Human Subjects Research

Human Subjects Research

The Institutional Review Board

For information regarding non-human animal research, visit Wartburg’s Institutional Animal Care and Use Committee (IACUC).

Institutional Review Board Chair: Dr. Brian McQueen
IRB@wartburg.edu
brian.mcqueen@wartburg.edu
(319) 352-8755

Meeting Time: Tuesdays, 8 a.m.
Protocol Submission Deadline: 5 p.m. on Wednesdays (Submissions after 5 p.m. will be considered the following week.)

Instructions to Researchers

Research Checklist

NOTE: Research projects determined to be exempt from IRB review still need to be registered with Wartburg's IRB. Refer to information on this page regarding Exempt Status.

Are you trying to answer a hypothesis with your activity that will lead to conclusions that will be expanded to a wider population?
Are your findings generalizable? 

For example, a psychology study that surveys 20 students to draw conclusions about college students in general does fit this definition. For example, an oral history/biography that aims to record a person’s story but does not draw general conclusions does not fit into this definition.

Are you planning on disseminating your results to a wider audience? 
Some examples of dissemination to a wider audience include presentation of data/new knowledge at campus (RICE Day), local or national poster sessions or meetings, inclusion of data/new knowledge in grant applications, publication of data/new knowledge in professional journal either in print or online, and presentation of data/new knowledge to administration of community partnership or other off-campus organizations. 
 
If you have answered yes to all of the questions above, you need to seek approval for your research.   
If your project requires IRB approval, one of the committee members would be more than happy to work with you to meet the ethical guidelines for your protocol. If you are new to the IRB process, we encourage you to meet with a committee member prior to completing the protocol form.  If you have research or classroom activities that involve sensitive populations (i.e. children, elderly adults, people with intellectual disabilities) or involve significant stress to the participant, we recommend that you consult IRB prior to completing the protocol form.

If you are not affiliated with Wartburg College, but want to use Wartburg College resources to conduct your research and/or you want to collect data from Wartburg College students, faculty or staff members, please review the information for “Unaffiliated Researchers” at the bottom of this page. You must still seek approval from our committee prior to beginning your research at Wartburg. 

Approval Process

  • When determining approval, the committee carefully assesses the benefits associated with the research and any potential for risks. Benefits can be theoretical or applied in nature. Risks may include potential for physical or mental harm. Risk can also include situations in which participants’ anonymity or confidentiality is compromised. Proposed studies that pose minimal risk to participants can be submitted for expedited review.
  • Review the information about informed consent, debriefing, and expedited review sections of this website before completing the human subjects protocol form.
  • If you are a student researcher, send the electronic version of your completed form (with accompanying materials included in the same electronic file) to your research advisor. Your research advisor should assist you in preparing a complete and clearly written protocol. Your research advisor must review and approve the protocol before sending it to the IRB via email. The IRB will not provide feedback for protocols that are incomplete or poorly written.
  • The research advisor must email the completed protocol form to IRB@wartburg.edu. The committee will not review protocol forms or revisions that are submitted directly from students.
  • To ensure a timely review and approval of your protocol, you must send your protocol before the deadline noted at the top of this page. Late submissions may be reviewed at the committee’s discretion.
  • If substantial changes are required, the committee may only return partial feedback to the researcher; the committee will then consider an improved submission.
  • If your protocol is discussed, someone from the IRB will contact you via email regarding the board's decision and any instructions for necessary revisions.

Helpful Hints for Approval

  1. If you have questions about the submission form, consult an IRB member before submitting the form.
  2. Principal investigators, collaborators, and faculty advisors should carefully review protocols before submission. 
  3. If your protocol is not approved, any resubmissions should not include comments and/or questions back to the committee. Discuss any questions/clarifications with an IRB member before you resubmit your protocol. 
  4. Carefully review any resubmission to ensure that all requested changes are clearly included. Include a list of changes in an email message accompanying the resubmission. Highlight changes you have made within the protocol/materials.
  5. If you use template language or copy directly from sample materials or protocols, be sure to change the language as appropriate to reflect your study. Including irrelevant, incorrect, or misleading details will limit the committee’s ability to effectively evaluate your protocol.
  6. Include the protocol number in the file name and any correspondence with the committee.
  7. If you are a student who is actively conducting the research, you are considered a Principal Investigator; the faculty member overseeing your project is your Research Advisor. 

Regulations

Regulations Protecting Human Subjects in Research

The federal regulations protecting human subjects in research are contained in Title 45: Part 46 of the Code of Federal Regulations and are administered by the United States Department of Health and Human Services. These regulations have developed over time since the passing of The National Research Act in 1974. In 1979 The National Commission for the Protection of Human Subjects deliberated over the ethical principles which ought to dictate human subject’s research. The Belmont Report is the document that the commission produced. Its contents form the philosophical underpinnings of Title 45: Part 46 of the Code of Federal Regulations.

In addition to the federal regulations, individual academic and professional disciplines have agreed upon ethical standards which govern research conduct as it pertains to the protection of human subjects. As most of these standards are quite similar between disciplines, IRB has concentrated its efforts on the guidelines of the American Psychological Association. All IRB decisions regarding research protocols will be made, therefore, in an attempt to uphold both federally mandated and discipline-specific ethical standards.

Considerations

Vulnerable Populations (e.g. children)

Populations are considered vulnerable if there are concerns about their ability to understand information presented to them and make reasoned decisions about participation in research (for example, prisoners and children). Special protections exist for vulnerable populations in terms of review and informed consent. For example, research with children must secure the consent of parents. Investigators should review the specific federal regulations designed to provide special protections for vulnerable populations.

Informed Consent

Researchers using humans as research subjects must obtain the legally effective informed consent of the subject or the subject's legally authorized representative. The investigator must seek such consent only under circumstances that provide the prospective subject sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion. The information shall be conveyed in language understandable to the subject. No informed consent may include any language which appears to make the subject waive or appear to waive any legal rights, or releases or appears to release the investigator or the institution from liability for negligence.
Basic elements of informed consent:

(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.

(2) A description of any reasonably foreseeable risks or discomforts to the subject.

(3) A description of any benefits to the subject or to others which may reasonably be expected from the research.

(4) A statement describing the extent, if any, to which confidentiality and/or anonymity of records identifying the subject will be maintained.

(5) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;

(6) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights. This should include both the lead investigator and the chair of the IRB.

(7) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Debriefing Human Subjects

A debriefing is a careful review of the participant’s experience after s/he has completed the study. It has two purposes. The first purpose is to ensure that ethical standards are upheld. A debriefing allows the researcher to assess any changes in the participant’s psychological or physical state resulting from involvement in the study. If a participant is experiencing psychological or physical distress, the researcher must assist the participant in finding appropriate aid. If the researcher has used deception, the researcher must explain the deception fully and explain why deception was a necessary part of the study. 

The second purpose of debriefing is to provide participants with additional information about the study. This information can include details regarding the purpose of the study, the researcher’s hypotheses, and potential applied uses of the results. Some researchers provide participants with information about resources, such as websites or books, which contain additional information about the area of study. The researcher provides the participant with contact information for the researcher and the Human and Animal Research Review Committee, which the participant can use if s/he later has questions or concerns about the study. Some researchers distribute the final results of the study to participants at a later date; others invite interested participants to contact them to inquire about the results.

A debriefing can be completed in an interview or written format. The interview format is most appropriate for studies during which participants interact with researchers one-on-one and studies that include deception and/or present psychological or physical risk to the participant. A written debriefing form is most useful when the research is low-risk and when data collection is carried out in a group setting.

If your study includes deception, and you are concerned that participants will inform prospective participants about the nature of the deception, you can make a request to postpone debriefing participants about deception until the end of the data collection period. However, the problems associated with contamination of data must significantly outweigh the potential problems of delaying a full debriefing.

Expedited Review

To qualify for expedited review, a research project must fulfill the following criteria:

  1. The research project must pose minimal risk* to participants.

*Minimal risk: The probability and magnitude of harm or discomfort anticipated in the 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.

  1. Identification of the participants and/or their responses cannot place them at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

Expedited Review Process

  1. The principal investigator (and research advisor if applicable) will complete the standard Wartburg IRB Human Subjects Protocol form and choose “expedited” as type of review.
  2. The researchers will submit the form and accompanying materials (in the same electronic file) to irb@wartburg.edu
  3. The chairperson of the IRB will assign two members of the committee to review the protocol. The members will make one of the following determinations:
  • Approved
  • Request for additional information and/or revisions
  • Forward to full IRB committee for a full review

Click for more information regarding federal guidelines for expedited review.

 

Forms & Requests

Informed Consent

Please review the informed consent, debriefing, and expedited review information on this website before downloading these forms.

Debriefing

Please review the informed consent, debriefing, and expedited review information on this website before downloading these forms.

IRB Human Subjects Protocol Form

Complete the IRB Human Subjects Protocol Form. Send the completed form and any additional materials (e.g., advertising/recruiting materials, informed consent, questionnaire/interview questions, experimental materials, debriefing materials) in a single electronic file to irb@wartburg.edu. 

Requesting Exempt Status

The committee has adopted the federal standards for exempt research. Projects that are determined to be exempt from review still must be registered with Wartburg's IRB. You may review the appropriate categories for exemption in this section. If you believe that your research is exempt from review, complete the Exempt Status Request Form and email the electronic version of the form and any necessary additional information to IRB@wartburg.edu

Request to Approve Modifications

If you modify aspects of a protocol that the Wartburg IRB had approved previously (e.g., change an in-person study to an online study; add new questionnaires; modify recruitment procedures), you need to submit a request to approve modifications to the protocol. Complete the Request to Approve Modifications Form and send an electronic version of the form (along with any new or modified materials in the same electronic file) to IRB@wartburg.edu.

Adverse Events: Incident Report

Any incidents such as unanticipated problems, adverse events, or injuries to human subjects during the course of research must be reported to the IRB Chair within 7 calendar days by the primary investigator upon discovery of the incident. If the incident report concerns a student protocol, the faculty supervisor should submit the report. Download the Incident Report Form and email the form to IRB@wartburg.edu.

Unaffiliated Researchers

If you are not affiliated with Wartburg College, but you want to use Wartburg College resources to conduct your research and/or you want to collect data from Wartburg College students, faculty or staff members, you need to complete the following form and submit it via email to irb@wartburg.edu.