Investigator’s
Manual for
the Protection of Human Subjects |
Index |
Index |
A
Abuse
child, 1,
2
informed consent language, 1
elder, 1
Addendum, 1, 2
Adverse event (see Form HS 6 & 7) 1
Advertisements (see recruitment), 1,
2
Alternatives to participation, 1
Anonymous data, 1
Application (Form HS -1), 1
addendum, 1, 2 (see adverse events)
advertisements, 1
Claim of Exemption (see exempt)
continuation, 1
modification, 1
renewal, 1
Approval from participating institutions, 1
Assent (see Children and HS Form-3a), 1,
2
Assessing capacity to consent, 1, 2
Assurance of Compliance, (see Multiple Project Assurance,
MPA)
Audit of research records, 1
B
Benefit, 1, 2,
3, 4
to science, society, 1, 2
to subjects, 1, 2, 3
(see informed consent)
Belmont Report, viii, 1, 2, 3, 4
National Commission for the Protection of Human Subjects,
1, 2,
3, 4,
5, 6,
7
C
Cancer reporting
HSPC policy, 1
State of California, 1
Capacity to consent, 1, 2 (see informed consent)
Cell line, 1
Moore decision, 1
Center Grants, 1
Certification of IRB approval, 1
Certificate of Confidentiality, 1
Children, 1, 2, 3, 4, 5
assent, 1
classroom projects, 1, 2
exempt research, 1
parental permission, 1, 2
permission of the school, 1
recruitment, 1
sample assent form (Form HS-3a)
wards of the state, 1
Claim of Exemption (see exempt)
Clinical Research Center (see Appendix 15)
Closing Studies (Form HS- 8, also known as
completion/termination), 1, 2
Cognitively Impaired, 1, 2, 3
capacity to consent, 1
mentally incompetent, 1, 2
severe cognitive disorders, 1
withdrawal of psychotherapeutic drugs, 1
Compensation for injury, 1
Commercial products (see also Cell line), 1
Completion of Study, 1
Confidentiality, 1, 2
audio/video tapes, 1, 2
certificate of, 1
guidelines to ensure, 1
Conflict of Interest disclosures, 1
Consent (see Informed Consent)
Continuation review, 1
Controlled Studies, 1
D
Data Safety Monitoring Board (DSMB), 1,
2, 3, 4
Death, reporting, 1
Debriefing, 1
Deception, research using, 1, 2
Delays in processing applications, 1,
2
Devices (see Investigational Device Exemption/IDE)
Drugs (see Investigational New Drugs/IND)
E
Educational testing, 1
Emergency care, 1
Emergency room research, 1
Emergency use of a test article, 1
UCLA policy, 1
Employees as subjects, 1
Exempt (Claim of Exemption Form HS-7), 1, 2, 3, 4
Existing data, 1
non-genetic research, 1
Expedited review, 1, 2
F
FDA (Food and Drug Administration) 1,
2, 3, 4, 5, 6, 7, 8, 9
Federal regulations (see 45 CFR 46)
Fetuses, 1
abortion, 1
compliance with State and local laws, 1
ethical review of research, 1
ex utero research, 1
in vitro fertilization, 1
in utero, 1
informed consent, 1
material, 1
Financial obligation, 1
Final report (see closing studies)
510(K) devices, 1
45 CFR 46, viii, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Foreign sites, 1
Full Committee Review, 1
G
Grant proposal, 1
H
Human subjects
defined, 1
special subject populations/vulnerable populations
(see Chapter 8)
Human Subjects Protection Committee (HSPC/GCHSPC/MHSPC)
addresses, 1
appeal of review, 1
authority, viii, 1, 2
consultants, 1
decisions, 1
meetings, 1
membership, 1
review, 1, 2, 3, 4, 5, 6, 7,
8, 9
study design, 1
I
Incapacitated individuals, 1
Identification of investigators, 1
Informed consent, 1, 2
additional elements, 1
alternatives to participation, 1,
2
anticipated benefits, 1
assent, 1, 2
youth, 1
assessing capacity to consent, 1,
2
audits, 1
children, 1, 2, 3, 4
compensation for injury, 1
confidentiality, 1, 2, 3, 4
deception, 1
debriefing, 1
drug trials, 1
emergency care, 1
financial obligation, 1
foreign language, 1
form (samples)
assent (Form HS-3a)
medical (Form HS-2)
non-medical (Form HS-3)
glossary of terms, 1
identification of investigators, 1, 2
inclusion criteria, 1
injury, research related, 1
injury clause, 1
modifications, 1
new findings, 1
participation and withdrawal, 1
payment for participation, 1
potential risks and discomforts, 1
possible commercial products, 1
privacy, 1
procedures, 1
process, 1, 2
purpose, 1
radiation, 1
rights of research subjects, 1
video-taping (audio-tape/photog), 1
voluntary, 1
waiver of, 1, 2
Ionizing radiation, use of, 1
Institutional Review Board (IRB) (see Human Subject
Protection Committee/HSPC)
Internal Scientific Peer Review Committee (ISPRC), 1
Investigator,
changing, 1
qualifications, 1, 2, 3
responsibilities, 1
(as) sponsor, 1
(as) student, 1
Investigational Device Exemption, (IDE), 1, 2, 3
classes, 1
Investigational New Drug (IND), 1,
2, 3
biologics, 1
controlled studies, 1
HSPC responsibility, 1
informed consent, 1
emergency use, 1
parallel track, 1
single patient, 1
treatment use, 1
J
Jonsson Comprehensive Cancer Center - Internal Scientific Peer
Review Committee (JCCC- ISPRC), 1
Justice, 1, 2
L
Lay language, 1, 2
Letter of compliance, 1
Life threatening, 1, 2
M
Medical Radiation Safety Committee (MRSC), 1, 2
Minimal Risk , 1, 2, 3, 4
Minorities, 1, 2
Modifications (see Addendum)
Multiple Project Assurance of Compliance (MPA), viii, 1, 2, 3, 4
Multiple Project Grants, 1
N
New findings
obligation to inform, 1
Non-UCLA sites, 1, 2
O
"Off label" use of drugs, 1
Office for Protection from Research Risks (OPRR), viii, 1, 2, 3, 4, 5
Office for Protection for Research Subjects (OPRS), 1, 2, 3, 4, 5, 6
P
Parental permission (see informed consent), 1
Participation in research (see informed consent), 1
Payment for participation, 1, 2, 3, 4
Permission of schools, 1
Pilot studies, 1, 2
Placebo, 1, 2
Positron Emission Tomography (PET), 1
Potential risks (see informed consent), 1
Privacy (see informed consent), 1,
2
Program projects, 1
Prisoners, 1, 2
additional duties of HSPC, 1
Protocol (see addendum), 1, 2
modifications, 1
Psychological risk, 1
Press releases, 1
Q
Questionnaires, 1, 2
R
Radioactive Drug Research Committee (RDRC), 1
Radioactive materials and radiology, 1
Record retention, 1, 2, 3
Recruitment , 1, 2 (see also selection of subjects)
children, 1
classroom subjects, 1, 2, 3, 4
clients of institutions, 1
off-campus, 1
payment for participation, 1
permission of schools, 1,
2
recruitment tools, 1, 2
Renewal, 1
Research
classroom projects, 1
conducted off-campus, 1
definition of, 1
files, 1
recruitment off-campus, 1,
2
research using classroom subjects, 1, 2
review by HSPC/OPRS, 1
review by other institutional committees (see
JCCC-ISPRC and MRSC/RDRC), 1
Research Advisory Panel, (State of California), 1
Respect, 1, 2
Retention of signed consent forms, 1,
2, 3
Review, levels of, 1
appeal of HSPC review, 1
Rights of research subjects, 1, 2
Risk/benefit, HSPC consideration of, 1,
2, 3, 4
Risks to subjects, 1, 2 (see also minimal risk)
loss of confidentiality, 1, 2
physical risks, 1
placebo group, 1, 2
psychological risks, 1, 2
social/economic risks, 1, 2
S
Selection of subjects, 1, 2
Sensitive information, 1
Student
(as) research subject, 1
researchers, 1
Subject’s Bill of Rights, 1
Survey research, 1, 2
T
Terminally ill, 1
Termination of study, 1
Tissue/material,
Extra, 1
Residual, 1
Training Grants, 1
V
Videotaping (see informed consent), 1
Vulnerable subjects, (see Chapter 8)
see also: children, cognitively impaired, employees,
fetuses (in vitro/in utero), minorities, pregnant women,
prisoners, students, terminally ill
W
Waiver of consent (see informed consent), 1, 2
Waiver of parental or guardian permission (see informed
consent), 1, 2
Withdrawal of Psychotherapeutic drugs, 1
Withdrawal from research
consequences of, 1
Withholding information (see deception), 1
Women, 1
active recruitment of, 1
(of) childbearing potential, 1
NIH Guidelines, 1, 2
pregnant women, 1, 2
research with potentially toxic drugs, 1
risk to fertility, 1
risk to fetus and/or infant, 1
sample consent language, 1
Y
Youth assent, 1
Investigator’s
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