Human Subjects Protection Program Appalachian State University Robert R. Johnson Graduate Studies and Research Appalachian State University From: Guidelines.

Human Subjects Protection ProgramAppalachian State University

Robert R. JohnsonGraduate Studies and Research

Appalachian State University

From: Guidelines for the Review of Research Involving Human Subjectshttp://www.graduate.appstate.edu/rsp/irb/index.shtml

If I asked you to participate in a study I was conducting, what types of things would you like to know?

Development of Protection of Human SubjectsDevelopment of Protection of Human Subjects

For much of its history, the norms for For much of its history, the norms for involving human participants in research involving human participants in research were thought best left to the individual were thought best left to the individual investigators. Slowly, and largely in investigators. Slowly, and largely in response to revelations of specific abuses of response to revelations of specific abuses of human subjects in research, consideration human subjects in research, consideration was given to what constituted ethical was given to what constituted ethical research and what type of oversight was research and what type of oversight was needed.needed.

EVENTSEVENTS

Nazi Atrocities of World War II1. Key task of the prosecutors was to distinguish

between Nazi experiments and U. S. wartime research, both of which used human subjects.

2. AMA developed code of research ethics (1946)3. Nuremberg Code – Judges presented 10 “basic

principles” for research using human subjects.

Brooklyn Jewish Chronic Disease Hospital1. This 1964 NIH funded study involved the injection of cancerous

cells into debilitated elderly patients.2. The investigators claimed to have informed consent, but many of

the patients were incapacitated or did not speak English and those able to give consent were not told that the cells to be injected were cancerous.

Events (cont.) Willowbrook State School for the Retarded

1. This study involved the injection of a mild strain of the hepatitis virus to children entering the hospital.

2. Although parental consent was obtained, the consent form may have been misleading, as desperate parents may have been unduly influenced by the availability of preferential and later exclusively research-related admissions to the institution.

Tuskegee Syphilis Study (circa 1932)

1. Although a formal protocol never existed, the study intended to trace the natural history of syphilis in the poor, black males living in Macon County, Alabama.

2. Participants were not told the purpose of the study. They were led to believe that they were being treated for syphilis.

3. Investigators continued the study even after penicillin became widely available for the treatment of syphilis.

4. In exchange for participation, the men received some unrelated health care, free meals and transportation, and later in the study, to encourage autopsy, a $50.00 burial stipend.

The Belmont ReportThe Belmont Report

On September 30, 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research submitted its report entitled, “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects in Research.” This report set forth the basic ethical principles underlying acceptable conduct of research involving human subjects.

Belmont ReportBelmont Report

RESPECT FOR PERSONS involves a recognition of the personal dignity and autonomy of individuals, and special protection of those persons with diminished autonomy.

This sets for the requirement for informed consent

-informationsubjects must be given sufficient information on which to decide whether or not to participate

-comprehensionsubjects must be able to comprehend the information that is given to them

-voluntarinesssubjects’ consent to participate must be free from coercion and undue influence

Belmont ReportBelmont Report

BENEFICENCE entails an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm.

This involves the concept of risk/benefit assessment.

-all possible harms, not just physical and mental must be considered

Belmont ReportBelmont ReportJustice requires that the benefits and burdens of research be distributed fairly.

This principle mandates that the selection of research subjects must be the result of fair selection procedures and must also result in fair selection outcomes.

-subjects should not be selected either because they are favored by the researcher or they are held in disdain

-care should be taken to avoid the injustice that arises from social, racial, sexual, and cultural biases institutionalized in society

-subjects should not be selected because they are readily available or they are easily manipulated because of such things as illness or economic condition

Appalachian State UniversityAppalachian State UniversityInstitutional Review Board (IRB) Statement of PurposeInstitutional Review Board (IRB) Statement of Purpose

The IRB is responsible for protecting the rights and welfare of human subjects participating in research projects. The IRB acts according to policies set forth the United States Department of Health and Human Services Public Health Service Act as amended (45 CFR 46).

Any research that involves human subjects, whether funded internally or from extramural sources, or not funded, that is undertaken by ASU faculty, staff, or students, supported by or conducted at ASU, must be reviewed and approved by the IRB prior to soliciting subjects or collecting any data from any human subjects.

DefinitionsDefinitions

Research refers to a systematic investigation, including research development, testing and evaluation, designed to contribute to generalizable knowledge.

Human subject refers to a living individual about whom a researcher obtains either identifiable private information, or data through intervention and/or interaction with the individual.

Student ResearchStudent Research

Research conducted by students, such as thesis research and some class projects, requires the approval of the IRB prior to execution.

Individual projects conducted primarily for instructional purposes within the context of a formal class, and not designed to contribute to generalizable knowledge, do not meet the definition of “research” as defined in the federal guidelines.

Review ProcessReview Process

Request for Review must be submitted to the IRB (c/o Graduate Studies and Research)

http://www.graduate.appstate.edu/rsp/irb/reqforrev/index.shtml

Review Process (cont.)Review Process (cont.)In order for any research protocol to be approved, the IRB must determine that all

of the following requirements are satisfied:

1. Risks to the subjects are minimized and are reasonable in relation to anticipated benefits of the research,

2. selection of the subjects is equitable given the purposes and setting of the research,

3. appropriate informed consent will be sought for each subject of the subject’s legally authorized representative, and such consent will be appropriately documented,

4. the research plan makes appropriate provision for monitoring the data collected to insure the safety of subjects,

5. Appropriate provisions are made to protect the privacy of subjects and to maintain the confidentiality of the data, and

6. where some or all of the subjects are likely to be vulnerable to coercion or undue influence, appropriate additional safeguards have been included to protect the rights and welfare of these subjects.

Categories of Review*Categories of Review*

*NOTE: Only the IRB Administrator is authorized to determine which protocols may be subject to limited review or may be exempt from review by the Board.

EXEMPT RESEARCH

EXPEDITED REVIEW

FULL BOARD REVIEW

Exempt Research - Exempt Research - examplesexamples Research conducted in established or commonly accepted

educational settings, involving normal educational practices, such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

NOTE: The Board interprets this provision to exempt from review those research protocols in which subjects will consist exclusively of students in a faculty member’s own classes. However, where the research requires using students in classes which are the usual responsibility of other faculty or staff members, the research protocol will require review and approval by the Board (unless the research is exempt under some other provision of law or University policy.

The Board makes this interpretation based on its belief that the phrase “normal educational practices” is intended to encompass only those situations in which a faculty member, or a student under a faculty member’s supervision who is also an instructor, conducts research in his or her own classroom.

Exempt Research (cont.)

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), surveys, interviews or observation of public behavior, unless: (i) information obtained is recorded in such a manner that participants can be identified, directly, or though identifiers linked to the subjects; and (ii) any disclosure of an individual’s response(s) outside of the research could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, or reputation.

Research involving the collection or analysis of existing data, documents, records, pathological specimens, or diagnostic specimens, if such sources are a matter of public record or if the information is recorded in such a manner that subjects cannot be identified, directly or though identifiers linked to the subjects.

Expedited Research* Expedited Research*

**NOTE: Research activities present no more than minimal risk, where minimal risk is defined as the probability and magnitude of harm(s) or discomfort(s) anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations.

*NOTE: The expedited review procedure may not be used where the identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, or reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

Expedited Research - Expedited Research - examplesexamples

Collection of data from voice, video, digital, or image recordings made for research purposes

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.

Expedited Research - Expedited Research - examplesexamples

Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:from healthy non-pregnant adults who weigh at least

110 pounds (there are limits to amount drawn).

from other adults and children, taking into consideration the age, weight, and health of the subjects (there are specifications on method of collection, amount, etc…..)

Full Board ReviewFull Board Review

All protocols that do not qualify as either “Exempt” or “Expedited”

Protected ClassesProtected Classes

Children Prisoners Fetuses Pregnant women Human in-vitro fertilization

ReviewReview

Complete the Request for Review

http://www.graduate.appstate.edu/rsp/irb/reqforrev/index.shtm

NOTE: Review may take up to one month.

NOTE: Approval may be up to one year. Certain protocols may be reviewed more often than yearly (e.g. high risk/benefit ratio).

Procedures to Initiate ReviewProcedures to Initiate Review Name(s) and department(s) of investigator(s) Title of study Signature of responsible faculty member Whether or not external funding is proposed Purpose of study Description of subjects Description of methodology, including a copy of instruments used Potential benefits and risks to the subjects Anticipated beneficial knowledge resulting from the study Qualifications of investigator(s) Description of any deception A copy of any recruiting materials or scripts Method for insuring informed consent, including a copy of the proposal

informed consent statement

Informed ConsentInformed ConsentA copy of the Informed Consent must be submitted with the Request for Review. The

following elements must be present in each Informed Consent Document.

1) the title of the study, information on the purpose(s) of the research, a description of the method(s) and procedure(s) to be followed, including, the intention to publish or disseminate the results of the study, and the amount of time the subject will spend in actual project participation.

2) a description of any reasonably foreseeable risks or discomforts to the subject, including expected total time participation. If disguised of deceptive procedures are to be used, a plan to debrief participants must be explained to the IRB.

3) a description of any benefits to the subject or to any others as a result of the information obtained from the research.

4) A disclosure of appropriate alternative procedures that may be advantageous to the subject when making an informed decision whether or not to participate in the research (this pertains primarily to medical research and drug trials).

5) a description of the measures taken to insure the confidentiality of data and the anonymity of individual subjects, if applicable, as well as any circumstances under which confidentiality CANNOT be guaranteed.

Informed Consent (cont.)Informed Consent (cont.)

6. The name and phone number of a contact person(s) who will be available to answer any questions the subject or his/her authorized representative may have regarding the research. This third party is the IRB Administrator.

7. a clear explanation that the research is voluntary and that no penalty or loss of benefits which the subject is otherwise entitled will occur should the subject either refuse to participate or decide to discontinue participation (at any time).

8. disclosure of costs to the subject, if any, because of his/her participation in the research: disclosure of compensation/reward to the subject, if any, for his/her participation in the research.

9. for projects of more that minimal risk to subjects, a statement must be included that describes how the costs of medical care or other therapies required as a result of injury of mishap while participating in the research will be handled.

10. the approval and expiration date for the Consent Form11. the Consent Form must not include a statement releasing the investigator,

sponsor, institution or its agents from liability or negligence.

Composition of IRBComposition of IRB

Scientist Non-scientist Ethicist Non-affiliated Associate Dean of Graduate School

NOTE: Each member is appointed by the Chancellor for fixed term.