Please create a high-level masters level PowerPoint (13 slides) with speaker notes on each slide for the following 2 questions
Please comment on the following questions:
1. What are important elements to consider, or steps to take, when crafting an informed consent form, case report forms, and the study protocol?
2. When thinking about the documentation and the process of informed consent, what strategies or tools might be used to ensure that informed consent has truly been obtained?
**Please utilize the following YouTube videos as well as the Attached PDFs, which is requirement of the paper – feel free to utilize other resources if needed but these videos and pdf are part of the requirement**
https://www.youtube.com/watch?v=U8q04RF4sPU
https://www.youtube.com/watch?v=_y9bnOwnKRY
https://www.youtube.com/watch?v=2ZtWQTIa8aM
PowerPoint Presentation Protocol Development, IRB Application, and Site Initiation Beth Loots, MPH MSW Contents Developing the protocol, consent, and other documents IRB application Other committees and applications Site initiation Visit (SIV)/study kickoff Next steps in general funding pathways Sponsored Projects Investigator-Initiated 1. Confidentiality Agreement (CDA) 1. Respond to FOA RFA or other funding mechanism 2. Review of protocol created by sponsor2. Feasibility assessment at the site before applying 3. Feasibility assessment3. Study application including budget & justification 4. Site Selection Visit (SSV)4. Scientific peer review of application 5. Contract and budget negotiation5. Notice of Award (NOGA) 6. Clinical Trials Agreement (CTA) with Sponsor6. Development of protocol by the site 7. SRC, IBC, IRB application, applications for services, any service agreements or other arrangements 8. Site Initiation Visit (SIV)8. Study Kickoff Meeting Developing the protocol, consent, and other documents Who writes the protocol Sponsored projects – Sponsor (or CRO); investigator reviews for scientific and practical validity. Schedule of events needs to accurately reflect activities at the sites. PI may suggest modifications. Investigator initiated – PI writes study application that eventually is converted into protocol. PI or investigative team (local or multi-site collaborators) writes the protocol. Many trials have a Steering Committee which will write the protocol (though in reality this should be tasked to one or two people to gather together input and write it) Where to start – protocol writing 1. Protocol from sponsor – IRB may accept as is; may also want a local implementation plan. 2. Protocol from grant – use the IRB template (or other available/allowed template) to create your protocol Writing the protocol – clearly explain: Purpose and aims of the study What is the scientific background that led to this research Who is going to be recruited and why What will be asked of the study participants What are the numbers expected to enroll What is the recruitment and enrollment plan What incentives or reimbursements will the participants receive What will be done with the data or samples What protections are in place for the confidentiality of data and safety of the participants Inclusion/exclusion criteria Inclusion – participant must...yes/no checklist (pull from protocol) Exclusion – participant must not...yes/no checklist (pull from protocol) Is the participant eligible for this study yes/no Must be specific to the condition being studied Carefully craft to include enough of the study population to be able to recruit, but not so much that it misses the point of the study (or people too unhealthy) Participants must meet the I/E criteria per FDA Data Safety Monitoring Plan (DSMP) Location Part of the protocol Within the IRB application Attached to the application What it is Description of framework for oversight and monitoring of the study DSMP must include Summary of the protocol Roles and responsibilities Who will monitor and when Trial safety Events that would stop a participant from continuing in the study Stopping rules (things that would stop the study from proceeding) Measures in place to prevent foreseeable risks Reportable event When will events be reported to monitors, regulators, and IRB Data management, analysis, and quality assurance Data sources, security, and quality control measures National Center for Complementary and Integrative Health. NCCIH Clinical Research Toolbox. https://www.nccih.nih.gov/grants/toolbox and https://www.nimh.nih.gov/funding/clinical-research/data-and-safety-monitoring-plan-writing-guidance Approaching the consent form Helpful to write the consent form after you've written your protocol Pull out the relevant information from the protocol Using a provided template, convey key study information Informed Consent Form (ICF) Core Elements Purpose, duration, and procedures Risks or discomforts Benefits Alternatives to participation in research Confidentiality Compensation and treatment for injury Contact person Participation is voluntary; no penalty or loss of benefits for not participating Liu, M. and Davis, K. A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons from a Horse Named Jim. Second Edition. New Jersey: Wiley-Blackwell. 2010 Working with various versions of the ICF Your IRB(s) will usually have required templates Sponsor will also have a consent template If you have multiple sites relying on a central IRB, then you may have additional templates and/or language from those Budget-related language around who pays for injury needs to reflect contract agreement You'll need to edit the consent template from the Sponsor to align with IRB template Get approval from Sponsor for your version before submitting to the IRB Consent form parameters Non-technical language Understandable to participant or LAR (Legally Authorized Representative) Accurate Complete Clear Required unless waived by IRB https://www.youtube.com/watch?v=U-kwHG36Y_k Writing the ICF Figuring out what to include at what level detail Write it at an 8th grade level (or lower) Use lay language especially for medical terms Second person, 'you' language Conditional tense 'would' language Avoid acronyms and abbreviations 12 point font Footer/header with study name, PI, date, page # Liu, M. and Davis, K. A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons from a Horse Named Jim. Second Edition. New Jersey: Wiley-Blackwell. 2010 Consent translations Translate consents as needed for study population. More equitable than a short form. Consents should be in the language of the participant. Usually get IRB approval for English version first and then send for translation Submit and get approval for translated consents before enrolling participants Documentation of informed consent ICF read by or to participant Short form information presented orally (for example for non-English speakers in some circumstances) Waiver by IRB for documentation of consent Applies for example when medical record reviews are done or when it would be impracticable to get consent for a minimal risk study. Could be given for online consents when no ink signaure available. Think about waiver of consent if only doing medical record review, especially if don't regularly see patients and/or if important to get data from whole population HIPAA form Study participants must sign a document with HIPAA language to give access to the PHI (Protected Health Information) needed to conduct the trial Either a standalone document or part of the consent form template Must be in lay language HIPAA document must include What data will be used Who is asking for it Who will receive it What the purpose is How long Signatures Can revoke authorization What happens if doesn't sign Potential for future disclosure to other parties Norris, D. (2019). Clinical Research Coordinator Handbook. 5th Edition. New Jersey: Deborah Norris. Assent Assent is required for patients under 18 who are able to understand and agree/disagree to participation in research Usually for older kids and teens, aged 7 – 17. Might get verbal assent from kids younger than 7. Should explain the risks/benefits of participation in study to them and inform of alternatives Children cannot consent, so parent/guardian must consent in addition to child assent Assent Usually for low risk studies that do not offer prospect of direct benefit, the child/adolescent's right to refuse should be respected If child/adolescent does not assent, then parents and physicians may decide to proceed if not doing so would have medical consequences IRB may decide assent is not required for studies that offer a clear direct benefit to the child IRB has assent templates the site should use Recruitment materials Recruitment itself cannot occur until IRB approval has been obtained All recruitment related materials must be submitted to the IRB before they are used Flyers, brochures, videos, or other media Advertisements Letters to participants Email, text, or phone call recruitment templates Social media posts, pages, ads Promotional items Study newsletters Data collection forms Development should begin early in process of study development Work backwards from final results desired to ensure don't collect unnecessary data Always collect the raw data (can categorize later) Order the questions in a logical way for participant Don't use free text fields if possible Self-administered, interview, online? CRFs medical record review – query-able fields are best and least labor intensive Data collection documents Demographic information (gender, DOB, race, ethnicity, socioeconomics, etc.) Disease or condition (date of onset, diagnosis, medications, labs, other assessments) Eligibility screening documents Contact information forms Study-specific CRFs (to collect data from medical records) Surveys or interview questions (related to outcomes of interest) Documents to help run the study (consent checklists, process checklists, manual of procedure, templates for notes, guides for research lab orders, etc.) Study forms (specimen collection form, visit procedures documentation, etc.) Medical history CRF Could be interview (self-report) and/or medical record review depending on study List of conditions or questions about aspects of conditions; medications or procedures involved May look for key indications of infections, hospitalizations, other AEs characteristic of condition Ideally yes/no/unknown and/or ideally pre-populated fields v. open text field Ideally simple enough that a coordinator can abstract (v. MD) Usually does require some familiarity with the clinical condition Usually includes date range May want onset of condition Current or resolved Every form Study name Site number Patient ID Visit date Visit type Institutional Review Board (IRB) application IRB purpose Reviews studies of human subjects Ensure the rights and welfare of study participants Either internal at the institution or external IRB relied upon by institution Reviews initial application and periodic (annual) review Authority to approve, defer, suspend, or stop research activities Minimum 5 individual members, with requirements for makeup of the Board IRB submission documents Protocol Investigator Brochure or package insert Curriculum vitae (cv) for each investigator Consent form (ICF); assent form if applicable Recruitment materials Information given to pt such as educational materials or incentives with payment schedule Surveys or other data collection instruments Funding information Local study team members (some IRBs want just PIs, some want all team) Application form if required IRB is reviewing – big picture Study design Risk benefit ratio Fair and equitable selection of subjects Informed consent process Protection of privacy and confidentiality of data iu, M. and Davis, K. A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons from a Horse Named Jim. Second Edition. New Jersey: Wiley-Blackwell. 2010 What is the IRB looking at - details Consent form and procedures for consent Voluntariness of research clearly communicated/no coercion IRB coverage for those parties 'engaged in research' Clear explanation of study procedures Inclusion of non-English speaking participants Monitoring of study participants and safety reporting Confidentiality measures "Minimal Risk" "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" IRB reviews studies to determine if they are: Minimal risk Greater than minimal risk Greater than minimal risk studies may require a DSMB In pediatrics, minimal risk studies require 1 parent consent whereas greater than minimal risk requires 2 Usually greater than minimal risk studies must pose prospect of direct benefit Not usually the focus of the IRB Your specific processes to get the study done, unless they impact the rights and welfare of the study participants (for example, you may be able to list 'clinic recruitment' rather than all of the details that go into making clinic recruitment happen) Your internal case report forms that are not seen by participants (though they should match up with the study protocol) Details such as the specific tubes used for blood collection (though the tests being done should be listed in the protocol) Your system for project management such as tracking boards (again, unless it impacts the