1 / 22

Concise Summary of Key Information

Concise Summary of Key Information. Melissa Epstein, PhD, MBE, IRB Director, Einstein IRB With thanks to the University of Kentucky Office of Research Integrity & Ada Sue Selwitz. The Common Rule.

braziel
Download Presentation

Concise Summary of Key Information

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Concise Summary of Key Information Melissa Epstein, PhD, MBE, IRB Director, Einstein IRB With thanks to the University of Kentucky Office of Research Integrity & Ada Sue Selwitz

  2. The Common Rule This term refers to subpart A of the Code of Federal Regulations (CFR) title 45 (public welfare), part 46 (protection of human subjects.) These regulations were released in 1981 by the Department of Health and Human Services in response to the Belmont Report. These core regulations were adopted by more than a dozen federal departments and agencies in 1991 (hence the term, “Common Rule"). The Common Rule describes the requirements for assuring compliance by research institutions; requirements for researchers obtaining and documenting informed consent; and requirements for IRB membership, function, operations, review of research, and recordkeeping.

  3. A brief history of the regulatory changes • July 26, 2011--Advanced notice of proposed rulemaking (ANPRM) seeking comments on potential revisions to the Common Rule • September 8, 2015--Notice of Proposed Rulemaking (NPRM) seeking comments on proposals to comprehensively revise the Common Rule • January 19, 2017--Final rule implementing major revisions to the Common Rule effective January 22, 2018 • January 22, 2018--Interim final rule delaying the effective date and general compliance date of the revised Common Rule to July 19, 2018 • April 20, 2018 -- Delayed the general compliance date for the 2018 Requirements for an additional six months to January 21, 2019. • January 21, 2019 – Revised Common rule goes into effect. Known as the Final Rule.

  4. Consent Regulations at 45 CFR 46.116 (a)(5)(i) • Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.

  5. Preamble to the Final Rule lists 5 factors • A statement that the project is research and participation is voluntary • A summary of the research including: purpose, duration, list of procedures • Reasonable, foreseeable risks or discomforts • Reasonable, expected benefits • Alternative procedures or course of treatment if any This part of the informed consent must be organized and presented in a way that facilitates comprehension.

  6. We are giving you a template…. • And lots of samples to work with.

  7. What is the Key Information section? • Is NOT a summary of full protocol (like an abstract) • Does NOT need to include all required elements of informed consent • Does NOT have to look identical to our template • Typically does not include exclusions unless the exclusion involves restrictions that would affect someone’s decision to participate • SHOULD include the information that is most crucial to a participant’s decision whether or not to participate

  8. How do you figure out what is “key”? • Varies with context of the study • Investigator’s experience with study population • Empirical research • Systematic participant feedback • Potential participants input • (Patient) Associations or Support Groups

  9. Key Information Template • Introductory paragraph: We are asking you to choose whether or not to volunteer for a research study about ________ • What is the study about and how long will it last? This section describes the purpose, procedures, and duration of this study (For detailed description use the detailed consent) • What are the key reasons you might choose to volunteer for this study? (Complete description in detailed consent) • For studies with no direct benefit, we suggest: The study will not include a direct benefit to you. However, some participants appreciate knowing they have contributed to research that may benefit others in the future.

  10. Key Information Template • What are the reasons you might NOT choose to volunteer for this study? (e.g. Most important risks and/or advantageous alternative treatment/procedures) (Complete description in detailed consent) • Do you have to take part in this study? (Will not lose services or rights you would normally have) • What if you have questions suggestions or concerns? (Standard contact information for PI and IRB office)

  11. Guidance • Do I have to begin my consent document with the Key Information Section? • Full Board and Expedited studies approved after 1/20/2019 are required to include a Key Information Section • Unless your study is MINIMAL RISK (expedited) and your consent form is five pages or shorter (including the Signature blocks). • The Key Information Section is required for all studies submitted after 12/15/2018 for Full Board review and after 12/20/2018 for Expedited review. • Is this required for all consent documents? Not for the following: • If your study is MINIMAL RISK (expedited) and your consent form is five pages or shorter (including the Signature blocks) the new Key Information section is not required. • If your study is under one of the six Exempt Categories, the new Key Information section is not required. • When does the new requirement go into effect? • The new section is required for all studies approved by Full Board or Expedited review after 1/20/2019. Studies that received Full Board review or began Expedited review prior to 1/20/2019, but did not receive final IRB approval until after 1/20/2019 are also subject to this requirement. • Do I need to revise my existing IRB approved consent documents? • No. Any study that received final IRB approval prior to 1/21/2019 will not need to amend its consent documents to meet this requirement.

  12. Sample Placebo Controlled Trial

  13. KEY INFORMATION For: Randomized, Placebo-Controlled Trial to assess the safety and effectiveness of Investigational E-FLEX in the treatment of Arthritis (1 of 4) We are asking you to choose whether to take part in a clinical research study that will test the benefits and safety of E-FLEX stiff in patients with Arthritis. This page is designed to give you key information to help you decide whether to participate. We have included detailed information after this page. Ask the research team questions. If you have questions later, the contact information for the research investigator in charge of the study is below. what is the STUDY ABOUT AND HOW LONG WILL IT LAST? The purpose of this study is to compare the effects, good and/or bad, of E-FLEX with a placebo (an inactive pill). The Food and Drug Administration (FDA) has approved E-FLEX to treat some conditions. FDA has not approved E-FLEX to treat arthritis. If you are eligible for the study, we will use a computer program to place you in one of the two groups. The group the computer picks is by chance, like a flip of a coin. You will have an equal chance of getting in either group. The test group will take E-FLEX. The placebo group will take an inactive pill. Neither you nor the study staff will know to which pill you get. They both look the same. Participants in both groups will have monthly research study visits for one (1) year. See Appendix A for the study visit schedule.

  14. KEY INFORMATION For: Randomized, Placebo-Controlled Trial to assess the safety and effectiveness of Investigational E-FLEX in the treatment of Arthritis (2 of 4) what are key reasons you might choose to volunteer for this study? Some doctors have noticed an improvement in arthritis on patients taking E-FLEX. While on the study, we will monitor your arthritis. If your arthritis worsens, the study doctor may take you off the study so that your personal doctor may treat you. The study will provide the E-FLEX or placebo pill, research tests and care at no cost to you. For a complete description of benefits, refer to the Consent Document below. what are key reasons you might choose not to volunteer for this study? You may decide that you do not want to participate in this study because there is a 50/50 chance of being in the placebo group. If you are in the placebo group, you will take a pill daily for one year that will not help your arthritis. If the study computer places you in the test group, there is no guarantee that E-FLEX will help your arthritis. Research has not been done to confirm whether it will improve arthritis. You may have side effects while on the study. The most serious effect that has happened in one percent of people who have taken E-FLEX is shortness of breath. The researchers do not know all of the side effects that could happen. Appendix B lists the type and rate of known side effects from taking E-FLEX. For a complete description of risks, refer to the Consent Document below.

  15. KEY INFORMATION For: Randomized, Placebo-Controlled Trial to assess the safety and effectiveness of Investigational E-FLEX in the treatment of Arthritis (3 of 4) DO YOU HAVE TO TAKE PART IN THE STUDY? If you decide to take part in the study, it should be because you really want to volunteer. You will not lose any services, benefits or rights or access to care you would normally have if you choose not to volunteer. You can withdraw at any time during the study. The following graph may help you consider your options.

  16. KEY INFORMATION For: Randomized, Placebo-Controlled Trial to assess the safety and effectiveness of Investigational E-FLEX in the treatment of Arthritis (4 of 4) what if you have questions, suggestions or concerns? The person in charge of the study is _________________ {Principal Investigator, PI}. If you have questions, suggestions, or concerns regarding this study or you want to withdraw from the study his/her contact information is: {PI contact information}. If you have any questions, suggestions or concerns about your rights as a volunteer in this research, contact staff in the Einstein Institutional Review Board (IRB) between the business hours of 9am and 5pm EST, Monday-Friday at 718-430-2253 or irb@einstein.yu.edu

  17. Sample Comparative Effectiveness Study

  18. KEY INFORMATION For COMPARATIVE EFFECTIVENESS STUDY OF DRUG AAND DRUG B IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE PATIENTS(1 of 4) This research study will compare two medicines commonly used to treat Chronic Obstructive Lung Disease (COPD). COPD makes it hard to breath due to damage to the lungs. We are inviting you to take part in the study because your lung doctor diagnosed you with COPD. This page is designed to give you key information to help you decide whether to participate. Ask the research team questions. If you have questions later, the contact information for the research investigator in charge of the study is below.

  19. KEY INFORMATION For COMPARATIVE EFFECTIVENESS STUDY OF DRUG AAND DRUG B IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE PATIENTS(2 of 4) what is the STUDY ABOUT AND HOW LONG WILL IT LAST? We do not know if Drug A or Drug B is better at improving health related quality of life (HRQoL) in COPD patients. By doing this study, we hope to learn which medicine is best at improving breathing and HRQoL. If you agree to participate: • The study doctor will not pick which drug you will take. We will use a computer to place you in one of the two study groups. The group the computer picks is by chance, like a flip of a coin. You will have an equal chance of being in either group. If you want more information about randomization, we will show you a brief video. • You will receive either drug A or drug B. We will not tell you which of the two medicines you get. You will take the beginning dose of the study medicine as directed for one year. The dose of the study drug will not change while you are on the study. • You will have four (4) research clinic visits during the study. The study doctor will perform a brief exam and ask five (5) questions about your quality of life. • After the study, we will tell you which of the two medicines you took. You and your lung doctor can decide if you should continue taking the drug once the study is complete.

  20. KEY INFORMATION For COMPARATIVE EFFECTIVENESS STUDY OF DRUG AAND DRUG B IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE PATIENTS(3 of 4) what are key reasons you might choose to volunteer for this study? There is no guarantee that you will benefit personally from being in this study. However, some participants appreciate knowing they have contributed to research that may benefit others in the future. The research team will give you guidance on how to manage your COPD. The study provides the medicine and research visits to you at no cost. For a complete description of benefits, refer to the Consent Document below. what are key reasons you might choose not to volunteer for this study? Both medicines used in this study are FDA Approved to treat COPD. You should not participate in this study if you do not want to leave the choice of medicine up to chance. The study computer picks which medicine and dose you receive instead of a doctor choosing. The Detailed Consent (page X) provides a list of possible risks for each study medicine. The study doctor will know which medicine you are taking. The research team will monitor your COPD closely. If your COPD gets worse or you do not tolerate the medicine, we can remove you from the study. Your lung doctor can then prescribe another medicine based on his/her medical opinion.

  21. KEY INFORMATION For COMPARATIVE EFFECTIVENESS STUDY OF DRUG AAND DRUG B IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE PATIENTS(4 of 4) You do not have to participate in the study to receive medication for your COPD. Other treatments, including drug A and B, are available for your lung doctor to prescribe outside of the study. If you decide not to be in the study, your lung doctor will choose a treatment he/she thinks is best for you. For a complete description of alternate treatment/procedures, refer to the Consent Document below. DO YOU HAVE TO TAKE PART IN THE STUDY? If you decide to take part in the study, it should be because you really want to volunteer. You will not lose any services, benefits or rights or access to care you would normally have if you choose not to volunteer. what if you have questions, suggestions or concerns? The person in charge of the study is _________________. If you have questions, suggestions, or concerns regarding this study or you want to withdraw from the study his contact information is: {PI contact information}. If you have any questions, suggestions or concerns about your rights as a volunteer in this research, contact staff in the Einstein Institutional Review Board (IRB) between the business hours of 9am and 5pm EST, Monday-Friday at 718-430-2253 or irb@einstein.yu.edu.

  22. Questions? • Key Information Section template and guidance: https://www.einstein.yu.edu/administration/institutional-review-board/forms.aspx#key-info • Set up a consult: https://www.einstein.yu.edu/administration/institutional-review-board/ Link on the right

More Related