hints by nuhman10


									                                     IRB Helpful Hints
 Do I Need To Submit to the IRB? The IRB only has jurisdiction over research involving human
  subjects/participants. Visit this page http://www.fau.edu/research/researchint/irbabout.php for
  assistance in determining whether you need to submit an application to the IRB and if you are doing
  research involving human subjects.

 Student Research vs. Class Project.
  Student Research refers to human subjects research conducted by students in pursuit of an Honor’s
  thesis, Master’s thesis, dissertation, DIS, or other similar research. Student research projects should
  be submitted to the IRB and be actively monitored by the Responsible Principal Investigator.

   Class Research refers to students’ involvement in course activities that are primarily intended to teach
   them how to conduct human subjects research, rather than contribute to generalizable knowledge.
   Results of these activities are generally not published or disseminated outside of an instructional
   setting. *In most cases, class research does not need to be reviewed by the IRB. If at a later point,
   you decide to continue a class project as a research project, submit an IRB application for review and

 Online Research Projects. For research conducted via the internet, include a copy of the consent that
  will be displayed online and note that the participant chooses to participate by clicking the “agree”
  button. The participant should also certify that they are at least 18 years of age or older. On the IRB
  application, briefly describe the website and who administers it, as well as how data security will be
  maintained. A statement should be included in the Data Collection and Storage section of the consent
  that addresses the limitations of maintaining confidentiality of online information. (e.g., “Every effort will
  be made to keep your personal data confidential however, as with any online transaction, the ability of
  the data to be tracked to a specific computer is always possible.”

 Types of Review & Deadlines.
  If you check Category A or B in Section 1, your application qualifies for expedited review and you may
  submit it to the IRB office at any time. You do not need to submit the application by a specific deadline.
  If the Board determines that your application does not qualify for expedited review, you will be
  contacted and your protocol will be assigned to the next scheduled meeting. Please allow 4-6 weeks
  for the IRB review process.

   If you check Category C in Section 1, you are stating the protocol is greater than minimal risk, and it
   must undergo the Full Board review. IRB meetings are scheduled monthly and you must submit
   Category C applications by the published deadline. The IRB meeting schedule is posted at
   http://www.fau.edu/research/researchint/irb_meetings.php Please allow 4-6 weeks for the IRB
   review process.

 Study Start Date. When submitting a new protocol application, the proposed start date of the study
  should not be less than 4-6 weeks after the date of protocol submission. This allows adequate time for
  the IRB to review and approve your application. You must not start data collection involving human
  subjects before the IRB approves your application.

 CITI Training Certificates. All members of the research team must complete human subjects
  protections training. In short, anyone who will be involved in consenting, recruiting, or obtaining data
  from study participants must complete CITI training, unless it is already on file in the IRB office. Obtain
  training by going to: http://www.fau.edu/research/researchint/citi_training.php
Helpful hints cont.

      Proofreading. Perform a simple spell check of your application and supporting documents before
       submitting them to the IRB. Typographical or grammatical errors affect the subject’s understanding of
       the study and can delay the review process.

      Sponsored Studies. If your protocol is, or will be funded by an outside organization, please note this
       on the IRB application. You will also need to submit the section of the grant or contract that describes
       your proposed scope of work with human subjects. Please ensure that the research described in your
       funding proposal matches the work described in the IRB application, and that the titles match. The IRB
       must ensure that the research it approves is consistent with what the sponsor is supporting.

      Letters of Cooperation. If you are collecting data from persons at an institution outside of FAU, or an
       outside institution is helping you with recruitment, the IRB requires a letter of cooperation from an
       appropriate person at that institution. The letter should be on institution letterhead and signed, however
       an email is sometimes acceptable if sufficient detail is provided. We have provided a template for
       letters of cooperation to help guide you as to the language the letter should include. Please refer to
       reference document #2 in the IRBNet library of forms and templates. *Please note: Studies involving
       Florida Public Schools, or Florida Department of Health sites, which are governed by a separate
       research approval process may have their own review processes. Please contact these agencies to
       adhere to their specific procedures.

      Collaborative Research. If your research involves co-investigators at other sites who are enrolling
       subjects or collecting data, their institution may require IRB approval as well. Please check to see if
       this is a requirement before submitting your IRB application. This will enable all investigators to cross-
       reference IRB approval and consent documents prior to beginning data collection.

      Writing the Consent Form. Provide enough detail in the consent so that the procedures, benefits, and
       risks of the study are clear and obvious to the participant. Use the consent form template appropriate
       to your study procedures that are found within the document templates listed in IRBNet. Please ensure
       that the details of the study described in the IRB application match details outlined in the consent and
       recruitment materials (e.g., the application should not state surveys will take an hour to complete when
       the consent form says 15 minutes). However, please do not copy and paste lengthy methodology from
       a protocol into the consent form.

      Assent for Children. In general, minors between ages 7 and 17 can give their written assent to
       participate in research. However, researchers sometimes write an assent document that contains long
       complex sentences and technical terms. An assent must be tailored to the emotional and educational
       level of the child. Short, simple sentences and friendly, conversational language is preferred. If very
       young children are involved, and they are capable of assenting, you may wish to write a brief assent
       script that describes what will be said to the child. It is acceptable to not provide assent procedures if
       the child is extremely young or not capable of understanding. However, please address this in the IRB
       application. Note: Parental consent is also required for research involving minors, even if an assent is
       used, except where a request for waiver of parental consent has been approved by the IRB. Sample
       templates are found within IRBNet. Please refer to our full policy regarding “Children in Research” at:

      Waiver of Written (“Documented”) Consent. If your study does not require documented consent,
       you must provide the IRB with a substantive, written justification as to why this requirement should be
       waived. Please refer to the “Waiver of Informed Consent” Policy at
       http://www.fau.edu/research/docs/policies/researchint/waiver_informed_consent.pdf If a study is
       minimal risk and does not require the use of identifiers, the following alternatives may be used as
       appropriate to obtain informed consent: a) consent cover letter, b) consent language as an
       introductory paragraph in a survey; or c) a verbal script.
Helpful hints cont.

      Translating Consents Into Other Languages. If you plan to recruit subjects who do not speak
       English, you may need to translate your consent documents to obtain true “informed” consent.
       However, since the IRB may request changes, please wait until after the IRB has approved the English
       version of the consent documents before seeking translation services.

      Safeguarding Data. The IRB application asks you to address how your research data will be
       protected. “Anonymity” means that an individual subject cannot be identified. No personal identifiers
       (e.g., name, signature, SS#, address, etc.) will be collected or associated with the data being used for
       research. “Confidentiality” implies subjects' identities are known but will be protected to some extent by
       the investigator. Discuss how data will be coded and/or physically stored in this section of the
       application, and in the consent form. Note: If you audiotape or videotape research subjects, their data
       is NOT anonymous, but you can describe the measures that will be taken to keep it confidential.

      Recruiting Participants. Attach any recruitment or advertising materials (flyers, scripts for radio or
       television ads, etc.) that will be used to your IRB application. Also make sure you disclose in the IRB
       application and the consent form any incentives (money, extra credit, gift cards, etc.) that will be used
       to attract and retain participants. Please Note: Due to Florida’s strict laws, FAU is not able to conduct
       lotteries as incentives for research participants. Instead, consider incentives that can be given to every
       participant, such as a candy bar, a scratch-off lottery ticket, or some other nominal item.

      Appropriate Signatures. Your IRB submission, even though it is now submitted electronically via
       IRBNet, still requires signatures. Please obtain ALL electronic signatures before submitting the IRB
       application. The assurance section at the bottom of your form tells you which signatures you need
       before submitting to the IRB.

      Responding to IRB Concerns. Once you have submitted your application, the IRB will either issue an
       approval, or send a memo requesting clarification about your application through the IRBNet system.
       When responding to the IRB, please submit Form 5 and upload any revised documents that the IRB
       has requested within IRBNet.

             Questions? Contact us: http://www.fau.edu/research/staffdirectory.php?expanddiv=researchint

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