Inside Fletcher: Faculty

Chapter 10 - Institutional Review Board (IRB)

Instructions for Fletcher Faculty, PhDs, and Masters Students

As of October 1, 2008 all Fletcher Faculty and all Fletcher students (except PhDs) will submit their applications for exemption (or full review) from IRB to Lara Sloboda, IRB Administrator at Tufts (SBER@tufts.edu). Please go to http://www.tufts.edu/central/research/IRB/main.html  for more information on your need for going through the IRB process, forms (click on “forms”) and deadlines.

If you are applying for exemption you only have to:

PhD  Students

Fletcher PhDs will continue to submit their IRB applications for exemption to Jenifer Burckett-Picker, Director of the PhD Program. Applications for review can be submitted electronically to Jenifer.Burckett-Picker@tufts.edu.

Please see Fletcher Instructions for Securing Approval of Human Subjects Research and Sample Application below. 

Instructions for Securing Approval of Human Subjects Research Members of the Fletcher community who are dealing with Human Subjects data or who are observing or interviewing human subjects for a thesis, dissertation or other research agenda may need approval from the University’s Institutional Review board (IRB).  IRB exemption may be secured via Fletcher’s IRB representative in the manner described below.  IRB approval and/or review is not optional if humans are the subject of research.  Failure to comply with U.S. government regulations could result in the loss of federal funding to the University and potential problems in publication for investigators.

1. Please read these instructions to see if your research is classified as Human Subjects Research (HSR).  According to federal guidelines,

A Human Subject is “an individual about whom an investigator …conducting research obtains

(a)  data through intervention or interaction with the individual, or

(b) identifiable private information.”

Research is defined as “A systematic investigation designed to develop or contribute to

Generalizable knowledge.”(If you are not sure your study is HSR, see faculty advisor.)

2.  If the above definitions do not apply, then your work is not HSR and no further action is required on your part. (PhDs send JBP paragraph requesting “exclusion”.)

3.  If you are conducting HSR, but think you are eligible for an exemption under the categories in “Exemptions from IRB Review”, complete the Fletcher Human Subjects Review Exemption Form noting the exemption number which applies to you, and attach a research description and oral consent script, and CITI –SBER Education Module completion form.  If your request for exemption is approved you will be notified by via email; no further action on your part is required.

4.  If any one of your answers to questions #2-­‐4 of the HSR Exemption Form is “yes,”or your request for exemption is not approved, you must complete the Tufts IRB Protocol Application (6 pages) and  IRB Cover Sheet (2pgs) Forms (asking for either “expedited”(one IRB  member reviews it) or “full”(full IRB Board reviews it) and complete the required CITI Education Module (SBER choice) at: http://www.tufts.edu/central/research/IRB/Forms.html

Please go to Fletcher Intranet–Students-­‐IRB website for IRB forms and sample cases.

Exemptions from IRB Review

If you believe that you might qualify for an exemption from HSR, you must request the exemption.  The Code of Federal Regulations sets out the following situations where research may be exempted from regular IRB review:

1.  Research conducted in established or commonly accepted educational settings, involving normal educational practices.  An example of this would be a comparison of the effectiveness of two generally accepted instructional strategies. 

2.  Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior UNLESS the information is recorded in a manner in which the subject can be identified AND disclosure would place the subject at risk of criminal or civil liability or be damaging to financial standing, employability, or reputation.  This does not apply where the subjects are children except where it involves passive observation or public behavior. 

3.  Research involving the use of educational tests, survey procedures, interview procedures or observation of public behavior where subjects are elected or appointed officials or candidates for public office.

4.  Research involving the collection or study of EXISTING data, documents, records, or specimens if the sources are publicly available or the information is recorded by the investigator in such a manner that subjects cannot be identified directly or through identifiers or codes.  (Note: Even brief use of identifier or code disqualifies the exemption.)

5.  Research and demonstration programs designed to study, evaluate, or examine Federal public benefit or service programs.

6.  Taste and food quality evaluation and consumer acceptance studies involving wholesome foods without additives or with additives or chemicals For PhD students IRB exemption established "safe" levels.  For further information on exemption, refer to:  http://www.hhs.gov/ohrp/ and http://www.nsf.gov/bfa/dias/policy/hsfaqs.jsp#e

Fletcher Ph.D. Student Human Subjects Review Exemption Form (Research must be “minimal risk” to qualify for exempt status.  This means probability of discomfort or risk, anticipated in research is not greater than that ordinarily encountered in daily life or during routine tests.  Risk can include physical or emotional harm, as well as loss of reputation or risk of financial harm.

1.   I believe that my research is exempt from human subjects review due to exemption #__  (see Exemptions from IRB Review list).

2.  I am interviewing and/or observing pregnant women, children under the age of 18, and/or prisoners.                              YES____              NO____

3.  I will be using deception (not giving subjects’ complete information or giving misleading information) to conduct my interviews.  Yes __         No__

4.  I will be conducting experiments on the population that may have adverse physical, psycho/sociological, political and/or economic impact.  YES ____     NO____

(If your answer to # 2-­‐4 is “Yes”, you are not eligible for exempt review and must complete the Tufts IRB Protocol Application and Cover Sheet. If answers to questions   2  to  4  are  “No”,  please  attach  your “Research Description” (at least one page) that includes information  on background, objectives, subject  population and  number, recruitment process, description of how research will be conducted, how confidentiality will be maintained (and if not, why it is not necessary), justification for  exemption and why risk to participants is minimal, benefits to participants and to society (if any), conflicts of interest (if any) and  explanation of where data will be stored (and if it is identifiable,  whether  identifiers will be stored with or separate from the data as well as when identifiers would be destroyed) and who will have access to it.  Attach any questionnaires, interview instruments, recruitment documents, that will be used in English and foreign lang.

An official “Written Consent Form” is not required for exempt studies. Just write a paragraph or two explaining the oral consent process.  This informed consent” statement should explain to participants in simple English the  purpose of study, procedures, any repercussions and what they’ll be required to do. It should explicitly state that participation is voluntary and note that you’ll give them 15 minutes to decide if they want to volunteer.. Attach foreign language translation if oral consent is not in English.

Is your study funded?  Yes___ No___ If,  yes, have you filed “Conflict of Interest Disclosure” form with the Vice Provost’s Office? __Yes  __No __

Not applicable

Return this form to Jenifer  Burckett-Picker (for PhD students)

Date: _____________

Your name:   _________________________________(typed)

_____________________________________________(signature)

Program:  PhD____MALD ____ MA ____ GMAP ____ Faculty ____

Thesis/dissertation  advisor:  ________________________________(typed)

_____________________________________________________(signature)

Title of research _____________________________________________________

Research is for: Dissertation ____ Thesis _____ Other (explain)

___________________________________________________________

___Approved:  JBP Signature:_______________________Date ______

___Not Approved:  reason/action to take

 

____________________________________________________________

 

 

Deadlines for PhD submission of IRB applications to Jenifer Burckett-Picker

 

Submit by this date

Receive approval to start research by this date

August 30

September 15

September 30

October 15

October 30

November 15

November 30

December 15

December 30

January 15

January 30

February 15

February 28

March 20

March 30

April 20

April 30

May 20

May 15*

June 10

 

* Please note that there is no Fletcher review from early June to late August and so plan your summer research application so that the completed form is received by Jenifer by this date. Also note that according to Tufts IRB regulations you must receive approval before you start your research. If you miss the May 15th deadline for Fletcher review for summer research, you will need to deal directly with the Tufts IRB at http://www.tufts.edu/central/research/IRB/main.htm.