Presentation on theme: "Research Involving Human Subjects All research involving the participation of human subjects must be submitted for review by the IRB (Institutional Review."— Presentation transcript:
Research Involving Human Subjects All research involving the participation of human subjects must be submitted for review by the IRB (Institutional Review Board for the Protection of Human Subjects)
Where Do I Find Information? Most information on guidelines, procedures, and submitting research applications can be found at http://www2.oakland.edu/researchhttp://www2.oakland.edu/research Contact Judette Haddad (Compliance Coordinator) at firstname.lastname@example.org or 370- email@example.com Contact Christine Hansen (Chair, IRB) at firstname.lastname@example.org or 370-2304 email@example.com
Faculty Responsibilities All investigators conducting research involving human subjects need to be familiar with Oakland University IRB Guidelines (http://www2.oakland.edu/research/web/compliance/irb_guidelines.ht m)http://www2.oakland.edu/research/web/compliance/irb_guidelines.ht m Faculty training is available periodically throughout the year. Take the tutorial at http://www2.oakland.edu/research/research2/tutorial/index.cfm?mi=17&hi=3& http://www2.oakland.edu/research/research2/tutorial/index.cfm?mi=17&hi=3& Faculty must inform students with whom they are working to read OU Guidelines All research must be exempted or approved before it can be conducted Research must be conducted as described in the approved or exempted application Research applications must be submitted through the Research Application Manager (RAM)
Review Categories May be “Exempt” Projects that present no more than “minimal risk” to the participants and do not compromise the privacy or confidentiality of the participants involved Reviewed by IRB Chair Common in Educational Research May be “Expedited” Reviewed by 2 IRB Committee Members Common in Educational Research for data collection methods that use audio/visual data collection Full Board Review Full Committee meets once per month (must be received by the Research Office at least 14 days before the next meeting date) Researcher presents the research proposal Committee members ask the researcher questions regarding the research and participation of human subjects Vote is taken (in the absence of the researcher) and recommendations are made
What is “minimal risk”? The risk to the subjects does not exceed the risks encountered in ordinary everyday life or in the performance of routine medical, dental, or psychological examinations.
What Does the Board Consider? The risks to the subjects. Risks must be justified by potential benefits. Risks must be minimized to the extent possible. The anticipated benefits. Must be clearly communicated in research proposal. The importance of the knowledge that may result. The informed consent process to be employed.
Analyzing Risks and Benefits To judge the application the IRB needs full information about: the selection and recruitment of subjects, research design, scientific rationale, conflicts of interest.
Informed Consent Participants must understand the nature of the research. Participants must be able to knowledgeably and voluntarily decide whether or not to participate. Participants must understand the risks and benefits of participation. The IRB must determine that informed consent will be properly obtained.
How to Apply Submit and application at http://www.oakland.edu/research All sections of the form must be completed An endorsed hard copy of the signature page must be forwarded to the Research Office, 544 O’Dowd Hall All research must be conducted or sponsored by an Oakland faculty member.
What Happens? For research falling within the categories of exempt or expedited review, you will receive written notification of approval within 2 weeks of approval. If your project is referred for formal review by the full committee, you will be sent a written invitation to attend the committee meeting at which it will be discussed. Investigator will provide explanations and rationale for all procedures, discuss the risks and benefits, and information about informed consent procedures. If approved by the majority of IRB members attending the meeting, you will be notified in writing within a few days.
Approved Research Any changes to original application must also be approved (report changes to IRB through e-mail message to Judette Haddad). IRB approval is valid for a maximum of one year – a “continuing review” application must be submitted to extend the research beyond one year. Continuing review forms are sent 2 months prior to approval expiration date (must be completed by PI and e-mailed back to Judette Haddad).
Important Components of Protection Minimizing Risk Maintaining Confidentiality Maintaining and Destroying Records Maintained for at least 3 years and then destroyed in a manner that will protect the identity of human subjects. Reporting Adverse Events Related to Research
Elements of Informed Consent Information Research Procedures Purpose Benefits Risks Alternatives Who is conducting the research Opportunity to ask questions To researcher (about research) To Chair of IRB (about rights as human subject)
Elements of Informed Consent Comprehension Organized Ample time for consideration Opportunities for questions Lay language appropriate for subject
Elements of Informed Consent Voluntary Consent if voluntary, free of coercive elements Unjustifiable pressures occur when persons in authority urge a course of action for a subject Coercion is likely whenever possible sanctions are involved (implied or actual) Undue influence occurs through an offer of an excessive, unwarranted, inappropriate or improper reward Consent process may not involve the use of “exculpatory language” Right to withdraw
Consent Form Requirements Description of study (purpose, duration, procedures) Description of foreseeable risks/discomforts Description of benefits Disclosure of alternative procedures Description of confidentiality of records and anonymity For more than minimal risk, other information* Statement of who to contact for (1) research questions (2) research related illness or injury (3) rights for research subjects Statement that participation is voluntary and that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits. Most cases require that informed consent be documented in writing. Assent forms are needed when the study involves children.*
Administering the Consent Form Pass out two forms – one for the subjects to sign and return to you and one for them to keep for their records. Read the form aloud as the subjects read it to themselves. After reading it aloud, summarize what is stated on the form. Allow time for questions. Allow subjects time to consider whether they want to participate or not before signing.
Tips: Before you Apply Write the major components of the application (Abstract, Protocol, Consent Form(s), Instruments) Use the “suggested language” on the checklist within the consent form Include (attach) other items given to subjects such as survey questionnaire or advertisements. Get a login and password for the RAM Be familiar with the questions that are asked on the application Allow ample time for the review process to take place