Text Box: For IR Use Only
IR File No:  ___________
Date received: _________
Approval expires: ______
Rose-Hulman Institute of Technology

 

Application for Review of Research

Involving Human Participants

 

 

Federal regulations and Rose-Hulman Institute of Technology’s Human Research Protection Policy require that all research involving humans as subjects be reviewed and approved prior to the commencement of recruitment and data collection.  Any person (RHIT faculty member, student, staff member, or other person) wanting to engage in human subject research must receive written approval from the Institutional Reviewer (IR) or, if required, by the Institutional Review Board (IRB) before conducting the research. 

 

1.  Title of Project:

 

2.  Principal Investigator:  Name:                           

            ¨ Faculty  ¨ Student* ¨ Staff  ¨ Other—specify ________________

            *Students are required to have a faculty, staff, or professional sponsor.

    Campus Box No. or Mailing Address:

 

    Phone:                                Email:

 

3.  Co-Investigator(s) or Sponsor (student research must be sponsored by faculty or qualified staff):

     Include all additional investigators with contact information.

            ¨ Faculty  ¨ Student ¨ Staff  ¨ Other—specify ________________

    Campus Box No. or Mailing Address:

 

    Phone:                                Email:

 

4.  Project Description:  Provide a brief description using layperson’s terms of the proposed research, including purpose and research questions or hypothesis.  Describe briefly how information will be collected, recorded, stored, and disseminated and procedures for maintaining confidentiality. List any funding sources sought or attained.  Describe incentives, if any, being offered for participation in the study and any costs, if any, to the participants. 

5. Informed Consent: State below or attach your informed consent form/statement. 

 

6.  Indicate the categories of participants to be included in the study (check all that apply):

     ¨ Abortuses/Fetuses                                                                  ¨ Patients

     ¨ Decisionally Impaired                                                              ¨ Prisoners

     ¨ Decisionally Impaired (Institutionalized)                                ¨ Pregnant Women

     ¨ Minors (17 years of age or less, give age range:____       ¨ Students - Submit Form S, when using RHIT students

     ¨ Normal Volunteers

 

7.  Does this research involve information that may identify participants?  ¨ Yes ¨ No

 

8.  Describe the informed consent procedures to be followed, including circumstances under which consent will be sought and obtained, who will seek it, and the method for documenting consent.  Include a copy of your informed consent form.

 

9.  Risks: 

¨ The risks are minimal (i.e. 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).

¨ The risks are greater than minimal. 

 

10.  Some categories of research may be exempt from full IRB review, including those below. Check the categories that apply to your research project:

 

¨ 1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

 

¨ 2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless (i) information obtained is recorded in such a manner that human participants can be identified, directly or through identifiers linked to the participants; and (ii) any disclosure of human participants’ responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, or reputation.  Note: According to 45 CFR 46.401, if the participants are children, this exemption applies only to research involving educational tests or observations of public behavior when the investigator(s) does not participate in the activities being observed.

 

¨ 3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior that is not exempt under #2 (above) of this section if: (i) the human participants are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

 

¨ 4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that participants cannot be identified, directly or through identifiers linked to the participants.

 

¨ 5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

 

¨ 6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. 

 

 

11.  Estimated starting date:                                         Estimated completion date:

 

 

INVESTIGATOR ASSURANCE

 

I certify that the information provided for this project is correct and that no other procedures will be used in this protocol.  I agree to conduct this research as described.  I will request approval from the IR for changes to the study’s protocol and/or consent procedures and will not implement the changes until I receive approval for these changes.  I understand that changes may require approval of the IRB before proceeding.  I will comply with the RHIT’s Human Research Protection Policy for the conduct of ethical research.  I will report significant or adverse effects or noncompliance to the IR via phone or e-mail immediately, and then in writing within 5 days of occurrence.  I will be responsible for ensuring that the work of colleagues involved with this project complies with this protocol.  I will complete, on request by the IR, a Continuation Request or Completion of Research Activities forms. 

 

 

________________________________                                    ___________

Principal Investigator’s Signature                                          Date

 

 

________________________________                                    ___________

Submit all materials to the IR:  Robert Throne, Campus Mail #114

 
Faculty/Qualified Staff Sponsor                                                Date