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Penn state is redoing its IRB website and application system. I think that the appropriate application is attached. 

I am part of another project assessing a course that I teach and have gone through the IRB process once (although I need to fess up that my collaborator wrote the application).

Review Time Lines

 

Below is a breakdown of the review time lines for each review level. These review time lines are not definite, but can be used as a general guideline for researchers preparing to submit an application.

Exempt Review Time Line

The review time line for studies submitted as exempt is typically 7 business days; however, this time line will not start until ORP staff are able to confirm that the review level is exempt. 

 

1. EXEMPTION REVIEW (Non-Committee Review)

The following types of research may be exempted from IRB review if the research study meets one or more of the following exempt criteria. ORP determines whether a particular research study is exempt. If exempt, the investigator will be so notified by ORP.  

General exclusions from Exemptions:  (1) The research is FDA-regulated.  (2) The research involves prisoners and is conducted or funded by the Department of Health and Human Services (DHHS), Department of Defense (DOD).  (3) The research involves interactions with Prisoners.

Exempt Research Categories

Category 1: Research conducted in established or commonly accepted educational settings, involving normal educational practices.  (Both the procedures involve normal education practices and the objectives of the research involve normal educational practices.)

Category 2: 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. 

In addition: 

  • If the research involves children and is conducted, funded, or subject to regulation by the Department of Health and Human Services (DHHS), Department of Defense (DOD), Department of Education (ED) or Environmental Protection Agency (EPA), the procedures are limited to (1) the observation of public behavior when the investigator(s) do not participate in the activities being observed and (2) the use of educational tests. 

Category 3: Research involving the use of educational tests, survey procedures, interview procedures, or observations of public behavior that is not exempt under Category 2 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.

Category 4: Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens 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. (For research conducted, funded, or otherwise subject to regulation by any federal agency, "existing" means "existing at the time the research is proposed."  Otherwise, it means "existing at the time the research is proposed or will exist in the future for non-research purposes.")

Category 5: Research and demonstration projects that are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; (iv) possible changes in methods or levels of payment for benefits or services under those programs.  

In addition:

  • The program under study delivers a public benefit or service.

  • The research or demonstration project is conducted pursuant to specific federal statutory authority.

  • There is no statutory requirement that the project be reviewed by an IRB.

  • The project does not involve significant physical invasions or intrusions upon the privacy of subjects.

  • The funding agency concurs with the exemption.

 

Category 6: Taste and food quality evaluation and consumer acceptance studies if: (i) wholesome foods without additives are consumed; or (ii) a food is consumed that contains a food ingredient at or below the level 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 (FDA) or approved by the Environmental Protection Agency (EPA) or the Food Safety and Inspection Service of the U.S. Department of Agriculture (USDA).

PSU Category 7:  NOTE:  This category does not exist in the federal regulations under Title 45 Part 46 Subpart A 46.101(b) and is used solely by The Pennsylvania State University as per the terms of its Federal Wide Assurance with the government.  Social Science research in which participant interaction is limited to providing a response to a non-invasive stimulus.  In addition, the following are exclusions: (i) federal funding or federal training grants; (ii) biomedical procedures; (iii) sponsor or other contractual restrictions; (iv) clinical interventions (including clinical behavioral interventions); (v) prisoners as participants; (vi) children as participants; (vii) the use of deception; (viii) receipt of an  NIH issued Certificate of Confidentiality to protect identifiable research data. 

What do I need to submit for review?

Exemption studies require:

  • A completed application submitted via the IRB eSubmission process (PRAMS or CATS-IRB)
  • All measures (e.g., surveys, interview outlines, etc.) uploaded into PRAMS or CATS-IRB
  • The grant proposal (if applicable) uploaded into PRAMS or CATS-IRB

 

 

 

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IRB application template
196.13 kB13:10, 27 Jun 2014sadesActions
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Is there any type of online training required?
Posted 18:11, 23 Jul 2014
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