IRB Process Effective January 19th, 2018

Institutional Review Board What is an IRB? What is its job? What are its guiding Principles? Belmont Report (i.e., Respect for Persons, Beneficence, Justice) Code of Federal Regulations, Title 45 – Public Welfare, Part 46 Protection of Human Participants (aka The Common Rule) USM Policies and Procedures, Section III and Section IV What is an IRB? Administrative body, required by federal law, that provides oversight for human subjects research What is its job? Determine whether anticipated risks to human subjects OUTWEIGH or are JUSTIFIED BY the anticipated benefits What are its guiding Principles? Belmont Report (i.e., Respect for Persons, Beneficence, Justice) Code of Federal Regulations, Title 45 – Public Welfare, Part 46 Protection of Human Participants (AKA The Common Rule) USM Policies and Procedures, Section III and Section IV Review of research is guided by the Belmont report which specifies three principles: Respect for Persons – autonomy of human subjects should be protected; those with diminished autonomy require additional protections Obtain informed consent; respect and protect the privacy of human subjects Justice – treat people fairly and ensure that the burdens and benefits of the research are shared equitably Avoid exploitation of vulnerable populations or populations of convenience; avoid coercion; select subjects equitably. Beneficence – minimize harms and maximize benefits within the constraints of sound research design All research MUST have some anticipated benefits When studies involve more than minimal risk, the researchers must finds ways to mitigate or manage those risks or make the risks that the risks are justified by the anticipated benefits 45CFR46 (also known as the Common Rule) provides guidelines for the establishment of IRBs, their composition, what constitutes human subjects research, and what type of review different studies will require. A revised common rule will be coming into effect on January 18th, 2018. At the same time, our IRB will be rolling out some new processes as well. Given all of this, the IRB has the right and responsibility to not only review the risk benefit ratio of your study but also the rationale and the design – A study that lacks an appropriate rationale or that is poorly designed cannot meet its aims and therefore only has risks. As such, the IRB may request clarification, elaboration, or modification to your rationale and design so as to ensure that the risk/benefit ratio is acceptable.

Determine Whether Your Study Requires IRB Review IRB Process Step 1

What is Human Subjects’ Research? HUMAN SUBECT RESEARCH Living individual about whom an investigator obtains, uses, studies, generates or analyzes: Private information Identifiable information Through either Intervention Interaction A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge Private information – any information about behavior that occurs in a context where the participant can reasonably expect that no observation will occur (e.g., doctor’s office; in their home) Identifiable – meaning that the identity of the subject may be readily ascertained either through direct identifiers (e.g., SSNO, name) or through indirect identifiers combined with publicly available data (e.g., date of birth, zip code and gender combined with voter registration data) Intervention – physical procedures or manipulations of the subject or his/her environment Interaction – any communication including interviews, surveys, etc Generalizable knowledge means that the research has the intention of disseminating the findings in some form outside of the their department or institution. Thus, quality improvement studies that will be used internally only does not qualify as research.

Ensure All Study Personnel Have Completed Human Subjects’ Protections Training IRB Process Step 2

Human Subjects’ Protections Training CITI PROGRAM Complete all modules Should take several hours Score at least 80% Print out and submit copy of Completion Certificate New User Click on Register to set up a free account Click on Affiliate with Another Institution; follow instructions Under Towson University Courses, Click on Add a Course Question 1: Responsible Conduct of Research – optional Question 2: Skip Question 3: Faculty/Staff  Select Social & Behavioral Research OR Biomedical Research Students  Students Conducting No More than Minimal Risk Research Question 4: Not at this time, thank you Hit Submit NOTE: Studies will not be submitted for review UNTIL evidence of Human Subjects’ Protection Training has been provided by ALL study personnel involved in data collection or analysis

Determine Level of Review IRB Process Step 3

Minimal Risk As defined in 45CFR46.102.j, 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 risks ordinarily encountered in daily life or during the performance of routine physical or psychological tests. Harm or discomfort – physical, psychological or social harm Encountered in daily life – risks of the activity to the population to which the findings will be generalized Routine physical and psychological tests- blood draws, achievement tests

TYPES OF RESEARCH AND REVIEW CATEGORIES Exempt Expedited Full Board Minimal risk research Data are anonymous OR No sensitive information collected Meets specific criteria Sensitive information is collected Reasonable protections are in place to ensure confidentiality Greater than minimal risk Does not meet criteria for Exempt or Expedited research TU Review Categories Accelerated Review Standard Review Full Board Review you intend to modify the study procedures or consent document, (b) a participant complains about the study (regardless of the reason) or there is an adverse event, (c) there is a protocol deviation/violation (e.g., anonymous participants become identifiable), and/or (d) new findings indicate that the study risks, or the risk/benefit ratio has changed. Continuing Review? No Unless…* Progress Report every 3 years Annually via Standard Review, Unless…* …(a) you intend to modify the study procedures or consent document; (b) a participant complains about the research or there is an adverse event; (c) there is a protocol violation/deviation; and/or (d) new findings indicate that the study risks, or the risk/benefit ratio, have change

Review Categories Accelerated Review Standard Review Full Board Review Deadline Rolling 3rd Friday of each Month Form Request for Accelerated Review - Choose either Adult or Minor/Legal Minor version Request for Standard or Full Board Review Reviewer Chair or Assistant Chair Single IRB Member Quorum of the IRB Time until Feedback or Approval ~ 1 week ~ 3 weeks ~ 4 weeks

Complete and Submit the Application IRB Process Step 4

The Successful IRB Application Provides detail about: Study rationale as well as aims or hypotheses Anticipated benefits Inclusion/Exclusion criteria Recruitment plan How informed consent will be obtained Provides detail about: Study procedures (i.e., in chronological order, what will subjects be asked to do) Measures to be used Anticipated risks and plans for mitigating or managing risks If applicable, a statement that there are no foreseeable risks At TU, except in rare circumstances, only those 18 years of age and older who are legally able to provide informed consent for medical treatment may provide informed consent to participate in research. In describing the study procedures, be sure to make clear that the study is designed in such a way as to meet its aims; as discussed earlier, even with minimal risk research, a study that cannot meet its aims only has risks and no benefits and is therefore not approveable.

The Successful IRB Application Provides detail about: How confidentiality or anonymity will be assured How data will be stored to ensure security and who has access to data If/when/how data will be destroyed If/how subjects will be compensated Informed Consent/Assent** Includes all required elements (use TU Consent/Assent template) 8th grade reading level (adults) Appropriate reading level (children/adolescents) Sufficient detail so that participants understand risks and what is expected of them ** If data are anonymous, use an information sheet

The Successful IRB Application At minimum, attach the following: Informed consent form or information sheet Measures (or detailed description of questions, if proprietary), interview questions Human Subjects’ Protections Training certification If student PI, Faculty Advisor signature If appropriate also attach: Informed assent form Recruitment materials, including: Content of e-mails or letters Scripts for verbal recruitment Fliers Content of ads and where they will be placed Links to relevant websites

Revising Your Application Based on Reviewer Comments IRB Process Step 5

Revising your Application Address ALL reviewer concerns Submit a cover letter with the reviewer’s comments and your response/revision If you disagree with a suggested revision  In your response, provide a detailed explanation for why you disagree with the comment; be advised the reviewer may still require the revision if the rationale is not convincing Submit a revised protocol AND consent form Use track changes, highlighting, or different colored font for revisions DO NOT BEGIN DATA COLLECTION UNTIL APPROVAL FOR THE STUDY HAS BEEN GRANTED!! Once approved, you will receive notification from the IRB office – you may begin data collection!

Amending Your Application After Approval IRB Process Step 6

Amending Applications All substantive changes to consent forms or protocols MUST be reviewed and approved by the IRB If not sure if change is substantive, ask Submit E-mail describing the change and its rationale Protocol with track changes, highlighting, or different colored font Consent form with track changes, highlighting, or different colored font Include: new questionnaires; recruitment materials, etc NOTE: You may not implement protocol changes until the IRB has approved the amendment

Some Final Thoughts What to do if . . . I want to include 17-year-old college students I want to pay participants I want to use data panels Someone complains about the research A participant experiences an adverse event There is a protocol deviation/violation NOTE: For more detailed information on all of these topics, see the Principal Investigator’s Instruction Manual which is available on the IRB website