Submitting a Proposal

Albion College Guidelines for Submitting an Institutional Review Board Proposal

Introduction

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

The primary purpose of the IRB is to protect the rights and welfare of the human participants, to review all research projects involving human participants, including those which the investigator believes to be exempt from expedited or convened 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 Use 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 a project 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

There are two levels of IRB review of research involving human participants:

  • Expedited
  • Convened

The determination of which level of review is appropriate for a particular study is based on the nature of the protocol, level of potential risk to human participants, and the participant population. Institutional Review Board (IRB) approval for research with human subjects is required regardless whether the research is conducted by faculty or students, by individuals or a group.  Failure to obtain proper approval in advance may jeopardize your data, preventing you from publishing the results.  If there is any doubt about whether you need IRB approval you should contact the chair of the IRB committee for clarification.

Proposal Review Process

After a proposal has been submitted, you will receive an email with your assigned proposal number that should be used on all correspondence relating to the study. Reply to the message and electronically attach your proposal documents.  Once your electronic version is received, your study will be reviewed by members of the IRB committee.

Often the committee members have questions or comments about the proposal and would like to see information clarified or explained further. Therefore as part of the proposal process, principal investigators (PI) are typically asked to resubmit a revised proposal for further review. 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. Proposal decisions can generally be anticipated within a two-week turnaround time.

Approval of research: 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: Normally the IRB will request some changes to the consent form and/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. Revision submissions generally extended the approval turnaround.

Deferral (convened committee action only): Sometimes the IRB, in a convened review, determines that substantive changes must be made before approval may be granted. Convened committee 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.

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

Approval Information

Approvals are granted by email from the IRB committee chair. Data collection dates are from the date of approval until the end date given on the proposal cover sheet. 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 via email to [email protected]. 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.

Detailed Information About the Proposal

Prior to beginning a research project that involves the use of human participants, the principal investigator (PI) must submit the following (in this order):

  • Cover Sheet: Self-Report of Review Status Form
  • Signature Page
  • Check list for Research Review
  • Final checklist
  • Consent form
  • Any other materials used in the study

Cover Sheet: Self-Report of Review Status Form

The Cover Sheet: Self-Report form provides the committee with the important details that pertain to your proposal.

Signature Page

The Signature Page MUST be signed by the principal investigator (PI). 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.

Checklist for Research Review

Completing the checklist for research review, will help determine if you have selected the appropriate level of review necessary for your study. If there is any doubt about which level of approval the proposal requires, please see the document for levels of review, or contact the chair of the IRB committee for clarification.

*** Please note, the cover sheet, signature page, checklist for research, and final checklist are included within the appropriate Form by clicking on a link below.

  • Expedited
  • Convened

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

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

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 being 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 (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 (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 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). If you use deception in your study you must explain the deception and why it was used. Make sure that you use simple language throughout – your purpose is to educate, not to bury the participant in uninformative discipline – specific jargon.

  • Debriefing forms are normally one page in length
  • If deception is used in your study, it is mandatory that the nature of the deception be carefully explained, together with the reason(s) for using it
  • Inform participants that if they are uncomfortable with having being deceived, they are free to withdraw their data from the sample
  • Suggest where participants can get counseling if they feel this is necessary
  • 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 (faculty 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) or questions regarding 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.

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).

Submitting the Proposal

To submit an Institutional Review Board proposal for approval, you must complete the appropriate documents (in this order):

  • Cover Sheet: Self-Report of Review Status Form (Expedited or Convened)
  • Signature Page
  • Check list for Research Review
  • Consent form
  • Final checklist
  • Any other materials used in the study

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 it under the office door.

Within 24 hours of receiving your proposal, you will receive an email with your assigned proposal number that should be used on all correspondence relating to the study. Reply to the message and electronically attach your proposal documents.  Once your electronic version is received, your study will be reviewed by members of the IRB committee.

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 Convened proposal the committee will need to conduct a complete review, which may require more than two weeks. 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 the semester.

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

If the IRB committee has questions about or sees issues with your proposal, you will receive an email message. It is typical for the IRB to request some changes to the consent form and/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 your revised proposal has been reviewed and the IRB has determined that no further changes are needed, final 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.

Revised September 2018