Exempt Review


Purpose

The purpose is to outline the policies and procedures for exemption from human subject regulations.

Definitions

Exempt is a classification of research review which is not subject to federal human research regulations. It is, however, still subject to state laws, institutional policies, and the requirements for ethical conduct of research. Thus, review must be performed to ensure the protection of humans in research. Exempt review is performed by trained individuals as part of, or as assigned by, the Exempt Review Committee (ERC).

In order to qualify for exemption, a research study's activities must fall entirely within one or more of the six categories for exemption. It must also not place subjects at greater than minimal risk or involve a population prohibited from exemption.

Minimal risk means the probability of and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Policy

Any investigator who intends to conduct research involving human subjects, and who on the basis of the categories described below believes that research to be exempt, must submit an application package to Marywood University's ERC for review and approval prior to initiation of research activities. The ERC makes the final determination about exemption eligibility. Members of the Exempt Review Committee may exercise all of the authorities of the Institutional Review Board (IRB).

An exempt submission must be transmitted through IRBNet, Marywood University's online submission and management system, and include an application for exemption form and all necessary attachments. In most cases, an informed consent form is required. However, documentation of informed consent is not, which means that no signatures are required from subjects on an informed consent form.

Please see the ERC checklist for required documentation, and the Exempt Review Committee's website for instructions, forms and templates.

Activities Excluded from Exempt Review

  1. Educational tests, surveys, interviews or observations of public behavior, where data obtained will be recorded by the investigator/s in such a manner that human subjects can be identified (directly OR via codes), AND any disclosure of their responses outside the research may reasonably place them at risk of criminal or civil liability, or be damaging to their financial, employability, or reputation
  2. Prisoner research
  3. Research with children under age 18 involving surveys, interviews or observation of public behavior where the investigator participates in the activities being observed
  4. Fetus or neonate research
  5. Collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are not publicly available OR if the information is recorded by the investigator in such a manner that subjects can be identified, directly OR through identifiers (e.g., codes) linked to the subjects
  6. Audio/visual recording of subjects
  7. Deception of subjects
  8. Drugs, internally taken substances, investigational devices, or biologics
  9. Prospective bio-specimen collection (e.g., tissue, blood, plasma, urine, saliva, etc.)
  10. Procedures routinely employed in clinical practice (e.g., sensory testing, sensors on skin, EKG, MRI, etc.) or physical activities (e.g., moderate exercise, muscular strength testing, body composition assessment, etc.)

Not all vulnerable populations are excluded from exemption. For instance, while there are additional protections for pregnant women in the regulations, exemption is allowed if the study involves no greater than minimal risk and fits into one or more of the six exemption categories. On the other hand, some research with vulnerable subjects might require full IRB review instead (e.g., mentally ill residing in a facility).

The US Office of Human Research Protections provides a series of Decision Charts to aid in determination of review type.


Exemption Categories

Research activities in which the only involvement of human subjects will be in one or more of the following categories may be exempted. The most frequently used categories are 2 and 4.

Category 1: Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods [46.101(b)1].

Note: This is the only category under which Marywood University allows for children to be participants. However, if the activity proposed is not typically a part of the classroom curriculum or instruction, the study cannot be exempted. Exemptions do not apply where children will be surveyed, interviewed or observed (where the researcher participates in the observation).

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 [46.101(b)2].

Category 3: 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 2, 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 [46.101(b)3].

Category 4: 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 [46.101(b)4].

Category 5: Research and demonstration projects which 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; or (iv) possible changes in methods or levels of payment for benefits or services under those programs. [46.101(b)5]

Category 6: 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 [46.101(b)6].

Procedures

  1. The investigator and all research team members (co-investigators, research assistants and advisors/sponsors) complete mandatory online training.
  2. The investigator reads policies and procedures concerning human subjects research and instructions on how to submit (center of page).
  3. The investigator visits www.irbnet.org to register (affiliating with Marywood University), and confirms registration via e-mail. Co-investigators and research advisors/sponsors must also register. Registration by research assistants is optional.
  4. The investigator downloads necessary forms and templates, completes them, and gathers supporting documentation, as needed. ERC forms and templates are available on the ERC's website or via IRBNet's forms and reference library.
  5. The investigator proofreads and runs a spellcheck on all completed documents.
  6. Following the written instructions for IRBNet (video tutorials are also available), the investigator creates a project, shares it with research team members (if applicable), applies an electronic signature, and then submits it to the ERC.
  7. The investigator monitors his/her e-mail account for communications from the ERC. Once the ERC publishes its decision letter at IRBNet, it will email a notice containing instructions on how to access the letter.
  8. The ERC's decision letter will communicate required modifications, if any, how to apply tracking to documents prior to modifying them, and how to submit the modifications via IRBNet.
  9. Once approved, the ERC will email a notice about approval, prompting the PI to access the approval letter and all stamped documents (documents part of the consent process) in IRBNet. Stamped versions of documents must be used in the research.
  10. The investigator submits to the ERC any requests for revisions after approval, deviations/violations from the approved protocol or materials, unanticipated problems or serious adverse events, should they occur. See appropriate policies and procedures about these topics.
  11. As approval is granted for one year only, the investigator submits either a closure report upon completion (at or by expiration date), or if not closing, a continuing review application to the ERC, allowing enough time so there is no lapse.

History

5/23/2017 - Updated format, added definitions, clarified exclusions and added procedures

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