimate and
   minimize risk to subjects?

25. What are the potential benefits of this study to the subjects? If there are direct
   benefits, please describe. If there are no direct benefits, please simply state
   this. You may note benefits that may be possible from your research, but you
   cannot promise a result of your study as being a benefit. Remuneration or any
   incentive or reward for participation is not considered a benefit.

   INFORMED CONSENT PROCEDURES (Please use the templates on the
   IRB website http://www.tc.edu/irb in preparing your consent form/s, and note
   that Informed consent is a process, not a form).

26. What are your procedures for obtaining subject’s informed consent to
   participate in the research?

27. How will you describe your research to potential subjects? [Please note: if
   working with a population under eight (8) years of age, a script is necessary.]

28. What will you do to ensure subjects’ understanding of the study and what it

29. If you are recruiting students from a classroom during normal school hours,
   what will the alternative activities be for those who wish not to participate?
   (This should also appear in your consent form/s)

30. Are you a teacher, administrator, counselor, case worker or in any other way
   affiliated with the research site? If so, how will you insure voluntary
   participation and minimize the appearance of coercion or undue influence in
   your study?

   Submit all consent forms/scripts, using the template on the IRB website. Drafts
   of consent forms will not be accepted. Each consent form must be a separate
   document and titled for its respective subject population (e.g. teachers, parents,
   etc.). All consent documents must be in English, even though you may translate
   them. All consent documents should be printed on Teachers College
   letterhead or include the name and address of the college, per the online
   Informed Consent and Participant’s Rights templates. If your research
   project requires using documents that are translated into other languages, please
   submit both the translated English version AND the translated document with
   your application.

   You must sign and date the document. TC strongly urges investigators to use
   back translation (translation into the target language and back into English) as a
   method of ensuring the translation’s accuracy. Revised consents will also need
   to be translated.

31. Use this section to provide a request for a full or partial waiver of informed
   consent. Please see the following link at the OHRP for further information:


32. Where will research be conducted? If you are conducting research or any part
   of your study, or recruiting subjects from schools or other institutions, approval
   must be obtained from the appropriate administrator, IRB, or representative of
   that institution. Submit the letter(s) of approval or letter(s) indicating that
   approval has been granted "pending the receipt of TC IRB approval.”

NOTE: If you are conducting any part of your research within NYC
DEPARTMENT OF EDUCATION [DOE] Schools: It is required that you
receive approval from TEACHERS COLLEGE prior to submitting to the
NYC Board of Education’s Division of Assessment and Accountability.
Applications are available on the TC Web at: http://www.tc.edu/irb

Please attach Informed Consent, Participants’ Rights and Assent for Minors,
Recruiting materials, survey materials, etc as appropriate.

                Some Quick Tips for completing your IRB Application
Please note: There is a wealth of information about doing research involving human subjects on the U.S.
Department of Health and Human Services website for the Office for Human Research Protections (OHRP) at:

Please proof-read your application and documents for grammar and spelling errors, avoid the use of
jargon or highly technical terms and write the full name of any acronym the first time you use it.
The IRB makes a distinction between the words ‘anonymous’ and ‘confidential’ in terms of research.
An anonymous study would mean that no identifying information would be collected and subjects
would not be known to the researcher/s. A study involving interviews or any contact between
subject/s and researcher/s cannot be considered anonymous, but can be considered confidential if
measures are taken to protect subjects’ identities and de-couple personal identifiers from collected
data (e.g. through the use of codes or pseudonyms throughout the research process).
RISKS: Focus groups
Any study which involves using a focus group is currently required to go through an Expedited Review.
There is an inherent risk in using focus groups, since individuals will know each other and will be sharing
personal opinions or information. You should explain how you will work to minimize such risk and state
that confidentiality cannot be guaranteed, on your Informed Consent form/s.
RISKS: Small pool of participants
If your study will draw from a small group of participants and you are requesting information that may
identify certain members of this community, you should clearly state the risk on your Informed Consent
form/s and explain how you will minimize this risk [e.g. by aggregating data or by disguising, masking or
not including identifying information in any final or published materials).
Please do not overstate the benefits of your study, as this can be considered coercive if it sounds like you
are trying to ‘sell’ your study to potential participants. A potential direct benefit should refer to a
personal or specific benefit that a participant may gain by participating in a study. If there are no direct
benefits to participation, you should state this on your Informed Consent form/s. Potential general
benefits of a research study may be (briefly) described as indirect benefits.
If your study involves any potential issues of coercion or undue influence, these should be clearly
addressed on your Informed Consent form/s, and you should include a statement that participation is
voluntary and that subjects may refuse to participate or withdraw from the study at any time with no
negative or positive consequences in terms of student grades, class standing or other entitlements.
EXEMPT Studies: Informed Consent
Exempt research is not subject to federal regulations but the IRB strongly recommends that you provide
participants with the basic elements of Informed Consent: describe the research and procedures involved
in your study, the risks, benefits, how confidentiality will be protected and state that participation is
voluntary and participants may withdraw from the study at any time without penalty. Contact
information for the PI and the TC IRB office should also be provided (per Participant’s Rights template).
EXEMPT Studies: Category #4
If you are claiming this exemption (Research involving the collection or study of existing data,
documents or records), answer all questions on the application, even if you only indicate ‘Not
applicable’, but answer any question relating to your study in order for the IRB to understand the
purpose of your research and your research questions. Please state whether your data includes
identifiers that can be linked to subjects, provide information about the source of your data, note
if it’s publicly available or provide proof that you have permission to use the data.

                               Categories of IRB Review--Quick Reference

EXEMPT RESEARCH - Constitutes no more than minimal risk AND only involves human subjects in one or
more of the following categories:

1. Research conducted in established educational settings, involving normal educational practices, such as: (i)
research on education instructional strategies or (ii) research on the effectiveness of or comparison among
instruction techniques, curricula, or classroom management methods.
2. Research involving the use of (a) educational tests (cognitive, diagnostic, aptitude, achievement); (b) surveys,
interviews, or observation of public behavior* UNLESS (i) information is recorded with identifiers linked to
subjects and (ii) subjects' responses could place subjects at risk (e.g., criminal or civil liability, financial standing,
employability or reputation).
*No exemptions are allowed under (b) when children are involved in survey/interview procedures, or observations
when investigator participates in activities being observed.
3. Research involving educational tests, surveys, interviews, or observation of pubic behavior is exempt if: (I) the
subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute requires
confidentiality of identifiable information to be maintained permanently.
4. Research involving the collection or study of existing data, document, or records. Sources must either be publicly
available or information must be recorded by the investigator in such a manner that subjects cannot be identified,
directly or through identifiers linked to subjects.
5. Research conducted by or subject to the approval of federal department or agency heads and designated to
evaluate possible changes in or alternatives to those programs or changes in methods of payment for benefits under
those programs.
6. Taste or food quality evaluation involving wholesome/safe foods.
Note: Federal regulations indicate that certain research is exempt from review. However, under Teachers College's
Policy for the Protection of Human Subjects, a research protocol proposing the use of human subjects must be
submitted to the IRB to determine if it qualifies for exempt status. Exemptions do not apply to research conducted
on pregnant women, prisoners, or vulnerable populations.

EXPEDITED RESEARCH-- Constitutes no more than minimal risk AND only involves human subjects in one or
more of the following categories:

4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely
employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are
employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness
of the medical device are not generally eligible for expedited review, including studies of cleared medical devices
for new indications.) Examples: (a) physical sensors that are applied either to the surface of the body or at a distance
and do not involve input of significant amounts of energy into the subject or an invasion of the subjects privacy; (b)
weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography,
electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography,
ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular
strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and
health of the individual.

5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be
collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this
category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This
listing refers only to research that is not exempt.)

6. Collection of data from voice, video, digital, or image recordings made for research purposes.

7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception,
cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or
research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or
quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations
for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not

8. Continuing review of research previously approved by the convened IRB as follows:
(a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed
all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
(b) where no subjects have been enrolled and no additional risks have been identified; or
(c) where the remaining research activities are limited to data analysis.

9. Continuing review of research, not conducted under an investigational new drug application or investigational
device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and
documented at a convened meeting that the research involves no greater than minimal risk and no additional risks
have been identified.

Note: Expedited review categories 1-3 apply to biomedical research not typically conducted at Teachers College,
and consequently do not appear on this list.


If your project does not precisely fit under any of the categories under either the EXEMPT or EXPEDITED review
sections listed above, then it must be submitted under STANDARD review procedures. Standard Review is used for
all projects involving vulnerable populations, except some minimal risk research involving children. Research
involving deception and any research that entails more than minimal risk to the subject, even if it otherwise appears
to fall into one of the exempt or expedited categories, must be submitted under standard review procedures.


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