Human Subjects Protocol Form

The IRB application form is designed to capture the essential elements necessary to assist the investigator(s), supervisor, and reviewers to thoroughly assess the measures that are being observed to protect the human subject’s rights throughout the research process. The form is fillable to assist the researcher in preparing the document in the online environment. Checkbox responses open when they are double clicked.

Effective August 30, 2012, all investigators, students, and research staff conducting research with human subjects must complete training and education requirements every 3 years. Research will not be approved until the training requirements are met. Documentation of training must be provided to the IRB Office with all new applications or renewals.

Human Subjects IRB Application-2014(doc)

DIGITAL OR WET INK SIGNATURES ARE REQUIRED ON ALL IRB PROTOCOL SUBMISSIONS including new applications, amendments or changes to approved research, and continuation requests.

For further instructions on how to create your own digital signature with Adobe Pro, please follow the link provided for a short tutorial video offered by Adobe.

http://tv.adobe.com/watch/acrobat-x-tips-tricks/how-do-i-add-a-scanned-signature-to-a-digital-signature/

To create an electronic signature through Microsoft Office:

http://www.youtube.com/watch?v=D8K4Hk0UXGQ

*Note: Unsigned documents, including those with only typed signatures, will not be processed or forwarded for committee approval.

 

IRB Levels of Review include:

1. Exempt:

  1. Six specific categories of research that meet exempt status: IRB Exempt Categories
  2. The Human Subjects Review Officer reviews and applies exemption status
  3. Status does not remove requirement for informed consent

2. Expedited: 

  1. Can be carried out by the IRB chairperson or experienced reviewers
  2. Human Subjects Review Office approves the review
  3. Expedited reviews are minimal risk to the subject and includes the same criteria as full committee reviews and continuing review is required at least annually
  4. Nine specific categories in the regulations: IRB Expedited Categories

3. Full-Committee IRB Review 

  1. Required for research that has more than minimal risk
  2. Concerns issues with confidentiality
  3. Potential conflicts of interest
  4. Complex and controversial issues
  5. Protected subjects and vulnerable population