What Every Investigator and hisher research staff Should Know about Conducting Human Research Activities Based on David Lettermens Top Ten PI Responsibility 1 In designing the study the investigator should take into consideration the three underlying ethical principles for con ID: 934660
Download Presentation The PPT/PDF document "IRB’s Top Ten* Investigator Responsibi..." is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
Slide1
IRB’s Top Ten*
Investigator Responsibilities
What Every Investigator (and his/her research staff) Should Know about Conducting Human Research Activities
*
Based on David Lettermen’s Top Ten
Slide2PI Responsibility #1
In designing the study, the investigator should take into consideration the three underlying ethical principles for conducting research with human subjects as delineated in the
Belmont Report.
Slide3Belmont Report?
What’s that?
My research is ethical!The Belmont Report outlines the ethical underpinnings of all of the federal regulations governing the use of human subjects.
Slide4Ethical Principles
Respect for PersonsEach person is autonomous
Respect for the person’s privacy when identifying him/her as a potential subjectRespect for the person’s autonomy includes obtaining consent for research proceduresRespect for the person’s willingness to share confidential information
Slide5Ethical Principles
BeneficienceThe research will do no intentional harm
The research will provide opportunity for benefit, either to the individual, to the group which the individual represents, or to societyThe risks associated with the research are minimized as much as possible
Slide6Ethical Principle
Justice
That the burdens (i.e., the risks) of the research will not be put upon any one particular group because of convenience, vulnerability, or lack of autonomyThe benefits of the research will not be exclusive to any one particular group but will be made available to anyone who might reap those benefits.
Slide7PI Responsibility #2
Research investigators should acknowledge and accept their responsibility for protecting the rights and welfare of human research subjects and for complying with all applicable federal regulations dealing with protection of human subjects.
Slide8Federal Regulations?
What regulations apply to my research?
Which ones can I avoid?Common Rule (Federal Policy for the Protection of Human SubjectsEffective August 19, 1991Adopted by 16 Federal AgenciesBased on Subpart A 45 CFR 46
Slide9Slide10Department of Health and Human Services
Core Requirements
(Subpart A) Fetuses and Pregnant Women (Subpart B) Prisoners (Subpart C)Children (Subpart D)Institutionalized Mentally Disabled (Proposed Subpart E)
Slide11Food and Drug Administration
Informed Consent
21 CFR 50Institutional Review Board 21 CFR 56
Slide12Are there ever times when I do not have to apply these regulations
?
There are certain categories of research that are exempt from DHHS regulations. The regulations do not have to be applied when the only involvement of human subjects falls within one or more categories on the following list.
Slide13Exempt Categories
Research conducted in established or commonly accepted educational settings, involving normal educational practices.
Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior, unless: (1) Information obtained is recorded in such a manner that human subjects can be identified directly or through identifiers linked to the subjects; AND (2) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, or reputation.
Slide14Exempt Categories, cont.
Research not exempt under “2” may be exempt if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research thereafter (e.g., Department of Justice and National Center for Educational Statistics)
Slide15Exempt Categories, cont.
Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to subjects.
Please note: according to OHRP to quality for this exemption the data, documents, records, or specimens must be in existence before the project begins.
Slide16Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment of benefits or services under those programs.
Exempt Categories, cont.
Slide17Taste and food quality evaluation and consumer acceptance studies: (I) if wholesome food without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the FDA or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the US Department of Agriculture.
Exempt Categories, cont.
Slide18PI Responsibility #3
Investigators are responsible for ensuring that all research involving human subjects is submitted to and approved by the appropriate Institutional Review Board (IRB).
Slide19So, what needs IRB review?
*The IRB has purview over all research that involves human subjects.
HUMAN SUBECT is defined as a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information. [45CFR46.102(f)]
Slide20When is it research?
“RESEARCH”
Research is a systematic investigation designed to develop or contribute to generalizable knowledge [45CFR46.102(d)]
Slide21Does that mean I need IRB review for chart reviews?
What about poster presentations?
Slide22The answer to both questions is “YES”!!
Chart reviews are the systematic collection of identifiable private information
If you are sharing your findings with anyone outside the research team, it is considered meeting the definition of “generalizable knowledge.
Slide23Applicability: FDA
Clinical InvestigationsRegulated Products
DrugsDevicesBiologicsFood/Color Additives
Slide24What is designated as a “clinical investigation”?
Involves use of a
Test ArticleOne or more Human SubjectsMeets requirements for Prior Submission to FDA orResults intended to be part of an Application for Research or Marketing Permit
[21 CFR 56.102(c)]
Slide25PI Responsibility #4
Investigators are responsible for complying with all applicable IRB policies, procedures, decisions, conditions, and requirements.
OKAY, OKAY – so I need IRB review. What do I do next and what does all that mean?
Slide26Complete an IRB Application
http://www.research.usf.edu/cs/irb.htm
Slide27Mechanisms for Review
Expedited Review
Full ReviewExpedited Review CriteriaNo More Than “Minimal Risk”Falls in One or More Federally Specified CategoriesMinor Change in Previously Approved Research
Slide28Definition of Minimal Risk
“Minimal Risk” mean that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves from those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. 45 CFR 46.102(i)
Slide29What are the “federally specified categories” that qualify my research for expedited review?
Clinical studies that no not require an IDE or IND
Collection of blood samples Noninvasive prospective collection of biological specimensNoninvasive data collection used in clinical practiceData, documents, records, specimens collected for non-research purposesVoice, video, digital, or imaging recordings for researchResearch on individual or group characteristicsContinuing Review (under certain conditions)
Slide30My research involves other kinds of procedures. Now
what happens?
Full Review RequirementsConducted at Convened MeetingQuorum PresentNonscientific Representative45 CFR 46.111 SatisfiedApproval by MajorityConflict of Interest Abstain from Vote/Leave RoomPI Informed of Outcome In Writing
Slide31What Does it Take to Get My IRB Application Approved?
Criteria for IRB Approval of Research
[45 CFR 46.111]To approve research, an IRB should determine that all of the following conditions exist:
Slide32Risks to subjects are minimized;
Risks are reasonable in relation to anticipated benefits, if any, to subjects and to the advancement of knowledge;
Selection of subjects is equitable;Informed consent will be sought;
Informed consent will be documented;
Where appropriate, research plan makes adequate provision for monitoring the data collected to ensure safety of subjects;
Slide33There are adequate provisions to protect the privacy or subjects and to maintain the confidentiality of the data;
Where any of the subjects are likely to be vulnerable to coercion or undue influence, additional safeguards have been included in the study to protect subjects.
In addition, local IRB policies and requirements apply.
Slide34Statement from Actual Informed Consent Document
“…investigator may at his/her absolute discretion terminate the procedures and/or investigators at any time.”
Slide35And Yet Another Statement from an Actual Consent Form
“…will be permanently able to perform sexual acts.”
Slide36And Finally….from an actual consent form…
“We will insert three catheters, one in each arm.”
ARENA Newsletter, 1989
Slide37What has to go in my consent form to make sure it is approved?
General Requirements
45 CFR Part 46.116 Basic Elements 45 CFR Part 46.116(a) Additional Elements 45 CFR Part 46.116(b)
Alteration or Waiver
45 CFR Part 46.116(d) Documentation
45 CFR 46.117
Slide38Investigator Responsibilities #5 & #6
Unless otherwise authorized by the IRB, investigators are responsible for
obtaining and documenting informed consent in accord with federal regulations (45 CFR Part 46.116 and .117 and 21 CFR Parts 50.25 and 50.27) and as approved by the IRB.
Slide39General Requirements
Obtained from the subject or the subject’s legally authorized representative
Language understandable to the subject/representativeObtained under circumstances that provide subject w/opportunity to consider whether or not participate and that minimize coercive influencesNot include language through which the subject appears to waive his legal rights or which releases the investigator, sponsor, or institution from liability for negligence
Slide40Basic Elements
The study involves research!
Explanation of the purposeDuration of subject’s participationDescription of proceduresIdentification of experimental proceduresDescription of risks or discomfortsDescription of potential benefits to subject or othersDisclosure of alternatives availableExtent of confidentiality that can be made (FDA statement)
Slide41Basic Elements, cont.
If research is greater than minimal risk, explanation of compensation and availability of medical treatment
Whom to contact (3 contacts) Contact for questions about the research Contact for questions about subject rights Contact if research-related
injury should occur
Statement that participation is voluntary, refusal to participate involves no penalty or loss of benefits, and that subject may discontinue at any time.
Slide42Additional Elements
If required by the IRB, one or more of the following should be provided to the subject:
Statement that there may be unforeseen risksDescription of circumstances under which subject’s participation may be terminatedAdditional costs to subjectConsequences of withdrawing from studyStatement that significant new findings which may related to the subject’s willingness to participate will be shared
Approximately number of subjects involved in the study
Slide43“Do I always have to obtain consent? My study is so low risk!!”
An IRB may waive consent or alter the elements
IF it finds and documents the following:Research involves no more than minimal risk;Rights and welfare of subjects will not be adversely affected;Research could not be practicably carried out without waiver or alteration; and
If appropriate, subjects will be provided pertinent information after participation.
Slide44Documentation of Informed Consent
Informed consent will be documented using:
A written form approved by the IRB (in our case and appropriately stamped with the IRB approval period)Signed by the subject or his legal representative; andA copy of the form will be given to the person signing the form. (Be sure to document in the research/medical records that the form was given to the subject.)
Slide45“I can’t get written consent in a telephone survey. What do I do?”
IRB may waive documentation of informed consent if:
The only record linking the subject and the research is the informed consent document and the principle risk would be harm resulting from breach of confidentiality; each subject must be asked whether he/she wants documentation (not included in FDA regulations); orThe research presents no more than minimal risk and involves no procedures for which written consent is normally required.
Slide46“What’s the difference in requesting a waiver of documentation and a requesting a waiver of consent?”
Waiver of documentation will usually mean that the IRB requires that you provide the subject with written information but don’t obtain a signature.
Waiver of consent means that you meet the 4 criteria previously described and there is no consent process.
Slide47“What can I do to make sure subjects really do understand the research?”
Train individuals obtaining informed consent (they should be able to answer questions the subjects may have about the research)
Use technology or innovative approachesBe sensitive to subjects’ needsMake adjustments in the process, as necessaryObtain IRB approval for substantive changes and a plan to re-consent, when necessary
Slide48“We were in a hurry; we just grabbed the only copy of the consent form we could find.”
It must be the most recently IRB approved form or it’s just not valid!
The subject or legally authorized representative must date and sign the form.The subject must be given a copy of the form.Maintain documentation!!!! If it isn’t documented, it didn’t happen.
Slide49Investigator Responsibility #7
The investigator is responsible for ensuring that the research is implemented as specified in the approved protocol and for promptly submitting to the IRB a modification to the previously approved protocol
prior to initiating the change.
Slide50In lay terms…
“I changed my mind - do I need to tell the IRB?”“The protocol says I will only enroll subjects with blue eyes but this subject has green eyes – can I enroll him?”
Modifications – need to obtain prior IRB approval!
Exceptions – need to obtain sponsor and IRB approval!!
Slide51Investigator Responsibility #8
Research investigators are responsible for reporting progress of approved research to the IRB, as often as and in the manner prescribed by the approving IRB on the basis of risks to subjects, but no less than once per year.
Slide52“Why do you keep sending me those letters about my IRB approval?”
Federal regulations [45 CFR 46.109(e) and 21 CFR 56.109(e)] state that an IRB “shall conduct continuing review at intervals appropriate to the degree of risk, but not less than once per year…”
Slide53It is the
PI’s responsibility to seek a new approval if the study is to continue.
However, USF will help you out. We will send you a reminder notice approximately 75 days before your IRB approval is to expire.If you ignore the reminder notice and IRB approval expires, you will have to stop all research procedures and data collection.
Slide54http://www.research.usf.edu/cs/download01.htm/
Download the Continuation Review Form
Complete the form and submit the required information (copies of the application, the informed consent, abstract or progress report, etc.)Call the Division of Research Compliance if you have questions (813-974-5638) and have your IRB number ready.
Slide55“How does the IRB decide if a study can continue?”
The criteria for issuing continuing approval is the same as that for initial review.
The questions on the application are there for a reason. If the application is incomplete, it may slow your review or cause your approval to lapse.The IRB will take into consideration the progress that has occurred on the study to determine if there has been a change to the risk/benefit ratio and if the study continues to be appropriate for the intended population.
Slide56Investigator Responsibility #9
Research investigators must promptly report to the IRB and to the sponsoring Federal department any injuries, adverse events, or other unanticipated problems involving risks to subjects and others, in accord with IRB polices and requirements.
Slide57“What do I report and when do I report it?”
https://irb.research.usf.edu/ers/o6-start.asp
Gives you all the information you need about reporting AE’s, injuries, and unanticipated events.USF IRB Policy 706: http://www.research.usf.edu/cs/irb_policies/706.pdf
Slide58Investigator Responsibility #10
Research investigators are responsible for retention of signed consent documents and IRB records for at least five years past the completion of the research activity.*
*Sponsors may require that study documentation be retained for a longer period of time.
Slide59“I am running out of space. How much longer do I need to keep all of this paper and what do I need to keep?”
Research protocols
All IRB and sponsor correspondenceContinuing Review reportsOriginal DataSigned Consent/Assent Forms
Remember, if it isn’t documented or you can’t produce documentation, the feds (and in worse case scenarios, lawyers) won’t consider it done!
Slide60Investigator Top 10 Responsibilities
Design Ethical Research
Comply with Federal RegulationsObtain Prior IRB ApprovalObtain Informed Consent/AssentDocument Informed Consent/AssentImplement Research As Approved and Obtain Prior Approval for ModificationsSubmit Progress Reports
Report Unanticipated Problems
Retain Records for 5 years after study closes
Slide61USF Division of Research Integrity & Compliance
Web site:
http://www.research.usf.edu/cs/irb.htmPhone: (813) 974-9343Location: University Professional Center 3702 Spectrum Blvd., Suite 155 Tampa, Florida 33613Mail: USF Division of Research Integrity and Compliance
12901 Bruce B. Downs Blvd., MDC 035
Tampa, FL 33612-4799