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Protocols and Procedures

Protocols and Procedures for Research Involving Human Subjects
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 which 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:

The rights and welfare of the subjects involved;
The appropriateness of methods used to secure informed consent;
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.
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 from 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:

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.

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 whom 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;
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. Statement of the purpose of the research
b. Description of the procedures to be applied to the minor;
c. Description of the potential risks and discomforts associated with the research;
d. Description of any benefits to the minor;
e. Statement that the minor does not have to participate if he/she does not want to;
f. Statement that the minor is free to withdraw at any time;
g. 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.