Janet Koehnke, PhD
Chairperson, Communication Sciences and Disorders
& IRB Committee Member
4/11/2012
Research Mentoring and the IRB
Student and FS prepare submission for IRB
Student sends submission to IRB
pIRB office processing; Is the
submission complete?
Sent to a reviewer
Scheduled for Full Board, Expedited or Exempt Review in accordance with regulations
Review Performed – either Full Board or by designated reviewer
ppDoes the Submission Meet Criteria for
Approval?
Yes, Approval Processing
Approval letter and stamped documents sent to PI
No, Modifications required.
Email sent to Student PI with clarifications and revisions. Student and FS must respond
within 30 days
Common Problems• Missing documents• Documents incomplete• Personnel not completed CITI• No faculty sponsor signature• Provided information is not consistent among
all documents
Email sent to PI identifying problems with submission. PI asked to re-submit
Yes
No
Yes
No
Overview
of Process
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Faculty Sponsor Roles and ResponsibilitiesWhat is a faculty sponsor?
As a faculty sponsor you provide valuable references about research strategies designed to reduce the risk to human subjects. You are a student researcher’s primary contact for protections of human subjects and research questions. YOU ARE ESSENTIAL TO THE PROCESS & MAKING IT RUN SMOOTHLY
Why am I signing the student’s application to the IRB?
You are a primary authority expected to ensure that the application is ready for submission to our offices. The IRB acknowledges your signature as a confirmation that you have reviewed the application and all required documents for completeness, accuracy and sound research design. SEE FACULTY SPONSOR AGREEMENT
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FACULTY SPONSOR AGREEMENTI agree: 1. That submitted information in this application is accurate and complete2. To ensure that the student PI conducts this study in accordance with ALL Montclair State
University’s IRB policies, guidelines, and approvals and federal, state, and local laws that relate to research involving human participants
3. To meet regularly with the student PI to monitor the study 4. To ensure that the student PI promptly supplies the IRB with requested information5. To ensure that the student PI promptly implements any requested changes by the IRB during the
Continuing Review process6. To ensure that the student PI does not to begin the study until AFTER IRB
WRITTEN APPROVAL is granted7. That when applicable, protocol information approved by MSU’s IRB for this study will be
consistently represented in ALL funding applications and processes.8. To ensure that after Continuing Review approval is granted, the student PI obtains WRITTEN
APPROVAL from the IRB prior to implementing ANY requested changes during the research covered by the approval for this Continuing Review. Changes must be requested by submitting the Application for general amendment form found at the MSU’s IRB website.
9. To ensure that during emergencies, the student PI only makes necessary study changes that will ensure the participants’ well being without getting prior IRB approval
10.To ensure that the student PI maintains the Human Participants Protection Tutorial requirement prior to continuing the research, in accordance with MSU IRB guidelines4
FACULTY SPONSOR AGREEMENT11.To ensure that all the student PI’s research staff, who will have contact with human participants and/or their
data, maintain the Human Participants Protection Tutorial requirement prior to continuing the research, in accordance with the MSU IRB guidelines
12. To ensure that all the student PI’s research staff will be qualified to conduct the research13.To ensure that the student PI immediately reports any problems involving risks to participants (e.g., complaints,
injuries, adverse events) to the IRB, sponsors, Data Safety and Monitoring Boards, and other agencies14.That if research must continue in the student PI’s absence (during vacations, sabbaticals, etc.), the student PI
will arrange for another PI to carry out his/her responsibilities15. That if I (the Faculty Sponsor) am not available to advise the student PI’s research (during
vacations, sabbaticals, etc.), I will arrange for another Faculty Sponsor to carry out my responsibilities
16. To ensure that the student PI submits a Continuing Review form for the activity described in this protocol if it has not been completed by the date of approval expiration. This form is available on the MSU’s IRB website
17.That if the Continuing Review form is not returned on time, the study becomes inactive, and I will ensure that ALL of the student PI’s research activities will cease on the study’s expiration date
18. To ensure that the student PI submits a Project Completion form at the end of the project. This form is available on the MSU’s IRB website
19.That if the Project Completion form is not returned by the expiration date AND a Continuing Review approval has not been granted, the study becomes inactive, and I will ensure that ALL of the student PI’s research activities will cease on the study’s expiration date
20.To ensure that the student PI complies promptly with IRB requests to completely suspend, withdraw, or terminate this study’s research activities
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What happens during the IRB review
review is governed by (45 CFR 46.111) reviewer is assigned to a protocol & carefully reads all submitted documents consent form (45 CFR 46.116)
should accurately reflect the study should contain information that agrees with what is in the IRB application should be written in simple lay language must be appropriate to the participant pool (language)
reviewer pays particular attention to: how participants are recruited to be in the study how the privacy of participants will be protected the physical, psychological, and sociological risks to participants any discomfort or stress to participants
Reviewer must be certain benefits outweigh the risks
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What the IRB reviewers will NOT do Critique the design of the research –unless it poses a
significant risk to the subjects
Critique the research procedures – unless deception is involved and not properly addressed
Evaluate the grammar, spelling, etc. of any documents – unless the language makes the message ambiguous or unclear
Comment on the importance of the research proposed –unless the risks appear to outweigh the benefits
Comment on the methods proposed to recruit subjects –unless these methods involve coercion
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Protocol Design: the best approach to reviewing a student protocol Justification of research study should be evident to the reviewer;
benefits clearly described Specifically, high(er) risk requires thorough justification Be sure discipline specific terms are explained/defined
Clarity of recruitment procedure Be sure there is no indication that subjects may be coerced For e.g., PI asks their own students to participate in a study
Consent procedure Consent form Accurately reflect study Readability/Language level appropriate for audience
Limit risks to participants8
RECRUITMENT PROCESS Who? How? When?
Privacy during recruitment Snowball sampling “Researchers use this sampling method if the sample for the study is
very rare or is limited to a very small subgroup of the population. This type of sampling technique works like chain referral. After observing the initial subject, the researcher asks for assistance from the subject to help identify people with a similar trait of interest.” (Joan Castillo - fromhttp://www.experiment-resources.com/snowball-sampling.html#ixzz1rTFzAUZj)
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Recruitment Process cont. Coercion versus Undue Influence during recruitment
“Coercion occurs when an overt or implicit threat of harm is intentionally presented by one person to another in order to obtain compliance. For example, an investigator might tell a prospective subject that he or she will lose access to needed health services if he or she does not participate in the research.” [from http://answers.hhs.gov/ohrp/questions/7250]
“Undue influence, by contrast, often occurs through an offer of an excessive or inappropriate reward or other overture in order to obtain compliance. For example, an investigator might promise psychology students extra credit if they participate in the research. If that is the only way a student can earn extra credit, then the investigator is unduly influencing potential subjects. If, however, she offers comparable non-research alternatives for earning extra credit, the possibility of undue influence is minimized.” [from http://answers.hhs.gov/ohrp/questions/7250]
Recruitment and consent occurring simultaneously can be a problem Recruitment of minors also requires parental/guardian consent
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INFORMED CONSENT PROCESS Informed consent begins with recruitment and continues
throughout the study Process vs. Consent form Consent vs. Assent and minors Consent form Language Reading level (6th-8th) Accurately depicts the study – time involved, tasks required, etc. Clearly explains risk Should highlight autonomy in the decision to participate and to
continue participation to the end of the study
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DATA COLLECTION AND PRIVACY Confidential vs. Anonymous
Privacy in Focus groups – the need to remind participants that information exchanged is confidential
Data Location and security De-identifying data after data collection Who retains the data after the student graduates? When/how is it destroyed either 4 years after study completion
OR when PI is finished with it, whichever comes later
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Faculty Sponsorship – Syllabus requirement
Consider the following: Time spent to review each protocol Simplify the research methods Grouping students Particularly if their projects are similar or related
This may be a time to encourage working in groups – i.e., helping each other
Share approved protocols from one group to the next Have previously successfully completed applications available as examples
Spanning two semesters for research project
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Simplifying student protocols
Limit use of vulnerable populations
Limit identifiable data collection to necessary data for proving the hypothesis
Minimize the chances of causing stress or distress in the subjects
Manage expectations on the student’s expertise to conduct the study
Avoid studies requesting information about illegal activities
Try to avoid the need to videotape large groups
Avoid coercion
Avoid creating situations where subject identity may be exposed
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Common Problems with Applications involving Student PIs FS did not review the application prior to submission, or on subsequent
resubmissions Grammar mistakes and typos in application & consent document No justification for research No stated research question(s) or hypotheses No indication of what the final product will be, what are their plans after
data analysis? Presenting? Publishing? Application is incomplete Items missing – e.g., letter of agreement, assent forms Questions are not answered – e.g., how data will be secured, what will be
done if there is an adverse event Lack of awareness regarding risks to participants No data security plan in place Lack of understanding of adverse events Need to provide a means for reporting them even if none expected
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Simplifying the Dreaded IRB
Let them know that this is an important part of the research process
Start by having them complete the CITI training This will familiarize them with the reasons IRB approval is necessary This should help them understand what “risk” means and get them to think
about how to minimize it in their project This should explain coercion and help them think of ways to avoid it
Have a formal meeting with each student (or in small groups) to be sure they have the basic information they need to complete the IRB application
Be sure they understand that the goal of the IRB is to protect human subjects from harm of any kind If they were going to participate in a study they would want this
protection16
Practice versus Research
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Research is only what they are doing to obtain data Practice is what is done routinely in a particular activity, but NOT for the
purpose of research Example It is common practice to teach students about various writing styles and have
them complete assignments for class If however, a researcher wants to compare two approaches to teaching
writing styles and evaluate the effectiveness of the approaches based on the quality of the assignments or other metrics, that is research
Another Example Speech therapy to remediate incorrect articulation of /r/ may involve a
variety of different approaches A researcher wants to compare the effectiveness of two different approaches
and recruits 2 groups of subjects in order to systematically apply the two and compare them – this is research
Motivating Students to Complete the IRB process
Provide clear deadlines in your syllabus based on known IRB meeting dates
Impose penalties in grading if work is not completed in timeframe required
Remind students that failure to get IRB approval means they may not graduate in a timely fashion
Assure them that the IRB wants them to get through the process as quickly and easily as possible
Encourage them to ask you questions Have them start by completing a draft of the IRB application and
then meeting with you to go over it
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Misconceptions about the IRB & the review process The IRB Chair makes the decision of whether or not a project is
approved. Each application is assigned to a different board member to review and
approve. Full category studies are reviewed by the entire board. Amy Krenzer, IRB Coordinator, sends you her comments. Amy forwards you the comments of the IRB reviewer or IRB board in the
case of a Full Board review. The IRB Board does not want to approve human subject research. We are here for the soul purpose of protecting human research subjects
and approving applications to ensure the ethical conduct of research Board members are paid. Board members are volunteers; they volunteer their time and effort.
All submissions need review at the monthly full board meeting. Only full category applications are reviewed by the full board. Exempt
and expedited reviews are done by individual IRB reviewers.19
IRB Submission for a two semester timeline
SEP OCT NOV DEC JAN FEB MAR APR MAY JUN JUL AUG
Develop Research Design
IRB InitialReview
Research and Data Collection (cannot start w/out IRB approval)
SUBMISSION Courses should consider staggered submission
IRB revisions reviewed
Submission of Project Completion Forms
Prepare IRB application with Faculty Sponsor (FS) Review
Email sent to PI and FS with revisions
Review Process
PI revisions re-submitted with FS approval (30 days)
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IRB contact information IRB Coordinator: Amy Krenzer [email protected] Ext. 7583
Research Compliance Administrator: Hila Berger [email protected] Ext. 7781
IRB Chair: Dr. Debra Zellner Ext. 4327
IRB Office: College Hall 248
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QUESTIONS?
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The End!
