FORMS & GUIDANCE

How to apply:

All applicants for IRB must apply via the InfoReady Review website.

Instructions for completing the web-based research ethics training offered by CITI

Faculty and students who submit IRB applications are required to complete a web-based research ethics training module. If you have already completed the ethics training offered by NIH or CITI, please email the completion certificate to IRB@ship.edu. If not, you will need to complete the CITI ethics training, as the NIH’s training module is no longer available. (When registering, select Social, Behavioral... in question number 3, rather than the Responsible Conduct of Research (RCR) Social, Behavioral... in question number 1.)

Here is the link : http://about.citiprogram.org/en/homepage/
Click on the REGISTER button.
Enter Shippensburg University in the Organization Affiliation window.
Click on the “I AGREE” button.
Complete your registration by creating a login and password, as instructed.
Select and complete the Social-Behavioral-Educational Researchers – Basic course, which is comprised of the following 14 modules:

Belmont Report and Its Principles
History and Ethical Principles - SBE
Defining Research with Human Subjects
The Federal Regulations
Assessing Risk
Informed Consent
Privacy and Confidentiality
Research with Prisoners
Research with Children
Research in Public Elementary and Secondary Schools
Unanticipated Problems and Reporting Requirements in Social and Behavioral Research
Populations in Research Requiring Additional considerations and/or Protections
Research and HIPAA Privacy Protections
Conflicts of Interest in Human Subjects Research

Caution: this training module is substantially longer than the previous one at NIH, and it takes most users in excess of two hours to complete it satisfactorily. When you complete it, download your certificate and then email it to me at IRB@ship.edu. Thank you.

Items to Include with Application

When you are ready to submit your human subjects research protocol via InfoReady, here is the information you will be asked to provide:

LIST OF INVESTIGATORS: If you are collaborating on the research, please include a list of all investigators on the project with contact information for each.
INFORMED CONSENT: Whether you are obtaining informed consent verbally or in writing, you must submit a copy of the form. This form must clearly explain ALL possible risks and will assure the subjects/participants that they are free to withdraw from the study/experiment/project at any time without penalty.

- Informed Consent for adult research subjects/participants will include: I acknowledge that I am at least eighteen years old, and that I understand my rights as a research participant as outlined in the consent form. I acknowledge that my participation is fully voluntary.
  - Informed Consent Template for ADULTS
- Written informed consent is required of parent or legal guardian of all subjects less than eighteen years of age, whether or not the minor child will be exposed to risk. If minor subjects/participants are in the fifth grade or higher, assent must be signed as well.
  - Informed Consent Template for PARENTS or LEGAL GUARDIANS authorizing a child's participation in a study
- INFORMED ASSENT for Minors 8-17 Years of Age.
  - Informed Assent Template for MINORS
  - Sample
INSTRUMENT(S): The instrument(s) is the questionnaire or items you are collecting from your research participants. The instrument(s) may be quantitative, qualitative, or a mix of both. It is important to note that applications cannot be reviewed without your instrument(s). Even if you are conducting qualitative research, you need to provide a list of the planned, open-ended questions.
AGENCY LETTER OF SUPPORT: If you are going through an outside source to obtain access to your sample, you will need to provide a letter from the agency, organization, etc. on their letterhead outlining that you are being given permission to conduct your research through them.
FACULTY LETTER OF SUPPORT (For all Undergraduate and Graduate Student Research): A supporting letter from the faculty advisor must be included if the application proposes research to be completed by a student researcher. If a faculty member assigns research projects to members of a class (e.g., research methods courses, research seminars) AND the faculty member submits all class applications in aggregate, one letter of faculty support and oversight will suffice for this purpose. The faculty advisor is expected to review the completed packet of materials before it is submitted to the Committee for review. It is recommended that faculty members submit the application packet on behalf of their student(s) as a way to be sure that they are certain on materials being submitted under their direction.
OTHER MATERIALS: Any additional items you feel will aid the Committee in making a decision. Often, this includes attaching the Methods section of the paper, grant application, etc.
NEW DIGITAL POLICIES: Please refer to the following document for more information - New Digital Policies

In addition, the Committee may require further information about the proposed research project; or it may request the investigator to attend a meeting to supply additional information or answer questions posed by the research. After the review is completed, the investigator will be notified of the Committee action in writing (i.e., e-mail). Formal acceptance letters are available upon request (e.g., for inclusion with grant proposals).