4/10/03rv
Concordia University
Saint Paul, MN
Protocols and Procedures
for Research
Involving Human Subject
Application and Information Packet
Under the terms of compliance with federal standards regarding human subject research,
all research involving human subjects will be reviewed for compliance prior to
application for funding or the initiation of the research project. Both faculty and student
projects are subject to compliance review if human subjects are involved. Completed
applications should be submitted to the chair of the Human Subjects Review Committee
for action. The Human Subject Reviews Committee will serve as a source of
information regarding human subject research and will make decisions regarding the
compliance of proposed research projects using human subjects.
The Human Subjects Review Committee will review research projects initiated by
faculty, staff, and students as well as review and approve the implementation of research
studies being conducted by individuals or groups external to the University community
which use members of the University community as subjects.
Definitions:
Human subject – a living individual about or from whom a faculty or student researcher
obtains: (1) data through intervention or interaction with the individual; or (2)
identifiable private information.
Research – a systematic investigation, including research development, testing and
evaluation, designed to develop or contribute to generalizable knowledge. Activities,
which meet this definition, constitute research for the purpose of this policy, whether or
not they are conducted or supported under a program that is considered research for other
purposes.
Procedures for Obtaining Approval for Projects Involving Human Subjects
Faculty and students planning to initiate research involving human subjects may discuss
the concept of the proposed project with members of the Human Subject Review
Committee in order to obtain advice and guidance in preparing the research proposal.
Questions concerning the review process or elements of the proposal can also be
discussed.
Any research proposal involving studies of human subjects will be reviewed according to
the following guidelines:
2
1. The rights and welfare of the subjects involved;
2. The appropriateness of methods used to secure informed consent;
3. The balance of risks and potential benefits of the investigation.
No research can be initiated prior to formal written approval from the Human
Subject Review Committee.
Notification of approval will be sent to the principal investigator. For student
researchers, the approval will be sent to the faculty advisor, who will then forward the
approval notice to the student or students implementing the research project. Included in
this packet are the guidelines and forms needed to prepare the procedure.
Research proposals must be received by the chair of the Human Subject Review
Committee a minimum of 30 days prior to the initiation of the research project.
Proposals for research projects eligible for either expedited review or exemption from
review can be reviewed by the chair of the Human Subject Review Committee or a
designated member of the Human Subject Review Committee. The minimum timeline
for consideration of exempted or expedited review is five working days prior to the
initiation of the research project.
Research Qualifying for Expedited Review –
Certain research projects may qualify for expedited review by the human subject review
committee. The guidelines for classifying this type of research are subject to ongoing
review and may change from time to time based on new information or changes in the
social context in which research is conducted. Research activities subject to expedited
review will involve no more than minimal risk to human subjects. This means the risk of
harm anticipated in the proposed research are no greater, considering both probability and
magnitude, than those ordinarily encountered in daily life or during the performance of
routine physical or psychological examinations or tests. Categories of such research that
typically meet these requirements include:
1. The recording of data from subjects 18 years of age or older using noninvasive
procedures routinely employed in clinical practice. This includes the use of physical
sensors that are applied either to the surface of the body or at a distance and do not
involve input of matter or significant amounts of energy into the subject or an
invasion of the subject s privacy.
2. Voice recordings made for research purposes such as investigations of speech defects.
3. Moderate exercise by healthy volunteers.
4. The study of existing data, documents, records, pathological specimens, or diagnostic
specimens.
3
5. Research on individual or group behavior or characteristics of individuals, such as
studies of perception, cognition, game theory or test development, where the
investigator does not manipulate subjects behavior and the research will not involve
stress to the subjects.
A project may receive expedited review if it falls into one or more of the categories listed
above and if implemented through standard methods and practices. Researchers who
believe their projects qualify for expedited review must complete the Human Subject
Protocol form and include a brief case statement which (1) describes the nature of the
project and (2) shows how the project qualifies for expedited review by meeting the
above guidelines. The proposal and case statement must then receive the approval of the
chair and one other member of the human subjects review committee. Approval
generally follows the discussion of the project between the principal investigator and the
two members of the human subject review committee.
After approval, the protocol form is signed and dated by the human subject review
committee chair and the project is reported at the next full meeting of the human subject
review committee.
Protocol forms are available form the chair of the human subjects review committee.
Research Projects Exempt from Review
Concordia University recognizes there are broad categories of research which do not use
living human subjects or which present little or no risk of harm to subjects. These
research projects will be exempt from review by the human subjects review committee.
The University has an interest in tracking these research projects and the faculty, staff, or
students who initiate such a research project must still complete a protocol form along
with a statement of rationale for the requested exemption and submit it to the chair of the
human subject review committee. If the chair concurs with the non-exempt request the
proposal will be recorded and the approved application returned to the researcher.
If the chair of the human subject review committee does not agree that the project should
receive an exempt classification, then the project will be submitted to another member of
the human subject review committee. If the second reader agrees with the researcher,
then the project is exempt. If the second reader also declines to give an exempt from
review classification , the proposal is turned back to the researcher with suggestions for
revision to the project which would allow for an exempt classification, or the researcher
may submit the project for review under another classification.
The following categories of research are exempt from formal review by the human
subjects review committee:
1. Research undertaken without the intention of involving living human subjects;
2. Research in which the only involvement of human subjects will be in one or more of
the following categories:
4
a. Research that will be conducted in established or commonly accepted
educational settings and that will involve normal educational practices, such
as (1) research on regular and special educational instructional strategies, or
(2) research on the effectiveness of or the comparison among instructional
techniques, curricula, or classroom management methods.
b. Research that will involve the use of educational tests (cognitive, diagnostic,
aptitude, achievement) when information to be taken from these sources will
be recorded in such a manner that subjects cannot be identified, either directly
or through identifiers linked to the subjects.
c. Research that will involve survey or interview procedures if (1) responses will
be recorded in such a manner that the human subjects cannot be identified,
either directly or through identifiers liked to the subjects, and (2) the subject
responses, if they became known outside the research, could not reasonably
place the subject at risk of criminal or civil liability or be damaging to the
subject s own behavior, such as illegal conduct, drug use, sexual behavior or
use of alcohol.
d. Research that will involve the observation (including observation by
participants) of public behavior, if (1) the observations will be recorded in
such a manner that the human subjects cannot be identified, either directly or
through identifiers linked to the subjects, and (2) the observations, as
recorded, if they became known outside the research, could not reasonably
place the subject at risk of criminal or civil liability or be damaging to the
subject’s financial standing or employability and (3) the research will not deal
with sensitive aspects of the subject’s own behavior such as illegal conduct,
drug use, sexual behavior or the use of alcohol.
e. Research that will involve the collection or study of existing data, documents,
artifacts, or records, if these sources are publicly available or if the
information will be recorded by the investigator in such a manner that subjects
cannot be identified, directly or through identifiers linked to the subjects.
The human subject review protocol form is available from the chair of the human
subjects review committee.
Protocol Guidelines and Format
Description of Study: Using the numbering format below, please provide the following
information:
1. Subjects: Describe the population and sample. Indicate efforts that will be made to
assure equitable selection. When vulnerable populations are involved, describe why
they are necessary. If subjects are to be paid, describe the circumstances.
2. Purpose, Methods, Procedures: Describe in detail:
a. the purpose,
b. the research methods, and
c. the procedures of the study.
5
3. Risks: Describe any potential risks to the subjects –physical, psychological, social or
legal—and assess the likelihood and seriousness of those risks. If the methods of
research create potential risks, describe other methods, if any, that were considered
and why they will not be used. Describe procedures – including confidentiality
standards for minimizing potential risks.
4. Benefits: Describe the anticipated benefits of the research to the individual subjects,
to the particular group or class from which the subject population is drawn, and/or to
society in general.
5. Risk/Benefit Ratio: Assess the relative weights of the study’s risks and benefits.
6. Costs to Subjects: If the investigation involves the possibility of added expense to the
subject or to a third party, such as an insurer – for example longer hospitalization,
extra laboratory tests, travel, times missed from work or school – indicate how this is
justified. Be sure this is mentioned in the consent form.
7. Informed Consent: Describe the method of obtaining informed consent, the person
(s) who will be responsible for obtaining it, and where the informed consent forms
will be stored. Be sure to include all elements of an informed consent. (See
guidelines included in the packet). When children are subjects for research “Assent”
from the child and “Permission” from a parent or legal guardian must be obtained.
8. Deception: If deception is used in the study design, explain why it is necessary and
how subjects will be debriefed.
9. Privacy: Describe how the research design protects subject rights to decide when,
where, to whom and to what extent their attitudes, beliefs, and behaviors will be
revealed.
Basic Elements of Informed Consent
The following information must be communicated in writing to all research subjects.
Additional consent may be required when children are involved in the research. When
subjects are from populations for who English is a second language it may also be
necessary to prepare consent forms in the first language of these parties.
The following are the minimum required elements of informed consent. Additional
information may be included at the discretion of the investigator:
1. Statement identifying yourself and your affiliation with Concordia University;
2. Invitation to participate in the study as part of a research project:
3. Explanation of the purpose of the research, the expected length of time of the
subject’s involvement, a description f the procedures to be followed, and the
identification of activities which are experimental in nature;
6
4. Description of any benefits to the subject or others which may reasonably be expected
from the research;
5. Description of compensation for participation (money, extra course credits, etc.);
6. Statement describing the subject’s anonymity and of the extent to which
confidentiality identifying the subject will be maintained;
7. Names, addresses, and phone numbers of the people to contact for answers to
questions about the research, and the office to contact for questions about the rights of
research subjects (chair, Human Subjects Review Committee, 641-8277);
8. Assurance that participation is voluntary and that the subject may withdraw from the
process at any time;
9. Child Assent Form [if the subject is 7 -18 years of age, both a child assent form and a
consent form is required. The child assent form must be brief and contain language
appropriate to age level. Only the following elements must be present on the child
assent form. This form must also be signed by a parent or guardian.]
a.
b.
c.
d.
e.
f.
g.
Statement of the purpose of the research
Description of the procedures to be applied to the minor;
Description of the potential risks and discomforts associated with the research;
Description of any benefits to the minor;
Statement that the minor does not have to participate if he/she does not want to;
Statement that the minor is free to withdraw at any time;
Statement that the minor should discuss whether or not to participate with his/her
parent or guardian prior to signing the assent form;
h. Statement that the parent or guardian of the minor will be asked to consent on behalf
of the minor;
i. Offer to answer all questions;
j. Simplified concluding assent statement.
7
Use this form to discuss the content requested from question 10 on the application
Evaluation
Criteria
Describe subjects
(age, gender,
numbers, etc.)
Purpose of
Research
Procedures
(attach surveys or
other
instrumentation)
Risks to the
subjects; Benefits
to the subjects
Analyze riskbenefit ratio
Costs to the
subjects
(time, travel,
finances, etc.)
Method of
obtaining
informed consent
Will deception be
used? Why?
Privacy
(how will you
ensure
confidentiality)
Answer Questions Here
8
Concordia University
Saint Paul, MN
Protocol Form
Research Involving Human Subjects
Reviewed Classification Requested:
_____ Exempt
____ Expedited
_____ Full Review
1.
Project Title:
2.
Principal Investigator: Name
______________________________________________________
first
middle
last
Phone # ___________________ College/Department
______________________________
Investigator’s Address
________________________________________________________
________________________________________________________
3.
Please list co-investigators:
________________________________________________________
4.
Duration of the Study: ___________ to ______________
start
conclusion
[Protocol must be renewed annually]
5.
Type of Submission: _____ New ______ Renewal* ____ Modification
*Renewal refers to projects which are ongoing i.e. class related project which are conducted each semester or annually.
The principal investigator must inform the Human Subjects Review Committee regarding the projects being implemented on an
annual basis.
6.
Will this research be conducted at a location other than CSP?
____ No
____
Yes: If yes, attach approval documentation if
appropriate.
Identify location of the study:
____________________________________________________________
Subjects (please estimate numbers):
____ patients as experimental subjects
____ patients as controls
____ minors (under 18) not English
____ CSP students/faculty/staff
____ pregnant women, unborn children
____ mentally disabled respondents
7.
____ prisoners
____ normal adult volunteers
____ persons whose 1st language is
____ physically challenged
____ other __________________
9
Procedures: [Attach relevant materials such as questionnaires, interview schedules,
written instruments, etc.]
____ survey questionnaire
____ investigational device
____ interview, phone - in person
____ placebo
____ medical or other personal records
____ payment of subjects
____ filming, taping, recording
____ observation
____ participant observation
____ anthropological fieldwork
____ psychological intervention
____ incomplete disclosure of purpose
____ blood, tissue, secretia samples
____ other
___________________________
8.
9.
Check one:
____ faculty/staff research
____ fellow/post-doctoral research
____ student research (undergraduate)
____ student research (graduate)
If the principal investigator is a student, please complete the following:
Advisor’s Name ________________________________
please print
Address ______________________________________
_______________________________________
Telephone ____________________________________
Advisor’s Signature ____________________________
10.
In lay terms please describe your research. Include your research questions and
methods to be used. Describe the purpose of the research and a description of the
tasks subjects will be asked to complete (i.e. what will the subject need to do).
______________________________________
Principal Investigator’s Signature
Date
____________
10
To be completed by Human Subjects Review Committee: One copy to the principal
investigator, one copy to files of Human Subjects Review Committee.
Classification: ____ Exempt ____ Expedited
Declined _____
____ Full Review
Reasons:
Approved with modifications: _____ [See attached]
Approved _____
_______________________________________
__________
signature, chair human subjects review committee
date
________________________________________________
signature, second reviewer - expedited review only
____________
date
Copies to: principal investigator
humans subjects review committee file