Marshall University 
Huntington, WV

 

SUBJECT:  Behavioral and Social Sciences Research

 

PURPOSE:  To define and explain Behavioral and Social Science research.

 

POLICY:  To ensure that the appropriate type of review is conducted within the constraints of the federal regulations and the facility’s policies and procedures.

 

SCOPE:  This policy covers Behavioral and Social Sciences research conducted under the auspices of IRB#2.  Behavioral and Social Sciences research involves surveys, observational studies, personal interviews, or experimental designs involving exposure to some type of stimulus or intervention. 

 

RESPONSIBILITY:

The IRB Chairperson is responsible for ensuring that the appropriate type of review is conducted within all federal regulations and organization’s policies and procedures.

 

The IRB Members are responsible for ensuring the reviews are conducted appropriately, ethically, and within the constraints of the federal regulations and organizational policies.

 

The Principal Investigator (PI) is responsible for ensuring that every research subject’s rights, welfare, and safety are protected.  He/she is responsible for the protocol design, which must minimize risks to subjects while maximizing benefits.  The PI must ensure that all members of the research team always comply with the findings, determinations, and requirements of the IRB.  He/she must also ensure the adequacy of the informed consent process, regardless of which members of the research team are authorized to actually obtain and document consent.

 

The IRB Coordinator is responsible for maintaining the documentation of the activities of the IRB and reporting the information at the next IRB meeting.

 

 CONCERNS OF BEHAVIORAL AND SOCIAL RESEARCH

 

A.  Social and Psychological Harms  

The IRB carefully examines the research to determine the probability of risk or harm to subjects.  These considerations apply to medical/biological research as well as social and behavioral research.

 

(1)   The IRB considers the potential for participants to experience stress, anxiety, guilt, or trauma that can result in genuine psychological harm.

 

(2)   The IRB considers the risks of criminal or civil liability or other risks that can result in serious social harms, such as damage to financial standing, employability, insurability, or reputation; stigmatization; and damage to social or family relationships.

 

(3)   If information is being collected on living individuals other than the primary “target” subjects the IRB considers the risk of harm to those “non-target” individuals, as well.

 

The IRB reviews the proposal for appropriate preventive protections and debriefings, adequate disclosure of risks in the informed consent information, and mechanisms to protect the confidentiality and privacy of persons participating in or affected by the research. 

 

B.  Privacy and Confidentiality Concerns 

The use of confidential information is an essential element of social and behavioral research.  These considerations apply to medical/biological research as well as social and behavioral research.

 

(1)   The IRB ensures that the methods used to identify potential research subjects or to gather information about subjects do not invade the privacy of the individuals.  In general, identifiable information may not be obtained from private (non-public) records without the approval of the IRB and the informed consent of the subject.  This is the case even for activities intended to identify potential subjects who will later be approached to participate in research. 

 

(2)   The IRB ensures that adequate measures are taken to protect individually identifiable private information once it has been collected to prevent a breach of confidentiality that could lead to a loss of privacy and potentially harm subjects.

 

 C.  Safeguarding Confidentiality

When information linked to individuals will be recorded as part of the research design, the IRB ensures that adequate precautions will be taken to safeguard the confidentiality of the information. The more sensitive the data being collected, the more important it is for the researcher and the IRB to be familiar with techniques for protecting confidentiality.  These considerations apply to medical/biological research as well as social and behavioral research.

 

(1)   If the IRB reviews research in which the confidentiality of data is a serious issue, the IRB will have at least one member (or consultant) familiar with the strengths and weaknesses of the different mechanisms available. 

 

(2)   For survey and interview research, the IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: 

   

(3)   Coding of records, statistical techniques, and physical or computerized methods for maintaining the security of stored data are among the available methods for ensuring confidentiality.

 

(4)   A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.

 

(5)   Federal officials have the right to inspect and copy research records, including consent forms and individual medical records, to ensure compliance with the rules and standards of their programs.  Although likely not applicable for this type of research, the FDA requires that information regarding this authority be included on the consent information for all research that it regulates. The provisions of the Privacy Act of 1974 protect identifiable information obtained by Federal officials during such inspections.

 

(6)   The IRB may require that an investigator obtain a Department of Health and Human Services (DHHS) Certificate of Confidentiality (CoC).  The CoC protects against the involuntary release of sensitive information about individual subjects for use in Federal, state, or local civil, criminal, administrative, legislative, or other legal proceedings. 

 

 

PROCEDURE:

 

1.  Exempt Review 

To obtain exempt status the research activity must meet one of the below listed categories. 

             

(1)  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.

       (The research cannot involve prisoners as participants.  The research cannot be FDA-regulated)

 

(2)  Research involving the use of educational tests (e.g., cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

(a)  information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and

(b)  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.

            - If any disclosure of the human participants' responses outside the research could reasonably place the participants at risk of loss of

              insurability, information obtained is recorded in such a manner that human participants can be identified, directly or through

              identifiers linked to the participants

      (If the research involves children as participants, it cannot involve survey or interview procedures.  If the research involves children as participants and observation of public behavior, the investigators may not participate in the activities being observed.  The research cannot involve prisoners as participants.  The research cannot be FDA-regulated.)

 

(3)  Research involving the use of educational tests (e.g., cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2)(b) above if:

(a)  The human subjects are elected or appointed public officials or candidates for public office; or

(b)  federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

                (The research cannot involve prisoners as participants.  The research cannot be FDA-regulated)

 

(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.

      (The data being gathered must exist at the time the research is proposed.  The research cannot involve prisoners as participants.  The research cannot be FDA-regulated)

 

(5)  Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:

(a)  public benefit or service programs;

(b)  procedures for obtaining benefits or services under those programs;

(c)  possible changes in or alternatives to those programs or procedures; or

(d)  possible changes in methods or levels of payment for benefits or services under those programs.

       (The research must be conducted pursuant to specific federal statutory authority.  The research must have no statutory requirements for IRB review.  The research must not involve significant physical invasions or intrusions upon the privacy interests of participant.  The research must have authorization or concurrence by the funding agency.  The research cannot involve prisoners as participants.  The research cannot be FDA-regulated)

 

(6)   Taste and food quality evaluation and consumer acceptance studies,

(a)  if wholesome foods without additives are consumed; or

(b)  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 (FDA) or approved by the Environmental Protection Agency (EPA) or the Food Safety and Inspection Service of the U.S. Department of Agriculture.  This also applies to FDA regulated research. 

       (The research cannot involve prisoners as participants.)

 

 

2.  Expedited Reviews

Behavioral and Social Science research qualifies for expedited review if the research:

 

(1)  Clinical studies of drugs and medical devices only when condition (a) or (b) is met:

 

(a)  Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required.  (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)

 

(b)  Research on medical devices for which (i) an investigational device exemption application (21 CFR 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.

  

(2)  Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

       

(a)  From healthy, non-pregnant 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; or

 

(b)  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.

      

      (3)  Prospective collection of biological specimens for research purposes by noninvasive means. 

 

Examples: (a) hair and nail clippings in a non-disfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) 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; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) 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; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.

 

(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. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)

 

Examples: (a) 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; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

 

(5)  Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).  (Note: Some research in this category may be exempt from the DHHS regulations for the protection of human subjects at 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)

 

       (6)  Collection of data from voice, video, digital, or image recordings made for research purposes.

 

(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 exempt from the HHS regulations for the protection of human subjects.  45 CFR 46.101(b)(2) and (b)(3).  This listing refers only to research that is not exempt.) 

 

       Expedited Continuing Review:

 

(8)  Continuing review of research previously approved by the convened IRB as follows:

 

(a) Where (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.

 

(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.

 

 

A.  Research Involving Existing Data and Documents. 

Minimal risk research involving materials, (including data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes, may be reviewed using expedited procedures.  (Note: The intent is to define two categories here, each appropriate for expedited review.)

 

(1)      Non-exempt research involving materials that have already been collected (for any previous research or non-research purpose) at the time when the research is proposed.

 

(2)      Non-exempt research involving materials that will be collected in the future for a non-research purpose.

 

B.  Research Involving Data from Voice, Video, Digital, or Image Recordings Made for Research Purposes. 

The IRB may utilize expedited procedures to review research that involves the collection of data from voice, video, digital, or image recordings made for research purposes.

 

C.  Research Involving Individual or Group Characteristics or Behavior or Research Employing Survey, Interview, Oral History, Focus Group, Program Evaluation, Human Factors Evaluation, or Quality Assurance Methodologies. 

The IRB may utilize expedited procedures to review the following:

 

(1)   Research on individual or group characteristics or behavior, or

 

(2)   Research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

 

(3)   This category covers a wide range of non-exempt social and behavioral research activities when they present no greater than minimal risk to subjects. Examples include, but are not limited to, research on perception, cognition, motivation, identification, language, communication, cultural beliefs or practices.

 

D.  Research Involving Deception or Withholding of Information. 

The IRB applies both common sense and sensitivity to the review of research involving incomplete disclosure or outright deception.  Where deception is involved, the IRB needs to be satisfied that the deception is necessary and that, when appropriate, the subjects shall be debriefed.  (Debriefing may be inappropriate, for example, when the debriefing itself would present an unreasonable risk of harm without a corresponding benefit.)  The IRB has the responsibility for assuring that the proposed subject population is suitable.

 

Deception can only be permitted where the IRB documents that a waiver of the usual informed consent requirements is justified under the following criteria and the IRB must find and document that all four of the following criteria have been satisfied:

 

(1)      The research presents no more than minimal risk to subjects.

(2)      The waiver or alteration shall not adversely affect the rights and welfare of the

        subjects.

(3)      The research could not practicably be carried out without the waiver or alteration.

(4)      Where appropriate, the subjects shall be provided with additional pertinent  

        information  after participation.

 

In making the determination to approve the use of deception under a waiver of informed consent, the IRB considers each criterion in turn, and documents specifically, in the IRB minutes and/or in the IRB protocol file, how the proposed research satisfies that criterion.

 

 

FOLLOW-UP RESPONSIBILITY: Director, Office of Research Integrity

 

REFERENCES:         38 CFR 16.101(b)(1)

                                    38 CFR 16.101(b)(2)

 

 

Revised  5-1-2007