Submit a Proposal

Albion College Guidelines for Submitting an Institutional Review Board Proposal

Revised and Updated September 2015

Introduction

What is the IRB? The Institutional Review Board (IRB) is a committee established to review, monitor and approve research involving human participants conducted by Albion College faculty, students, staff or members of the Albion Community.

The primary purpose of the Institutional Review Board (IRB) is to protect the rights and welfare of the human participants, to review all courses and research projects involving human participants, including those which the investigator believes to be exempt from expedited or full review.

What is a human participant? A human participant or subject is defined by Federal Regulations as "a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information."

Policy on Research Involving User of Human Participants

Albion College is committed to the ethical treatment of all human research participants who take part in research conducted by its faculty, staff and students. The College's policies and procedures pertaining to the treatment of human research participants are designed to conform to the Department of Health and Human Services Title 45, Code of Federal Regulations, Part 46 (as amended).

Albion College's Institutional Review Board (IRB) is responsible for assuring that research activities conducted under the College's auspices do not violate the rights and welfare of human research participants. All research using human research participants that falls under the federal definition of research must be approved by the IRB. Research activities that are subject to IRB review include: faculty research, administrative/staff research, and student research (e.g., independent studies, thesis research, student-designed research for courses). Classroom research projects, including group projects and assignments, as well as classroom demonstrations that involve data gathering and analysis, may also be subject to monitoring by the IRB if data are collected from people not enrolled in the class, if research results will be disseminated outside of the classroom, or if data are collected within the classroom using invasive procedures or in a way that involves increased risk to students. If there are questions about whether something is subject to monitoring by the IRB, the researcher or instructor should contact the chair of the IRB. Collection of data from students for the purposes of educational assessment (e.g., use of standardized tests) is exempt from IRB review, as are public discussions or publications of pedagogical practices and their results. Except to the extent necessary to protect the rights and welfare of human research participants, the IRB will not infringe on academic freedom. The IRB will maintain confidentiality of activities that the IRB reviews.

If an investigator does not comply with the IRB policies, the IRB may require appropriate remedies up to and including the suspension or revocation of the privilege to conduct or supervise research at Albion College. The IRB may amend its operating policies as mandated by the federal government; all other changes to IRB policies must be approved by the Faculty Steering Committee. IRB procedures may be amended by the IRB.

General Proposal Information

For Albion College students, there are two levels of IRB review of research involving human participants:

  • C-2, Expedited review
  • C-3, Full review

For faculty/staff/community members, there are three levels of IRB review of research involving human participants:

  • C-1, Monitored review
  • C-2, Expedited review
  • C-3, Full review

The determination of which level of review is appropriate for a particular study is ultimately made by the IRB based on the nature of the protocol, level of potential risk to human participants, and the participant population. Regardless of the level of review, all applications should use the appropriate submission form.

Proposal Review Process

After a proposal has been submitted, your study will be assigned an IRB number that should be used on all correspondence relating to the study until the study is closed. It is then reviewed by members of the IRB committee. The current committee makeup can be found on the IRB website (www.albion.edu/research).

As part of the proposal process, principal investigators (PI) are often asked to resubmit a revised proposal for further review. Often the committee members have questions or comments about the proposal and would like to see information clarified or explained further. Commonly the PI is asked to revise the proposal. Once the revised proposal has been received, it will again be reviewed, and approval decisions can generally be anticipated within two weeks of the revision submission.

Possible outcomes of a review: A study may be approved; approved with stipulated changes; disapproved; deferred; or it may be deemed exempt from continuing review.

Approval of research: Approval decisions can generally be anticipated within two weeks of the completed revised submission. Once a final decision on the proposal has been made, you will receive official confirmation by email from the committee chair.

Stipulated minor changes or clarifications required prior to approval: It is common for the IRB to request some changes to the consent form or protocol prior to approval. These are called "stipulated changes." If there are stipulations, you will receive a communication from the IRB with details. You should electronically respond to the communications. If your corrections are acceptable, your proposal will continue through the review process. Approval decisions can generally be anticipated within two weeks of the revision submission.

Deferral (full board action only): Sometimes the IRB, in a full board review, determines that substantive changes must be made before approval may be granted. Full board review is required for responses to deferral. Once a final decision on the proposal has been made, you will receive official confirmation by email from the committee chair, usually within two weeks of the date of submission.

Please note: If there are extensive spelling and grammatical errors, the IRB chair may refer you to the Academic Skills Center for corrections before the proposal is reviewed.

Approval Information

Approval decisions can generally be anticipated within two weeks of the completed revised submission. Once a final decision on the proposal has been made, you will receive official confirmation by email from the committee chair.

Approvals are for one (1) year from the initial review date. All projects are subject to renewal, usually annually. If the research is continuing or data analysis is not yet completed, you may request a renewal approval by contacting .You must include your IRB number, title of your study, and details regarding the extension. Projects are subject to continuing review through the data analysis phase. At completion of this phase, inform the IRB that your project is completed at .

Detailed Information About the Proposal

Signature Page to Complete IRB Proposal

A copy of the signature page is included within the Status Form C website (link at left). All student proposals must have a faculty or staff sponsorship. The student must give a copy of the IRB proposal to their sponsor with sufficient time. Advisors: Your signature indicates that the student’s proposal meets previously established standards for scholarship in the particular field.

Cover Sheet: Self-Report of Review Status, IRB Form C

Prior to beginning a research project that involves the use of human participants, the principal investigator (PI) must submit the Cover Sheet: Self-Report of Review Status, IRB Form C, a self-report indicating whether in his/her view the research qualifies as exempt or requires expedited or full review. A copy of the cover sheet self-report of review status, IRB Form C, is included at the end of these instructions.

Please use templates for the Informed Consent, and Parental Permission (if applicable) before submitting your proposal. They can be found on the IRB website (links at left).

Checklist for Research Review Status

The Checklist for Research Review Status form must be completed by the PI. Completing the checklist will determine which level of review is necessary for your study.

  • IRB Form C-1 – Checklist for Research Qualifying for Monitored Review
  • IRB Form C-2 - Checklist for Research Qualifying for Expedited Review
  • IRB Form C-3 – Checklist for Research Qualifying for Full Review

Consent Form for Participants (template available)

The standard expectation is that all participants will sign a document containing all the elements of informed consent. The informed consent process gives potential participants a description of the study that is clear and complete enough for the individual to judge whether she or he wants to participate. The consent form should provide readily understandable information. Some or all of the elements of consent, including signatures, may be waived under certain circumstances.

Consent forms need to:

  • State explicitly that the study is conducted for research purposes.
  • Explain what procedures will be followed (what participating in the study will actually require of the participant)
  • Provide an estimate of the duration of participation
  • Explain potential benefits and compensation that can be expected
  • Explain potential risks of participation (NB: No study is entirely free of risk; many studies will entail “minimal risk,” which means that the risks of participating are not expected to exceed those of normal daily interactions).
  • Clearly explain that participation is always voluntary, and that the participant can withdraw their consent at any time without penalty.
  • Include a statement indicating that the participant can skip any questions/tasks with which they feel uncomfortable without any penalty.
  • Include contact information (e.g., name and email) of the researcher.
  • Include the IRB contact information in case a participant has any questions about their rights as a participant.

At the conclusion of the study, the consent forms need to be kept in a secure location for seven years.

Debriefing Form (Debriefing forms must be provided when deception is used)

The debriefing process is a critical aspect of data collection. Its purpose is to provide a description of the study that is educational, and thus, informative. It also serves as an opportunity to thank participants for their assistance with the research, and provides them with another opportunity to ask any questions they may have about the research. At the same time, it needs to satisfy the ethical concerns of the Albion College's Institutional Review Board. A good general guide is to keep in mind both its educational and ethical functions.

After thanking the participant, briefly explain the purpose of the study, the logic, what you predict (and why), and possible applications of this work (if any). Make sure that you use simple language throughout -- your purpose is to educate, not to bury the participant in uninformative jargon.

  • Debriefing forms are normally one page in length.
  • It is mandatory that the nature of the deception be carefully explained, together with the reason(s) for using it.
  • Suggest where participants can get counseling if they feel this is necessary.
  • Inform participants that if they are uncomfortable with having being deceived, they are free to withdraw their data from the sample.
  • Remind participants that their results are confidential to the experimenters, and that all results are published anonymously as a group data.
  • Make sure you provide the appropriate names and contact information (phone number and email address) in case a participant wishes to express concern about the study.

If the study involves any kind of possible stress, however mild it might seem (e.g., as in c, or in answering a depression or anxiety questionnaire), the participant must be told how they can contact a counselor (e.g., provide telephone number of Student Counseling Service for student participants).

Inform participants that if they would like any information about the results of the study once it is completed, they should feel free to contact you. Provide a name – your own or that of your supervisor, along with up-to-date contact information that they can take with them.

You should provide one or two complete and easily accessible general references for those interested in learning more about your topic. The articles should be obtainable from a website or from the college's library facilities. Conference proceedings, book chapters and technical reports are all harder to access and therefore should not be included unless available in PDF form from the author or supervisor. If the subject requests contact information or reading materials (i.e., c-f), provide on a separate take-away page.

Should you need to ask participants to refrain from talking about the study while you are still running it, you should explain why (e.g., participants with full knowledge of the study may react differently than those who do not possess that knowledge).

Final Checklist: (Checklist to assist with your application being processed with minimal corrections)

The final checklist is a tool to help determine that you have met all the requirements for the IRB proposal process. Failure to meet these requirements will result in your proposal being delayed.

Submitting the Proposal

To submit an Institutional Review Board proposal for approval you will need to fill out the appropriate IRB forms:

  • Cover Sheet: IRB Form C
  • Signature Page
  • Checklist for Research Review Status: C-1 or C-2 or C-3 (Parts I through IV)
  • Consent form (if applicable)
  • Debriefing form (if applicable)
  • Final Checklist

Submit one (1) hard copy of the completed proposal to Schara Swan in the Department of Psychological Science office, Olin 308. Make sure you give it to Schara Swan or one of her staff members; do not slide the forms under the office door.

Within 24 hours of receiving your proposal, you will receive an email message that will include your proposal number; upon receiving this message, you will be asked to reply to the message and attach your proposal electronically.

IRB Proposal Submission Deadlines

The IRB committee will review proposals on a rolling basis and you can expect about a two week turnaround time, but final approval will be dependent upon completion of revisions. If you submit a C-3 proposal the committee will need to conduct a full review. Please allow ample time for a proposal to be reviewed.

No new proposals will be accepted during the college breaks. Please plan accordingly and submit your proposal at least two weeks before the end of classes.

Protocol for re-submitting, if the committee has required revisions:

If the IRB committee has questions about your proposal, you will receive an email message. It is common for the IRB to request some changes to the consent form or protocol prior to approval. These are called "stipulated changes." If there are stipulations, you will receive a communication from the IRB chair with details. You will be required to address their concerns, by REPLYING to the message you were sent and include the corrections you have made. You should electronically respond to the communications. If your corrections are acceptable, your proposal will continue through the review process.

Once reviewed and agreement that no further changes are needed, conditional approval will be given. At this time, you will need to re-submit the entire updated proposal, including your IRB number, electronically to Schara Swan. Once Schara has a clean copy of your re-submitted proposal, the email approval from the chair will be sent and the data collection can begin.

Contact Information

Committee Chair
Professor Lynne Chytilo
204 Bobbitt Visual Arts Center
517/629-0373

Committee Coordinator
Schara Swan
308 Olin Hall
517/629-0279