Institutional Review Board

Dear Researcher,

We are pleased by your plan to conduct research at Coppin State University. The Institutional Review Board (IRB) and entire Coppin Family are committed to the development and perpetuation of research that is grounded in conventional and accepted standards and practices. As such we believe it is important to provide a user friendly method by which you can seek approval to conduct research using human subjects at Coppin State.

This letter and attachments will provide you with the information required by Coppin and the Federal Government (U.S. Department of Health and Human Services, DHHS/Office of Human Research Protections/OHRP) to insure that your research does not present a risk to human subjects. To insure that we comply with federal regulations, please provide all of the requested information.

The “Application to Use Human Subjects in Research” and appropriate forms, should be completed and returned to the IRB office at irb@coppin.edu. You will receive a response within 14 days for the date of receipt of the application packet. Should you have questions, please do not hesitate to contact us at irb@coppin.edu.

Sincerely,
IRB Chair

Application Format and Contents

The following information is included in the application. The headings are specified below and in the order presented below. Each item is to be identified and addressed separately, otherwise the application will not be reviewed.

1. Brief Description. A brief description (one paragraph) of the significance of this project in lay terms.
2. Methods and Procedures. Describe the methods and procedure to be used during the research project. Outline the sequence of events involving human subjects.
3. Benefits. Describe the benefits (if any) to the subjects involved in the research. (See Human Subjects Handbook).
4. Risk. Describe the risks (if any) to the subjects involved in the research. (See Human Subjects Handbook).
5. Study Participants. Describe the study participants, including number, characteristics, and method of participant selections. If a random sample is to be drawn, specify the specific random technique to be used. Justification is required if study participants is restricted to one gender or ethnic group.
6. Sample Size. A 10% sample frame is recommended for statistical analysis. In each independently drawn sample, the number of cases should not be lower than 30 cases. Justification is required is the study utilizes a smaller sample.
7. Informed Consent. A description of what the Principle Investigator will do to insure the study participants will be informed of all details of the study and consent to participate in the study.
8. Confidentiality and/or Anonymity. A description of how confidentiality and/or anonymity will be maintained.

Email your completed application, and any applicable attachments from the section below, to the IRB office at irb@coppin.edu. 

Important Attachments

Applications must include each of the following items, if appropriate to the proposed research:

• Informed Consent Document. The informed consent document must include the pertinent items from the Basic Elements of Informed Consent.
• Questionnaire, Survey, Testing Instruments. A copy of the questionnaire, survey, or testing instrument (if any) to be used in this project must be attached. There must be separate validation of instruments that are not established, not vetted, or not in the public domain.
• Institution Board Authorization Form
• Advertisements or Posters. A copy of any advertising that will be used to recruit subjects.
• Telephone Scripts or Other Recruitment Scripts. A copy of any telephone surveys or other recruitment scripts that will be used.
• Debriefing Materials. Any written or orally presented information indicating that study participants will have the opportunity to contact the Principal Investigator.
• Letters of Approval. Letters of approval from each cooperating school, hospital, organization, club or similar type of group. If subjects are obtained through this type of group or organization, a written letter of approval, from an individual authorized to approve such activities, is required. Projects that utilize Coppin’s data (I.e. student records, names, etc. Must have the authorization of the appropriate person authorized to release such data.