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Compliance

Human Subjects Institutional Review Board (HSIRB)

Undergraduates - Instructions and Application Materials

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In the application, you will need to complete the following components:

Project Description

• Purpose (why are you doing the study?)
• Research Procedure (exactly what participants will do as part of the study)
• Research Design (Will you have control vs. experimental subjects?)
• Location (where the study will take place, you may need site approval)
• Duration (When the study will occur)
• Data analysis

Benefits of Research

How will subjects benefit from participating in your research? (money, extra-credit?)
If subjects do not have any benefits, does society benefit. If not you should rethink your study.

Subject Selection

Describe in detail how you intend to go about contacting and recruiting participants.
You will have to attach all written advertisements, posters, and recruitments scripts.
Recruiting Subjects May Consist of:

• Flyers that are handed to Subjects
• Public Announcements
• News Stories

Risks To Subjects

Describe all possible risks (physical, social, and psychological) as a result of participating in your research.Risks include even mild discomforts or inconveniences, as well as potential for disclosure of sensitive information.Example, the amount of time it takes to fill out your study. There are always risks - Identifying risks

Protections for Subjects

Describe the measures to be taken to protect subjects from possible risks or discomforts - Keep your project low risk

Confidentiality of Data

Describe the precautions that will be taken to ensure the privacy of subjects and confidentiality of information.
Be explicit if data are sensitive.
Coding Procedures: Describe the coding procedures for subject identification numbers. (could click on coding to get more info)
Data Retention. Include the method, location, and duration of data retention. (NOTE: Federal regulations require data to be maintained for at least 3 years.)

Instrumentation

All Questionnaires, Interview Scripts, and data collection instruments must be identified and attached as appendices.
Coding Sheets for videotape or audio-tape and other data collection procedures are required.

Informed Consent Process

For all research, regardless of whether or not a signed consent document is required, describe the process by which informed consent will be obtained.

If the participant is a child or mentally retarded, explain how the parent(s)/guardian(s) will be contacted for consent and how the researcher will insure that the participant understands to what he/she is assenting.

A copy of all consent/assent documents, including non-English and Braille translations if applicable, must be provided.

Sample Consent Forms

Hints for Informed Consent - (This Process Is Always Required)

Informed Consent is a process by which research subjects learn about your project, it's potential risks and benefits, its procedures to protect their safety, well-being, and privacy. It may be given orally in some circumstances (a signed consent form is not always needed to verify the occurrence of consent.)

When Seeking Consent, You Will Need to Make Sure That:

• The subject has the legal and mental capacity to give consent.
• The subject has sufficient opportunity to consider participating.
• The possibility of coercion or undue influence is minimized.
• The language is understandable
• The subject is not asked to waive any legal rights.

Consent Document Should Be:

• Easy to Read.
• Bold type face when you have elderly or sight impaired people are subjects.
• 8th Grade Level of reading (or lower). If you are using children you should make sure that their assent is documented. If the child can read you may use easy to read forms.

Your Forms Should Be Inclusive

• If you have appendices these may be confusing for the subject
• Flow Charts or Diagrams may help to simplify the subjects understanding of a complicated study.

The Signed Informed Consent Process Can ONLY Be Altered When Research Meets the Following Criteria: [The formal lingo will be stated first with an explanation in plain English afterwards]

1. The research involves no more than minimal risk to subjects. (That means that if you have a project that places subjects at a significant amount of risk you may not waive the consent process.)
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects; (This basically means that the subjects will not be harmed [emotionally, physically, socially] as a result of your project.
3. The research could not practicably be carried out without the waiver; and (meaning that you actually could not do your research if you had to use a formal consent document. If your research would be easier if you did not use the document that instance doesn't count!)
4. Whenever appropriate, subjects will be provided with additional pertinent information after participating (or debriefing). If you do not inform your subjects beforehand, you definitely have to inform them after you are done with the study. This is normally called debriefing- where the experimenter either in writing, verbally, or both explains to the subject why they were not informed.

Consent Document Checklist

Questions? Contact Research Compliance at (269) 387-8293.