Presentation on theme: "Protecting Human Participants in Research Office of Research Integrity and."— Presentation transcript:
Protecting Human Participants in Research http://orip.syr.edu/humanresearch.html http://orip.syr.edu/humanresearch.html Office of Research Integrity and Protections Tracy Cromp Director Jeanne Diederich IRB Administrator
What Is the Institutional Review Board and what is it’s role?
The Institutional Review Board is designated to protect the rights and welfare of human subjects participating in research conducted at or sponsored by an institution. The SU IRB is comprised of 9 members from relevant and diverse academic backgrounds and 2 non-affiliated community members, with one IRB Chair and three Co- Chairs.
Because SU receives federal funds, we are obligated to have a FWA with the government. As part of the FWA SU pledges to follow the ethical principles outlined in the Belmont Report AND federal regulations 45 CFR 46-Part A-also known as the Common Rule when reviewing Human Subjects protocols. Federal Wide Assurance
The Belmont Report Basic Ethical Principles 1. Respect for Persons 2. Beneficence-(1) do not harm and (2) maximize possible benefits and minimize possible harms 3. Justice- fair procedures and outcomes in the selection of research subjects
Regulations for: The roles and responsibilities of the IRB The definition of research IRB review of research Criteria for IRB review/approval of research General requirements for informed consent Federal Policy for the Protection of Human Subjects Common Rule 45 CFR 46 (Part A)
The IRB at SU reviews all research studies involving Human Subjects conducted at the university for compliance with federal, state, and local laws as well as institutional policy whether or not they are funded.
Definition of Human Subjects Research as defined in 45 CFR 46 Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Systematic investigation-attempts to answer a research question; is methodically driven-collects data in an organized and consistent way; attempts to analyze data or information in some manner; and intends to draw conclusions from the result. Generalizable knowledge-contributes to a theoretical framework of an established body of knowledge; publication; presentation; workshop; conference; results are intended to inform the field of study; web based publications, etc.
Is the data being obtained about living individuals? Is the data collected through interaction/intervention with individuals? Is identifiable private information being obtained?
Categories of IRB Review Exempt Expedited Full Board
What determines which category for my research? The category of research is determined by the level of risk to the participant.
Exempt Review Exempt research studies present risks so benign, that the federal regulations determine these types of studies to be exempt from review. At SU the IRB must make this determination.
Exempt Review The research must qualify for exemption under one or more of the 6 categories as defined by the federal regulations. Examples-anonymous surveys, existing data that is already in existence and publicly available, research conducted in established or commonly accepted educational settings involving normal educational practices.
Exempt Review Process Exempt applications are reviewed by the ORIP Director, Tracy Cromp. Turn around time for review is approximately 5-7 business days. There are no deadlines for exempt applications. Allow a minimum of 4 weeks for the review process. Exempt studies are authorized for a period of 5 years.
Your research is not exempt when: Any part of the research requires that subjects be deceived. Involvement in the research exposes Human Subjects to discomfort or harassment beyond levels encountered in daily life. Disclosure of the subject’s responses outside of the research could place them at risk of criminal/civil liability, be damaging to their social and/or financial standing, employability or reputation. Data analysis on data that will come into existence after the research begins. The research involves prisoners/legally restricted persons as participants.
Expedited Review Expedited research activities present no more than minimal risks to participants– no greater than those encountered in daily life
Expedited Review The research procedures must be listed in one or more the 9 categories defined by the federal regulations. Examples-research on individual or group characteristics or behaviors; research employing the use of surveys, interviews, focus groups, program evaluation and/or the collection of data through non- evasive procedures (moderate exercise, BP screening, muscular strength, flexibility testing, body composition assessment).
Expedited Review Process Expedited applications are reviewed by the IRB Chair or one of the three IRB Co-Chairs. If deemed necessary expert consultant may also be asked to review-e.g.-disabilities expert. Turn around time for review is approximately 7-10 business days. There are no deadlines for expedited applications. Allow a minimum of 4-6 weeks for the review process. Expedited studies are approved for a period of one year, (unless the IRB determines more frequent review is necessary) and are renewable for up to 7 years.
Your research is not Expedited when: Involvement in the research exposes Human Subjects to discomfort or harassment beyond levels encountered in daily life. Disclosure of the subject’s responses outside of the research could place them at risk of criminal/civil liability, be damaging to their social and/or financial standing, employability or reputation. The research involves prisoners/legally restricted persons as participants.
Full Board Review Full board research activities involve greater than minimal risks to participants.
Full Board Review Involvement in the research exposes Human Subjects to discomfort or harassment beyond levels encountered in daily life. Disclosure of the subject’s responses outside of the research could place them at risk of criminal/civil liability, be damaging to their social and/or financial standing, employability or reputation. The research involves legally restricted/prisoners as participants. Examples-illegal behaviors-underage drinking, illegal drug use; situations of abuse-child/spousal abuse; disclosure of medical status, etc.
Full Board Review Process Full board applications must be reviewed at a convened meeting of the IRB with a majority of IRB members in attendance. There is a hard deadline for full board applications. Full board applications must be received two weeks prior to the scheduled IRB meeting. The IRB meets monthly except during the month of July. The meeting schedule is posted on our website.
Full Board Review Process Allow a minimum of 8 weeks for the full board review approval process. Full board applications can be approved for up to 365 days from the date of review (unless the IRB determines more frequent review is necessary) and are renewable for up to 7 years.
Application Content What is the purpose of the research-what is your research question/rationale for the research? What is your approach/what methods will you employ -what you will do to answer your research question-what will participants be asked to do? What are the characteristics of the participants-special populations? Additional form may be required. What are the risks-physical, psychological, financial, etc. How will risks be mitigated? What are the benefits of the knowledge gained-to the participant, society at large? How will you ensure the privacy of the participant and confidentiality of the data? What type of informed consent will you obtain?
Student researchers cannot be Principal Investigators on Human Subjects research projects that require IRB review and oversight at SU. It is Institutional Policy that the Principal Investigator be a member of the SU faculty at one of the following positions/levels: Assistant, Associate, Full Professor; Academic, Research, or Professor-of Practice, Department Dean/Chair; or Administrative Staff with the position of Director of higher. All applications should be completed under the guidance of the faculty mentor/person listed as PI on the protocol. Application Information
Informed Consent Avoid the use of technical terminology. Should be written using explanations or definitions at the reading level appropriate for the targeted population (Suggested reading level-8 th grade). The Informed Consent must include: A statement that the study involves research A description of the purpose for the study A description of the procedures A description of the time commitment A statement that participation is voluntary A description of how Confidentiality/Privacy will be protected A description of the Risks/Benefits The contact information-PI/Researcher and SU IRB When appropriate-incentive-permission to record/photograph/videotape
Completed Application Packet The fully completed and signed application. All research instruments-questionnaires/surveys/interview questions, focus group topics, etc. All recruitment tools, oral scripts for direct-in-person recruitment, ads-placed in newspapers-on the internet- social media sites, flyers, emails, letters, etc. All informed consent documents and/or assent documents for children when appropriate Any additional forms that may be necessary as indicated in the application-special populations, international research, research conducted in schools, genetic research, etc.
Outcomes of Review Once your application has been submitted, the IRB can: Approve Request modification(s) or additional information Disapprove Re-Categorize the research as Exempt, Expedited or Full
Student Projects Student projects (including Capstone projects) involving human participants that are conducted solely to fulfill course requirements do not require IRB review. Master’s or doctoral theses involving human participants must be submitted for IRB review.
Student Projects IRB review is not required for research projects conducted solely to fulfill course requirements and the results of the classroom assignment are only used and shared as follows: In the classroom; and/or, If the project involves gathering data from or about a company, agency, or organization, the data/results are shared only with the company, agency, or organization; and/or Project results are presented at departmental or interdepartmental seminars designed to exhibit coursework, or to continue the learning process related to presentations.
Student Projects HOWEVER: If data will be shared beyond the circumstances described above (e.g. for publication, presentation at academic conferences/workshops, in thesis/dissertation, etc.) then the project must receive IRB approval prior to initiation. Even if the project stays within the class and IRB review is not required, the instructor of the class should be aware of the types of questions being asked and all ethical principles regarding teaching should be followed in addition to the ethical standards regarding privacy and confidentiality.
Training Requirements CITI Training is required for all Expedited and Full Board Applications. All persons listed in the protocol application that will have direct contact with participants and or identifiable human participant data are required to complete the CITI training appropriate to their role in the research. No Expedited or Full Board studies will be approved until CITI training requirements are satisfied.
Amendments Needed whenever anything changes in materials originally submitted (the “protocol”) Changes to the protocol cannot be implemented prior to IRB review/approval - Exception: if the change is essential to protect human participants from harm
Reminders…. No human subjects research can be conducted without IRB approval or exemption. Allow enough time for your application to be approved, it can take up to two months if revisions are needed.
Where do I go for help? The Office of Research Integrity and Protections 121 Bowne Hall Phone Number: 443-3013 Email: firstname.lastname@example.org@syr.edu