Managing the Project
Ensuring Equitable Subject Selection
Obtaining Approval for Advertising
Compensation for Participation in Research
Changes (Modifications) in the Protocol
Obtaining Continuing Review
Informed Consent Process
Preparation & Maintenance of a Research Audit File
Managing the Flow of Information on the Protocol
Reporting Adverse Experiences/Events
Procedures for Resolving Regulatory Non-Compliance
ENSURING EQUITABLE SUBJECT SELECTION
BROOKWOOD BAPTIST HEALTH COMPLIANCE:
The Brookwood Baptist Health complies with the Federal regulations for the protection of human subjects that require equitable subject selection, and with the National Institutes of Health policy regarding gender and ethnic representation in Institutional populations.
SUBJECT SELECTION POOLS:
This means that all reasonable efforts will be made by Brookwood Baptist Health researchers to select subject pools that are reflective of the local population from which subjects are recruited. Certain studies must focus on particular groups of subjects due to the research question involved. For example, a study on prostate cancer will likely not include female subjects and a study on characteristics of refugee communities may enroll only subjects of a particular national origin.
ENSURING EQUITABLE SUBJECT SELECTION:
The best way for researchers to ensure that their efforts at equitable subject selection are reasonable is to have accurate information about the population from which subjects are available and to tailor their recruitment strategies accordingly. To achieve a balance of subjects, recruitment efforts in various media and in languages other than English may be required.
OBTAINING APPROVAL FOR ADVERTISING
ADVERTISEMENTS MUST BE APPROVED BEFORE USE:
Advertisements and recruitment materials for Institutional subjects (posters, flyers, paid or unpaid newspaper/magazine ads, scripts for radio/TV, electronic mail, or solicitations from outside sources) which will be viewed by potential research subjects are considered an extension of the informed consent and subject selection processes. Accordingly, such materials are governed by Federal regulations for the protection of Institutional subjects and require IRB review and approval.
Generally, such materials are included with the original application as part of the overall recruitment plan. Advertisements may also be submitted for approval at any time following approval of the protocol. Because submission of an unapproved advertisement would be considered a minor change in the approved research plan, some advertisements may meet the criteria for expedited review and approval.
Advertising Materials are Reviewed by the Institutional Review Board to Ensure that:
1. they are neither misleading nor coercive to potential subjects; and
2. no claims are made either explicitly or implicitly that might lead a subject to believe that an investigational/experimental treatment is proven safe and effective and/or equivalent or superior to other treatments.
FDA Recommends that Recruitment Materials Should Contain the Following Information:
1. The name of the Institution, the name of the Department or Division, and the name of the contact person with a telephone number (including area code) to call for information about the study.
2. The purpose of the research and, in summary form, the eligibility criteria that will be used to admit subjects into the study (e.g., adults on medication for high blood pressure, diabetic patients on insulin; normal, healthy adults; etc.);
3. A straightforward, truthful description of the benefits, if any; and
4. The location of the research and time commitment, if appropriate (e.g., subjects will have to come to Birmingham Baptist Medical Center on 4 separate occasions; the research will take two (2) hours on one day, etc.).
Describing Compensation
If monetary compensation is offered, it must not be presented as an inducement to participate.
Acceptable: Subjects will be financially compensated for their participation; subjects will receive $5.00 for each blood sample; subjects will receive a free physical examination and blood tests.
Unacceptable: EARN $500! Get FREE medical care!
Submission and Approval:
If not included in the original protocol submission, a copy of the advertising materials should be submitted with an "AMENDMENT TO A PREVIOUSLY APPROVED PROJECT" submission form. When approved, the Investigator will receive an approval letter signed by the Institutional Review Board Chairman. The approved copy of the advertisement will be placed in the Institutional Review Board protocol file.
Changes to Advertisements:
Any subsequent changes in the content of an approved advertisement must also be submitted on an Application for Amendment form for IRB review and approval prior to use.
Occasionally, newspapers or magazines may alter copy to fit available space. Therefore, when submitting an advertisement to a newspaper or magazine, a cover letter should be included stating that the text has institutional approval and cannot be altered.
COMPENSATION FOR PARTICIPATION IN RESEARCH
COMPENSATION OF HUMAN SUBJECTS:
Compensation of Institutional subjects may be an incentive for participation or a way to reimburse a subject for travel and other expenses incurred due to participation. However, payment for participation is not considered a research benefit. Although payments are usually monetary, subjects may be offered other rewards such as free medication or travel vouchers.
AMOUNT OF COMPENSATION:
Regardless of the form of remuneration, Investigators must take care to avoid coercion of subjects. The amount of compensation must be proportional to the risks and inconveniences posed by participation in the study.
While the entire payment should not be contingent upon completion of the entire study, payment of a small proportion as an incentive for completion of the study is acceptable, providing that such an incentive is not coercive. The Institutional Review Board should determine that the amount paid as a bonus for completion is reasonable and not so large as to unduly induce subjects to stay in the study when they would otherwise have withdrawn.
For research that requires subjects to undergo only minor inconvenience or discomfort, a modest payment will usually be adequate. Reimbursement for travel and/or baby-sitting may also be provided. For studies involving the assumption of significant risks or discomforts, payments should be greater, but not so great as to exert undue inducement on potential volunteers.
DISCLOSURE OF PAYMENT
All information concerning payment, including the amount and schedule of payment(s), should be set forth in the informed consent document.
METHOD OF PAYMENT:
The Internal Revenue Service (IRS) requires that Brookwood Baptist Health (or whoever is paying the subjects for their participation) report payments in excess of $600 per calendar year on Form 1099-Misc. The filing of these forms necessitate the name and Social Security number of the subject be collected on a Form W-9 and released to the Accounting Office to process the Form 1099-Misc. This must be addressed thoroughly in the informed consent document so that it is clear to the subject that his/her identity will be released for the purpose of payment.
If you complete this research study you will receive at least $600. As a result, you must complete a Form W-9 before the research begins. This form contains your name and social security number and will be released to the [Investigator's Practice Name] Accounting Office. If you receive at least $600 per year from the [Investigator's Practice Name] they are obligated to report the payment to the Internal Revenue Service on Form 1099-Misc. This Form tells the Internal Revenue Service that a payment was made to you but it does not say that you were paid for participation in this research study or whether it is taxable income to you. The IRS Forms W-9 or 1099 will not associate you with this study. It will only indicate that you received payment from the [Investigator's Practice Name].
CHANGES (MODIFICATIONS) IN THE PROTOCOL
WHEN TO MODIFY:
Once a research protocol is approved by the Institutional Review Board, the Principal Investigator or the sponsor may feel that changes are necessary for the safety of the subjects, for the integrity of the data, or for administrative reasons (such as changes in research personnel). These changes are called modifications. Examples of modifications include: changes in study personnel, changes in research site, changes in number of subjects, changes in inclusion/exclusion criteria, changes in research interventions and changes in the research design.
THE ROLE OF THE INSTITUTIONAL REVIEW BOARD:
Per Federal regulations, any desired modification in an approved research protocol must receive approval from the Institutional Review Board prior to implementation. The Institutional Review Board carefully evaluates modification requests to determine whether the proposed changes would in any way effect potential risks to subjects and, by extension, whether changes to the informed consent document should also be required.
SPONSOR MODIFICATIONS:
Modifications are made only to Institutional Review Board approved protocols. Occasionally, and especially in externally-sponsored studies, a sponsor may modify the protocol before it has received final approval from the Institutional Review Board. Investigators are urged to await receipt of the Institutional Review Board approval letter before submitting a request for modification.
CHECKLIST FOR SUBMISSION OF AN AMENDMENT APPLICATION
- "AMENDMENT TO A PREVIOUSLY APPROVED PROJECT" form (The Investigator may have two or more active studies using the same drug/device. However, do not submit more than one study per application form.)
- Appropriate materials that are being amended. For a revision to the informed consent form, send a marked-up copy of the old informed consent form and an original revised consent form (use paper clips only) that can be stamped with the IRB approval stamp and returned.
- For amendments to the protocol submit one complete copy.
WHO SIGNS THE MODIFICATION FORM?
Modification forms must be signed by the Principal Investigator and dated before submission to the Institutional Review Board.
NOTIFICATION:
If a modification request is approved, the Principal Investigator will receive an approval letter signed by the Institutional Review Board Chair or his designee. If the modification includes a revision to the informed consent document, a copy of the revised document will be stamped "approved," dated and sent along with the approval letter. Approved modifications are filed in the official Institutional Review Board protocol file.
Note: Modifications do not extend a protocol's approval period.
APPROVAL PERIOD:
Current Institutional Review Board approval must be maintained as long as human subjects are, in any way, involved with the study, (i.e., until all patient follow up has been completed). The approval period is intended to cover screening, recruitment, administration of drug/device/ biologic, to the end of the follow-up phase.
A research protocol for which no new subjects will be enrolled must be periodically reviewed until such time that:
- Analysis of the data has concluded that no new information needs to be provided to enrolled subjects;
- There is no need to re-contact enrolled subjects to obtain additional research information
Failure to maintain current approval may render all collected data useless if such data is intended for submission to the FDA, (e.g., studies of investigational drugs and devices).
There is no grace period extending the conduct of the research beyond the expiration date of IRB approval. Extensions beyond the expiration date will not be granted. If the IRB does not re-approve the research by the specified expiration date, subject accrual must be suspended pending re-approval of the research by the IRB. Enrollment of new subjects must cease after the expiration of the IRB approval. If the Investigator is actively pursuing renewal with the IRB and the IRB finds that it may be in the best interest of previously enrolled patient's safety to continue study drug procedures, the IRB may allow continuation of drug administration during the time required to complete the review process.
The IRB has the authority to terminate or suspend approval of research that is not being conducted in accordance with regulatory and Brookwood Baptist Health policies regarding continuing review. When study approval is terminated by the Institutional Review Board due to lack of compliance with continuing review requirements, in addition to stopping all research activities, any subjects currently participating should be notified that the study has been terminated. Procedures for withdrawal of enrolled subjects should reflect the rights and welfare of subjects. If follow-up of subjects for safety reasons is permitted/required by the IRB (e.g., device studies), the subject should be so informed and any adverse events should be reported to the IRB and, when applicable, to the sponsor.
TIMING TO AVOID PROTOCOL EXPIRATION:
The Institutional Review Board may send a timely courtesy notice to remind the Investigator of the expiration date of approval of the protocol. However, it is the Investigator's responsibility to be aware of the expiration date and to submit the application in a timely manner. The Investigator is required to complete and submit the CONTINUING REVIEW OF A PREVIOUSLY APPROVED PROJECT form indicating any changes in protocol or problems encountered since the last review. This application should reach the Institutional Review Board office before the deadline for submission for the meeting. This will ensure that the approved protocol will not expire. A list of submission deadlines is available from the Institutional Review Board office at 205-715-5308.
FILLING OUT THE FORM:
The Investigator should complete all data fields.
CONTINUING REVIEW CHECKLIST:
- "Application to Request Scheduled-Continuation Approval of a Previously Approved Project" form signed by the Investigator (no signature stamps)
- A copy of the current informed consent form, if the project is still in the enrollment phase
- Any other pertinent information
Note: For continuing review approval on projects that are still actively recruiting subjects, the previously approved informed consent document will remain active until the Investigator or IRB decides that modifications are needed. Therefore, the informed consent form that is submitted with the Application for Continuing Review will not be restamped and returned.
LEGALLY EFFECTIVE INFORMED CONSENT IS A TWO-PART PROCESS:
- First: The Principal Investigator, (or an appropriate designee), must explain the study to the prospective subject verbally, providing all pertinent information, (purpose, procedures, risks, benefits, alternatives to participation, etc.), and must allow the prospective subject ample opportunity to ask questions.
- Second: Following this verbal explanation, the prospective subject should be provided with a written consent form and afforded sufficient time to consider whether or not to participate in the research. ("Sufficient time" can range from hours to days, dependent on how long it reasonably takes to evaluate risks, potential benefits and alternative treatments).
MEETING WITH SUBJECTS:
After allowing the prospective subject time to read the consent form, an Investigator (either the Principal Investigator or a Sub-investigator) must meet with the potential subject and answer any questions s/he may have. (Designees may orient potential subjects, but Investigators are responsible to complete the consent process.)
SIGNATURES:
An Investigator also must sign the consent form to assure that the subject meets all study criteria, was correctly and appropriately consented and fully understands the requirements of the study.
DATING THE CONSENT:
The Investigator's signature cannot pre-date the subject's signature and cannot be dated after the subject's enrollment in the study.
Note: Simply asking a subject to read and sign a consent form, absent an oral presentation and discussion, does not qualify as informed consent.
CONSENT FROM MINORS
REQUIREMENTS:
Minors are not considered legally competent to provide informed consent for research. The Brookwood Baptist Health Institutional Review Board has taken the position of prohibiting children under the age of 19 (legal age of majority in Alabama) to be considered as subjects for research purposes.
OBTAINING CONSENT FROM PRE-SURGERY PATIENTS
TIMING:
When research will be performed intra-operatively, or when a surgical procedure itself contains any research component, consent should be obtained prior to the time pre-surgery medication for the procedure commences.
Informed consent for the research can be obtained the day before or at the time surgical consent is obtained. However, the patient must clearly understand that s/he is consenting to a clinical procedure as well as participation in research.
Under no circumstances should consent for participation in research be obtained after pre-surgery medication has been given.
CONSENT BY PROXY
WHO CAN PROVIDE CONSENT:
If a prospective subject cannot consent on his/her own behalf due to incapacitation, the only person who may provide such consent is a legally authorized representative of the subject. Legally authorized representatives are court appointed Guardians and persons holding Durable Powers of Attorney with Healthcare Proxy.
WHO CANNOT PROVIDE CONSENT:
While often permitted to make medical decisions for their relatives, "next-of-kin" (including spouses, siblings and other family members) who have not been legally authorized to make decisions on behalf of a prospective subject may not provide consent for research, unless specifically approved by the Institutional Review Board under the surrogate consent exception policy.
IF UNABLE TO OBTAIN CONSENT:
Investigators who are unable to confirm legal authorization of representation for an incapacitated prospective subject are advised to exclude the candidate from the study.
EXCEPTIONS:
The Institutional Review Board may approve exceptions to consent requirements under special circumstances defined by Federal regulation and State statute.
REQUIREMENTS FOR SURROGATE CONSENT EXCEPTION
The Board's policy on informed consent is that a participant in a clinical research study must consent themselves in order to participate in the research study. As a general rule, surrogate consent is not allowed. The Board may allow surrogate consent, provided that the principal investigator demonstrates, in advance, to the satisfaction of the Board that all of the following requirements will be met. Principal investigators desiring to utilize surrogate consent in a research study must provide sufficient information below to demonstrate to the Board's satisfaction that all of the following requirements will be met, and must certify by signing this application that they will comply with all Board requirements for the use of surrogate consent.
1. The clinical investigation cannot practicably be carried out without surrogate consent because
· The subjects will not be able to give their informed consent as a result of their medical condition; and
· There is no reasonable way to identify prospectively the individuals likely to become eligible for participation in the clinical investigation.
2. There is available no alternative method of approved or generally recognized therapy that provides a demonstrated greater likelihood of successfully treating the patient's medical condition.
3. The potential risks from participation in the clinical investigation are reasonable in relation to the potential benefits from participation in the clinical investigation.
4. Fully informed consent will be obtained from a legally authorized representative or surrogate in accordance with these IRB requirements.
· Substituted judgment standard (the surrogate providing consent must attempt to make the decision that the research subject would have made regarding participation in the research study)
· Order of choice of surrogate (as required by Alabama Code §22-8A-1 et seq. (1975, as amended))
· Certification by surrogate (as required by Alabama Code §22-8A-1 et seq. (1975, as amended))
5. The clinical investigation will be regularly monitored by an independent Data, Safety & Monitoring Board, which is operated in accordance with IRB requirements and provides copies of its regular reports to the IRB.
6. If at any time during the clinical investigation, the research subject becomes competent, informed consent will be obtained from the research subject as soon as possible.
TRANSLATION OF CONSENT
FEDERAL REGULATIONS:
Federal regulations require that informed consent documentation be presented in language understandable, (including appropriate language and reading level) to the prospective subject. The Federal regulations recommend 5th through 7th grade reading level.
OTHER LANGUAGES:
Investigators seeking to include subjects speaking languages other than English, (including foreign languages, sign language and Braille), or subjects who cannot read, are urged to contact the Institutional Review Board for guidance.
PREPARATION AND MAINTENANCE OF A RESEARCH AUDIT FILE
PURPOSE OF A RESEARCH AUDIT:
To preserve subject welfare and integrity of research data, various internal and external entities may request access to a Principal Investigator's study records for purposes of conducting an audit. Audits may be conducted for cause (i.e., to investigate an allegation) or for quality control/improvement purposes
EXAMPLES:
Examples of internal entities that may audit research records are the Institutional Review Board and the Brookwood Baptist Health Quality Management and Risk Management. Examples of external entities that may audit research records are the U.S. Food and Drug Administration, the Office for Institutional Protections and corporate sponsors of research (such as pharmaceutical companies).
EXTERNAL AUDITS:
Any time an audit of study records is conducted by an entity other than the Institutional Review Board, it is the responsibility of the Principal Investigator to inform the Institutional Review Board promptly. If the Principal Investigator is given notice of an audit by an external entity, the Institutional Review Board may send a (mutually agreed upon) representative to observe proceedings of any audit which may occur. Finally, the written report of any audit findings for a Brookwood Baptist Health study must be forwarded to the Institutional Review Board for their records.
DOCUMENTATION:
Documentation is an integral and important component of conducting research with human subjects. From the first draft of a protocol through to the completion of a study, much that occurs is dependent on the consistency, accuracy and accountability of the study's accumulated documentation, (e.g., correspondence between the Investigator and the Institutional Review Board, a study sponsor, a funding agency, regulatory agencies; various reports including case report forms, personal and/or medical information on subjects, etc.)
SUGGESTED WAYS TO ORGANIZE DOCUMENTS:
The following is provided to assist Investigators and their staff to organize the numerous documents, making them easily retrievable when needed. (In funded studies, sponsors may require such files, maintained in a specific fashion.) Although the information provided below is weighted toward clinical studies, variations of it can be employed in almost any research study with human subjects.
1. All files should be kept in one designated area (e.g., the Principal Investigator's office, lab, etc.).
2. All documents should be maintained in chronological order. A sturdy three ring binder, containing dividers with some or all of the following headings (depending on the study), is recommended:
- Sponsor Correspondence if the study is formally funded or sponsored (e.g., NIH, NSF; drug/device company).
- Investigator's Assurance and other forms, such as the HHS form 596 and/or FDA 1572 forms.
- Institutional Review Board Approvals, subdivided, as follows:
1. Initial Approval
(a) Retain and insert a copy of the original Institutional Review Board application form, signed by the Principal Investigator and faculty sponsor (if necessary).
(b) The original Institutional Review Board approval letter.
(c) A copy of the final approved protocol, along with any modifications. (If there is a "master" protocol, it might also be filed separately under the heading "Master Protocol" toward the back of the file or in a separate binder.)
2. Modification Forms - Requests/Approvals: Include a copy of the Institutional Review Board modification form signed by the Principal Investigator.
3. Continuing Review - Applications/Approvals: Include a copy of the continuing review application signed by the Principal Investigator. Add (clip or staple) the new, original Institutional Review Board approval letter covering the next approval period as well as the original stamped consent form.
4. Adverse Event Reports - "AEs": Include a copy of each, noting the dates that each report was sent to the Institutional Review Board, sponsor, FDA, etc. If any change to the protocol or consent form is made as a result of adverse experiences, maintain a copy of the changes with the pertinent AE reports.
5. Approved Consent Form(s): Include the originals of each (if there are more than one) approved consent form. The most currently approved consent form is the one from which copies are to be made when enrolling new subjects.
If the consent form requires revision during the course of the study, retain the original in the file and send a copy of it with a revised original for Institutional Review Board review and approval.
To avoid the possibility of using an obsolete version, retain the most currently approved version on top, and draw a diagonal line through each page of the obsolete version when the newly approved one is received.
Subdividers can be used to separate years (e.g. '90 -'91 approval, '91 - '92 approval, etc.) for studies which will continue over several years.
6. Approved Advertising (when applicable): Maintain a copy of each advertisement (including posters, "scripts," etc.) approved for use by the Institutional Review Board (and containing the Institutional Review Board stamp). Notes can be made on each advertisement showing when it was placed and where. Any correspondence relating to advertising can be maintained in this section as well.
7. Study Closure/Completion: Complete the "APPLICATION FOR TERMINATION OF A PREVIOUSLY APPROVED PROJECT" and submit it to the Institutional Review Board to close a study. The report must be signed by the Principal Investigator.
In studies sponsored by a drug or device company, the following, additional sections will likely be required:
d. Subject Enrollment/Assignment Log
e. Drug Dispense/Return Log and Drug Receipt/Ship Log: These will be the originals received from the sponsor for drug receipt, dispensing date, drug count, and final return.
f. Shipment Receipts/Lab Supplies: If the study requires that samples be sent to a central lab, or if the sponsor provides lab supplies (special catheters, test kits, etc.) the accompanying invoices, shipment logs, or UPS/Fed Ex receipts will need to be retained.
g. Monitor See Log (as applicable)
h. Master Protocol: As mentioned previously, a large, bulky master protocol may be maintained in a separate section. When revisions/modifications to protocols are made by a sponsor, most sponsors will provide Investigators dated replacement pages. Unless the sponsor specifically requires the old pages be discarded, it is suggested that a horizontal line be drawn through the page(s) or section(s) being revised and the new information inserted.
i. Sponsor Agreement(s)/Contract(s): This material should include the contract/agreement signed by the Principal Investigator and the sponsor, and any other correspondence/documents pertaining to agreements between the institution or Investigator and the sponsor relative to performance of the study.
j. Miscellaneous
MANAGING THE FLOW OF INFORMATION ON THE PROTOCOL
EXTRAMURAL SPONSORS:
PROTOCOL-RELATED CORRESPONDENCE:
- All protocol-related correspondence sent to Principal Investigators by external sponsors of Brookwood Baptist Health research projects (whether granting agencies or corporate entities) should be forwarded to the Institutional Review Board for review.
- Because sponsors do not usually communicate directly with the Institutional Review Board about protocol issues, the Brookwood Baptist Health relies on Principal Investigators to keep the Institutional Review Board informed on matters such as proposed modifications to existing protocols, adverse event reports, and notices of imminent quality control reviews and audits.
REGULATORY AGENCIES:
PROTOCOL-RELATED CORRESPONDENCE:
- All protocol-related correspondence sent to Principal Investigators, including reports of audits by regulatory agencies, such as the US Food and Drug Administration (FDA), should be forwarded to the Institutional Review Board for review.
- Because the FDA usually does not communicate directly with the Brookwood Baptist Health about Investigational New Drug (IND)-related matters, the Brookwood Baptist Health relies on Principal Investigators to keep the Institutional Review Board informed of any regulatory issues raised by government agencies and to alert the Institutional Review Board promptly of any planned or unplanned audits. Failure to advise the Institutional Review Board promptly of an audit by an external regulatory agency is considered regulatory noncompliance.
RESEARCH COLLABORATORS OUTSIDE THE BROOKWOOD Baptist Health:
If individuals or organizations outside of the Brookwood Baptist Health will be involved in any Brookwood Baptist Health research project, it is the responsibility of the Principal Investigator to fully disclose such collaboration to the Institutional Review Board and to the Institutional Review Board office. This collaboration should be listed on FDA form 1572, in the informed consent document, in the Application for Approval of a New Project submitted to the IRB. Furthermore, the Principal Investigator must inform outside collaborators of the Brookwood Baptist Health's requirements for the performance of human subject research and obtain all necessary assurances that such collaborators will contribute to the project in a manner that complies with those requirements. The Principal Investigator is also responsible to insure that adverse events occurring at collaborating sites are promptly reported to the Institutional Review Board, as required.
DEFINITION OF A REPORTABLE ADVERSE EVENT:
STUDIES INVOLVING DRUGS AND BIOLOGICAL PRODUCTS
An Adverse Event observed during the conduct of a study involving drugs and biological products is defined as an unanticipated problem involving risk to human subjects. An Adverse Event must be reported to the Institutional Review Board, only if it were unexpected, serious, and would have implications for the conduct of the study such as a significant, and usually safety related, resulting in a change in some aspect of the protocol. Based on guidance from the U.S. Food and Drug Administration, Adverse Event reports must be filed with the Institutional Review Board when any of the following occurs:
- A single occurrence of a serious, unexpected event that is uncommon and strongly associated with drug exposure.
- A single occurrence, or most often a small number of occurrences, of a serious, unexpected event that is not commonly associated with drug exposure, but uncommon in the study population
- Multiple occurrences of an Adverse Event that, based on an aggregate analysis, is determined to be an unanticipated problem.
- An Adverse Event that is described or addressed in the investigator’s brochure, protocol, or informed consent documents, but occurs at a specificity or severity that is inconsistent with prior observations.
- A serious Adverse Event that is described in the investigator’s brochure, protocol, in informed consent documents, but for which the rate of occurrence in the study represents a clinically significant increase in the expected rate of occurrence.
- Any other Adverse Event or safety finding that would cause the sponsor to modify the investigator’s brochure, study protocol, or informed consent documents, or would prompt other action to ensure the protection of human subjects.
ADVERSE EVENTS IN CLINICAL TRIALS OF DEVICES CONDUCTED UNDER AN INVESTIGATIONAL DEVICE EXEMPTION
An adverse device event is defined as any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.
ADVERSE EVENT REPORT SUBMISSION
SUBMISSION OF REPORTS FOR ADVERSE EVENTS IN STUDIES UNDER THE JURISDITION OF THE HUMAN RESEARCH REVIEW BOARD:
Adverse Events fitting the previous definition of an unanticipated problem involving risk to human subjects, if it were unexpected, serious, and would have implications for the conduct of the study must be submitted by the Principal Investigator. To report an Adverse Event, the Principal Investigator must complete and submit the appropriate Adverse Event Report Form. Adverse Event reports must be submitted to the Brookwood Baptist Health Institutional Review Board electronically to [email protected].
ADVERSE EVENT CHECKLIST:
- Adverse Events occurring in studies under the jurisdiction of the Institutional Review Board must be submitted on the appropriate application form to report inside events and signed by the Principal Investigator. This report must be submitted within five (5) working days from the time the Principal Investigator discovers the adverse event. Attach all pertinent backup material including medical records making sure that all subject identifiers have been removed. Only one copy is required.
- Adverse Events occurring at other sites will be reported to the Principal Investigator by the sponsor. It is the responsibility of the Principal Investigator to submit information on these events to the Institutional Review Board on the appropriate application form to report outside events. Only one copy is required.
- All follow-up adverse event reports will be received by the Principal Investigator from the sponsor and must be submitted to the IRB on the appropriate inside or outside Adverse Event form.
NOTIFICATION:
The Investigator will not receive AE acknowledgement from the Institutional Review Board office. Reviewed AEs are maintained in the official Institutional Review Board protocol file.
PROCEDURES FOR RESOLVING REGULATORY NON-COMPLIANCE
INTRODUCTION:
The Brookwood Baptist Health Institutional Review Board is responsible for compliance with the regulations, policies and procedures that apply to the conduct of research with human subjects. The Institutional Review Board staff apprise Investigators and research staff on applicable regulations, so that occurrences of noncompliance may be avoided to the greatest extent possible. When potential occurrences of noncompliance are revealed, the following process will be followed.
DISTINGUISHING REGULATORY NON-COMPLIANCE FROM SCIENTIFIC MISCONDUCT:
When an allegation of inappropriate conduct of research or scholarship is made, it is the responsibility of the Institutional Review Board or its designee(s) to determine whether to pursue the matter as an incident of regulatory noncompliance or scientific misconduct. Through the process of investigating and attempting to resolve an incident originally regarded as regulatory noncompliance, new information may be revealed which suggests reclassification as possible scientific misconduct may be warranted. Guidance on distinguishing between regulatory noncompliance and scientific misconduct is provided below in the form of examples. In the event a clear determination cannot be made, the President's Advisory Group will be consulted.
Regulatory Non-Compliance
Failure to obtain/maintain approval for research
Failure to obtain informed consent when required
Failure to file adverse event reports
Coercion of human subjects
Performance of an unapproved procedure
Performance of research at an unapproved site
Failure to file protocol modification
Failure to adhere to regulations, policies, procedures or special conditions related to research
Scientific Misconduct
Plagiarism, including:
- Misrepresentation of authorship
- Misappropriation of data
Fabrication of data
Falsification or destruction of data
Other serious deviations from accepted scientific practices, such as:·
- Obstruction of another's research
- Violation of confidentiality
- Intentional deception, omission, or research dishonesty
- Repeated incidents of regulatory noncompliance
PROCEDURES FOR RESOLVING REGULATORY NONCOMPLIANCE:
Potential occurrences of regulatory noncompliance in research may be revealed by a complainant or through formal and informal monitoring activities. If an allegation of potential noncompliance is unresolvable through informal channels, the following process will be used. Criteria for determining whether an occurrence of noncompliance may be resolved informally, and methods for addressing and reporting such occurrences, are established by each regulatory oversight committee with responsibility for compliance.
STEP 1. ADMINISTRATIVE AUDIT:
The purpose of an Administrative Audit is to determine whether a possible occurrence of regulatory noncompliance warrants further attention.
An Administrative Audit is initiated when a written allegation is received from a complainant, when a complainant is unwilling to submit a written allegation but the Institutional Review Board deems an Administrative Audit necessary, or when monitoring activities reveal cause and when informal resolution is not achieved.
Administrative Audits are conducted by the Institutional Review Board or their designee(s).
An Administrative Audit may include: review of files, literature, and other documents that could serve to validate or dismiss the allegation. When an Administrative Audit reveals information that appears to substantiate an allegation of noncompliance with policies or regulations, all efforts will be made to resolve the matter informally.
Possible outcomes* of an Administrative Audit are:
- dismiss allegation, or
- achieve compliance with the cooperation of the Investigator (and report to Institutional Review Board and/or Federal Agency when required), or
- recommend reclassification as possible scientific misconduct.
The results of an Administrative Audit will be communicated in writing to the Investigator promptly after commencement of the audit.
This communication will either: notify the Investigator that the allegation was dismissed, confirm that compliance was achieved, or apprise the Investigator that the incident may be investigated as a matter of scientific misconduct.
In cases where the result of an Administrative Audit suggests that an Investigator has demonstrated an apparent pattern of disregard for research regulations, policies, or procedures, the Institutional Review Board may temporarily or permanently suspend approval of present and future studies.
STEP 2. SANCTIONS FOR REGULATORY NONCOMPLIANCE:
Whenever possible, technical assistance will be provided to Investigators to assist them with achieving compliance without the need for imposition of sanctions. However, in cases where cooperation does not occur, and when it is determined that the safety or welfare of subjects or the integrity of the institution are or have been placed at risk, sanctions may be imposed.
The Institutional Review Board has the regulatory authority to:
- require frequent review of,
- suspend approval for,
- terminate individual research protocols until compliance is achieved, and to
- report certain noncompliant activities to governmental entities.
The Institutional Review Board may recommend additional sanctions to the Brookwood Baptist Health through the President's Advisory Group.
Possible sanction recommendations are:
- research privilege probation,
- suspension of research privileges,
- termination of research privileges, and
- embargo of publications.
When sanctions beyond the authority of the Institutional Review Board are to be applied, the decision will be communicated in writing by the President of the Brookwood Baptist Health to the Investigator (with a copy to the Institutional Review Board Chair and the appropriate protocol files).
RECLASSIFICATION AS POSSIBLE SCIENTIFIC MISCONDUCT:
If, at any point in the process of attempting to resolve an alleged incident of noncompliance, it is determined that, in fact, the allegation is more properly addressed as an incident of scientific misconduct, a recommendation to the President's Advisory Committee will be made to reclassify the allegations such.
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