Contents for Investigator's Guide

Definitions

Rights of Human subjects in Research

The Investigator's Responsibilities

Preparing the Application
Criteria Used to Approve an Application

Risk
Equitable subject Selection and Recruitment
Suggestions When Using Students and
Employees As Research subjects

Privacy Protection and Certificates of Confidentiality

Student Research

Student Research vs. Research Practicum/Methods Classes
Student Participation in Research
Research Conducted in Schools

Timeline for eIRB Applications

Advertising and Recruiting

Food and Drug Administration

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Investigator’s Guide
to Human Subjects Research
Wake Forest University – Reynolda Campus

This document provides topic-specific information as a supplement to the IRB Policies and Procedures.   Please consult the Policies for more comprehensive guidance.

Any University faculty, staff, or student conducting research involving human subjects must submit an application to the IRB. To determine if your project meets the definition of human subjects research, go to http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm. 

Definitions (45 CFR §46.102)

• Adverse events are events that are unfavorable, harmful, or detrimental to the welfare of the subjects. They are either unanticipated or anticipated but generally involve a higher level or greater frequency than expected.
• Assent is the affirmative agreement of the child to participate in research.
• Benefit is the positive value or advantage of being part of a research study.
  This value may be concrete for an individual (e.g., a greater chance of having a good therapeutic outcome) or may be more intangible and general (e.g., the illumination of basic processes or causes that underlie a research topic). Compensation or inducement for study participation is not considered a benefit and should not be considered in balancing risk/benefit ratios.
• Children are persons who have not attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. In North Carolina, residents under 18 years of age are considered children unless they are “emancipated” by court order, marriage or military service.
  • Emancipated Minor: A legal status conferred upon persons who have not yet attained the age of legal competency as defined by state law, but who are entitled to treatment as if they had by virtue of assuming adult responsibilities, such as self-support, marriage or procreation.
  • Mature Minor: Someone who has not yet reached adulthood (as defined by state law) but who may be treated as an adult for certain purposes (e.g., consent to medical care). A mature minor is not necessarily an emancipated minor.
• Exempt research is research that is not subject to federal regulations and does not require informed consent.
• Expedited review is a process that the IRB may use when the research involves no more than minimal risk to subjects.
• Full board review is a process that the IRB will use when the research involves more than minimal risk.
• Human subject means a living individual about whom an investigator conducting research obtains: 1) data through intervention or interaction with the individual, or 2) identifiable private information.
• Informed consent is a continuing process that involves giving human subjects an explanation of the proposed research, its purpose, procedures, risks and benefits, and informing them that participation is voluntary and may be discontinued at any time without penalty.
• Intervention includes physical procedures by which data are gathered, and manipulation of the subject or the subject’s environment for research purposes.
• Interaction includes communication or interpersonal contact between investigator and subject. Administering a survey, even if you have no face-to-face contact with the subject, is considered to be interaction.
• Key personnel is defined as the principal investigator (PI) and other individuals who contribute to the research in a substantive, measurable way. Examples include but are not limited to the PI, co-investigators, the study coordinator, and other project personnel who:
  • design studies,
  • supervise studies,
  • administer informed consent,
  • administer questionnaires or surveys or collect data directly from
    subjects using other methods,
  • code data, or
  • otherwise collect or analyze human subjects data.

  Typically, these individuals have doctoral degrees or other professional degrees,
  although individuals at the masters or baccalaureate level may meet this definition. The PI typically identifies the key personnel on a research project.

• Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than that ordinarily encountered in everyday life or during the performance of routine physical or psychological examinations or tests.
• Private information must be individually identifiable (e.g., school transcripts, health records) if obtaining the information is to constitute research involving human subjects.
• Research means a systematic investigation (including research development, testing and evaluation) designed to contribute to generalizable knowledge.
• Special populations refers to subjects who may be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, handicapped or mentally disabled persons, or economically or educational disadvantaged persons, and for whom special safeguards must be built into the study to protect their rights and welfare.

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Rights of Human Subjects in Research

All activities involving humans as research subjects must provide for the safety, health and welfare of every individual. A subject has the right:

• to obtain appropriate information about the research study
• to freedom from undue embarrassment, discomfort, anxiety and harassment and to professional care, as necessary, relative to participation in the research
• to privacy and confidentiality in the use and storage of personal information
• to have any misconceptions corrected by the investigator
• to refuse to participate without loss of benefits to which the individual would otherwise be entitled
• to be informed of any changes in the research including significant findings developed in the course of the research that may relate to his or her willingness to continue participation in the study
• to an explanation of any deception used in the course of the research
• to the results, and conclusion of the research
• to withdraw from a research project at any time without penalty

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The Investigator’s Responsibilities

Safeguarding the rights and welfare of all human subjects in research is a primary responsibility of the investigator.

1. Preparing a complete application that includes a description of the research protocol, the proposed informed consent form(s) and copies of all relevant information and documentation (questionnaires, test instruments, recruitment tools, scripts, debriefing statements, contact letters, etc.), securing signatures, and submitting the application in eIRB in a timely manner.
2. Obtaining IRB approval prior to initiating any human subjects research.
3. Complying within the deadlines with all IRB decisions, conditions and requirements for promptly reporting any changes in the research as well as any adverse events.
4. Completing the required human subjects research certification and recertification programs, as necessary, prior to beginning research.
5. Selecting subjects fairly and equitably.
6. Following the requirements for informed consent, when applicable.
7. Cooperative research investigators must fully apprise the IRB of research activities at any collaborating site(s).
8. Applying for Continuing Review if the research is to continue beyond the renewal date.
9. Reporting immediately to the IRB and, as required by Federal regulation, grant requirements, or contract to any federal Departments or Agencies and/or study sponsor, any modifications, adverse or unanticipated problems (injuries, continuous anticipated problems, subject complaints, etc.) involving risks to subjects that arise in connection with the use of human subjects in this activity.
10. Cooperating with the IRB when monitoring and oversight is being conducted by ORSP by being available to answer questions, having relevant research documents accessible, and responding to any written requests within the timeframe designated by the IRB.
11. Submitting a closure form when the research is completed.
12. Keeping all confidential research data including signed consent documents together with IRB letters of approval in a secure location for as long as the data are scientifically useful and destroying them thereafter.

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Preparing the Application

General information on the IRB, instructions, forms and templates, instructions for using eIRB and IRB meeting dates can be found online.

Criteria Used to Approve an Application

The IRB considers the following (45 CFR §46.111):

• Risk.
• Is there greater than minimal risk from physical, mental or social discomfort? The IRB will consider risk of criminal/civil liability, financial risk, employment risk, stigmatization, insurability and embarrassment in deciding whether the risk is truly minimal.
• Are any risks to partiicipants minimized by using procedures consistent with sound research design?

Is the research designed to minimize exposure to risk, and reasonable in relation to anticipated benefits to subjects and the importance of the knowledge that may result from the research?

• Equitable Subject Selection and Recruitment. Does the research consider:
• all populations that might potentially benefit from the research rather than those that are readily availability
• the purposes of the research
• the setting in which the research will be conducted
• whether recruitment is equitable and free of undue influence?
• Undue influence  might include:
• parents and adolescents in the same room
• athletes recruited under their coach’s watchful eye
• parents receiving a letter from their children’s principal asking permission to enroll their children in a research study
• compensation set so high that prospective subjects are tempted to misrepresent themselves in order to participate in the study.
• Suggestions When Using Students and Employees as Research Subjects

Involving students or employees as research subjects can present special problems. Information about how students and colleagues will be recruited and how coercion will be avoided should be included in the information submitted to the IRB.

Recruiting Students.

• Students should be given a choice of studies in which to participate. Per Federal regulations, they must be given an opportunity to decline participation without jeopardy and still receive credit for participating in the research.
• Unless the research question is directly related to class material, or the study process is being used as a teaching opportunity, such as in a research methods class, the IRB discourages the use of class time to recruit subjects or complete study instruments, etc. Subjects might be solicited through sign-up sheets or general announcements rather than direct invitations.
• Use of extra credit points as reward for research participation should be limited to specific circumstances where the research is closely tied to the course subject matter. The number of points awarded should not be sufficient to augment a student’s grade by a whole step, e.g., from B to A.
• The use of financial rewards should also be limited to dollar amounts proportionate to the inconvenience of participation.
• Whenever possible, a teaching opportunity in the form of an “educational debriefing” should be employed. Students should know something about the IRB review process, the rationale for the study, the process of data collection, and intent of the researcher.

Recruiting Employees.

• Researchers who include colleagues or subordinates as research subjects must be able to provide a rationale other than convenience for selecting them and must show that the recruitment method does not lead colleagues to think they will be compromised by not participating.
• The compromised circumstances and a fear of retribution, even subtle cues of compromise, can place colleagues or subordinates in a position of involuntary participation in a research project.
• Recruitment through bulletin board advertisement (screened and approved by the IRB) or recruitment through a third party unassociated in a work relationship with the employee are usually the best strategies.

 

• Informed Consent process and documentation. See Wake Forest University Institutional Review Board Policies and Procedures, Informed Consent Process.

• Vulnerable populations protected. See Wake Forest University Institutional Review Board Policies and Procedures, Children in Research Involving Human Participation.

• Privacy and Confidentiality. Privacy refers primarily to the methods used to obtain information about subjects; confidentiality to the methods used to ensure that information obtained by investigators is not improperly divulged.
  
  Confidential data is recorded so that the information is not immediately identified with the subject who supplied it but such a link is possible. Confidential data is usually “coded”, i.e., the subject is assigned a unique identifier that will be used to identify the data. The code identifies the data and the subject’s identity is kept separate from the code and data. Coded data is not anonymous. (Data that is anonymous can never be linked directly or indirectly to the subject, either because the name/identity of the subject is never obtained by the PI or because there is no code linking the data to the subject’s name/identity.)
  
  The IRB must ensure that the researcher has made adequate provision to protect the privacy of subjects by considering:
• the private nature of the information sought
• the likelihood that subjects would consider the release of information as an invasion of privacy
• the importance of the research
• the availability of alternative ways to conduct the study
• how the confidentiality of the study data will be safeguarded

Because IRB approval must be secured when a researcher wishes to access existing records to identify subjects for participation in a study and will record subjects’ names or use other methods of identification for follow-up, the Board must determine if subjects’ consent must be secured by considering the following:

• the sensitivity of the information to be reviewed
• the vulnerability of the subject population
• the purpose for which the investigator seeks access to the information.

Certificates of Confidentiality

Under circumstances in which there is concern that disclosure of identifying information could be compelled, researchers may apply for a Certificate of Confidentiality issued by the National Institutes of Health (NIH).The Certificate helps researchers protect the privacy of human research subjects enrolled in biomedical, behavioral, clinical and other forms of sensitive research against forced disclosure of research subjects’ identifying information or identifying characteristics, i.e., name, address, social security or other identifying number, fingerprints, voiceprints, photographs, genetic information or tissue samples, or any other item or combination of data about a research subject that could reasonably lead, directly or indirectly by reference to other information, to identification of that research subject.  

See also http://grants.nih.gov/grants/policy/coc/contacts.htm for more information.

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Student Research

When the investigator is a student, responsibility for the conduct of research and for the welfare and supervision of human subjects lies with both the student and faculty advisor. All student researchers must have a faculty advisor.  In eIRB the faculty advisor is the PI and students are Co-investigators, study coordinators or other team members.

Student Research vs. Research Practicum/Methods Classes

See also: Wake Forest University Institutional Review Board Policies and Procedures, Levels of Review.

All activities that meet the definition of research with human subjects and are conducted by students for a class or honors project that may be published or publicly presented (e.g., poster session) must be reviewed by the IRB. This includes, but is not limited to, undergraduate and graduate thesis and dissertation research.
Courses designed to train students and give them opportunities to practice such research methods as interviewing, observing or participating do not lead to generalizable knowledge and are not undertaken with this goal in mind. Therefore, simulations of research using human subjects and course-assigned data collections are not considered subject to IRB review since they are:

• designed for educational purposes only,
• the data will not be generalizable nor published outside the classroom,
• the student subjects are clearly informed that the activities are an instructional exercise and not actual research, and
• the data will be destroyed once the assignment is completed.

Although the IRB does not review such class projects, it does strongly encourage instructors to become fully familiar with each student’s project(s) and to discuss it with the student. Students should be taught about ethical conduct of human subjects research,

Regardless of whether class or student projects constitute research, it is imperative that instructors of these courses are adequately trained in human subjects protections (See also:  Policies and Education and Training). 

Faculty are responsible for instructing their students in the ethical conduct of research including basic human subjects rights, the role of the IRB, and procedures to maintain confidentiality and obtain informed consent from each subject. Students should understand the importance of integrating these issues into their future research and practices. Instructors may facilitate this by:

• reviewing students’ plans and suggesting improvements in design and methodology
• recommending appropriate protections for privacy and confidentiality, suggesting anonymous data collection and storage of identifying information separate from collected data whenever possible
• explaining ways in which students should be attentive to the welfare of vulnerable populations and of individuals in sensitive situations

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Student Participation in Research

Faculty advisors must review, approve and submit all protocols prepared by students under their supervision; and supervise students in all aspects of the conduct of research: recruitment, data collection, data entry and analysis, secure storage and destruction of data, and presentation of findings. In eIRB, faculty advisors assume the role of principal investigator (PI). Students are co-investigators, study coordinators or study team members.
Faculty who would like to give their students an opportunity to participate in research (whether their own or other various research projects) for course credit must:

• have procedures in place (and describe them in the protocol document) to avoid undue influence and maintain confidentiality of participation/data.
•  include the research option in the original course syllabus If participation in the research can fulfill a course requirement .
• provide a comparable alternative, such as literature review, writing a paper, or attendance at colloquia or research seminars, for students who decline to participate in the research.
• ensure that participation is voluntary, i. the student can withdraw at any time without penalty. This means if a student decides to withdraw from the study at any time, the student must still receive credit. When a research project requires attendance in multiple sessions, the student may withdraw from the study at any time and receive credit for the sessions he or she has attended.

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Research in Schools

There are multiple levels of protection for children in the schools and thus multiple systems (i.e., teachers, principals, district supervisors and school boards) for researchers to negotiate, and authority structures vary from district to district.

• Research in Winston-Salem/Forsyth County Schools
• Students seeking to work with Winston-Salem/Forsyth County Schools (WS/FCS) should contact Dr. Leah McCoy, Education Department, WFU. If either the IRB or WS/FCS requests significant changes, revised proposals should be resubmitted to both. Directions for WS/FCS submissions are available at http://www.wfu.edu/~mccoy/resprss.html.
• The Winston-Salem/Forsyth County School system and the principal and teacher, as appropriate, of each school where research will be conducted must approve all studies before data collection can begin. Only parents or legal representatives of the research subjects, however, can consent to a child’s participation in research. Permission from the school system must be submitted in writing on Winston-Salem/Forsyth County letterhead.
• Researchers seeking to work with human subjects in other school districts should contact the school system administration for requirements for submitting proposals to conduct research in those schools or go online to get the necessary information.
• Informed Consent for Teachers
  Incidents in the classroom or reports about the teaching style and effectiveness of teachers could potentially affect the employment status of teachers and have done so in the past. Therefore, the study’s procedures must insure: 1) the confidentiality of the teacher and their actions in the classroom and 2) that there are adequate “informed consent” procedures to make sure that the teacher is fully aware of the risks and the procedures for confidentiality. In cases where the teachers run risks, it is necessary for these studies to be considered in the expedited category (or even in some cases, full board), rather than exempt.

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Timelines for eIRB Applications

The IRB generally meets the third Monday of each month to consider applications that require full board approval. Scheduled meeting are available on the IRB website.
Applications may be submitted at any time. However, those applications that may require full board review must be received at least one week before the scheduled meeting to be included on the agenda. For exempt or expedited protocols, the study team must respond to IRB concerns within 30 days or a withdrawal warning will be issued. After 30 days, the IRB will automatically withdraw the application.
Investigators who must address IRB concerns for full board protocols must do so within 60 days of notification of outcome. Reminders will be sent before the study is terminated administratively for non-activity.

Advertisements in Recruiting

Advertisements are part of the informed consent and subject selection process. Samples of all advertisements (flyers, newspaper ads, radio and television announcements, email ads, phone solicitations, bulletin board tear-offs and posters) as well as other recruiting tools (e.g., direct letters, letters from schools) must be submitted to the IRB. The IRB shall review the exact wording to be used except for the date and time the research is to be initiated.

Advertisements must include:

• institutional affiliation
• General purpose of the research
• Summary of eligibility criteria used to admit subjects into the study
• Description of the benefits of participation
• Indication of compensation
• Research location
• Contact information

Advertisements should not pressure readers into participating. Attention-getting devices such as extremely large, bold typefaces and dollar signs are prohibited.

Food and Drug Administration

Investigators who plan to submit a protocol that would fall under the guidelines established by the Food and Drug Administration (FDA) will be referred to the IRB at Wake Forest University Health Sciences (WFUHS).

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