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  • 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

    2

  • 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 researchers 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 students 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

    3

  • 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

    Universitys 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 MSUs 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 MSUs 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 PIs 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 PIs 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 PIs 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 PIs 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 MSUs 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 PIs research activities will cease on the studys 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 MSUs 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 PIs research activities will cease on the studys expiration date

    20.To ensure that the student PI complies promptly with IRB requests to completely suspend, withdraw, or terminate this studys research activities

    5

  • 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

    6

  • 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

    7

  • 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)

    9

  • 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

    10

  • 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

    11

  • 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