Definitions (Based on definitions in the Federal Regulations 45 CFR 12/13/01)
“Research”: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
We would not consider it to be research, when evaluation, using instruments designed to test on-going success of programs (e.g. alumni surveys) or employing routine classroom activities that involve informal surveying.
“Human Subject”: a living [human] individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or identifiable private information. “Intervention” includes both physical procedures by which data are gathered and manipulation of the subject or the subject’s environment that are performed for research purposes. “Interaction” includes communication or interpersonal contact between investigator and subject. “Private information” includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording take place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. N.B. Only research involving human subjects as defined above comes under the purview of the Committee on Human Research.
“Risk”: any harm or discomfort (physical, psychological, social or legal) that is anticipated in the research.
“Minimal Risk”: probability and magnitude of risks anticipated 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.
“Children”: persons who have not attained the legal age for consent to treatment or procedures involved in the research under the applicable laws of the Jurisdiction in which research will be conducted. The legal age in Maryland for consent is 18 years. For Children 10 and over their assent is required.
“Informed Consent”: a written document that human subjects, or their legally authorized representatives, both understand the nature and purposes of the research and freely give their consent to be participants in the study. (In certain specific cases, such as blind and double blind research protocols, some elements of disclosure may be waived or altered. Consult the committee for details.)
To meet this requirement, the investigator must provide the subjects with the opportunity to consider whether or not to participate and no coercion, explicit or implicit, must be used to obtain or maintain cooperation. Some of the basic elements for disclosure are as follows:(see sample form in this packet):
(1) Wherever possible, language must be put in terms of which a layperson can understand.
(2) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
(3) A description of any reasonable foreseeable risks to the subject.
(4) A description of any benefits to the subject or to others that may reasonably be expected from the research.
(5) A statement describing the extent if any, to which confidentiality of records identifying the subject will be maintained.
(6) For research involving more than minimal risk, an explanation as to whether any compensation or medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research related injury to the subject.
(8) A statement that participation is voluntary, refusal to participate will involve no penalty [such as lowered grade] or loss of benefic to which the subject is otherwise entitled.
“Confidentiality”: the requirement that any information about the subjects and obtained in interaction with the subjects in a research protocol be protected and safeguarded against disclosure that would be unwanted or presents possible embarrassment or harm to the subjects.
Some of the basic elements for maintaining confidentiality are as follows:
(1) The instruments for procuring data should be carefully constructed to ensure that only personal information that is essential to the study is acquired.
(2) Any information that reveals the identity of human subjects should be stored in files accessible only to the researcher and authorized personnel.
(3) Information about the identity of the subject should be changed into coded form as soon as possible. (Social Security numbers, even the last four digits are not adequate protection.)
(4) Publication of the data must carefully safeguard the identity of the subjects and care must be taken to protect the identity of institutions in the research protocol.
(5) Information that might link the subjects to the research must be disposed of in a timely fashion and in a way that safeguards the privacy of the subjects.
(6) Special care must be taken with information that asks subjects about sensitive or illegal activities (such information could be obtained by a government subpoena) and subjects need to know the limits of protecting their confidentiality.
Classifications of Research Review
Code of Federal Regulations 45 CFR 12/13/01
Sample Disclosure Form
I am currently conducting a study on (purpose of proposed research) .
I am seeking the assistance of (subjects) in completing a questionnaire concerned with (focus of questionnaire) .
The questionnaire is brief and should take about (length of time) of your time to complete. Every effort will be made to keep the information provided confidential. You name does not appear on the questionnaire.
Your cooperation and participation are strictly voluntary and your choice to participate or not to participate will in no way affect your grade. You may leave any particular questions unanswered or may choose not to complete the questionnaire. Your participation is very valuable and will help me (contribution of the proposed research) .
If you have any questions about this study or would be interested in the results, please contact (name, title, affiliation) , telephone .
Thank you for your cooperation.
If you have any adverse effects or concerns about the research, please contact the primary investigator or the Office of Graduate Studies and Research at Salisbury University at 410-548-3549 or toll free 1-888-543-0148.
Experimental Subject’s Bill of Rights
To be told what the study is trying to find out
To be told what will happen to you and whether any of the procedures, drugs, or devices is different from what would be used in standard practice
To be told about the frequent and/or important risks, side effects or discomforts of the things that will happen to you for research purposes
To be told if you can expect any benefit from participating and, if so, what the benefit might be
To be told the other choices you have and how they may be better or worse than being in the study
To be allowed to ask questions concerning the study, both before agreeing to be involved and during the course of the study
To be told what sort of medical treatment is available if any complications arise
To refuse to participate at all or to change your mind about participating after the study is started. This decision will not affect your right to receive the care you would receive if you were not in the study
To receive a copy of the consent form
To be free of pressure when considering whether you wish to agree to be in the study.