|
THE COMMITTEE ON HUMAN RESEARCH
UCSF GUIDANCE ON RESEARCH TOPICS AND ISSUES
CONSENT FORM AND REVIEW CHECKLIST
(Revisions in process)
1. Substantive Requirements
2. Legal Requirements
3. Technical Requirements
4. Recruitment Documents and Information
5. UCSF CHR Application Checklist
Substantive Requirements
| • |
language
level appropriate to study population |
| • |
purpose
of study clearly and accurately explained |
| • |
why
subject has been asked to participate clearly and appropriately
described |
| • |
procedures
described (including randomization) accurately reflect those
in protocol |
| • |
all study
procedures listed |
| • |
experimental
procedures clearly delineated from standard procedures |
| • |
all
risks of experimental procedures (only) and all drugs and devices
being used in study accurately conveyed (including unknown risks,
risks of combined treatments and/or drugs, risks to offspring,
risks of drugs, risk of randomization, financial risks) |
| • |
risks
described in descending order of severity and likelihood of
occurrence |
| • |
consequences
of risks described (e.g., consequence of lowered white cell
count) |
| • |
precautions
to minimize risks conveyed (e.g., 24-hour number listed
when medication is blinded and used for outpatient care) |
| • |
benefits
of experimental procedures (including randomization) accurately
conveyed and not overstated |
| • |
internal
consistency among purpose, procedures, risks, benefits and alternatives
maintained |
| • |
financial
risks/financial counseling (if appropriate)/costs discussed
in sufficient detail |
| • |
appropriate
statement discussing confidentiality of records (e.g., right
of study FDA and/or identified study sponsor to review records;
true risks of loss of confidentiality stated) |
| • |
alternative
treatments appropriately described |
| • |
appropriate
signatures requested (e.g., relatives, parents, legal representative) |
| • |
If
multiple consent forms are being used for a study, consent forms need
to be appropriate and labeled for each group. |
 |
|
Top of Page
Legal Requirements
| • |
UCSF
(and/or VAMC) standard wording used for treatment and compensation
for
injury information (for studies involving real or foreseeable risk
of biomedical harm) |
|
|
Top of Page
Technical Requirements
| • |
UCSF
header, as appropriate (consider also VAMC, SFGH, other sites) |
| • |
section
headings, as appropriate |
| • |
person
of subject (e.g., "I/you") consistent throughout form |
| • |
abbreviations
spelled out the first time used, as appropriate (e.g., MRI,
CT, i.v., ICU) |
| • |
first
and last name of investigator(s) and department affiliation
in Purpose |
| • |
faculty
advisor named for student investigators (in Purpose and/or Questions) |
| • |
investigational
drugs and/or devices, or investigational uses of approved
drugs and/or devices, referred to as "investigational" or "experimental" rather
than "new" |
| • |
Procedures
section to begin with, "If I agree to participate, the following
procedures will occur." |
| • |
procedures
listed, in numbered paragraphs, in order of occurrence, if appropriate |
| • |
total
length of time for procedures |
| • |
location
of procedures stated |
| • |
if
HIV testing being done for research purposes, pre- and post-test
counseling described |
| • |
if
audio or videotaping, disposition of tapes described |
| • |
if
questionnaire or interview study, option of refusing to answer
a question or stop at any time stated |
| • |
risks
listed in numbered paragraphs |
| • |
standard
statements used for the following risks: financial, MRI, radiation,
randomization, venipuncture, unknown risks |
| • |
CHR
contact information included (if Bill of Rights not given) |
| • |
Questions
section to include name and phone number of study investigator |
| • |
reimbursement
described, including how and when paid |
| • |
Consent
section confirms subject given a copy of the consent form
and Experimental Subject's Bill of Rights (latter required
for biomedical studies only) to keep |
| • |
standard "participation
in research is voluntary" statement used; appropriate "without
jeopardy" description used (i.e., "to my employment, student
status, medical care" -- appropriate category or categories
only listed) signature and date lines for patient |
| • |
signature
and date lines for person obtaining consent (unless only PI
is obtaining consent) |
| • |
signature
line for parent(s), if needed |
| • |
third
party signature lines and dates, as appropriate, with standard
statements above lines |
| • |
avoidance
of legal language and statements (including no subject or PI
certifications) page numbers (i.e., 1 of N) |
| • |
date
consent form was prepared, or not to be used after, on each
page |
| • |
grammatical
and typographical errors identified and corrected |
|
|
Top of Page
Recruitment Documents and Information
| • |
recruitment
described in protocol (by whom, when, where) |
| • |
copies
of texts of ads and/or notices used for recruitment submitted |
| • |
ads
and/or notices must identify UCSF |
| • |
contact
letters submitted (with appropriate information) |
| • |
text
of acceptance or refusal post card submitted |
| • |
information
sheets submitted (to conform with consent form requirements,
but no signatures) |
| • |
letters
of support from other study sites, agencies, and departments
involved in the study |
|
|
Top of Page
UCSF CHR APPLICATION CHECKLIST
| • |
appropriate
application format used (full committee, subcommittee, exempt) |
| • |
current
corresponding CHR Cover Page completed, all sections (e.g.,
procedures, funding) |
| • |
protocol
written according to Full Committee or Subcommittee Format, within
page limits, pages numbered |
| • |
special
issues addressed in sufficient detail, e.g.: assent for minors,
requests for waiver of consent, nonsignificant device exemption
requests, inclusion of women and minorities in research, genetic
testing, tissue banking
NB: Investigators may wish to call the CHR office (476-1814) for additional information. |
|
|
|
