Human Subjects Application

application and forms

Instructions and application materials

The following components will need to be completed in the Application for Initial IRB Review:

  • Data analysis.
  • Duration—when the study will occur.
  • Location—where the study will take place. Site approval may be required.
  • Project description.
  • Purpose—why is the study being done?
  • Research design—controlled versus experimental subjects.
  • Research procedure—exactly what participants will do as part of the study.

Benefits of research

How will subjects benefit from participating in this research? Examples: potential cure, may gain knowledge. If subjects do not have any benefits, does society as a whole benefit? If not, perhaps the study should be rethought.

Subject selection

Describe in detail how participants will be contacted and recruited. Lay out the recruitment steps in a step-by-step fashion. All recruitment materials must be submitted to the Human Subjects Institutional Review Board for review and approval. Recruiting subjects may consist of:

  • Emails
  • Flyers that are handed to subjects
  • Posters
  • Public announcements
  • Social media post

Risks to subjects

Describe all possible risks—physical, social and psychological—as a result of participating in this research. Risks include even mild discomforts or inconveniences, as well as potential for disclosure of sensitive information (e.g., loss of time, suffering allergies, phobias, etc.). There are always risks.

Protections for subjects

Describe the measures to be taken to protect subjects from possible risks or discomforts—keep the project low risk.

Confidentiality of data

Describe the precautions that will be taken to ensure the privacy of subjects and confidentiality of information. Be explicit if data are sensitive.

  • Coding procedures: Describe the coding procedures for subject identification numbers.
  • Data retention: Include the method, location and duration of data retention. Federal regulations require data to be maintained for at least three years.

Instrumentation

All questionnaires, interview scripts and data collection instruments must be identified and attached as appendices. Coding sheets for video or audio recordings and other data-collection procedures are required.

Informed consent process

Informed consent is a process by which research subjects learn about a project, its potential risks and benefits, and procedures to protect their safety, well-being and privacy. It may be given orally in some circumstances—a signed consent form is not always needed to verify the occurrence of consent. For all research, regardless of whether a signed consent document is required, describe the process by which informed consent will be obtained.

If the participant is a child or mentally disabled, explain how the parents or guardians will be contacted for consent and how the researcher will ensure the participants understand to what they are assenting.

A copy of all consent and assent documents, including non-English and Braille translations if applicable, must be provided.

When seeking consent, ensure that:

  • The subject has the legal and mental capacity to give consent.
  • The subject has sufficient opportunity to consider participating.
  • The possibility of coercion or undue influence is minimized.
  • The language is understandable.
  • The subject is not asked to waive any legal rights.

Consent document should be:

  • Easy to read.
  • Bold typeface when subjects are elderly or sight impaired.
  • At an eighth-grade reading level or lower. If children are involved, make sure their assent is documented. If the child can read, easy-to-read forms may be used.

Forms should be inclusive.

  • Appendices may be confusing for the subject.
  • Flow charts or diagrams may help to simplify the subjects’ understanding of a complicated study.

The signed informed consent process can only be altered when research meets the following criteria:

  1. The research involves no more than minimal risk to subjects. If a project places subjects at a significant amount of risk, the consent process may not be waived.
  2. The waiver or alteration will not adversely affect the rights and welfare of the subjects—this basically means the subjects will not be harmed emotionally, physically or socially as a result of the project.
  3. The research could not practicably be carried out without the waiver—meaning the research could not be done if a formal consent document were used. The research may be easier without the document, but if it can still be carried out, consent may not be waited.

Whenever appropriate, subjects will be provided with additional pertinent information after participating. If subjects are not informed beforehand, they absolutely must be informed after the study is concluded. In what is normally called a debriefing, the experimenter either in writing, verbally or both explains to the subject why they were not informed.