Download - IRB Basics Presenter: Janelle Greening, M.B.A., C.I.P. Compliance Officer Revised: April 2012 1
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UNIVERSITY OF MISSOURI CAMPUS
INSTITUTIONAL REVIEW BOARD
IRB Basics
Presenter: Janelle Greening, M.B.A., C.I.P. Compliance Officer
Revised: April 2012
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CAMPUS IRB WEBSITES
Campus IRB Website:www.research.missouri.edu/cirb
Online Electronic System:http://irb.missouri.edu/eirb MU faculty, staff and students can login without
creating an account.
Location: 485 McReynolds Hall
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IRB CERTIFICATION
www.citiprogram.org Create an Account Associate with UMC Campus SBR – User Group Basic Course: Select “Human Subject Research
Course” Refresher Course
*Do not complete the Responsible Conduct of Research modules – it will not count towards IRB training
Training is active for two years.
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JOIN OUR LISTSERV
Up-to-date IRB information Changes to policies and procedures Training opportunities Send an e-mail to
[email protected] and putting “SUBSCRIBE CIRB” in the body of the email
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STAFF MEMBERS: YOUR RESOURCE
Michele Kennett, Director Janelle Greening, Compliance Officer Compliance Specialists:
Melissa FreemanDenise Harrington
Campus IRB Phone Number: 882-9585Heidi Mitchel
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TOPICS TO COVER
IRB Functions Ethical
Principles Federal
Definitions 3 Levels of
Review Special
Categories of Research
Vulnerable Subjects
Recruitment Process
Informed Consent Investigator
Reporting Requirements
IRB Forms Criteria for
Approval
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TODAY’S OBJECTIVES
1. Basic understanding of the federal regulations governing human subject research
2. Basic understanding the federal definition of “human subject” and “research”
3. Understanding the importance of informed consent and respect for persons
4. Knowing your reporting responsibilities
5. Maintaining appropriate oversight of your research
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PURPOSE
1.Safeguard human subject research participants in accordance with the DHHS federal regulations 45 CFR 46
2.Comply with the ethical principles outlined in the Belmont Report, released in 1979
3.Comply with MU Institutional Policy Chapter 410: Research Involving Humans
4.Comply with the Federalwide Assurance Agreement
5.Comply with State or Local laws which provide additional protections for human subjects
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IRB FUNCTIONS AND OPERATIONS
Protect the rights and welfare of human subjects
Review, approve, require modifications, or disapprove all research activities involving human subjects
Approve changes in previously approved research (adding/removing components)
Provide continuing review of all humans subject research activities
Any other steps necessary to protect the human subject participants
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ETHICAL PRINCIPLES
Belmont Report:
1) A statement of the basic ethical principles to be used to resolve ethical problems that surround the conduct of research with human subjects
2) Identifies three basic principles for conducting research with human subjects
3) Provides a foundation for the federal regulations
4) MU must comply with the Belmont Report as outlined in our Federalwide Assurance Agreement
5) Focus on what is right or wrong
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CAMPUS IRB MEMBERSHIP
At least 5 members Diverse membership
1 non-affiliated member1 scientific member1 non-scientific member
Adequate expertise Consultants, if necessary
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RESPECT FOR PERSONS Recognition of personal dignity and
autonomy of individualsCreate a meaningful consent processProvide subjects with all necessary
information to make a decision to participate
Allow subjects to withdraw without penalty or adverse consequences
Demands that subjects enter into the research voluntarily and with adequate information
Persons with diminished autonomy are entitled to protection
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BENEFICENCE
Minimize risks of harm and maximize the potential benefits
Ensure the benefits justify the risks of harm
Risks may include:PhysicalPsychologicalLegalSocialEconomic
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JUSTICE
Fair procedures and outcomes in the selection of research subjects
Selection of research subjects needs to be scrutinized in order to determine whether some classes are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied.
Participants should not be selected for research solely because: they are available; vulnerable; or they cannot say no
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ACCOUNTABILITY
Institution Investigator IRB
We are all accountable for a successful local human subject protection program
Each is expected to play a role
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FEDERALWIDE ASSURANCE
A contractual agreement between MU and OHRP which guarantees this institution’s commitment that all human subject research complies with the regulations protecting human subject participants.
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ENGAGEMENT Assess whether our institution is
considered to be engaged in the research.http://www.hhs.gov/ohrp/policy/engage08.html
Examples of being engaged (requires IRB review at MU): Consenting participants Intervening or interacting with participantsObtaining identifiable private information
or identifiable biological specimens from any source for the research
MU is the lead on a contract or grant, even when the research is conducted elsewhere
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NOT ENGAGED Examples of activities that would not
require review by MU’s IRB: Inform subjects about the availability of the research; Provide subjects with information about the research but do
not obtain subjects’ consent or act as representatives of the investigators;
Provide subjects with information about contacting investigators for information or enrollment; and/or
Seek or obtain the subjects’ permission for investigators to contact them.
Permit use of our facilities. Release to investigators at another institution
identifiable private information or identifiable biological specimens pertaining to the subjects of the research.
Obtain coded private information or human biological specimens from another institution , but cannot readily ascertain the identity of the subjects.
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FEDERAL DEFINITIONS
1) Research2) Human Subject3) Minimal Risk
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RESEARCH A systematic investigation, including research
development, testing and evaluation, designed to develop or contribute to generalizable knowledge
Internal MU Definitions: Systematic Investigation: A "systematic investigation" is
an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question.
Generalizable Knowledge: Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program (e.g., publications or presentations.) However, research results do not have to be published or presented to qualify the experiment or data gathering as research. The intent to contribute to "generalizable (scholarly) knowledge" makes an experiment or data collection research, regardless of publication.
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HUMAN SUBJECT
A living individual about whom an investigator obtains:Data through intervention or interactions
with the individual; OR Identifiable private information
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HUMAN SUBJECT CONTINUED
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 investigator and subject
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PRIVATE INFORMATION
Includes information about behavior that occurs in a context in which: An individual can reasonably expect:
That no observation or recording is taking place, AND The information will not be made public.
Private information must be individually identifiable (i.e. the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
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MINIMAL RISK
The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those encountered in daily life or during the performance of routine physical or psychological examinations or tests.
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3 LEVELS OF IRB REVIEW
1. Exempt2. Expedited3. Full Board
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EXEMPT
Determination must come from the IRB Projects involving minimal risk Must fall under 1 of the 6 categories in
the federal regulations 45 CFR 46 Cannot involve prisoners or children
Investigators must complete the Exempt Application for initial review Modifications: Exempt Amendment Form Continuing Review: Annual Exempt
Certification Form Complete Applications: ~1 business day turnaround
time
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EXEMPT CATEGORIES1. Research conducted in established or commonly
accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) 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.
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EXEMPT CATEGORIES CONT…
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, 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 and thereafter.
4. 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 the subjects.
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EXEMPT CATEGORIES CONT…
5. Research 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 for benefits or services under those programs.
6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods 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 Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
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EXPEDITED Projects involving minimal risk Minor changes to approved research Must fall under 1 of the 7 categories of
initial review or 1 of the 2 categories of continuing review
Investigators must complete the Expedited/Full Board Application for initial reviewModifications: Amendment FormContinuing Review: Continuing Review
Status Report Complete Applications: ~5-10 business day
turnaround time
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FULL BOARD Projects not meeting the criteria for
Exempt or Expedited review Projects involving greater than minimal
risk
Investigators must complete the Expedited/Full Board Application for initial review Modifications: Amendment Form Continuing Review: Continuing Review
Status Report Deadline: 1st of every month or the following business
day
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CONTINUING REVIEW An IRB shall conduct continuing review of
research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year.
PURPOSE: Ensure the research remains justified and the rights and welfare of the participants continue to be fully protected.
Failure to provide the annual report could lead to study suspension, a loss of funding and/or publication possibilities, or reporting of noncompliance to sponsors or funding agencies.
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SPECIAL CATEGORIES OF RESEARCH TO DISCUSS
Internet Research International Research Ethnographic Research Survey Research Qualitative Research Collaborative Research Deception Studies
Any others you would like to discuss?
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RESEARCH THAT MAY NOT BE SUBJECT TO IRB REVIEW
Research using de-identified secondary datasets
Quality improvement/program evaluation only studies
Classroom research only submitted for a grade – not disseminated outside the classroom
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VULNERABLE POPULATIONS
Vulnerable as defined by the federal regulationsPregnant Women: 45 CFR 46.201Prisoners: 45 CFR 46.301Children: 45 CFR 46.401Wards: 45 CFR 46.409
Possible other vulnerable subjectsStudentsLow-IncomeEmployeesElderly
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PRISONERS
Constraints could affect their ability to make a truly voluntary and uncoerced decision whether or not to participate
Prisoner representative will review the study
Must fall under one of the categories for research involving prisoners
Parole boards will not take into account a prisoner’s participation in research
Additional duties of IRBs where prisoners are involved
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CHILDREN
Research must fall under one of the four categories for research involving children
Cannot be Exempt Child assent and parental
permission must be obtained unless waived
Describe for the IRB how child assent will be documented if not written
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WARDS
Greater than minimal risk studies where there is no direct benefit:Research is related to their status as
wards; orConducted in schools, camps, hospitals,
institutions, or similar settings in which the majority of children involved as subjects are not wards.
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OTHER VULNERABLE POPULATIONS
Students: Extra/Course Credit, Instructor initiated studies (Undue Influence)
Non-English Speaking: Comprehension Low-Income: Monetary incentives Elderly: Comprehension, Capability to
consent Employees: Employability risks
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SUBJECT RECRUITMENT
The four Cs of Recruitment from an IRB perspective
1. Consent (ongoing)
2. Coercion
3. Confidentiality and Privacy
4. Completeness (accuracy as well as truthfulness versus deception)
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ADVERTISEMENTS The advertisement is limited to the
information the prospective subjects need to determine their eligibility and interest, such as: The name and address of the investigator or
research facility The condition under study or the purpose of the
research In summary form, the criteria that will be used to
determine eligibility for the study A brief list of participation benefits, if any The time or other commitment required of the
subjects The location of the research and the person or
office to contact for further information
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COMPENSATION Describe the amount, method, and timing of
disbursement Compensation is not contingent upon
completing the entire study Any amount of compensation 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
Course/Extra Credit: The alternative assignment is comparable in time and effort
Accounting Services Approval is required when the investigator proposes to use internal or external funding, and offering cash or non-cash items to their subjects
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INFORMED CONSENT
Informed consent is a process that enables persons to voluntarily decide whether or not to participate as a research subject
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RESPECT FOR PERSONS
Consent is a fundamental mechanism to ensure the basic ethical principle of respect for persons is met through a provisional process of thoughtful consent for a voluntary act.
Consent is a procedure designed to educate the subject population in terms that they can understand.
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ISSUES TO CONSIDER Who is obtaining consent and do they have
proper training and oversight? Is it coercive? Is it voluntary? Does the subject have time to consider
participation? Does the subject understand the alternatives? Do they have the legal and mental capacity to
consent or is a Legally Authorized Representative required to consent on their behalf?
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BASIC ELEMENTS OF CONSENT
(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
(2) A description of any reasonably foreseeable risks or discomforts to the subject;
(3) A description of any benefits to the subject or to others which may reasonably be expected from the research;
(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
(6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and
(8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
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ADDITIONAL ELEMENTS OF CONSENT
(1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
(2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
(3) Any additional costs to the subject that may result from participation in the research;
(4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
(5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
(6) The approximate number of subjects involved in the study.
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TYPES OF CONSENT Written Consent Short Form Waiver of Documentation (no signature) Waiver of Consent
A copy of the consent document must be provided to the subject unless waived by the IRB
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SHORT FORM
For the occasional and unanticipated non-English-speaking subject, an alternative "short form" method is allowed
Used because no consent form in the subject's language was prepared
Routine use of the "short form" for obtaining informed consent is strongly discouraged
The short form consent process cannot be used for vulnerable subject populations
There will be a witness to the oral presentation Contact the IRB for additional requirements
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CRITERIA FOR WAIVERS Waiver or Alteration of
Consent
No more than minimal risk to subjects
Would not adversely affect the rights and welfare of subjects
Could not practicably be carried out without the waiver or alteration; and
When appropriate, debriefing session is available
Waiver of Documentation
That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
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COMPREHENSION/READABILITY
Does the subject understand the information provided?
It is your responsibility to enhance each subject’s comprehension of the information
Avoid complex terms and sentences No exculpatory language (waiving legal
rights) The investigator must consider:
The nature of the subject population The type of information conveyed The circumstances under which the consent
process will take place The primary language of the participant
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TEMPLATE LANGUAGE
Contact our office for template language:Certificates of confidentialityUse of electrodesStudies involving alcohol consumption IRB contact information Injury statement (greater than minimal risk
studies)Etc.
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NON-ENGLISH SPEAKING Translated documents shall be prepared after
IRB review and approval of the English version
Minimal Risk Studies: The qualifications of the individual performing the translation will be assessed by the IRB. A letter from the translator describing their qualifications must be provided with the translation documents.
Greater than Minimal Risk Studies: A certified translation is one that has been formally verified by a licensed translator or translation company for use in official purposes.
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PARENTAL AND YOUTH ASSENT
The parental consent process must contain all elements of consent unless a waiver is approved by the IRB
Consent may need to be obtained from one or two parents (greater than minimal risk studies with no direct benefit)
The IRB shall determine that adequate provisions are made for soliciting the assent of children. Are the children capable of providing assent? Is a waiver appropriate? Take into consideration age, maturity, and
psychological state
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CONSENT APPROVALS The Campus IRB will save a revised
copy of your consent document(s) to the document storage of eIRB. We will place a footer in the document with the approval date and IRB number.
You must use this copy when obtaining consent.
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INVESTIGATOR REPORTING RESPONSIBILITIES
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REPORTING REQUIREMENTS
Changes Deviations Unanticipated Problems Conflicts of Interest Subject Complaints Known or suspected noncompliance Funding Source / Personnel changes Suspension or closure of approved projects
Any issue that arises that could impact the adequate protection of human subjects involved in research
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CAMPUS IRB FORMS
Exempt Application Expedited/Full Board Application Exempt Amendment Amendment Form (Expedited/Full
Board) Annual Exempt Certification Form Continuing Review Status Report Event Report Site Additions Form Project Personnel Change Form Completion/Withdrawal Report
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SUPPORTIVE DOCUMENTATION Exempt Research:
Permission LettersAccounting ServicesCover LetterFunding Proposal Instruments
Interview Questions Survey Questions Focus Group Questions
Information provided to subjects about the research
Expedited & Full Board Research:Permission LettersRecruitment
MaterialsConsent DocumentsAccounting ServicesInstrumentsFunding ProposalsAny other documents
to support the research application
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DOCUMENT STORAGE: NEW FEATURE
The IRB now marks approved documents.
You must use the documents we mark approved in document storage.
Go to the upper right hand corner and select approved documents from the drop-down list.
Use the IRB approved consent documents stamped with our approval footer
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DATA STORAGE The research plan makes adequate
provision for monitoring the data collected to ensure the safety of the subjects
There also must be adequate provisions to protect the privacy of subjects and to maintain the confidentiality of the data.
All research records must be retained for at least seven years after completion of the research – including audio, video, and photographs Inspection Copying
Records must be retained at MU
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CRITERIA FOR IRB APPROVAL OF
RESEARCH1. Risks to subjects are minimized
2. Risks to subjects are reasonable in relation to anticipated benefits
3. Selection of subjects is equitable
4. Informed consent will be sought from each prospective subjects
5. Informed consent will be appropriately documented
6. When appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure the safety of the subject
7. When appropriate, the research plan makes adequate provisions to protect the privacy of subjects and to maintain confidentiality
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CONCLUSION
Every effort must be made to protect human subjects from harm.