- IMPORTANT: On January 19, 2018, new federal regulations regarding human subjects research went into effect; thus, our review process and related documents have changed to adhere to these new regulations.
- All submissions going forward will need to use these new documents and procedures, which are now available on this site. Submissions that use old documents will not be reviewed.
Summary of changes to HSRB Policies and Procedures:
As of January 19, 2018, amendments to the Common Rule, known
as the Final Rule, will be adopted by the Hendrix College Human Subjects Review
Board. These changes include:
- the addition of a “concise summary” on informed consent
forms (see the Appendix to the Policies and Procedures document);
- the expansion of categories of research that qualify as
exempt from HSRB review and require only minimal HSRB monitoring;
- the reduction of oversight of research that spans
multiple institutions to a single review board; and
- changes to post-approval monitoring of research
Thus, if you have conducted research under our previous
Policies and Procedures, we encourage you to direct your attention to the
sections of this document that address the above issues.
At this time, Hendrix College is not implementing
procedural changes related to Broad Consent, as detailed in the Final Rule.
Full information about the Final Rule can be found here: https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf
Hendrix College is committed to the ethical treatment of
all human participants in research conducted by its faculty, staff, and
students. The Hendrix College Human Subjects Review Board (HSRB) is
responsible for reviewing all research done under the auspices of the college
and to ensure that, in each project, human participants are treated in a just
and ethical manner.
Human Subjects Research
For research that does not qualify for exempt status (see HSRB Policies and Procedures and "Is my research exempt from review?"), there are two reasons why you would need HSRB approval prior to data collection:
The research conducted with human participants
involves more physical, mental, psychological, or social risk than people
would experience on a daily basis. It doesn't matter the type of
research – it could be based on interview, survey, or experimental
methodologies. If the research asks about sexual or health history, or
inquires about any other socially-sensitive information, it must come through
the Board. More detailed explanations of this kind risk can be found in the
Hendrix HSRB Policies and Procedures below.
The research conducted with human participants
will be published or presented off campus. Please note that
undergraduate research conferences have an exemption, unless they involve the
level of risk described in #1.
Submitting HSRB Proposals
If you have research that you want to be reviewed, you will
need to submit two versions of your proposal: a) one complete electronic copy,
including all Appendices and materials, via email (submitted to HSRB@hendrix.edu) and
b) one paper copy with original signatures to the mailbox of the HSRB Co-Chair, Dr. Lindsay Kennedy (DWR 140). Researchers must submit the most recent
and updated forms for HSRB proposals that are now available below. And, review cannot begin until we have both the electronic and
paper copies of your proposal.
IMPORTANT: Please note that the forms included on this website are editable PDF documents. You must download these forms before filling them out, in order to save your work; if you complete these forms in a web browser, your work will not save! To ensure maximum compatibility, it is recommended that you use the most recent version of Adobe Acrobat Reader (http://get.adobe.com/reader/) to complete these forms. Additionally, you may receive an error message when attempting to print one of these documents; however all documents should still print and save just fine. If you experience any other technical difficulties while completing these forms, please contact Dr. Lindsay Kennedy, Co-Chair of the HSRB, directly at firstname.lastname@example.org.
The HSRB requires that any student submitting an HSRB has completed online research ethics training through the National Institutes of Health Protecting Human Research Participants course. It is strongly recommended that you submit a copy of your online research ethics training completion certificates with any funding request for an Odyssey Undergraduate Research (UR) if your project will be likely to come through the HSRB for review.
NOTE: The NIH training course replaces CITI training. If you previously completed CITI training through Hendrix College, you DO NOT have to complete the NIH course. Instead, please indicate your prior completion on your HSRB application and the chairs will confirm your completion in our CITI database.
Procedures for Participant Compensation
If you will be compensating research participants (e.g., cash, gift card/certificate), you must review and abide by the new College guidelines for doing so in order for your proposal to be HSRB-approved.
The HSRB will only review proposals turned in during
Weeks 1-13 of each semester. So, if you intend to do research over a
winter or summer break, be proactive about submitting research proposals early.
It typically takes 5-10 business
days for an initial review to be conducted, at which point changes or
additional information may be requested and a re-review may need to be
conducted. It is therefore imperative that you request review in plenty
of time to go through this process before the start date of your research. Researchers
can also email and request a summer review (please note that there
is no winter break review), but there would need to be a compelling
reason that is directly related to the research (i.e., part of a summer
research experience involves faculty and students writing an HSRB proposal).
For summer review to be considered, this request must be made during week
1-13 of the semester prior to the research and there is no guarantee that
summer review will be granted.
At-risk (full board) research projects may not continue
past their approval expiration date (one year after approval). The date on
which your project's HSRB approval expires can be found on the HSRB approval
memo. If you are unsure of your project's approval expiration date, please
e-mail HSRB@hendrix.edu. If you wish to continue your research project (ongoing data collection) beyond its original approval expiration date, submit
the HSRB Continuing
Review form within 30 days of the project's
expiration date. Projects may be renewed twice over the course of the
project, resulting in three years total project time. If modifications will be
made to the study design or procedures, please submit an updated application
with modifications highlighted. If there are no changes to the research as
described in the original HSRB Application after a year, resubmit the most
recent version of your HSRB Application.
As of January 19, 2018, minimal risk (expedited review) projects no longer expire and, thus, do not require continuing review by the HSRB. At-risk projects that are at the data analysis only stage are also now exempt from continuing review procedures.
If there are substantive changes to a research proposal,
researchers will need to complete and submit the HSRB
Modification form to request approval for these
changes, with changes highlighted in all supporting documents (e.g.,
questionnaires, etc.). These changes may be implemented as soon as they are
approved by the HSRB.
At the completion of the project, researchers are
expected to submit the HSRB Final Report form. This report communicates to us
that your research has concluded properly. Research for which a Final Report
has not been received may be considered non-compliant.
Odyssey Projects and HSRB
If you are submitting an Odyssey project for
funding that involves research conducted with human participants, you will need
to get a consultation form that you take to a member of the HSRB (available members are listed on the
handout) and that you will
submit with your Odyssey application. These consultation forms
are available in the Odyssey office. These consultations can only be done
in person and will typically need to be scheduled in advance. Please be
aware that there is no guarantee of committee members being available the day
of the deadline, so you will want to be proactive about scheduling these