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IRB: Application Procedures & Instructions

Student researchers : Step 1 is to identify a faculty or staff director or collaborator, as all student projects must be supervised by a faculty or staff PI. Complete the forms below together.

 

Protocol Application : The IRB is accountable to federal policy to evaluate human-participants research using the criteria of beneficence, justice, and respect for persons. To facilitate this evaluation, investigators are required to complete, submit, and receive approval for a Research Protocol Application prior to initiating any data collection. The Research Protocol Application is a fillable form that requests key information required for IRB review. In the majority of cases in which a protocol is returned for revision, the problem is that incomplete or inconsistent information has been provided. Thus, investigators are encouraged to describe the research protocol in sufficient detail so the IRB can evaluate 

  • Recruitment of participants (Justice)

  • Incentives or potential coercion to participate (Respect for persons)

  • Procedures for obtaining informed consent to participate (Respect)

  • Safeguards for protecting confidentiality and privacy (Respect)

  • What participants will be asked to do (Beneficence)

  • Risks and benefits of participation (Beneficence)

  • Clarity to subjects that participation is voluntary (Respect)

The information and justification required for approval is increased for protocols that involve vulnerable populations (children, prisoners, pregnant women), deception, collection of identifiable information (particularly information covered under HIPAA or FERPA), or procedures that involve more than minimal risk. 

 

Informed Consent : For almost every study, investigators are required to inform potential participants fully of the procedures that will be expected of them, the time requirements, why they were selected for possible participation and how many other people are being recruited, any potential risks and benefits, the degree to which their information will remain confidential, the alternatives to participation, the procedures and any penalties for discontinuing participation, and whom to contact with questions, concerns, or to discuss problems. Only after this information is presented to potential participants at a reading level that is appropriate can a participant consent to be tested. 

 

The model consent form provides the required information. Investigators are encouraged to adapt this model consent document for their purposes.

 

Note that the requirement that each participant provide informed consent does NOT mean that each participant must physically sign a consent form. If the research involves minimal risk and the greatest threat to confidentiality is the participant’s name on a consent form, for instance, investigators can request waiver of documentation of consent (i.e., informed consent is still required, but no physically signed consent form will be collected).

 

Criteria for requesting waiver of documentation of consent:

  • The signature on the informed consent document would be the only record linking the subject to the research and the principal risk of harm to the subject would be a breach of confidentiality.  For example, for research on sensitive topics, such as domestic violence or illegal activities; OR 

  • The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context.  For example, minimal risk research that involves surveys/interviews conducted via telephone or online; OR

  • Where the participants are members of a cultural group in which signing forms is not a normal/acceptable practice.

Criteria for requesting waiver or alteration of consent:

  • The research involves no more than minimal risk to subjects;

  • The research could not be carried out practicably without the waiver or alteration;

  • The waiver or alteration will not adversely affect the rights and welfare of the subjects; and,

  • Where appropriate, the subjects will be provided with additional information about their participation.  Note: The intent of this waiver criterion is to require debriefing for participants in deception research

  • If the research involves identifiable private information or identifiable biospecimens, this research could not be carried out practicably without using the information/specimen in an identifiable form.

 

For research with children (people under the age of 18) or individuals with diminished intellectual capacity, assent from the participant and informed consent from the parent or guardian is typically required.

 

DOWNLOAD THE FILLABLE RESEARCH PROTOCOL APPLICATION HERE  

 

DOWNLOAD THE MODEL INFORMED CONSENT FORM HERE  

 

DOWNLOAD THE INFORMED CONSENT CHECKLIST HERE