What is research?
“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.
What is the common rule?
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:
- RESPECT for persons’ autonomy, meaning the researcher gives adequate and comprehensive information about the research and any risks likely to occur, understandable to the participant, and allows them to voluntarily decide whether to participate.
- BENEFICENCE, meaning the research is designed to maximize benefits and minimize risks to subjects and society.
- JUSTICE, meaning that the research is fair to individual subjects and does not exploit or ignore one group to benefit another group.
Research produces benefits valued by society. Regulatory oversight seeks to ensure that any potential harm of the research is balanced by its potential benefits.
What is a human subject?
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.
Is my research considered exempt from full committee IRB review?
“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)).
- This includes research on regular and special education instructional strategies.
- It also includes research on the effectiveness of or the comparison among instructional techniques, classroom management methods, or curricula.
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)).
- Educational tests include cognitive, diagnostic, aptitude, and achievement tests.
- Subjects should not be identifiable or be able to be linked to direct or indirect identifiers from the study.
- Disclosure of the research cannot put the subjects at risk of civil or criminal liability.
- Disclosure of the research cannot be damaging to the subject’s financial standing, employability, or reputation.
- Note: This category of exemption is not applicable to research involving minors (45 CFR 46.401 b).
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)).
- Existing data includes documents, records, pathological specimens, or diagnostic specimens.
- The aforementioned examples must be either publicly available or recorded by the investigator in such a way that human subjects cannot be identified directly or through identifiers.
Category 5: Research and demonstration projects designed to study public benefit or service programs (section 101 (b) (5)).
- This research is conducted by or subject to the approval of department or agency heads and must be designed to study, evaluate, or examine:
(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)).
- Wholesome food without additives must be consumed OR
- If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, 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.
What does NOT qualify for exemption from full committee review?
Research that does not qualify for IRB exemption at SU if the research includes the following:
- Pregnant women
- In vitro fertilization
- Decisionally impaired
- The use of school records of identifiable students or interviewing instructors about specific students
- Survey or interview procedures with children (participants under the age of 18 years)
- Observation of public behavior when the investigator(s) participates in the activities being observed
- Data collected that includes protected health or medical information when there is a direct or indirect link that would identify the participant
- Sensitive aspects of the participant’s own behavior, such as illegal conduct, drug use, sexual behavior or use of alcohol
- FDA research except in emergency circumstances
- Research that requires review by the UCSD Embryonic Stem Cell Research Oversight (ESCRO) Committee
What is deception?
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)
Is my research considered expedited from full committee IRB review?
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:
- Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required.
- Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
Category 2: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
- From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week.
- From other adults and children considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
Category 3: Prospective collection of biological specimens for research purposes by noninvasive means. Examples:
- Hair and nail clippings in a nondisfiguring manner;
- deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
- permanent teeth if routine patient care indicates a need for extraction;
- excreta and external secretions (including sweat);
- uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue;
- placenta removed at delivery;
- amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
- supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques;
- mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
- sputum collected after saline mist nebulization.
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:
- Physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy;
- weighing or testing sensory acuity;
- magnetic resonance imaging;
- electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;
- moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
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.
What constitutes minimal risk?
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)
What sorts of harm can arise from social and behavioral science research?
Here are some typical examples:
Harms commensurate with daily life, requiring no special protection:
- Mere inconvenience when a survey or other research interaction is administered at an inconvenient time or place or simply takes a long time to administer.
Harms that have the potential for serious effects, which IRBs should examine:
- Emotional or psychological harm, for example when a research interaction causes upset, or worry about breach of confidentiality.
- Social harm due to stigma or other negative social outcomes of breach of confidentiality.
- Physical harm if revelations about others get back to those persons, particularly when researchers study domestic violence, gang activity, political activity in a conflict zone, or other phenomena concerning violence-prone individuals.
- Financial harm if revelations result in loss of employment or insurance coverage.
- Legal harm when illegal activities are disclosed.
- Moral harm when participation in research strengthens subjects' inclinations to behave unethically.
(From NSF website)
How does FERPA affect my research?
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
How does PPRA affect my research?
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:
- Requirements that apply to “protected information” surveys that are funded in whole or in part by the U.S. Department of Education.
- Requirements that apply to "protected information" surveys that are funded by sources other than the U.S. Department of Education and that are administered or distributed by education institutions that receive funds from the U.S. Department of Education (i.e. public elementary and secondary schools and some private schools).
PPRA lists eight categories of protected information for survey responses:
- political affiliations of student or student's parent;
- mental or psychological problems of student or student's family;
- sex behavior or attitudes;
- illegal, anti-social, self-incriminating or demeaning behavior;
- critical appraisals of others with whom students have close family relationships;
- legally recognized privileged or analogous relationships;
- religious practices, affiliations or beliefs of student or student's parent;
- income, other than as required by law to determine eligibility for participation in a program or for receiving financial assistance under such program.
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.
What is confidentiality?
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:
- The instruments for procuring data should be carefully constructed to ensure that only personal information that is essential to the study is acquired.
- Any information that reveals the identity of human subjects should be stored in files accessible only to the researcher and authorized personnel.
- 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.)
- 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.
- 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.
- 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.
What is informed consent?
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:
- Wherever possible, language must be put in terms of which a layperson can understand.
- 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.
- A description of any reasonable foreseeable risks to the subject.
- A description of any benefits to the subject or to others that may reasonably be expected from the research.
- A statement describing the extent if any, to which confidentiality of records identifying the subject will be maintained.
- 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.
- 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.
- 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.
Who are protected as "children"?
“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.
What is permission?
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)).
What is assent?
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).