IRB Exemption Certification Instructions by jasminebyrd

VIEWS: 85 PAGES: 6

									                                          Office of Research
                                          Division of Research Integrity and Compliance
                                          OHRP Federalwide Assurance: FWA00001669


                                          IRB Exemption Certification Instructions
Research activities that involve human participants may meet the criteria for an exemption. This means that once
certified as exempt, the project does not need to have the federal regulations applied [45 CFR 46, 21 CFR 50 & 56,
and/or 38 CFR 16.101(b)].

Exemption certification may be granted in those studies where:
    The study does not involve specific research activities that would preclude an exemption (see Research
       Activities That Do Not Qualify for Exemption below).
    The only involvement of human participants will be in one or more specified exemption categories (see
       Exempt Categories and examples, pgs 2-5).

The investigator(s) is responsible for ensuring that the rights and welfare of the participants in the research are
protected and that methods used and the information disclosed to participants gain their voluntary participation and
are appropriate to the activity. For example: the activity involves research; a description of the procedures;
participation is voluntary; and contact information of the investigator.

The investigator makes the preliminary determination that a research project is eligible for exemption. Please use
the lists of Research Activities That Do Not Qualify for Exemption below and Exempted Categories (Pages 2-5) to
serve as guides in making this determination. However, Only the IRB Chairperson (or designee) can determine that
the activities meet the USF definition of human research activities, that the activities qualify as exempt, request
additional information for clarification, or determine that the study does not qualify as exempt.
If it is determined that the study does not meet the exempt categories, the Principal Investigator has the option of
submitting an Application for Initial Review for IRB consideration.

The investigator is required to notify the IRB of any changes or modifications made in the study's design,
procedures, etc, to ensure those changes do not nullify the exempt status of the research.

Research Activities That Do Not Qualify for Exemption at USF: Human research activities do not qualify for
exemption if the research involves any of the following:
   a) Prisoners;
   b) Survey or interview procedures with children;
   c) Observation of public behavior of children when the investigator(s) participates in the activities being
       observed;
   d) Deception;
   e) Fetuses;
   f) Human in vitro fertilization;
   g) Data collected which includes protected health or medical information when there is a direct or indirect link
       that would identify the participant;
   i) Human research that directly involves mentally disabled individuals, regardless of whether a legally
       authorized representation is required for informed consent; or
   j) If your research involves any approved or investigational FDA-regulated items (including foods or dietary
       supplements that bear a nutrient claim or health claim, infant formulas, food and color additives, drugs for
       human use, medical devices, biological products for human use, and electronic products, your study does
       not qualify for exempt review. Research involving these items requires an Application for Initial Review
       for consideration by the IRB.
   k) Focus groups: Since the PI cannot guarantee confidentiality regarding the content of the discussion to the
       participants.


Application for Exemption Certification                                                USF Institutional Review Board
Version: 2008-10-10                                                                                          Page 1 of 6
EXEMPT CATEGORIES:
Research activities are exempt from ongoing oversight required by the federal regulations when the only involvement
of human participants falls within one or more of the categories below. Read through the categories and choose all
that apply to your research. To help you with your decision, read the examples and commentary provided below each
category.
[ 1 ] 45 CFR 46.101(b)(1) EVALUATION/COMPARISON OF EDUCATIONAL STRATEGIES, TECHNIQUES,
or CURRICULA. This exemption category cannot be used for FDA regulated research.
 Research conducted in established or commonly accepted educational settings, involving normal educational
 practices, such as
(i) research on regular and special educational instructional strategies, or
(ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom
     management methods.
This is a category in which the study is exempt if the proposed research procedures are normal educational practices
conducted in commonly accepted educational settings. Minors can participate in the studies. “Commonly accepted
settings” are not necessarily restricted to accepted educational settings. It may be a situation where the educational setting
is a car, such as in driver’s education class, or a kitchen where mentally retarded minors or adults are learning to cook. It
is important for the Reviewer to be able to determine whether the research procedures are instructional in nature and
whether the procedures are conducted in a manner and location typical to that situation. The Reviewer can contact one of
the IRB College of Education representatives for guidance regarding whether the research is occurring in an “accepted
education setting” or whether it involves “normal educational practices.”
[ 2 ] 45 CFR 46.101(b)(2) EDUCATIONAL TESTS, SURVEYS, INTERVIEWS, or OBSERVATIONS
This exemption category cannot be used for FDA regulated research.
When the research involves children (i.e., “Children are persons who have not attained the legal age for consent to
treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research
will be conducted” (who do not meet the criteria for emancipation in the state in which the research is to be conducted)
this exemption must be limited to education tests (cognitive, diagnostic, aptitude, achievement) and observation of public
behavior, when the investigators do not participate in the activities being observed. Research using survey procedures,
interview procedures, or observation of public behavior, when the investigator participates in the activities being
observed, cannot be granted an exemption.

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,
interview procedures, or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human participants can be identified, directly or
     through identifiers linked to the participants; and
(ii) any disclosure of the human participants' responses outside the research could reasonably place the
     participants at risk of criminal or civil liability or be damaging to the participants' financial standing,
     employability, or reputation.

Several research activities are addressed in this category. These activities are:
    Use of educational tests
    Survey procedures
    Interview procedures
    Observation of public behavior.
The category defines two conditions, that when both exist exclude the activities from consideration for exemption.
   (1) the information gathered during these activities can be linked to the participant, either directly or by some coding
        system, and
   (2) should a third party gain access to that information, the participant would be placed at risk. The risk can be for
        criminal or civil liability or can be the risk of damaging a participant’s financial standing, reputation or
        insurability.
The category can include the observation of children if it is public behavior and the investigator(s) does not participate in

 Application for Exemption Certification                                                  USF Institutional Review Board
 Version: 2008-10-10                                                                                          Page 2 of 6
the activities being observed.

An example would be a survey randomly sent to individuals selected from an employment roster. The survey asks the
participants their opinions on the managerial skills of their supervisors, without naming the supervisors. The investigator
wants a 95% response rate so although he doesn’t ask the participant’s name or social security number, he codes the
questionnaires so he can tell who responds. After a certain period of time, he sends a second questionnaire to those
randomly selected individuals who did not respond to the first request.

With that code and list of randomly selected employees, a supervisor could link specific answers to a specific employee.
That could potentially place the employee’s job security and financial standing at risk.

If, however, there is no risk associated with a participant’s responses, having identifiers will not disqualify a study from
exemption. There are many studies that ask for information that, if disclosed, would not put a participant at any type of
risk. Therefore, that type of study could have identifying information on the survey or questionnaire and still be eligible
for exempt review. The responsibility of the Reviewer is to determine whether or not risks exist that would be
jeopardizing to the individual if identifying information or codes are linked to the data gathered during the research
activities.
[ 3 ] 45 CFR 46.101(b)(3) PUBLIC OFFICIALS OR CANDIDATES FOR PUBLIC OFFICE
This exemption category cannot be used for FDA regulated research
 Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,
 interview procedures, or observation of public behavior that is not exempt under category (b) of this section, if:
     (i) the human participants are elected or appointed public officials or candidates for public office; or
     (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable
          information will be maintained throughout the research and thereafter.
This category can be confusing and actually applies to two very different criteria.
Item (i) of this category includes the research procedures previously identified in item (b), i.e., use of educational tests,
survey procedures, interview procedures, and observation of public behavior. However, this category differs from the
previous one in the situations to which it applies. If the population targeted for the research activities are elected or
appointed officials or candidates running for public office, the research qualifies for exempt review.

An example of research that fits this category would be a survey, administered to town mayors, that contains questions that
might expose information which the public might not support. The PI can plan to report that data, identifying the mayors
who participated in the study and even identify how certain mayors answered specific questions, and still qualify for
exempt review. Public officials or candidates running for public office give up their right to confidentiality in lieu of the
public’s “right to know.”

The second part of this category addresses the use of educational tests, surveys, interviews, or observation of public
behavior to collect data for specific federal programs conducted or supported by the Department of Justice or any project
sponsored by the National Center for Education Statistics of the United States Department of Education. These agencies
have specific programs that create data bases which are then protected by law from ever being accessed by anyone other
than those federal agencies. No officer or employee of the Federal Government, and no recipient of assistance under the
provisions of this category is allowed to use or reveal any research or statistical information furnished under this category
by any person and identifiable to any specific private person for any purpose other than the purpose for which it was
obtained. Data collected for these programs will be immune from legal process and cannot, without the consent of the
individual concerned, be admitted as evidence or used for any purpose in any action, suit or other judicial or
administration proceeding.

The only circumstance in which an exemption application would be submitted to an IRB for consideration utilizing part
(ii) of the criterion would be if a PI was issued a grant to conduct research involving specific programs by the Department
of Justice or the National Center for Education Statistics.




 Application for Exemption Certification                                                   USF Institutional Review Board
 Version: 2008-10-10                                                                                           Page 3 of 6
[ 4 ] 45 CFR 46.101(b)(4) COLLECTION OR STUDY OF EXISTING DATA This exemption category cannot be used
for FDA regulated research
Research involving the collection or study of existing data, documents, records, pathological specimens, or
diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in
such a manner that participants cannot be identified, directly or through identifiers linked to the participants.

Please Note: According to the Office for Human Research Protections (OHRP), “to qualify for this exemption the data,
documents, records, or specimens must be in existence before the project begins. The principle behind this policy is that
the rights of individuals should be respected; participants must consent to participation in research.” This exemption
category cannot be used for FDA regulated research.

OHRP interprets the term “existing” to mean that all of the data, documents, records, or specimens to be used in the
research are in existence prior to IRB review and were collected for purposes other than the proposed research. The
Reviewer must assure that the investigator has shown that all of the data to be collected under this category are currently in
existence at the time of IRB review.

Based on the federal definition of “existing data,” research conducted on biological or pathological specimens obtained
prospectively and taken strictly for research purposes does not qualify for exempt review. Not only do these samples not
meet the definition of “existing” but these samples would not be “publicly available.”

Based on the federal definition of “existing data,” research conducted on biological or pathological specimens obtained
prospectively from future discarded clinical samples does not qualify for exempt review. Even though the samples
would be obtained for clinical purposes and would be discarded, because it is a prospective study, it does not meet the
definition of “existing” and, therefore, requires full review.

If the biological or pathological samples are being obtained by means of retrospective collection from existing sources,
there is a very narrow window in which the use of these samples for research purposes will qualify for exempt review. If
the PI receives the samples and these samples are truly anonymous, and no one can link a specific sample with a specific
participant, the study will qualify for exempt review. However, if the samples are given to the investigator with any
hospital numbers, codes or links that tie the data back to a list of participants, then there is a mechanism in which the
participant can be identified, directly or indirectly and the research does not qualify for exempt review.

If the collection of the data will be from documents or records that are in existence at the time of IRB review and there is
absolutely no identifiable information recorded with that data, the procedures will qualify for exempt review. However, if
the information is not publicly available and the investigator needs to cross reference the data collected with other records,
this will not meet the criteria for exemption and will need either full or expedited review. Also, if there is any prospective
component of the research procedures, for example information taken from existing records which will be compared to
information to be collected at some future date, the research will not qualify for exempt review.
[ 5 ] 45 CFR 46.101(b)(5) RESEARCH & DEMONSTRATION PROJECTS [APPLIES ONLY TO FEDERAL
PROJECTS] This exemption category cannot be used for FDA regulated research
This category applies to:
i. Programs under the Social Security Act, or other federal statutory public benefit or services programs;
ii. Procedures for obtaining benefits or services under those programs;
iii. Possible changes in or alternatives to those programs or procedures; or
iv. Possible changes in methods or levels of payment for benefits or services under those programs.
Please note:
     According to OHRP, this category of research is narrowly defined and only applies to Social Security Act
     Programs and other public benefit programs that are specifically designated by the Department of Health and
     Human Services or the Secretary of one of the 15 other Federal Departments which have adopted the Federal
     Policy.

This category is difficult to apply because other federal agencies do not interpret this category as narrowly as does OHRP.
Some other agencies will allow general “research and demonstration” projects to be exempt under this category. At the

  Application for Exemption Certification                                                 USF Institutional Review Board
  Version: 2008-10-10                                                                                         Page 4 of 6
 University of South Florida, research and demonstration projects in general (e.g. state funded public service programs) do
 not fit in this category. Only projects which are conducted under federal statutory authority or the Social Security Act fit
 under this exemption criterion.
 [ 6 ] 45 CFR 46.101(b)(6) or 21 CFR 56.103(d) FOOD QUALITY EVALUATION OR TASTE TESTING
Taste and food quality evaluation and consumer acceptance studies,
 (i) if wholesome foods without additives are consumed or
 (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or
      agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and
      Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection
      Service of the U.S. Department of Agriculture.
 This criterion addresses two different types of research activity.

 First, if the taste test involves wholesome food without any additives then it is eligible for exemption. The Reviewer must
 make sure that the food product to be researched is “wholesome” (no additives).

 An example of such a research project would be a taste-test conducted on different types of grapefruit to determine
 consumer preference. The grapefruits are those normally grown in different sections of the country, using normal
 agricultural practices, and do not involve the addition of food additives or chemicals. The participant merely indicates
 which of the grapefruit tasted they prefer.

 The second category is more difficult to understand. Research conducted on human participants who consume plants or
 animals raised for food products may qualify for exempt review.

 The Food and Drug Administration has determined levels of safety for various agricultural chemicals, referred to as GRAS
 (generally recognized as safe) and GRAE (generally recognized as effective) additives which are fed to animals raised for
 food production. If these agricultural additives are given to animals at or below the levels found to be safe by FDA, the
 research can receive exempt review.

 An example of such research would be taste-testing pork products where the swine have been fed corn and a chemical
 additive at a level designated below FDA guidelines that makes the animal gain weight more quickly. The objective of the
 study is to determine whether the addition of the chemical changes the flavor of the pork.

 There are also approved levels for environmental contaminants set forth by the Food and Drug Administration, the
 Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture that
 may affect the grass or grain consumed by grazing food animals such as chemicals sprayed on a field to combat
 chickweed. If the research involves taste-testing of food products that come from animals exposed to environmental
 contaminants and the investigator can show that the use of these contaminants was at or below those approved levels, the
 research can receive exempt review.

 In all of these situations, the investigator should provide some documentation that the alterations, either chemical,
 environmental or agricultural, have been found to be safe by FDA, USDA, and/or EPA.

 However, if there have been food and color additives incorporated into the food product and these additives are used in
 research with the intent to apply to FDA for marketing that additive, the research would not qualify for exemption. Even
 if the procedures are preliminary in nature, if the research would eventually lead to FDA approval for marketing the food
 or color additive, it would not qualify for exempt review. The additives are viewed as investigational by FDA and,
 therefore, do meet the exemption criteria.




   Application for Exemption Certification                                                 USF Institutional Review Board
   Version: 2008-10-10                                                                                         Page 5 of 6
 PI:                                                                               Application for Exempt Certification
                                                                                                   Submission Checklist
 For IRB Use Only
 Assigned IRB #
                                                                                        USF Institutional Review Board
                                                                            OHRP Federalwide Assurance FWA-00001669
    The following materials are required for IRB review. Please review your IRB submission for completeness of all
    required items. Complete submissions will ensure your submission is processed as efficiently as possible. Submit the
    original application and one copy. Incomplete or handwritten submissions will only be held for 30 days for
    replacement.

  Document Checklist for PI                                                                                                           IRB Staff
         Complete typed Application for Exemption Certification (do not leave blanks)
         PI signature of Assurance
         Co-Investigator / Faculty Advisor signature of Assurance (Faculty Advisor required for student
        research)
         Departmental / Scientific and Scholarly review signature
         Application Addendums
  Supporting Documents
         Student research – thesis/dissertation
         Grant Application / Contract (including budgetary information)
         DHHS-approved protocol
         Industry Sponsored Protocol
         Investigator Initiated Protocol (must be in lay language)
         Informed Consent Form / Study Information Sheet
         Affiliate approval letters (MCC, JAVAH, TGH, Shriners)
         Advertisement / Recruiting materials
         Study Instruments  Scales  Surveys  Questionnaires  Interview Scripts
              Other:_______________________________________________________
         Off-site research approval (letters of support)
         Separate HIPAA Research Authorization or HIPAA Waiver
         Conflict of Interest Management Plan (with documentation that the management plan has been appropriately
               reviewed and approved, if any research personnel (and/or immediate family) associated with this project has a
               perceived or real conflict of interest)
            Investigators’ CV (PI and Co-investigators)
            Investigators’ Responsibilities Certification (PI and Co-investigators)
           http://www.research.usf.edu/cs/irb_forms/inv_resp.doc
                On File at IRB Office
            Current Human Research Protections Training Certification (PI, Co-investigators and all other
           key personnel involved in the research)
                On File at IRB Office

  Mailing Address:                                                   Office Location:
  12901 Bruce B. Downs Blvd., MDC35                                  3702 Spectrum Blvd.
  Tampa, FL 33612-4799                                               Suite 155
                                                                     USF Research Park
                                                                     Tampa, FL

                                                                Phone:
                                                           (813) 974-5638
                                                         Fax: (813) 974-5618
  Additional Documents:


  Date PI Completes Application:            [        ]                       Date PI Submits Application:               [      ]




Application for Exemption Certification                                                                              USF Institutional Review Board
Version: 2008-10-10                                                                                                                     Page 6 of 6

								
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