Institutional Review Board Rhonda C. Holliday, PhD Chair Social and Behavioral Sciences IRB

To protect the rights and welfare of research participants The IRB Mission To protect the rights and welfare of research participants

The IRB Mission Approve, require modifications in or disapprove research activities Annual review of research progress Suspend or terminate approval of research

The IRB Mission The IRB ensures: Equitable subject selection Adequate informed consent Minimization of risks Privacy and confidentiality is maintained

IRB Members Academicians/scholars of various backgrounds and expertise Community/lay people IRB training

What does the IRB do? Review all applications Consult federal regulations to ensure that each project protocol is in compliance with the regulations. Determine the level of review required Assign study to a reviewer Ensure that investigator has appropriate ethical training (CITI course completed)

Federal Regulations Established to ensure protections for human subjects in research. Derived from the ethical principles recognized in the Belmont Report 1991- Numerous federal departments and agencies adopted a common set of regulations called the “Common Rule”- these govern human subjects research sponsored by the federal government.

Federal Regulations & MSM Policy MSM has provided a formal guarantee to the DHHS that it will follow procedures (Code of Federal Regulations) that will assure the protection of all human subjects involved in research projects (FWA # 4535 ) Guarantee applies to all human subjects research conducted: by anyone on the premises of MSM and to research conducted elsewhere by faculty, students, staff or other representatives of MSM in connection with their institutional responsibilities.

Belmont Report Respect for persons Beneficence Justice Individuals treated as autonomous agents Individuals with diminished autonomy entitled to protection Beneficence Do not harm Maximize possible benefits, minimize possible harms Justice Fairness in distribution (research costs & benefits) Inclusion of diverse populations

Is it Research?

IRB Reviews Type of review is determined by the amount of risk associated with the study. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests Greater than minimal risk No more than minimal risk

Type of Review Determined by the IRB Full Expedited Exempt

Types of IRB Reviews Full Board Review Studies are reviewed by a fully-convened IRB committee. The committee discusses the study and makes a decision about the approval of the study. This type of review is carried out for studies greater than minimal risk to subjects.

Types of IRB Reviews Expedited Review Studies are reviewed by a qualified member of the IRB committee. This member reviews the appropriate materials and consults with the PI if necessary to come to a decision about the approval of the study. This type of review is carried out for studies which involve minimal risk to subjects and fit into an expedited review category of research.

Expedited Review Clinical studies of drugs or devices only when it is not a new drug or device and not being used in a way that increases risk Collection of small volumes of blood Collections of biological specimens by non-invasive means Collection of data through non-invasive procedures Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes Collection of data from voice, video, digital, or image recordings made for research purposes Research on individual or group characteristics or behavior Continuing review of research previously approved by the convened IRB Continuing review of research where IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified

Types of IRB Reviews Exempt review The IRB Office screens studies for exemptions. If a study fits into an exempt category of research and is low risk to subjects, it will not need to go through expedited or full-committee review. If the study is not found exempt, it will need to go through expedited or full-committee review.

Exempt Review Research involving educational practices Research involving the use of educational tests that are anonymous Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior of public officials or candidates for public office or personally identifiable information will be maintained throughout the research and thereafter. Research and demonstration projects for public benefit or changes to public programs or services. Taste and food quality evaluation and consumer acceptance studies 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.

Type of Review Full board review More than minimal risk Vulnerable populations Primary and secondary reviewer; other members can review prior to meeting Voted on by members of the board (quorum must be present for voting to occur)

Type of Review Expedited review The research is minimal risk; and The research falls into one or more of the expedited categories; The research will not place participants at risk for civil liability or damage to their financial standing, employability, reputation, etc.; Assigned to one reviewer

Type of Review Exempt review Minimal risk Assigned to one reviewer Must fall into one of six categories Does not apply to research involving vulnerable populations

Documents for Review Research Protocol IRB Application Consent Forms Survey Instruments Recruitment Materials Human Subjects Certification (CITI certification) Other Pertinent Materials

Key Review Criteria Risk Validity Consent Is the risk minimized? Will the study yield results that matter Consent Is the consent form clear and easy to understand? Is the consent form appropriate for the population being studied

Criteria for Approval Risks are minimized Risk-benefit ratio is reasonable Selection of participants is equitable Informed consent is obtained as needed Consent documented as required Data is monitored to ensure safety Participant privacy/confidentiality is protected Vulnerable populations are protected

Minimize Risk Risks to subjects must be minimized Procedures with sound research design Procedures do not expose participants to unnecessary risk Use standard of care procedures whenever possible

Risk: Benefit Ratio Risk: Benefit ratio must be appropriate Evaluate risks specifically from the research Evaluate reasonable benefits, not long-range effects Consider appropriate risk for children

Equitable Selection of Subjects Consider the purpose and setting of the research Are vulnerable populations included? Should they be included? Provisions to include non-English speaking participants

Informed Consent Must be sought from a participant or a legal authorized representative Consent documented appropriately Consent process Required elements of Informed Consent Form

Data Monitoring Provisions for monitoring the data to ensure the safety of participants (when appropriate) Can vary depending on the level of risk All studies are required to report: Unanticipated problems involving risks to participants or others Adverse Events Non-compliance

Privacy and Confidentiality Privacy refers to people Persons and their interest in controlling access of others to themselves Controlling the access, extent, timing and circumstances of sharing oneself Confidentiality refers to data about people Participants understanding of ways that their identifiable information will be stored and shared Control circumstances of sharing information

Vulnerable Populations More vulnerable to coercion or undue influence Additional safeguards should be included

Vulnerable Populations Three categories Pregnant women, human fetuses and neonates Prisoners Children Other categories Employees Students Economic status Educational level Physical or medical disability Mental capacity

Common Rule Changes New requirements for informed consent Information that must be given to potential participants Allows for broad consent Storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimans New exempt categories Research may be required to undergo limited IRB review

Common Rule Changes Single IRB requirement U.S. Institutions engaged in cooperative research within the U.S. Continuing review for expedited studies is no longer required Data analysis only Observational follow-up in conjunction with standard clinical care Effective January 2018

IRB Tips Know and complete all of the required forms and paperwork Know the deadline for submitting IRB application Review an approved application Details, details, details Consent forms Reading level Including all required elements of the form Communicate with IRB to resolve any issues

What happens if I don’t get IRB approval from my research study? Dissertation or thesis work will not be accepted: Graduate students must present evidence of IRB approval for their studies involving human subjects. Thesis or dissertation work will not be accepted without it. Degrees will not be awarded for work based on non-IRB reviewed studies. Articles may not be published: most professional journals require evidence of IRB approval when considering articles for publication. MSM will not support unapproved research: Liability issues arising from unapproved research become the responsibility of the researcher. Persons conducting unapproved research are deemed to be acting outside the scope of authority granted to them by MSM.

Resources Office of Human Research Protection (OHRP): http://www.hhs.gov/ohrp/ Food and Drug Administration (FDA): http://www.fda.gov/ Final Rule Changes https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf MSM IRB: http://www.msm.edu/Research/hrpp/IRB/index.php http://www.msm.edu/Research/hrpp/IRB/IRBDocuments/IRBPolicies.pdf#search=Institutional%20Review%20Board http://www.msm.edu/Research/hrpp/IRB/IRBDocuments/MSMIRBDefinitions.pdf#search=Institutional%20Review%20Board Collaborative Institutional Training Initiative (CITI): http://www.citiprogram.org/