IRB Process PDF

The development of IRB: 1979 The Belmot Report: The Ehical FOundation 1. In 1953, was...

The development of IRB: 1979 The Belmot Report: The Ehical FOundation 1. In 1953, was the First US Federal Criteria we used for getting approval and informed consent for participants to be involved in research projects Policy for protection of human Respect for persons subjects. (created mechanism for Objectives: prospective review of proposed People are autonomous agents( individuals with diminished autonomy are entitled to protection) research. Be able to discuss: 3 elements of the informed consent process a. Forerunner to the IRB model Human rights research The human rights abuses in Thourohgness: enough information for them to understand Doesn't matter how thorough it is if they don't get it research 2. IRB Exist because in the past, They have to understand/ comprehension participation is voluntary and can stop at any time researchers would use underserved or the development of institutional people to be taken advantage for research, Vulnerable populations are due extra protection (extra steps need to be taken for people who don't have the ability to comprehend) review boards (IRB) didn't have the option, wasn't voluntary, and beneficience :Overall doing good or more good than harm and characteristics of human rights the people were exploited. research Steps to ensure well being of participants Nazi Medical war crimes 1946 Know the steps to make an IRB Study is designed according to principles Syphyllis study at Tuskegee 1932- submission 1972 Benefits are maximzed Know the Kettering Health IRB Process Jewish Hospital Cancer Study 1963 Determining that the study has a maximization of benefits and a minimization of risks. Know the steps to take if you make a 1963-1966 Willowbrook hepatitis Risks are minimized change to an IRB approved project Study Taking steps to guard confidentiality of participants and taking care of the data we collect (safety monitoring) 1979 The Belmot Report: The Ehical justice FOundation Distributive justice fair and equitable distribution of the benefits and burdens of research 3. 1996: Health Insurance Portability and Accountability Act (HIPAA) - Privacy Rule Fair procedures in the selection of research (no one due party bears burden of bad)(if ur doing research on vulnerable population u need to come up with a benefit) Standards for Privacy of Individually Identifiable Health Information Oversight of Privacy Rule are the responsibility of the HHS Office for Civil Rights Beginning of electronic medical information More so portability but not only privacy Institutional review board (main job to protect research subjects) An administrative group comprised of scientists and nonscientists, established to protect the rights and welfare Regulatory Criteria Required For Approval of human research subjects recruited to participate in Risks to subjects are identified and minimized research activities...” Procedures used are consistent with sound research Human Subjects Research Definitions IRBs must be federally registered and have specific design and do not unnecessarily expose subjects to regulations to follow Office of Human Research Protection: risk conducts Prospective review of proposed research and A systematic investigation, Risks to subjects are reasonable in relation to enact protections (BEFORE THE RESEARCH HAPPENS) and including research development, anticipated benefits monitors continuing research testing, and evaluation designed or When applicable, data is monitored to ensure the developed to contribute to Obligated to ensure that the federal and state regulatory safety of subjects generalizable knowledge criteria are met Vulnerable subjects are protected HIPAA Privacy Rule A living individual about whom the Kettering IRB manages Conflict of Interest and HIPAA researcher requirements related to research for Kettering Health and Selection of subjects is equitable Protected Health Information (PHI) may be accessed “under a Kettering College covered entity for purposes of treatment, payment, or hospital Obtains: Information or Privacy of person and confidentiality of data are Risk Assessment: operations” (such as QI) biospecimens through protected Minimal Risk means the probability & magnitude of harm or intervention or interaction with The list does not include research Informed consent is obtained discomfort anticipated in the research the individual, and uses, are not greater in & of themselves than those encountered in daily IRB has to know about it and approve it studies, or analyzes the Understandable language life or during the performance of information or biospecimens; Additional safeguards are required by law for PHI to be used or Possibilities of coercion or undue influence are routine physical or psychological examinations or tests disclosed for research purposes and requires IRB/Privacy Board OR minimized Characteristics of risks we need to be mindful of approval: Obtains, uses, studies, or Informed it is a “research study” Confidentiality and/or Privacy – Almost always a possibility Activities preparatory to research – screening PHI for analyzes, or generates Voluntary, Willingness of breach if using human subjects recruitment or document preparation identifiable private information and data; electronic data collection has risks or identifiable biospecimens Right to withdraw HIPAA Authorization – signed authorization for using PHI in Physical – Discomfort or bruising from procedures, research U.S. Dept. of Food and Drug Informed consent is documented intervention, needlesticks Administration Waiver of HIPAA Authorization – must meet specific criteria Waiver for exempt studies Psychological – Sensitivity of survey questions, “re-live” An experiment using a test article Limited data set - requires a signed Data Use & Transfer Rights, Risk, Safety, Privacy, Consent traumatic event Agreement Test articles may be drugs, Social – Potential damaging of reputation or status in devices, biological products, De-identified data set (all 18 identifier categories removed) Not community if information found out electronic products, foods and human subject research food additives, apps, and etc. Financial – Possibility of loss of job, insurance if information HIPAA Identifiers found out A person who takes part in research: Legal – Sensitivity of research, illegal activities, possibility of legal issues if information discovered 15 As a control subject As a recipient of a test article On whose specimen an investigational device is used Quality projects Evidence Based Practice Project or Program Research Practices/strategies to improve internal Synthesis of findings in literature processes and/or quality outcomes Scientific methods used to investigate a specific Identify best practice recommendations phenomenon Not designed to be generalizable to other groups or institutions (only used at that Implement practice or program Designed to be generalizable site) evidence of its effectiveness May include Pre/Post measures Data collected is typically “institutional not considered experimental or untested May include comparison or control groups level” and relevant internally Measure relevant outcomes before/after the new With or without randomization Follow conventional quality improvement practice or program is implemented strategies Includes quantitative, qualitative, small pilot studies, often program evalutation focused & large-scale studies Plan-Do-Check-Act cycles(quality improvement process) Meets the definition of Human Subjects Research per OHRP or FDA Steps to make an IRB submission Pre Submission Tasks 1. Identify the type of project you have Identify the type of project you plan to do a. QP/ EBP All projects will need a Cayuse account for electronic submission (kettering health) b. Research Link to request form: Request for Cayuse Access OR 2. Creat CITI Account and request a Cayuse Account Contact IRB Coordinators for an account or if having access issues a. Complete required CITI modules and COI disclosure in Cayuse Non-Research projects – do not need to complete a Conflict of Interest (COI) Disclosure (in Cayuse) or CITI training b. Set up a project master file in modules We do cayuse Research projects – will need to complete a COI Disclosure 3. Complete Cayuse SUbmission Smart (in Cayuse) and CITI modules Form PI is responsible to ensure all study team members have a. Answwer questions on submission completed CITI training and COI disclosure form relevant to your project, sections may change based on answers to questions 4. Advisor (or PI) certifies and then is submitted to the IRB a. Look for email communication form Cayuse or coordinatir with instructions or determination b. respond to any requests for changes or additional information 5. Conduct study/project After final determination is issued a. Follow approved protocol b. Use approved/ stamped consent and/ or Hippa forms 6. Notify IRB if a change will be needed to project a. Submit closure report when project is completed (research studies only)