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 ReportRespect 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 RegulationsTitle 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 non-

compliance.

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 committeeThe SCRIHS Chair is Elvin Zook, M.D. and the Vice-Chairs 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

IdentifiersIdentifiers 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 subjects- adverse 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 patient- must 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 auditingSCRIHS 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 Self-Assessment 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 Protocol-Related 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

ResourcesPlease 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

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