Review of Human Subjects Review Protocol Form

Subjects

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

a.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?

a.Was the purpose statement clearly defined (i.e. do you know what the study intended to do)? 

a.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? 

i.Research methods

ii.Procedures of the study

iii.Data analysis

a.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. 

a.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. 

a.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? 

a.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? 

a.If deception is used in this study design, was it clearly explained why it was necessary and how subjects will be debriefed? 

a.Were the procedures for protecting subject rights and confidentiality clearly defined? 

a.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)?

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?

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. 

3.Were the following elements of the consent form included and do they agree with the protocol form?: 

a.Explanation of the purpose of the research 

b.Expected length of time of the subject’s involvement

c.Description of the procedures to be followed

d.Identification of which activities are experimental in nature 

4.Were the risks to the subjects and benefits to the subjects or others clearly described?

5.Was the compensation for participation clearly described? 

6.Did the document include a statement describing the subject’s anonymity and the extent to which confidentiality with be maintained? 

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? 

8.Was it clear that participation is voluntary and that the subject may withdraw from the process at any time?

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?