IRB — Submission Information

Here you will find submission instructions and a link to our Moodle site. You will first need to complete an Application and Request for Approval Form and e-mail it to the IRB chair at katieann.skogsberg@centre.edu to be given access to the Moodle site.

Once you have access you can submit at any time.

Link to submission site

Instructions for submitting an application to the IRB

If this is your first application for IRB approval, you will need to request access to the Centre College IRB Application Submission site (hosted by Moodle) as noted above.

Before you submit your application to the Moodle site, please have the following documents prepared and compiled into a single PDF document:

1. The Application and Request for Approval Form as a cover sheet.

2. A complete protocol, organized as outlined below.

3. Research instruments such as surveys, questionnaires, interview scripts, manipulation protocols, debriefing forms, etc.

4. Informed consent document or script.

5. Certificate(s) verifying that all researchers involved in the project have completed the National Institute of Health's (NIH) "Protecting Human Research Participants" training (available at: http://phrp.nihtraining.com/users/login.php).

6. An application may also include the following attachments as appropriate:
a. evidence of permission from cooperating institutions
    (if any).
b. relevant grant application(s).
c. non-disclosure or other agreements with owners of     restricted data sets.
d. investigator licenses, skills training certificates, etc.

7. For students, an email or signed letter from his/her faculty supervisor certifying that the supervisor has read and approved the research protocol.

All documents must be submitted in English.

All documents must be submitted electronically through the IRB submission website.

Your protocol must containing the following sections:

1. Abstract

The abstract should address the specific aims and hypotheses of the investigation, including a definition of the problem, the contribution the research is expected to make, and the importance of the hypothesis to be tested. This section should also state the relation of the proposed research to previous scientific investigations in the field, including relevant laboratory and animal studies. Clear justification for the participation of human subjects in the research must be given.

If specific hypotheses are not being tested, then the questions to be answered or the information the researcher hopes to gain should be discussed. If the researcher proposes a pilot or exploratory investigation, then the researcher should discuss ways in which the information obtained will be used in future studies.

2. Personnel

Identify all personnel who will participate in or assist in conducting this research. Identify each individual by name, title, and responsibility. Briefly outline each individual's qualifications. If specific skills are required to complete the research, investigators should include proof of licenses, accreditation, and/or background information that verifies the researcher is qualified to perform the procedures indicated.

3. Methodology

A detailed description of all procedures to be performed on human subjects for the purposes of research must be included. Proposals concerning observational or interview studies should indicate the type of contacts and interactions with subjects and the means of observation or interview to be used. If questionnaires or surveys are to be administered, a copy of the instrument should be included with the IRB application. Standard psychological tests should be listed by name and described. If applicable, sample items, questions or stimuli should be included.

Devices or activities that are not customarily encountered by subjects in their daily living or unusual applications of such devices or activities must be described in detail.

Any procedures involving unusual electrical devices, radioisotopes, or investigational new drugs must also be described. Approval from appropriate campus or federal agencies must be obtained before IRB approval can be granted.

The "when" and "where" of the research must be described. The researcher should provide an expected start and end date for the data collection as well as for the overall research project. A tentative time schedule for the various procedures—or flow-chart where appropriate—should be provided showing how long each aspect of the study will take, the frequency and timing of ancillary procedures, the nature and duration of human discomfort, and the precise location in which the study is to be conducted. Frequency, duration, and location of interviews or observations should be indicated in behavioral or social science studies.

In cases where information provided to subjects regarding procedures and purposes of the study would invalidate the objectives, the investigator should detail specific reasons for not informing subjects of the procedures.

4. Participants

The researcher should describe the population characteristics of the proposed human subjects, as well as verify access to that population. A detailed and specific discussion of potential problems involving the subject group must be given. Effects of small sample size and composition on the preservation of anonymity will be considered by the IRB.

Justification must be provided for the use of subject groups that are members of a population whose capability of providing informed consent is or may be absent or limited. Such populations include fetuses, children, prisoners, persons with diminished cognitive capacity, and those who are confined to institutions (whether by voluntary or involuntary commitment). A pregnant, or potentially pregnant, woman's ability to provide consent is limited to activities where: (1) the risk to the fetus is minimal, or (2) the purpose is to meet the health needs of the mother, and the fetus will be placed at risk only to the minimum extent necessary. (See 45 CFR 46 subparts B, C or D.)

5. Potential Risks

The researcher is required to discuss any possible risks to the human subject. Damaging effects may be physical, psychological, legal, economic, or social. Some research involves neither risks nor discomfort, but rather violations of expectations. Such violations, if any, should be specified.

The researcher is then required to address how the risks will be managed. Researchers must describe procedures for protecting against or minimizing potential risk, including confidentiality safeguards. In addition, the safeguards' likely effectiveness should be assessed. Risk management procedures are applicable to groups (such as the exclusion of pregnant or potentially pregnant women from a study involving a new drug) as well as individual subjects.

6. Confidentiality and Anonymity

The researcher must describe how the identity of participants and their confidential information will be protected, including but not limited to:
• The separation of informed consent documents from the data    (such as completed survey) and from the research results;
• The use of numerical or otherwise symbolic codes to index and    organize the data (as opposed to personal identifiers such as    initials or first names) to protect the anonymity of the participant.
• The protection of subjects' confidentiality in publications.
• The disposal of research materials and informed consent    documents.

Anonymity is desirable but not required. If participants' anonymity is not to be maintained, the researcher must describe specifically why participants will not remain anonymous.

7. Potential Benefits

The researcher must present a justification for the proposed study. The discussion should focus on the significance of the new knowledge that is being sought and an evaluation of the benefits to individuals and/or society with respect to the risks involved in the study.

8. Other

The IRB relies on the expertise of the researchers to provide insight about any peripheral benefits or potentially harmful effects of the research. Based on your past experience and knowledge, please identify any extraordinary moral, legal, or ethical concerns (either beneficial or harmful), that may be linked to this research.