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
________________
*
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.
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
¨ 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