5.0 The Review Process

Any research that involves human subjects and is authorized and conducted under the jurisdiction of Drake University is subject to review by the Drake University IRB. No new research project or changes to previously approved research projects may be initiated until approved by the IRB. The IRB reviews new projects, changes to existing projects and ongoing projects as follows:
  1. Initial Review All new research projects must be submitted for initial review. The three types of initial review exempt, expedited and full board are defined in detail in Sections 5.2 and 5.3
  2. Review of Changes to Previously Approved Protocols Any amendments, addenda, supplements or other changes to existing projects must be submitted to the IRB for either expedited or full board review.
  3. Continuing Review of Approved Research Projects Continuing review of projects previously approved by expedited or full board review is conducted by the full board at its regular meetings. Continuing review of exempt projects is conducted by the IRB Chair.


    5.1 When is IRB Review Required
    5.1.1 Student Classroom Research Projects
    5.1.2 New Projects
     5.1.3 Changes to Previously Approved Projects
    5.1.4 Continuing Review of Ongoing Projects

    5.1 WHEN IS IRB REVIEW REQUIRED
5.1.1 Student Classroom Research Projects
Many of our University courses demand that undergraduate and graduate students engage in research activities as part of the regular academic experience. Where that research uses human subjects, Drake University wants to insure that all student researchers are cognizant of the need to protect human subjects from risk. While the vast majority of student research falls into categories that in no way may be construed as exposing subjects to more than minimal risk, the IRB, on behalf of the University, has a responsibility to students who may be subjects and to external research participants to ensure researcher awareness of possible risks. Nevertheless, classroom projects that meet certain criteria (see below) may not require IRB review. Faculty who require research projects of their students must certify that the projects being conducted in their courses would qualify for exempt status.

 

Classroom curriculum projects in which students conduct research involving human subjects need not be reviewed by the IRB if all three of the following conditions are satisfied:
  1. The project (s) involve minimal risk to subjects (i.e., A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed 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 [Federal Policy §___.102 (i)]. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination.)
  2. They do not involve vulnerable populations (i.e., children younger than 18 years, those with intellectual disabilities, prisoners, pregnant women).
  3. Results will never be distributed outside the classroom and/or institutional setting (e.g., disseminated at a conference, submitted for publication, presented at DUCURS, published in Drake Undergraduate Social Science Journal, posted on the World Wide Web). If there is even a remote chance that the data or the report/manuscript will be used in the future for a conference presentation, or related research project, the research must go through IRB review. If the project is not subjected to a pre-data collection IRB review, the data will most likely not be permissible for inclusion in future presentation or research.
Instructors wishing to have students conduct research that meet the aforementioned criteria must do the following:
  1. Instructors must receive further training by the IRB on evaluating proposals and identifying violations (to be renewed every three years),
  2. Instructors must submit an application to the IRB providing a description of general research assignment information:
    1. The types of research to be undertaken
    2. Nature of participants to be used
    3. Kinds of procedures to be used in the research projects,
  3. Instructors must complete and submit a Course Research Certification Form to the IRB (click here),
Instructors are to require students to complete a proposal for the classroom assignment that addresses: the purpose of the project, description of participants, data collection methodology, the consent process (see requirements for student proposals). Furthermore, instructors must submit a copy of the consent form used by each student, signed by the student conducting the research.Any research not within the described parameters proposed and submitted by the instructor to the IRB would require separate approval from the IRB. Furthermore, faculty and students should take note that any data collected under the guise of classroom research will not be eligible for publication or presentation outside of the classroom and post-hoc reviews will not be conducted for the purpose of publication or presentation outside of the classroom.

Requirements for student proposals

  • Overview of the project
    1. Purpose
    2. Rationale/significance
    3. General description of research strategy and design
  • Participants
    1. Who (general sample/population information, not by name)
    2. Criteria for selection
    3. How selected, e.g. volunteer or recruitment strategies
    4. Risk factors for participants (be specific)
  • Data collection methods
    1. Specific steps to gather data
    2. Instrumentation
    3. How data will be recorded (describe steps for confidentiality)
    4. Secure data storage
    5. Destruction of raw data
  • Consent
    1. Describe the consent process
      1. How will study be explained to participants
      2. Implicit or explicit consent
    2. If explicit consent is obtained, copy of consent form should:
      1. Identifying as a project through Drake University
      2. Outline data collection procedures
      3. Ensure confidentiality
      4. Explain the rights of the participant, e.g. to withdraw at any time with no penalty, what will happen with their data if they choose to withdraw, etc.
      5. Explain the risks to the participant
      6. Provide IRB contact information, instructor, and researcher’s contact information
      7. Include Date and Signature line(s)

5.1.2 New Projects
 To determine if the proposed activity requires review by the Drake IRB, answer the following three questions:

  • Is the proposed activity research?
    Research is a systematic investigation that includes research development, testing and evaluation and evaluation and is intended to develop or contribute to general knowledge. If, according to this definition, the proposed activity is not research, then IRB review is not required. If the proposed activity is research, continue with the next question.
  • Does it involve human subjects?
    Research investigators must determine whether their proposed research will involve human subjects. Regulations define “human subject” as a living” individual about whom an investigator (whether professional or student) conducting research obtains 1) data through intervention or interaction with the individual or 2) identifiable private information. If you determine that the research does not involve human subjects, then IRB review is not required. If you determine that the research does involve human subjects, IRB review is required. If it is not clear whether the research involves human subjects, seek assistance from the IRB Chair.
  • Will it be authorized and conducted under the jurisdiction of Drake University?
     All research involving human subjects regardless of the funding status or the source of any funding is under the jurisdiction of the University. In cooperative research projects involving one or more institutions in addition to Drake University, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with the individual IRB policies.
  • Does research no intended for publication require IRB review and approval?
    Even research involving human subjects that is not intended for publication requires IRB approval.

5.1.3 Changes to Previously Approved Projects
 Research investigators shall be responsible for submitting for IRB review all amendments, addenda, supplements or other changes to previously approved projects along with a copy of the original protocol when:

  • The research project proposes to involve or to change the involvement of human subjects and the involvement is significantly different from that which was originally approved by the IRB
  • The informed consent document is modified from that which was originally approved by the IRB

5.1.4 Continuing Review of Ongoing Projects
 Not more than one year from the date of IRB action (not from the date of project initiation), previously approved and on-going protocols must be submitted for renewal. The research investigator is responsible for seeing that the continuing review approval is completed before the deadline. There is no grace period, the approval will have lapsed and research cannot continue.

Routine projects of minimal risk will be reviewed at 12-months, however, projects of moderate or high risk involving adult subjects and projects of greater than minimal risk involving minor subjects may at the discretion of the IRB be reviewed more frequently, commensurate with the risk involved. The experience of the investigators will also be considered. At the time of initial IRB approval, the IRB will notify the investigator of the level of risk and the approval period assigned to the project. The IRB may modify the level of risk and length of approval period following review of changes to a project or following continuing review of a project, as appropriate. The research investigator will be notified of any such modifications.

In addition to scheduled continuing reviews, the IRB may elect to review the data accumulated by the investigator(s) or interview both the investigative staff and research subjects. The IRB may designate an IRB member or independent consultant to verify that no material changes in a research project have occurred since the previous review.

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Last Modified: 10/03/2009 05:50:10 by content editor