Correlations between Predictors and Emergent Awareness Variables
Performance Evaluation scores were calculated by subtracting the patient ratings from the actual performance percentile for each NAB task and/or subtask. AES-C was related to
medication immediate memory, r=.294, p<.05. Age was associated with medication delay memory evaluation, r=.302, p<.05 and address delay memory evaluation, r=.348, p<.05. No other relationships were detected.
Creating Evaluation Discrepancy Factor Scores
Assumptions were met for the creation of a PCA factor score for executive function evaluation; the judgment evaluation and driving evaluation scores were significantly associated r=.622, p<.001. The KMO suggested adequate sampling (.5) and Bartlett’s test of sphericity indicated was significant X2(1)=25.194, p<.001. Factor scores were also created for immediate memory evaluation (medication and address relationship, r=.701, p<.001), delay memory evaluation (relationship r=.609, p<.001), recognition memory (relationship r=.417, p<.01).
There was also adequate sampling (KMO=.5) and Bartlett’s test of sphericity indicated PCA was appropriate for these variable pairs X2(1)=35.54, p<.001 (immediate memory), X2(1)=23.9, p<.001 (delayed memory), and X2(1)=10.02, p<.01 (recognition memory). The
created factors scores histograms were examined for normality. All factor scores had a normal distribution. The only relationship present between factor scores and main predictors was the AES-C and the Recognition Memory score (r=.285, p<.05).
Table 14A. Correlations between main predictors and outcome variables for Emergent Awareness. Emergent Awareness: AES-C Stroop Interference Unstructured Task HVLT-R Recognition Executive Factor ns ns ns ns Immediate Memory Factor ns ns ns ns Delayed Memory Factor ns ns ns ns Recognition Memory Factor .285, p<.05 ns ns ns
APPENDIX H:
Institutional Review Board Approvals
October 26, 2015
Danielle Hergert, M.A. Psychology 4202 E. Fowler Avenue PCD 4118G Tampa, FL 33620
RE: Expedited Approval for Initial Review IRB#: Pro00023422
Title: The Independent Contributions of Emotion and Cognitive Dysfunction on Anosognosia in Huntington’s Disease Patients
Study Approval Period: 10/25/2015 to 10/25/2016
Dear Ms. Hergert:
On 10/25/2015, the Institutional Review Board (IRB) reviewed and APPROVED the above application and all documents contained within, including those outlined below.
Approved Item(s): Protocol Document(s): Pro00023422_Protocol V1
Consent/Assent Document(s)*:
Informant Consent_V1.pdf Patient Consent_V1.pdf Informant Online V1 **granted a waiver
*Please use only the official IRB stamped informed consent/assent document(s) found under the
It was the determination of the IRB that your study qualified for expedited review which includes activities that (1) present no more than minimal risk to human subjects, and (2) involve
only procedures listed in one or more of the categories outlined below. The IRB may review research through the expedited review procedure authorized by 45CFR46.110 and 21 CFR 56.110. The research proposed in this study is categorized under the following expedited review category:
(4) Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing.
(5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).
(7) Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
Your study qualifies for a waiver of the requirements for the informed consent process as outlined in the federal regulations at 45CFR46.116 (d) which states that an IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waive the
requirements to obtain informed consent provided the IRB finds and documents that (1) the research involves no more than minimal risk to the subjects; (2) the waiver or alteration will not adversely affect the rights and welfare of the subjects; (3) the research could not practicably be carried out without the waiver or alteration; and (4) whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Your study qualifies for a waiver of the requirements for the documentation of informed consent as outlined in the federal regulations at 45CFR46.117(c) which states that an IRB may waive the
requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: (1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or (2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. Your study qualifies for a waiver of the requirement for signed authorization as outlined in the HIPAA Privacy Rule regulations at 45CFR164.512(i) which states that an IRB may approve a waiver or alteration of the authorization requirement provided that the following criteria are met (1) the PHI use or disclosure involves no more than a minimal risk to the privacy of individuals; (2) the research could not practicably be conducted without the requested waiver or alteration; and (3) the research could not practicably be conducted without access to and use of the PHI.
[A partial waiver of HIPAA Authorization is granted for recruitment purposes only; Authorization will be obtained as part of the informed consent process. Pursuant to this partial waiver, the study team is allowed to access the USF Huntington's Disease Research Registry to obtain PHI of patients who provided their informed consent to participate in the registry to determine whether they meet inclusion criteria for this study. ]
with IRB policies and procedures and as approved by the IRB. Any changes to the approved research must be submitted to the IRB for review and approval via an amendment. Additionally, all unanticipated problems must be reported to the USF IRB within five (5) calendar days.
We appreciate your dedication to the ethical conduct of human subject research at the University of South Florida and your continued commitment to human research protections. If you have any questions
regarding this matter, please call 813-974-5638. Sincerely,
Kristen Salomon, Ph.D., Vice Chairperson USF Institutional Review Board
9/28/2016
Danielle Hergert, M.A. Psychology
4202 E. Fowler Avenue Tampa, FL 33620
RE: Expedited Approval for Continuing Review IRB#: CR1_Pro00023422
Title: The Independent Contributions of Emotion and Cognitive Dysfunction on Anosognosia in Huntington’s Disease Patients
Study Approval Period: 10/25/2016 to 10/25/2017
Dear Danielle Hergert:
On 9/28/2016, the Institutional Review Board (IRB) reviewed and APPROVED the above application and all documents contained within including those outlined below.
Approved Item(s): Protocol Document(s):
for recruitment/screening purposes only authorization have been renewed.
The IRB determined that your study qualified for expedited review based on federal expedited category number(s):
(4) Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing.
(5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).
(7) Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
As the principal investigator of this study, it is your responsibility to conduct this study in accordance with USF HRPP policies and procedures and as approved by the USF IRB. Any changes to the approved research must be submitted to the IRB for review and approval by an amendment. Additionally, all unanticipated problems must be reported to the USF IRB within five (5) calendar days.
We appreciate your dedication to the ethical conduct of human subject research at the University of South Florida and your continued commitment to human research protections. If you have any questions
regarding this matter, please call 813-974-5638. Sincerely,
John Schinka, Ph.D., Chairperson USF Institutional Review Board