IRB Components Assignment

Due: April 6, 2018 at 2:05 AM – submit on Blackboard (IRB Components Assignment Folder)

Instructions: You have been given a mock IRB Human Subjects Review application. Your task is to review the components of the application and determine whether or not there is enough information included within the application to approve it so that the researchers can begin their research study. You should use the CSP IRB website (https://concordia.csp.edu/irbpublic/), resources from class, and your knowledge acquired from your CITI training to review the application.

The IRB components are split into two sections: the protocol form and materials (15 points) and the consent/assent form(s) (15 points). Each section has a set of questions that you must answer and the point values associated with each question are included below. Additionally, you will be required to give a final decision on whether or not you would approve the application. This decision is worth 5 points and must include specific details as to why you made your decision.

You MAY work together with classmates to form your conclusions about the IRB application materials but you are required to write up your own assignment submission. This means that even though your answers may have the same conclusions, you must word them in your own way – I should NOT see two or more submissions with the same word-for-word answers. This is plagiarism and will result in a 0 for the assignment for any involved parties.

Protocol Form and Materials (15 Points)

Review the Human Subjects Review Protocol Form and any attached documents. Based on these documents, answer the following questions:

1. Subjects (1 points):
   1. Were the population, sample, and sampling procedures clearly defined in the protocol form? Were any vulnerable population utilized in this study? If so, was inclusion justified clearly?
2. Purpose Statement (1 point):
   1. Was the purpose statement clearly defined (i.e. do you know what the study intended to do)?
3. Methods, Procedures, and Analysis (4 points):
   1. Were the following sections described in detail and did the application packet contain the appropriate copies of any surveys or tests utilized in the study?
      1. Research methods
      2. Procedures of the study

• Data analysis

4. Risks (2 point):
   1. Were any potential risks (physical, psychological, social, or legal) described and the likelihood/seriousness of those risks assessed? Were the methods of minimizing potential risks described? If not, describe one or two potential risks you can identify with the investigation and ways to minimize those risks.
5. Benefits (2 points):
   1. Is there a clear description of the anticipated benefits to the research subject, the particular group/class from which the subject is drawn, and/or to society in general? Provide detail as to why you do or do not feel this description is adequate.
6. Costs to the Subject (1 point):
   1. Does the investigation involve the possibility of added expenses to the subject or a third party (i.e. insurer)? Will the subjects be compensated for their participation in the study? Are there clear details about how this compensation will be given?
7. Informed Consent (1 points):
   1. Were the methods of obtaining informed consent clearly defined (i.e. how consent would be obtained, who would be responsible for obtaining it, where will informed consent forms be stored)? Also, if children are subjects, were the procedures for attaining child assent and parent/guardian consent clearly outlined?
8. Deception (1 point):
   1. If deception is used in this study design, was it clearly explained why it was necessary and how subjects will be debriefed?
9. Privacy (1 points):
   1. Were the procedures for protecting subject rights and confidentiality clearly defined?
10. Additional Materials (1 points):
    1. Were any additional materials included in the application packet (i.e. advertisement materials, surveys, etc.)? If so, were these allowable materials? Why or why not? Also, were there any other aspects of the protocol form that were missing (i.e. look at the fill-in-the-blank sections to make sure it’s all filled out)?

Informed Consent/Assent Form(s) (15 points)

Review the Informed Consent/Assent Form(s) included with the application. Answer the following questions:

1. Did the informed consent form include a statement identifying the principal investigator and their affiliation? If so, who is the principal investigator and what is their affiliation? (1 point)
2. Was there an invitation to participate in the study as part of a research project? Either write this invitation here or highlight it in the consent form. (1 point)
3. Were the following elements of the consent form included and do they agree with the protocol form?:
   1. Explanation of the purpose of the research (1 point)
   2. Expected length of time of the subject’s involvement (1 point)
   3. Description of the procedures to be followed (1 point)
   4. Identification of which activities are experimental in nature (1 point)
4. Were the risks to the subjects and benefits to the subjects or others clearly described? (2 points)
5. Was the compensation for participation clearly described? (1 point)
6. Did the document include a statement describing the subject’s anonymity and the extent to which confidentiality with be maintained? (2 points)
7. Did the document include the names, addresses, and phone numbers of the people to contact for answers about the research and the office to answer questions about the rights of a research subject? (1 point)
8. Was it clear that participation is voluntary and that the subject may withdraw from the process at any time? (2 points)
9. If the study included subjects who are not of legal age for consent, was there a child assent form available that was brief and contained language appropriate to age level? (1 point)

IRB Review Decision (5 points)

Based on your answers to the above sections, which of the following decisions would you make about this IRB application and why?

• Approved – no modifications needed (i.e. you believe that the application contains an ethical research experiment and all human rights are met within the protocol as written)
• Approved with modifications (i.e. you believe that overall the research design as proposed has merit and with a few adjustments would meet the required ethical standards)
• Not Approved (i.e. you believe that overall the research design as proposed does not have any merit and will not be able to be adjusted to meet required ethical standards)