IRB: Review Process

When your Research Protocol Application is received at irb@covenant.edu you should receive an acknowledgment of submission, and your materials will be assigned a number.

 

An initial review will determine the review category for the research protocol:

• Exempt review : Research that falls into this category must be reviewed and approved by the IRB but is exempt from further (e.g., annual) review, unless there are changes in the research protocol. To qualify for Exempt Review, a protocol must present minimal (if any) risk to participants, and must fall within one of the following categories:

  • Exemption 1: Research in established or commonly accepted educational settings involving normal educational practices.

  • Exemption 2: Surveys and Interviews (with adults), Educational Tests, Observations of public behavior, so long as (a) no identifiable information is collected, (b) disclosure of identifiable information would not put participants at risk, OR limited IRB review determines that provisions for confidentiality and privacy are adequate

  • Exemption 3: Research involving Benign Behavioral Interventions with Adults, so long one of the conditions in Exemption 2 is satisfied, AND participants consent in advance to any deception 

  • Exemption 4: Secondary use of information or biospecimens, so long as (a) the information is not identifiable, or (b) identifiable health information is used as regulated by HIPAA

  • Exemption 5: Federal research and demonstration projects 

  • Exemption 6: Taste and food quality evaluation and consumer acceptance studies 

  • Exemption 7: Storage and maintenance for secondary research collected under broad consent

  • Exemption 8: Secondary research for which broad consent is required

 

• Expedited review : Protocol applications can be reviewed in this category if they (a) present no more than minimal risk to human subjects, and (b) fall into one of the following nine categories:

  • 1. Clinical studies of drugs and medical devices, only when specific conditions are met

  • 2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture, when specific conditions are met

  • 3. Prospective collection of biological specimens for research purposes by noninvasive means.

  • 4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. This includes weighing, use of wearable activity monitors, electromyography, and many other procedures

  • 5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).

  • 6. Collection of data from voice, video, digital, or image recordings made for research purposes.

  • 7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

  • 8. Continuing review of research previously approved by the convened IRB, under specific conditions.

  • 9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

 

• Full-board review : Protocols that do not qualify for Exempt or Expedited Review will be discussed at regularly scheduled IRB meetings.

 

Following review by the IRB, the investigator may receive queries, comments, and stipulations that require modification of the Research Protocol Application form or the Informed Consent Document. 

 

The principal investigator will be notified via electronic document when the research protocol has been approved and can begin.  Exempt and Expedited reviews are typically complete within 10 business days. Full-board reviews may take a month.

 

Before any changes can be made to the study, the approved Research Protocol Application must be amended and submitted for approval by the IRB. This includes the addition of personnel (e.g., student researchers).

 

Unexpected and adverse events must be reported to the IRB using irb@covenant.edu .