Protocol Comprehension Assessment

advertisement
Protocol Comprehension Assessment
Given the described situation, please answer the following multiple choice questions concerning the IRB
protocol:
1. Check all of those who would be listed in section 2) Investigators:
 Company X
 Telemedicine and Advanced Technology
Research Center
 UCF
 Dr. XYZ
 Graduate Student A





Graduate Student B
Graduate Student C
Undergraduate Researcher A
Undergraduate Researcher B
Undergraduate Researcher C
2. Which of the following statements is best for section 3) Objectives:
a) Our main objective of the study is to fulfill the research interests of Telemedicine and Advanced
Technology Research Center through scientific experimentation.
b) Our main objective of the study is to have students play video games and compare their
performance on given tasks.
c) Our main objective is to validate a serious game, Immune Attack, for learning. We hypothesize
those who play the serious game will have higher scores relative to baseline levels than those
who play the entertainment game.
d) Our main objective is to validate a serious game, Immune Attack, for learning.
3. Section 4) Background, should feature what kind of information?:
a)
b)
c)
d)
Funding sources such as all grants and contracts issued through Company X.
Prior research in the field of serious game research.
The research credentials of Dr. XYZ.
The appearance and atmosphere of the location research participants will be exposed to.
4. Section 5) Setting of the Human Research should state:
a) The validation study will take place our designated space in the UCF Psychology building in room
303L and 322.
b) The validation study features games that take place within the human immune system (Immune
Attack) and a pre-historic Earth-like planet (Spore).
c) The validation study takes place at the University of Central Florida, based in Orlando, FL.
d) The validation study requires students to sit at a desk in front of a computer, where they will use
a keyboard and mouse to play one of two video games.
1
5. Which of the following information should you include in section 6) Resources available to conduct
the Human Research (check all that apply):
 This study requires the use of two
desktop computers, CD-ROM copies of
the Immune Attack and Spore video
games, and approximately 500 sheets
of paper for student surveys.
 Participants will be recruited through
the university's SONA system.
 Researchers will use the UCF library's
online article database as well as
external sources such as Google Scholar
for the purpose of consulting published
research.
 Research participants will be paid $5
through funding provided by
Telemedecine and Advanced
Technology Research Center.
 This study should take 1 semester. Each
experimental session should take no
longer than an hour for participants to
complete.
 All individuals of the research team are
CITI certified and research assistants
will receive training as how to conduct
this experiment and use all of the
associated equipment
6. Which of the following information should NOT be included in section 7) Study Design –
Recruitment Methods:
a) Participants will be UCF psychology undergraduates, recruited through the university's SONA
System.
b) Approximately 150 participants will be recruited (75 in each of our two conditions).
c) They will be awarded 1.0 SONA credits for being part of the study after completing their
assigned session.
d) Participants will then fill out a form providing the address to which they would like their
payment mailed.
7. Regarding section 7b) Inclusion and Exclusion Criteria, all UCF psychology students are welcome to
participate in the study:
a) True
b) False
8. For this study, what statement should you put in section 7c) Study Endpoints?
a)
b)
c)
d)
This study will last for the entirely of the Spring 2012 semester.
N/A - This is only required for biomedical research
Each experimental session will last approximately one hour.
This study will end after all data has been collected.
2
9. Which of the following is a statement that should be included in section 7d) Procedures involved in
the Human Research
a) All participants will be asked to complete a demographics form and complete a biological
concept knowledge pre-test with information that is taught in the Immune Attack game.
b) Installation of the Immune Attack and Spore video games prior to start of the study should take
approximately 20 minutes each
c) All participant data will be input into SPSS by the undergraduate research assistants
d) As this study pertains only to video games, no medical procedures will be performed.
10. Which of the following statements should you include in section 8) Risks to participants?:
a) This study does not involve more than minimal risk to participants
b) Since we will be using a video game in our experiment, there is a small chance that some
participants may experience simulator sickness.
c) There is no risk at all to participants.
d) Both A and B
11. This study does not have any potential benefits. True or false?:
a) True - There is absolutely no true benefit for participating in this experiment
b) False - Simply being exposed to research is a benefit for students.
12. Which of the following statements is most appropriate for section 10) Provisions to protect the
privacy interests of participants?:
a) Protecting the privacy interests of participants do not apply to undergraduates.
b) Research will take place in the Psychology building and should not have any impact on
participants' privacy interests.
c) We expect undergraduates to be somewhat uncomfortable participating in our study.
d) None of the above.
13. Which of the following statements is most appropriate for section 11) Provisions to maintain the
confidentiality of data:
a) Student names and their accompanying information will be used only for this particular study
b) Students will be e-mailed their data at the conclusion of the study so they may use or destroy it
as they please
c) All participants will be assigned a unique identifier which will be present on all data collection
forms, however no records will be kept as to which participant is linked to what identifier.
d) All collected data will be delivered to the UCF Psychology faculty department upon completion
of the study for proper disposal.
3
14. For this study, it is appropriate to include information in section 12) Medical care and
compensation for injury.
a) True
b) False
15. Which of the following statements should be included in section 13) Cost to participants?
a) Participants will be paid $5.00 for their efforts.
b) This study will take one hour to complete.
c) N/A
d) None of the above.
16. In section 14) Consent Process, it should be stated that students may withdraw from the study at
any time but will be awarded SONA points only for the work they have completed:
a) True
b) False
17. What type of information should you include in section 14) Consent process? Check all that apply:
 The setting of the consent process.
 Instructions for obtaining assent.
 Instructions for obtaining parental
consent.
 The role of the individuals listed in the
application as being involved in the
consent process.
 The time that will be devoted to the
consent discussion.
 Any waiting period between informing
the prospective participant and
obtaining the consent.
 Any steps that will be taken to minimize
the possibility of coercion or undue
influence
4
18. How should you determine what to include in section 15) Process to document consent in writing?
a)
b)
c)
d)
Refer to your lab manager as to whether your typically require written consent.
You should always use a waiter of documentation of informed consent.
You should always obtain written consent.
You should refer to the "CHECKLIST: Criteria for Waiver of Written Documentation of Consent"
19. This study involves vulnerable populations.
a) True
b) False
20. You should describe your plans to control drugs and devices in section 17) Drugs and devices.
a) True
b) False
21. Which statement should you include in section 18) Multi-site Human Research?
a) We will be conducting this study in two different rooms - 303L and 322 in the UCF Psychology
building.
b) This research will use two different games, Immune Attack and Spore.
c) Yes, we will be collecting data in the UCF Psychology building, however data will be analyzed in
our lab in Research Park.
d) N/A
22. Which statement should you include in section 19) Sharing of results with participants?
a) At the end of the session, each participant will be provided with a debriefing form.
b) They will be informed by a debriefing document that they will be able to request study results.
c) The debriefing form we will provide them have information about contacting the IRB about this
study.
d) All of the above.
e) None of the above.
5
Download