“Research” is 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.
Eighteen federal agencies have established the same regulations regarding the protection of human subjects known as the “Common Rule.” The Code of Federal Regulations (CFR) is a printed compilation of each agency’s regulations. “The Common Rule” is subpart A of the Department of Health and Human Services (DHHS) regulations of human research 45 CFR 46. It is designed as a general protection of human subjects in research.
The policy is designed to ensure minimal standards for the ethical treatment of research subjects and to limit harms to participants in research. That means that no one should suffer harm just because they became involved as subjects or respondents in a research project. Institutions engaged in research should foster a culture of ethical research.
ETHICAL RESEARCH rests on three principles:
Research produces benefits valued by society. Regulatory oversight seeks to ensure that any potential harm of the research is balanced by its potential benefits.
A “human subject” is 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.
“The Common Rule” identifies six categories that are exempt from full committee review. Exempt research must still be submitted to the IRB for approval and read by at least one IRB member to confirm exemption status. An exempt study can continue indefinitely without further IRB review. However, if you revise your research procedures, participant population, etc., after beginning an exempt study, you must submit an amendment to the IRB so we can determine whether your study continues to qualify for an exemption.
Category 1: Research in educational settings involving educational practices (section 101 (b) (1)).
Category 2: Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior UNLESS subjects can be identified or disclosure of responses involves more than minimal risk (section 101 (b) (2)).
Category 3: Research involving educational tests (cognitive, diagnostic, aptitude, achievement), surveys, interviews, or observations of public behavior not exempt under preceding exemption (Category 2) if human subjects are elected public officials, and if federal statutes require confidentiality of identifiable information (section 101 (b) (3)).
Category 4: Research involving the collection or study of existing data if publicly available or unidentifiable (section 101 (b) (4)).
Category 5: Research and demonstration projects designed to study public benefit or service programs (section 101 (b) (5)).
i. Public benefit or service programs; procedures for obtaining
benefits or services under those programs;
(iii) possible changes in or alternatives to those programs or procedures;
(iv) possible changes in methods or levels of payment for benefits or services under those programs.
Category 6: Taste and food quality evaluation and consumer acceptance studies (section 101 (b) (6)).
Research that does not qualify for IRB exemption at SU if the research includes the following:
Deception in research involves lying to or intentionally misleading subjects. Withholding information may or may not be deception. For example, telling subjects that an urn contains an unspecified number of red and blue balls, and inviting them to participate in an experiment by guessing the number, would not involve deception because the subjects "know what they don't know". Concealing the fact that there is a hidden camera would be deceptive. The distinction is whether subjects have the information to make an informed choice about whether to participate in the research. Secretly filming their behavior denies them the opportunity to consider whether or not they want to be filmed for research. Not telling them how many balls are in the urn is part of the accepted framework for a participant to guess the number.
It may be important in some research to withhold the specific theoretical purpose of the research from subjects, in order not to bias their opinions. If done in a neutral way, it would not be deceptive. If subjects are intentionally led to believe that the research is for a purpose different than the actual purpose, this would be deceptive.
Deception potentially poses ethical problems and should be dealt with by weighing the benefits of the research against the harm (if any) from the deception. Aside from any potential harm to participants, deception can also harm the institution by building the perception among potential subjects that "researchers are liars." The IRB should follow the regulations in § 690.116.d.
(From NSF website)
Expedited review means that someone from the IRB, not simply the researcher, must read the protocol and determine that the project is indeed minimal risk, or a minor change to a previously approved protocol, and meets the criteria for expedited review (45 CFR 46.110). The following nine categories are generally considered expedited:
Category 1: Clinical studies of drugs and medical devices only when:
Category 2: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
Category 3: Prospective collection of biological specimens for research purposes by noninvasive means. Examples:
Category 4: Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. Examples:
Category 5: Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). Note: some research in this category may be considered exempt.
Category 6: Collection of data from voice, video, digital, or image recordings made for research purposes,
Category 7: Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. Note: Some research in this category may be considered exempt .
Category 8: Continuing review of research previously approved by the convened IRB as follows:
i. the research is permanently closed to the enrollment of new subjects;
ii. all subjects have completed all research-related interventions; and
iii. the research remains active only for long-term follow-up of subjects; or
b. Where no subjects have been enrolled and no additional risks have been identified; or
c. Where the remaining research activities are limited to data analysis.
Category 9: Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
The Common rule defines minimal risk as: "the probability and magnitude of harm or discomfort anticipated in the research 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." (section 690.102 (i))
"More than minimal risk" means that the degree of physical or psychological discomfort is above that which is ordinarily encountered in daily living or during the performance of routine physical or psychological examinations or tests. This could include disclosure of confidential information to individuals who could use that information to harm a subject in some way.
Researchers who gather such information are obligated to take all reasonable measures to provide a secure environment for data and to assure that it does not come into the wrong hands and that disclosure will not be potentially damaging.
Confidentiality should be guaranteed, unless the respondent explicitly agrees to disclosure. The release of any information that can be linked to an individual, potentially damaging or not, should be agreed upon.
"Delayed harm": It is conceivable that as a result of participating in a social science study a subject may experience some longer term psychological reaction, such as depression. It is also conceivable that material covered in the course of an interview may lead subjects to difficulties, potentially over a long period of time. Researchers might be asked to indicate what the probability of such harm is and what might be done to ameliorate it should it occur.
(From NSF website)
Here are some typical examples:
Harms commensurate with daily life, requiring no special protection:
Harms that have the potential for serious effects, which IRBs should examine:
(From NSF website)
FERPA: If you plan to obtain information from student education records as part of your research, be aware that the Federal Education Rights and Privacy Act (FERPA) sets forth consent requirements (and exceptions) for accessing information in student education records. As a general rule, schools must have written permission from the parent or eligible student to release information from a student’s education record. Follow this link for more information on FERPA: http://www2.ed.gov/policy/gen/guid/fpco/ferpa/index.html
PPRA: The Protection of Pupil Rights Amendment (PPRA) is a federal law that affords certain rights to parents of minor students with regard to surveys that ask questions of a personal nature. It applies to any “local educational agency” that receives funding from the U.S. Department of Education. It also applies to research funded by the U.S. Department of Education. There are two sets of requirements for surveys:
PPRA lists eight categories of protected information for survey responses:
Essentially, if the research involves “protected information” surveys, is funded wholly in part by the U.S. Department of Education, or are required, PPRA affords parents the right to provide active consent. If surveys include “protected information” and are being administered by schools that receive U.S. Department of Education funds, PPRA affords parents the right to inspect the surveys before they are administered and to opt the student out of the surveys.
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:
Informed consent is 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:
“Children” are 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.
If your study will include children as participants, the IRB must determine that parental/guardian permission and assent of children (if capable) are obtained.
Permission means that the agreement of parent(s) or guardian to the participation of their child or ward in research (45 CFR 46.402 (c)). If the research is not greater than minimal risk, one parent signature will suffice (45 CFR 46.404 or 45 CFR 46.405). If the research is greater than minimal risk (45 CFR 46.406 or 45 CFR 46.407), the IRB may require permission from both parents unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for care and custody of the child. The IRB may waive the requirements for obtaining parental guardian permission if the IRB makes and documents the findings under either 45 CFR 46.116(c) or (d); OR the IRB determines that a research protocol is designed to study conditions in children or a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects AND the following two additional criteria are met: (1) an appropriate mechanism is in place to protect the children; and (2) the waiver is not inconsistent with federal, state, or local law (45 CFR 46.408(c)).
Assent means that a child gives affirmative agreement to participate in research and is not simply a failure to object (45 CFR 46.402 (b)). The process of asking a child to participate in the research must be implemented using age-appropriate language and methods for any child that is capable of understanding and providing assent (generally the child is 7 years or older). A simple verbal explanation of what will happen and the opportunity for questions and discussion should be given for children 7-12 years old. If the child is between 13 and 17 years old, he or she should be fully informed about the study and give signed assent to their own participation. The IRB can waive assent if the capability of some or all children in the research is so limited that they cannot reasonably be consulted (generally children under the age of 7).
If a child reaches the age of consent (18 years old) during the research study, informed consent should be obtained from the now-adult subject unless waived by the IRB under 45 CFR 46.116(d).