Research at Salisbury University

Research Compliance

IRB/Committee on Human Research

Appendices A-D

• Appendix A: Definitions
• Appendix B: Classifications of Research Review
• Appendix C: Sample Disclosure Form
• Appendix D: Experimental Subject’s Bill of Rights
  

Appendix A

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.

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Appendix B

Classifications of Research Review

Code of Federal Regulations 45 CFR 12/13/01

1. Research Requiring Full Committee Review: The conditions listed on the cover sheet and application are not exclusive nor exhaustive but are offered as examples of the most common types of research at Salisbury University that require full committee approval. Additional criteria identified in the Code of Federal Regulations 45 Part 46 “Protection of Human Subjects” (effective 12/13/01) may require the CHR Chair to designate a particular protocol as needing full committee review.
    
2. Expedited Research: Additional research that qualifies as expedited is listed below.
    
   1. Collection of hair and nail clippings, in a non-disfiguring manner; deciduous teeth; and permanent teeth if patient care indicates a need for extraction.
   2. Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.
   3. Recording of data from subjects 18 years of age or older using non-invasive
      procedures routinely employed in clinical practice (including the use of physical
      sensors that are applied either to the surface of the body or at a distance and do no
      involve input of matter or significant amounts of energy into the subject or an invasion of the subject’s privacy; also including such procedures as weighing, testing sensory acuity, electrocardiography, electoencephalography, hermography, detection of naturally ocurring radioactivity, diagnostic echography, and electroretinography; but not including exposure to electromagnetic radiation outside the visible range [for example, x-rays and
      microwaves])
   4. Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often that two times per week, from subjects 18 years of age or older and who are in good health and not pregnant.
   5. Collection of both supra and subgingival dental plaque and calculus, provided the procedure is not more invasive than routing prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques.
   6. Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.

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3. Exempt Research: These six categories have been defined by federal regulation as exempt from full committee review.
    
   1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
      1. research on regular and special education instructional strategies, or
      2. 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:
      1. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects, and
      2. any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation. (Should the linkages be removed by authorized person other than the researcher, the protocol would still be considered exempt)
   3. Research involving the use of educational tests, surveys or interview procedures which is not exempt under Section 2, and in which respondents will be elected or appointed public officials or candidates for public office.
   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 subjects cannot be identified, directly or through identifiers linked to the subjects.
   5. Research and demonstration projects which are conducted by or subject to the approval of the department or agency heads, and which are designed to study evaluate, or otherwise examine:
      1. Public benefit or service programs;
      2. procedures for obtaining benefits or services under those programs;
      3. possible changes in or alternatives to those programs or procedures; or
      4. 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, if:
      1. (i) wholesome foods without additives are consumed, or
      2. (ii) a food is consumed that contains a food ingredient 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.

Appendix C

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 410-548-5395 or toll free 1-888-543-0148.

Appendix D

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.