Transcript SCRIHS Training

SCRIHS Training
Presented by:
Erin Campbell
Alisha Mirabile
Gary Fifer
Topics of discussion
•
•
•
•
•
•
Federal Regulations and Ethical Principles
New Policy and Procedures Manual
SCRIHS Education
New SCRIHS forms
Conflict of Interest Policy and Forms
Compliance Policy and Auditing
Ethical Principles (pg.13)
Belmont Report
Respect for Persons:
- treat persons as autonomous agents and;
- persons with diminished autonomy are entitled to
protection
Beneficence:
-anticipated benefits must be greater than anticipated
risks
Justice:
-subjects must be selected fairly
Declaration of Helsinki
Nuremburg Code
Common Rule (pg.15)
45 CFR 46, Subpart A
The Federal Regulations for Protections of Human
Subjects is referred to as the Common Rule
It is an agreement that all agencies within the
federal government will use the same federal
regulations and definitions in determining the
applicability of human subjects protections
Code of Federal Regulations
Title 45 Part 46 Subparts A-D
• Subpart A- Basic HHS Principles for Protection of
Human Research Subjects
• Subpart B- Fetuses, Pregnant Women and Human
In Vitro Fertilization
• Subpart C- Prisoners
• Subpart D- Children
Code of Federal Regulations
Title 21- Food and Drugs
• Part 50- Protection of Human Subjects
• Part 56- Institutional Review Boards
• Part 312- Investigational New Drug
Applications
• Part 600- Biological Products
• Part 812- Investigational Device
Exemptions
What is Human Subjects
Research? (pg.15)
Research is defined as any systematic activity
designed to develop or contribute to generalizable
knowledge
A human subject is a living individual about whom
an investigator conducting research obtains data
through intervention or interaction with the
individual, identifiable private information or
retrieving recorded data
Definitions (pg. 16)
• Intervention- includes both physical procedures by which
data are gathered and manipulations of the subject or the
subject’s environment that are performed for research
purposes
• Interaction- includes communication or interpersonal
contact between an investigator and a subject
• Identifiable Private Information- to make this
determination, ask yourself “If I realize that I omitted a
data point when I was reviewing a medical record or
interviewing a subject, can I go back to that record or
subject to “fill-in” the missing data?” If the answer is
“yes” then the information collected was identifiable
Investigators’ Responsibilities (pg.17)
• Study design- consider ethical principles
• Study conduct- responsible for ethical conduct or their
research as well as the conduct of any participating faculty,
students, staff, etc.
• Subject protection- acknowledge and accept responsibility
for protecting rights and welfare of subjects and complying
with regulations and policies
• Investigator and research staff training- make sure all
participating staff has completed the requirements
• IRB review- all research must be reviewed by SCRIHS
• Exemptions- investigator cannot make final determination
of exemption
• IRB decisions-comply with all SCRIHS policies,
determinations, conditions and requirements
continued
• Informed consent- obtain and document informed consent process in
accordance with regulations using most currently approved version
of consent form
• Informed consent(minors)- assent from minors
• Changes in research- prompt reporting of any proposed changes to
SCRIHS and not initiate changes without approval
• Continuing Review- no less than once per year, maybe more often
• Reporting adverse events and protocol deviations- in appropriate
timeframes
• Record retention- retain research files and signed consent forms
• Approval by hospitals if necessary
• Notify SCRIHS of closure or PI change
• Notify SCRIHS office if audited by federal government
Authority of the IRB (SCRIHS) (pg.20)
SCRIHS has the following authority regarding actions
taken on reviewed protocols:
• to approve as submitted
• require modifications to secure approval (approve pending
revisions)
• defer action on (table)
• disapprove
SCRIHS also have the authority to:
•
•
•
•
•
require progress reports from investigators
suspend or terminate approval of a study
place restrictions on a study
conduct reviews and audits of investigator research files
observe an investigators consent process
Federal Wide Assurance (FWA) (pg.17)
SIU SOM has an assurance with the federal government in
which the institution agrees to apply the federal
regulations, protect human research subjects, monitor
research, and report instances of serious or continuing noncompliance.
In our FWA, SIU has agreed to apply the Common Rule
and all of the subparts to all research, regardless of funding
support.
Our FWA has recently been renewed and is now approved
until August 11, 2008
What needs to be submitted to
SCRIHS? (pg.21)
•All research sponsored by SIU SOM
•All research conducted by or under the direction of any
employee or agent of SIU SOM
•Any research using any property or facility of SIU SOM
•Any research involving the use of SIU SOM’s non-public
information to identify or contact research subjects or
prospective subjects
•Any research conducted at Memorial or St. John’s under
the direction of any staff member of SIU or sponsored by
SIU
The SCRIHS committee
The SCRIHS Chair is Elvin Zook, M.D. and the ViceChairs are Mark Francis, M.D. and Gregory Brandt,
M.D.
The committee is currently made up of 20 members
Members from variety of specialties
Meeting are always held on the 2nd Wednesday of the
month in Dirksen conference room
Types of IRB Review (pg.41)
• Full board- reviewed by the full committee
at a convened SCRIHS meeting
• Expedited- reviewed by a sub-committee of
two SCRIHS members rather than the full
board
• Exempt- reviewed and approved by the
SCRIHS Chairman
Full board submissions
• Agenda deadline for full board submissions is
ALWAYS the last Wednesday of the month
• NO extensions are allowed
• SCRIHS staff reviews all submissions for
completeness.
• At investigator’s request, we will review the consent
form and suggest changes if necessary (must be done
prior to agenda deadline)
• SCRIHS staff will call if materials are missing-need
investigator or coordinator cooperation
Process for full board submission
• First step is to call the SCRIHS office and get a protocol number
and put it on the top right corner of all forms
• Fill out the Application for Approval form which has been
expanded (now includes the ASP and HIPAA Application)
• Submit the correct amount of copies (see Application) and collate
properly
• Include any advertisements, recruitment materials, questionnaires,
survey, data collection forms, etc.
• For sponsored studies, have sponsor send you all the materials
and then you submit them to SCRIHS
• Use our templates for consent forms and HIPAA Authorization
• Safeguards for vulnerable populations (cognitively impaired,
children, etc.)
• IND or IDE numbers
Communication from IRB
PI will receive a letter within a week of the meeting
date indicating the approval status of the study
(approved as submitted, approved pending
revisions, tabled, disapproved)
Majority of studies are approved pending revisions.
In this case, the PI has 90 days to complete the
requested changes and send the appropriate number
of copies of the revised materials to SCRIHS. If 90
day time period expires, PI must re-submit for full
board review again
NIH Grant Application Review
45 CFR46.103(f):
Requires that each application or proposal
for HHS supported human subjects research be
reviewed and approved by the IRB
45CFR46.122
Federal funds…may not be expended for
research involving human subjects unless the
requirements of this policy have been satisfied
Expedited Review (pg.41)
• SCRIHS staff and SCRIHS Chair will make a final
determination if the study can be reviewed via the expedited
process
• Must meet one or more of the 7 criteria set forth in the
regulations (45CFR46.110)
• Study must present no more than minimal risk to the subjects
– Minimal risk is defined as the probability and magnitude of
harm or discomfort anticipated in the research are no greater
in and of themselves than those ordinarily encountered in
daily life or during the performance of routine physical or
psychological tests
Process for expedited submission
• Call SCRIHS for protocol number and use it
• NO deadline for expedited submissions
• Send correct amount of copies (see Application)always send one extra consent form
• Sent to 2 reviewers, 2 weeks to review
• PI will receive a letter indicating approval status of the
study
• If one or both reviewers feel the study should be
reviewed by the full committee, the PI will be notified
by letter
• Waiver of informed consent and authorization
Exemption (pg.44)
•
•
•
•
Investigator CANNOT make final determination
MUST be approved by the SCRIHS Chair
No more than minimal risk
Research must fall into one of the exempt categories set
forth in the regulations (45CFR46.101(b))
• Some research involving sensitive topics or vulnerable
populations will not be approved via the exempt
process
• Example- retrospective chart review when no identifiers
are collected
• Manual gives examples of research that are excluded
from exempt review
Identifiers
Identifiers include any alpha-numeric codes, initials,
date of birth, social security numbers, medical record
numbers, etc. (see definitions on page 49)
Once the data is collected there should be no way to
link the data back to an individual
Investigator’s research staff cannot de-identify the
data for the investigator, de-identification must be
done by someone who has no interest or involvement
in the study
Exempt submission process
•
•
•
•
•
•
•
No deadline
No protocol number
NEW Exemption Application
Submit questionnaires, surveys, data collection forms
Submit to SCRIHS office, not Dr. Zook directly
SCRIHS Chair makes final determination
If study does not meet exempt criteria, PI will receive a letter and
the study will be reviewed either by expedited process or full
board
• NEW- exemptions valid for 5 years- submit new application if
study is still active
• Requirement for informed consent does not apply, however,
SCRIHS can ask investigator to provide participants with a letter
or information sheet explaining research
• Waiver of authorization (to gain access to PHI even if not
recording)
Amendment Summary (pg.49)
SCRIHS must review and approve ANY change to an
approved research study
Can include changes to subject selection criteria, addition
of a clinic visit, addition of a test or procedure, dosage
change, add or remove ASP, new advertisement (press
release, brochure, etc.), changes to risks, changes to a
survey, etc.
Federal regulations state that written procedures are needed
“for ensuring prompt reporting to the IRB of proposed
changes in a research activity, and for ensuring that such
change may not be initiated without IRB approval”
(45CFR46.103b(4)(iii))
Amendment Summary submission
process
• Changes have been made to the form- be sure to begin using new
forms
• Current procedure should be described together with the proposed
change and the reason for the change
• Sponsors usually provide list of changes and/or highlighted or
tracked copies
• SCRIHS needs a detailed list of the changes and a
highlighted/redlined copy along with clean copies of the revised
document which reflect the changes
• If the study is being implemented at one or both of the hospitals,
be sure to submit enough copies
– The best way to determine the amount of copies needed is to remember that
SCRIHS needs 1 copy of all documents for their file and each hospital
needs a copy of all documents, AND always send 1 additional copy of the
consent form that can be stamped and returned to you
Amendments that require re-consenting
Any changes to the protocol, consent form or authorization that could
change the subject’s willingness to be in the study or effect the subject’s
participation in any way will require subjects to be re-consented
Examples: adding/deleting a visit, dosage changes, adding/deleting a
test or procedure, change to the risks, change of PI, change in the costs
the subject will incur, etc.
As a courtesy, the SCRIHS office will send a memo along with your
signed Amendment Summary indicating the need for re-consenting
when applicable
Changes to the risks, long-term versus only while on study drug will
determine what subjects need to be re-consented
Administrative review vs. full board (pg.65)
Amendments that do not substantially alter the protocol or consent
form or significantly change the risk/benefit ratio of the study can
be reviewed by the SCRIHS staff and approved by the Chair
You will receive the original signed Amendment Summary form
and a consent form with a new stamp if one is included in the
amendment
Amendments that raise new ethical concerns, substantially alter
risks or the consent form, introduce new procedures, change
dosages, etc. must be reviewed by the full committee. Letter will
be sent to the PI indicating the committees decisions
SCRIHS reserves the right to require an amendment to go full
board if it is deemed necessary
Adverse Events (pg.52)
• 4 types of adverse events:
– Expected non-serious
– Expected serious
– Unexpected non-serious
– Unexpected serious
• All types are reportable expect for expected non-serious
(which are those listed in the consent form)
• Timetable for reporting AEs:
– Expected serious and unexpected non-serious must be reported
to SCRIHS within 5 working days of when you are made
aware (local vs. non-local)
– Unexpected serious must be reported to SCRIHS within 48
hours of when you are made aware (local vs. non-local)
AEs continued
• Serious- resulting in any of the following: death,
life-threatening experience, inpatient
hospitalization or prolongation of hospitalization,
persistent or significant disability/incapacity,
congenital anomaly or is considered medically
important
• Observational or Outcome studies- research that
does not involve intervention, alteration in
standard clinical care, or does not employ
invasive or non-invasive procedures in subjectsadverse events do not need to be reported
AE submission and review process
•
•
•
•
•
•
•
•
•
•
NEW form- be sure to use it
Necessary dates
Indicate local or non-local and initial report or follow-up report
Do not say “see attached”
Submit enough copies of attached reports for hospitals when
applicable
Reviewed administratively unless Chair feels it requires full
committee review- PI will receive a letter
SCRIHS staff tracks all AEs by protocol- if trend appears SCRIHS
reserves the right to require risk be added to the consent form or
moved within the consent
Follow SCRIHS template- committee will require it
Be sure you are reporting AEs to sponsors and FDA when necessary
There will be consequences for not reporting in timely manner
Protocol deviations (pg.56)
 NEW form
 Examples: non-adherence to exclusion/inclusion criteria,
incorrect storage of medication, failure to report AEs,
tests not done or done incorrectly, subjects seen outside
study visit/follow-up window, failure to use currently
approved consent, etc.
 Complete form with description, why it occurred,
outcome, any harm to subjects, sponsor response,
methods you will take to prevent future occurrences
 Serious deviations require full board review
 Multiple offenses can result in corrective action taken
against the PI
Continuing Review (pg.60)
• Required at least once a year
• SCRIHS has authority to require review more than once a year due to
risk/benefit ratio or for other types of monitoring
• Continuing review period appears on the Application as well as the
signature page of the consent form
• SCRIHS sends reminder letters as a courtesy, not required to do so
• PI is ultimately responsible for submitting continuing review on time
• Study will be administratively terminated if continuing review is not
submitted before the expiration date
• Must be received by the agenda deadline for the meeting that precedes
the expiration date or earlier
Continuing review submission
• NEW form- must complete all sections
• Meet agenda deadline, preferably before in case need for
clarification
• Correct amount of copies, collated properly, all necessary
documents included
• Last two patient signed consent forms
• Update consent to ensure most current SCRIHS consent
template is being used
• Letter of justification if no enrollment for 3 consecutive
years
• PI will only receive a letter if changes are required,
otherwise you will receive the signed CR form and a new
stamped consent form
• If copies of the consent forms are put in clinic, be sure they
are replaced each time the consent is updated (CR or AS)
Termination forms (pg.59)
• NEW form
• Definition- no further contact with subjects
is planned, no subjects are or will be treated
or followed, all data is gathered and
analyzed, and any final reports or
publications are complete
• Reviewed administratively
IRB stamps (pg.67)
 Receipt dates- all documents stamped to note date when documents
arrived in the SCRIHS office
 Approval stamp- “This consent is valid from ___ to ___ ”, stamped
on the signature page of every consent.
First date is date of SCRIHS meeting at which the study was initially
considered and approved (approved pending) OR for studies that have
gone for CR, it is the date of SCRIHS meeting at which the CR was
approved
Second date is the date by which the next continuing review must be
reviewed and approved (expiration date)
 Amendment stamp- you will only see them on front page of consent
form or authorization, serves as a SCRIHS tracking system
The consent process (pg.76)
• Only PI, Co-investigators or ASP can obtain consent (must have met education
requirements)
• PI responsible for making sure research staff is trained on proper consenting
processes
• ONLY USE MOST CURRENTLY APPROVED VERSION OF CONSENT
FORM
• Do NOT use expired consent form or unstamped consent form
• Discussion with subject, answer any questions, make sure subject is fully informed
and can make an “informed” decision about whether or not to participate, give
them time to take it home and think about it if necessary. Must be voluntary
• Patients who are sick and looking for a potential cure may not read or hear the
disclosure of risks and benefits in the same way as a normal healthy subject.
Important to be specific in descriptions and not be coercive
• PI or ASP should sign at the same time as subject, be sure all necessary signatures
and dates are obtained and subject receives a copy of signed consent
Elements of Consent (pg.73)
• Introduction and purpose
• Description of procedures (must
state investigational)
• All foreseeable risks (if applicable,
unforeseeable risks)- described in
lay terms
• Benefits (not coercive)
• Alternative procedures or courses of
treatment that are available
• Confidentiality
• Costs- include costs the subjects might
incur as well as any re-imbursements
or payments they will receive
• Research-related injury- compensation
and medical care available (SCRIHS
needs model consent or letter)
• Subject’s rights- voluntary, no penalty
or loss for not participating, may stop
at any time, circumstances in which
participation will be terminated by PI
• Contact info
• Signatures (assent form)
Miscellaneous consent issues
• Re-consenting when necessary, in an appropriate manner
and an appropriate time frame
• Subjects must receive a copy of the signed consent form,
PI keeps original in study file, copy must be put in
subjects SIU, MMC, and/or SJH medical record
• Only subject or a subject’s legally authorized
representative or power of attorney can consent to the
research (if there is no LAR or POA call the SCRIHS
office for guidance)
• Consent must be obtained prior to initiation of study
(surgery, drug, procedures, survey, etc.)
• Use appropriate template (blood draw, tissue banking, PK)
Assent (pg.83)
•
•
•
•
•
NEW forms
Any person under the age of 18 must have parental consent
No age requirements set in regulations
Under 5- as appropriate and depending on the study
5-11 years- verbal consent directed to child in age appropriate
language, parent sign consent and assent (verifying verbal consent
delivered), child should assent if possible
• 12-17- consent process should be directed to child and parent,
based on consent in appropriate language, parent signs consent,
child must sign assent
• Cognitively impaired- get assent (discussed later)
• Parents or LAR cannot force subject to participate and mere
failure to object should not be construed as assent
Waiver of informed consent (pg.85)
• Must justify 4 points
–
–
–
–
Research poses no more than minimal risk
Waiver will not adversely effect subjects rights or welfare
Research could not practicably be carried out without the waiver
Whenever appropriate, subjects will be provided with additional
pertinent information after participation
• Cannot just be inconvenient to get consent
• Usually not done with full board studies, common in
expedited studies
• Passive consent- low risk studies only, usually done with
mailed surveys, letter still required
HIPAA and research (pg.89)
• SCRIHS must review the Authorization to Use and
Disclose PHI
• Separate document from informed consent form
• Waiver of Authorization- must justify all points- PI will
receive a letter of approval
• De-Identification Certification form- must be done by
someone not involved in the research study
• Limited data set- contingent on execution of a data use
agreement
• Preparatory to research
• Research on decedents
• Partial Waiver of Authorization for Recruitment
Purposes
Subject Recruitment (pg.97)
•
Advertisements, brochures, flyers, phone scripts, press releases, postings on the web, etc
•
Do not imply favorable outcome or benefits beyond what is stated in consent or protocol
•
Do not make claims that the drug, device, procedure, etc. is safe or effective for purpose
under investigation
•
Do not use terms such as “new” or “novel” when describing investigational treatment,
medication or device
•
May state that subjects will be compensated but should not emphasize the payment or amount
to be paid
•
For ads that are to be taped for broadcast, SCRIHS must approve the wording of the
advertisement prior to taping
•
Subjects being interviewed should have already consented to the research and signed
appropriate media release
•
ALL must be reviewed by SCRIHS either at the time of initial review and approval or via an
Amendment Summary
•
Press releases must be reviewed by Public Affairs prior to SCRIHS and newspaper ads must
be reviewed by Marketing Dept. prior to SCRIHS
Coercion and undue influence (pg.101)
• Coercion- occurs when an overt threat or harm is
intentionally presented by one person to another in order
to obtain compliance
• Undue influence- occurs through an offer of excessive,
unwarranted, inappropriate or improper reward or other
overture in order to obtain compliance
• Incentives to participate in research may affect the
voluntary nature of the agreement
• Payment to participate in research is looked at closely
by SCRIHS to ensure subjects could not be influenced
to participate as a result of their financial situation
• Other types of incentives to participate (gifts other than
cash)
Finders Fees/Kickbacks
Defined as monies, or other incentives, for
referring or recruiting subjects for a clinical
investigation. Includes, but is not limited to,
providing meals, credit towards conferences, or
textbook expenses, in addition to actual cash.
Receiving such incentives may be a criminal or
civil violation of federal fraud and abuse laws
Cognitively impaired policy (pg.108)
• Major concern with research involving individuals with psychiatric, cognitive,
developmental disorders, or substance abusers is that their disorders may
compromise their capacity to understand the information presented which limits
their ability to make a reasoned decision about participation
• Policy- along with the Application for a new study, investigators must submit
written procedures for evaluating the mental status of prospective subjects to
determine whether they are capable of consenting, procedures for obtaining consent
or assent of subjects, and when appropriate, procedures for determining conditions
under which consent may be provided by an LAR
Also, in studies where cognition may change during the course of the study
(Alzheimer’s disease), procedures must be in place to evaluate the subject each time
they come in to study clinic to assure continuing comprehension about study
participation
• SCRIHS will assess procedures proposed by investigator and determine the risk
level and benefits the study poses to the cognitively impaired subjects
Research involving children (pg.112)
• SCRIHS must determine which of 4 categories the study
falls under:
– Research not involving greater than minimal risk (one parent’s
consent)
– Research involving greater than minimal risk but presenting the
prospect of direct benefit (one parent’s consent)
– Research involving greater than minimal risk and no prospect
of direct benefit, but likely to yield generalizable knowledge
about subject’s disorder or condition (both parents consent)
– Research not otherwise approvable which presents an
opportunity to understand, prevent, or alleviate a serious
problem affecting the health or welfare of children (Secretary
of DHHS must approve)
Research involving medical students (pg.116)
• SCRIHS reviews this research very carefully
• SCRIHS reserves right to require full board review even
if research meets expedited criteria
• Potential concern is coercion or undue influence
• Research must be reviewed and approved by the EPC
and Associate Dean for Education and Curriculum
(ADEC) prior to SCRIHS review
• For more guidance on this topic, contact SCRIHS office
Case reports (pg.126)
A case report is a report of treatment and therefore does not meet
Common Rule definition of research and does not require SCRIHS
approval.
However, you must be very careful when making this determination. If
any of the following are present, the activity is research rather than a case
report:
 Plan to perform treatment on some individuals but not others
 Investigational drug or device are involved
 Clear intent before treating subject to use systematically collected data
that wouldn’t ordinarily be collected in course of clinical practice
 Intent to manipulate medications to determine maximum effectiveness
 Extra tests conducted for sake of reportability
 Protocol or study plan exists
 Separate set of records or data sheets are maintained
 Primary purpose is to answer a research question, not to provide care
Investigational New Drug Applications and
Investigational Device Exemptions (pg.127)
• Request for FDA authorization to administer an
investigational drug to humans or use
investigational device on/in humans
• Submitted by sponsor or investigator
• SCRIHS will not review study without the IND
or IDE number
• Request for waiver of IND- must meet six
conditions
• Must state “investigational” (not experimental) in
consent form
Treatment IND and Single Patient IND (pg.132)
• Treatment IND- promising investigational new drugs made available
to patients with life-threatening or other serious diseases for which
no satisfactory alternative drug or therapies exist (purpose is to make
these drugs available to desperately ill subjects as early in drug
development stage as possible and obtain additional data on safety
and effectiveness of drug). Treatment protocol is added to existing
IND and investigator treats patients according to protocol. Drugs
must show promise of therapeutic benefit.
• Single Patient Use (Compassionate Use)- subject in desperate
situation and unresponsive to other therapies or there is no approved
or generally recognized treatment available. Also, usually little
evidence the proposed therapy is useful but it may be plausible.
Investigator must submit for IND or use sponsor’s IND (if there is
one)
• Both must be reviewed by SCRIHS before implementing
Gene transfer and stem cell research
• Area of research that is growing and that we
will start seeing more of
• Biosafety Committee approval
• Gene transfer studies regulated by FDA and
NIH
• Stem cells research, no set regulations and
unclear guidance by NAS
• Must get SCRIHS approval
• Call for guidance
Emergency Use (pg. 135)
• Use of investigational drug/device/biologic in cases when subject is
involved in a life-threatening situation or severe debilitating (i.e.,
blindness, loss or appendage, loss of hearing, paralysis) in which no
standard acceptable treatment is available and in which there is not
sufficient time to submit a study for SCRIHS approval
• Per FDA regulations (21CFR56.102(d))- emergency use is an
exemption from prior review and approval by the IRB
• Investigators should proceed with care in using this very selective
category of drug/device/biologic use per the federal regulations and
IRB guidelines
• One-time use only, any subsequent use must have prospective IRB
approval
• Data gathered via emergency use cannot be used for research purposes
continued
• Sponsor will usually add investigator to its IND application
• Sponsor should not ship drug without IRB approval to proceed
• Consent must still be obtained, prior to use of drug/device unless
impossible, in which case specific documentation must be completed
and consent obtained as early as possible
• CALL SCRIHS OFFICE FOR GUIDANCE IF THIS SITUATION
ARISES!!
• IF AFTER BUSINESS HOURS, CALL SCRIHS PAGER 467-3433
• Ramifications for not following proper procedures is signficant!
Humanitarian Use Devices (HUDs) (pg.140)
• Defined by the FDA as a device that is intended to benefit
patients in the treatment and diagnosis of diseases or
conditions that affect fewer than 4,000 individuals in the US
per year
• Humanitarian Device Exemption (HDE)- application that
exempts the device from the usual clinical research trials to
obtain full FDA approval
• HDEs are granted when there are not enough patients to
conduct statistically significant trials that would support
efficacy and safety
• Applicant must prove probable benefit outweighs the risk of
illness or injury, taking into account the probable risks and
benefits of currently available device and alternative
treatments
• HDE holder is usually the sponsor
continued
• HUD must be reviewed and approved at a
convened SCRIHS meeting (full board) and go
through continuing review
• SCRIHS can require approval on case-by-case
basis but usually will not
• Submit all materials received from sponsor,
including protocol, patient information booklet,
instructions for use, etc.
• SCRIHS approved consent is not required but
adequate information must be provided to patientmust still use hospital surgical consent
• Cannot use HUD in off-label manner
Compliance Policy (pg.143)
• Noncompliance is defined as any violation from the
study protocol approved by SCRIHS, any violations of
any conditions imposed by SCRIHS on the approval of a
study or conduct of research, or any violation of
institutional policies, federal or state laws and/or
regulations governing human subjects research
• Investigators and Department and Division Chairs are
responsible for reporting any regulatory noncompliance
to Dr. Toth, Dr. Zook and the SCRIHS office
• SCRIHS reserves the right to conduct the type of
investigation deemed necessary in response to
noncompliance and in order to obtain the required
information to take appropriate action
Actions taken by SCRIHS
• Procedures for handling noncompliance can be found in
Section XV of the procedures manual
• The actions SCRIHS can take include but are not limited
to:
–
–
–
–
Modification to any aspect of the conduct of a research study
Requiring re-consent of enrolled subjects
Letter of reprimand
Investigator and staff participation in educational and quality
improvement activities or conferences
– Enhanced monitoring
– Suspension of research privileges
– Termination of research privileges
SCRIHS auditing
SCRIHS staff will be conducting monthly random audits of
investigators’ research files starting January 1, 2006.
We will distribute a schedule at the first of the calendar year which will
indicate the department that will be audited each month. An investigator
from that department will be randomly selected and that investigator will
be given 24 hours advanced notice. The investigator will be required to
reserve a room for the day, make all their research files and regulatory
binders readily available and provide SCRIHS staff with lists of study
patients.
SCRIHS has developed a Quality Improvement Through SelfAssessment Form that can be used to perform your own internal review
of your research file. HIGHLY RECOMMENDED!!! Found on
SCRIHS website
Conflict of Interest Policy and Form (pg.153)
• Need to be aware of potential impacts of
financial interests and/or non-financial
relationships with commercial sponsors or other
external entities on the conduct of research and
the participation and protection of human
subjects.
• All investigators must read the Conflict of
Interest Policy and complete the ProtocolRelated Conflict of Interest Form
• Signature on Application for Approval and
mark boxes on Amendment and CR forms
Education Requirements
• Attendance at this seminar fulfills initial or continuing
certification requirements for this year
• Continuing education certification will be required
annually
• We will have an online system for researchers to
complete education requirements and a tracking system
to ensure compliance
• Contact Susan in SCRIHS office if you need verification
of completion for sponsors or granting agencies
• Be on the look out for informative training seminars on
variety of topics starting in 2006
• Future education requirements in the works
Resources
Please feel free to contact (call or email) any of the
SCRIHS staff for questions or assistance
Monthly schedule
The new manual has a great deal of links to helpful
resources
Changes to the manual, watch for emails
SIGN IN!!!