Gustavus Adolphus College

1. Purpose and Statement of Principles
   Gustavus Adolphus College acknowledges the value of conducting research using human subjects for the purposes of advancing basic knowledge and furthering undergraduate education. In order to assure adherence to state and federal regulations governing human subjects research, as well as to applicable standards of professional ethical conduct, the college accepts its responsibility to oversee the rights and welfare of human subjects involved in research conducted under its auspices. However, the primary responsibility for protecting human subjects remains with each individual who initiates, directs, or engages in this type of research.
   
   In order to ensure that the College effectively fulfills its responsibility, the Institutional Review Board (IRB)) is authorized to review and approve all research involving human subjects conducted under the College's auspices, regardless of funding source, including student research projects that utilize human subjects drawn from outside the class room. Dissemination of information concerning proposals will be limited to those who submit applications and to Federal regulators.
   
   
   1. Definition of Human Subjects Research
      In-class "teaching" activities in which students are active joint investigators creating and utilizing their own research proto-cols, designs, and instruments are not properly labeled "re-search." To be classified as research, activities must meet the definition of research provided in the Office for Protection from Research Risks (OPRR) document. Certain courses that teach research techniques (e.g., Experimental Psychology or Methods of Social Research) involve procedures that approximate research but do not meet the definition of research (NIH 1993, xxi):
      
      "'research [is] . . . an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby devil-op or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.'" (NIH 1993, pg. xxi)
      
      "Human Subjects Research" involves the collection of data from or about living human beings. It does not include research utilizing published or publicly available documents or data sets or research on elected or appointed public officials or candidates for public office.
      
      NOTE: In-class activities during which students are taught how to create research instruments are not research, although the instruments the students create could conceivably become part of research at some future time. Designing and creating practice questionnaires, interview schedules, and experimental protocols, when limited to classroom settings do not constitute research. Rather, they are part of a process of learning how to do research as defined above. Consequently, the practice design and creation of common types of research tools in classroom settings are not activities subject to committee oversight. However, if and/or when the tools have been created and the student investigators wish to try them out on respondents/ subjects who are not part of the research-tool-creating teams, then their activity may qualify as research, according to the preceding definitions. When "research" activity moves outside a class room setting in which it is created, it becomes necessary to determine whether the activity falls inside or outside of the range of activities qualifying for exemption from committee oversight.
      
      
   2. Institutional Review Board (IRB)
      
      The IRB consists of 8 members appointed by the Dean of the Faculty with the advice of the Faculty Senate as follows:
      1. 5 faculty members, selected by division and serving staggered 3-year terms--1 each from Education, Natural Science and Mathematics, Social Science, Fine Arts, and Humanities.
         
      2. 1 non-college member for a 1-year term.
         
      3. The Dean of the Faculty or the Dean's designated representative.
         
      4. 1 representative of an administrative department other than the faculty
      The IRB shall follow the guidelines set forth in the OPRR regulations in the 1993 Protecting Human Research Subjects--Institutional Review Board Guidebook, Chapter 1, Section B. Administration of the Institutional Review Board. A majority of the committee's members must have had prior experience conducting research with human subjects. The IRB shall not consist entirely of one gender. No committee member may participate in the review of research for which he or she is either a principal investigator or faculty supervisor.
      
      The committee shall select one member to serve as its Chair for a one-year term. The chair's term may be renewed for up to three consecutive terms.
   3. Exempt research categories.
      
      Certain categories of research activity involving minimal or no risk to human subjects do not require full committee review and approval. However, they may be subject to less intensive review procedures or be required to be made a matter of committee record. With the exception of projects excluded under the definition of human subjects research (I, A, above), such projects must be reported to the committee to enable it to meet its federally mandated obligations.
      
      
2. PROCEDURES
   1. Planning a Research Project
      A person who plans to conduct research involving human subjects should consult with the IRB or its designee as early in the research design phase as is reasonably possible before formal approval is requested. A project's potentially problematic aspects can be identified early and various design alternatives considered. At this time, disposition can also be made regarding the proposed project's eligibility for exempt status. Suggestions can be offered which will help facilitate project approval.
      
      
   2. Determining Human Subjects Involvement
      Initial determination as to whether a research project should be considered human subjects research should be made by the project investigator (PI). The PI should consult with the IRB for advice concerning this question. Final authority for making this determination rests with the IRB or its designee.
      
      As a rule, research utilizing local campus data gathered solely for internal institutional consumption does not require review (e.g., course evaluations, routine institutional research projects, or personnel evaluations conducted for administrative purposes). If, however, there exists any probability that the results of such research will be disseminated in any way to any external group, organization, government body, or communications medium, then the research must receive prior committee approval.
      
      
   3. Review Categories
      Once determination has been made that a proposed activity constitutes human subjects research subject to review, it will be reviewed under one of two categories, Expedited Review or Full Review. The relevant procedures are described below. Each researcher makes an initial determination regarding the appropriate review category, although the IRB or its designee may require review under the other category. The researcher may request a higher level of review than that required.
      
      Project categories are listed below, along with examples of the types of projects included in each category:
      
      
      1. Exempt Category
         
         Determination of exempt classes of research is based on the following:
         
         Some research that involves human subjects may be exempt from the regulations requiring IRB review [Federal Policy ¤___.101(b)]. Examples include educational testing and survey procedures where no identifying information will be recorded that can link subjects to the data, and disclosure of the data could not reasonably place the subjects at risk of civil or criminal liability or be damaging to the subjects' financial standing, employability, or reputation; and research that involves the use of existing data, documents, or specimens, where no identifying information will be recorded that can link subjects to the data. [Emphasis added.] (NIH 1993, pg. 1-1)
         
         Student and faculty research activities which meet the criteria outlined above are exempted from IRB committee oversight beyond the need to certify to the committee that:
         1. The research involves the use of existing data, documents, or specimens, where no identifying information will be (or has been) recorded that can link subjects to the data. (It is not necessary to report to the committee the use of published documents or data sets that meet this criterion.)
            
         2. Their activities produce and/or record no identifying information that can link subjects to the data. (Investigators certify to the committee that their research design meets this criterion and submit an abstract of their design substantiating this fact.)
            
         3. Disclosure of the data will not reasonably place the subjects at risk of civil or criminal liability or be damaging to the subjects' financial standing, employability, or reputation. (Investigators certify to the committee that their research design meets this criterion and submit an abstract of their design substantiating this fact.)
            
            In addition, the investigators must certify that they have taken measures sufficient to assure that they have met the three essential criteria of informed consent, voluntary participation, and minimal risk.
            
            Investigators who conduct exempt classes of research must provide the IRB statements for their records certifying that the research qualifies for exemption according to the preceding criteria. This information enables the IRB to maintain required documentation.
            
      2. Expedited Review
         
         • Anonymous mail or telephone surveys on innocuous topics.
           
         • Anonymous non-interactive, non-participant observation of behavior in public settings.
           
         • Secondary analysis of existing data sets.
           
         • Educational research conducted in classroom settings.
           
         • Research using educational records, if information taken from them is provided to the researcher in a manner concealing subjects' identities.
           
         • Surveys or opinion polls
           
         • Observation of individual or group behavior of normal adults involving no psychological or physiological intervention or deception.
           
         • Research in this category generally does not require written documentation of informed consent, but oral consent is required for all research involving direct interaction with subjects. The investigator must be familiar with Informed Consent procedures included under Section III Guidelines. All research in schools requires written permission from the school district.
           
           
      3. Full Review
         
         • Research that could put subjects at more than minimal risk.
           
         • Research involving psychological or physiological intervention.
           
         • Non-curricular, interactive research in schools.
           
         • Research involving deception.
           
         • Research on vulnerable populations, e.g., minors, prisoners, and the mentally incompetent.
           
         • Research conducted outside the United States, regardless of the procedures involved.
           
         The IRB may require full review of any research submitted under Expedited Review
         
         
      4. Initiation of Expedited or Full Review
         The review of human subjects research at the College is a collaborative process intended to result in mutually acceptable research procedures which accomplish the investigator's scientific objectives while protecting the rights and welfare of research subjects. The IRB tries to be as flexible as possible and reviews each project as a separate case rather than imposing rigid requirements. Every attempt is made to take full account of all relevant factors that can affect the outcome of the review. The IRB understands its role as being primarily educational and encourages consultation at all stages of the research process.
         
         The principal investigator initiates the review process by completing a formal application (See attached sample). If the PI is a student, the application must be signed by a supervising faculty member. The applicant should respond to all questions in the form of a brief (2-3 pages), typed statement. Copies of all research instruments including survey forms, observation protocols, consent forms, etc., should be attached to the application. It is essential to attend closely to the following issues: informed consent, voluntary participation, confidentiality and/or anonymity of data sources, and debriefing, when required. Rationales explaining each should be included.
         
         The review of human subjects research applications is confined solely to questions concerning procedures affecting the rights and welfare of the subjects. The review of such applications does not imply evaluations of the content or scientific merit of the project, unless subjects are found to be "at risk."
         
         Full review normally takes two weeks. Expedited review normally takes three class days. The committee will provide written responses to all applications, and they must be received by the PI before data collection can begin.
         
         If an investigator is unhappy with the outcome of the review, he or she may appeal the decision to the full IRB, after consulting with the chair of that committee.
         
         
      5. Conditions of Approval
         
         IRB project approval signifies only that the committee agrees that the proposed research procedures adequately protect the rights and welfare of the research subjects. It should not be taken to indicate College approval to conduct the research.
         
         IRB approval applies only to the procedures described in the research proposal. Investigators must secure prior approval from the IRB for any procedural changes that will materially affect the welfare of a project's human subjects. Investigators must also report to the IRB any problems that arise in connection with the use of human subjects.
         
         Project approval is valid for one year only. Investigators must request a continuation for the approval yearly if the research activity lasts more than one calendar year. No more than two (2) continuations will be granted for a given project. After three years, the project must be resubmitted for reapproval.
         
         
      6. Student Research
         All student investigators must have a supervisor (usually a faculty member) who is responsible for insuring that the student investigators comply with all procedures of the approval process. Students' faculty supervisors must sign their proposals, certifying that the projects are under their supervision.
         
         Class projects that require the collection of data from sources outside of the classroom setting may be reviewed as one proposal, at the discretion of the instructor. If the entire class is not using the same procedure, each student or group of students using a different procedure must submit the required information for their phases of the project, but the class project will still be considered as one proposal.
         
         Students should design research projects, which are eligible for expedited review. Approval for such projects take very little time. Students are not, however, prohibited from conducting research in the full review category. They are advised that additional time may be required to obtain approval from the full IRB. In all cases of student research, it is the instructor's responsibility to ensure that student’s use only approved ethical research procedures.
         
         To expedite the approval of external class projects, instructors can obtain approval before the semester begins under two circumstances:

1. if all of the students are using the same procedures (e.g., a class survey) and the instructor has established the research procedures before the term starts, or
2. if the instructor submits a list of alternative procedures for approval, and the students will choose one from the list.
   
Projects conducted as instructional demonstrations where research subjects are not solicited from outside the classroom generally do not need to be reviewed. Care should be taken, however, to protect the rights and welfare of students who act as classroom research subjects.

APPENDIX A

GUIDELINES

In addition to the basic requirements for conducting human subjects research, specific research topics often present additional concerns relating to the rights and welfare of research subjects. The IRB reserves the right to delay approval of protocols in these topics until additional information addressing those concerns is received.

1. A. Informed Consent
   Unless otherwise authorized by the IRB, no investigator may involve a human being as a research subject under the auspices of the College unless the investigator has obtained the informed consent of the subject or the subject's legally authorized representative.
   
   "Informed consent" means each individual asked to participate as a subject in a research project must be able to choose freely whether to participate. When appropriate, the subject's legally authorized representative must be asked, and must be able to choose freely. Free power of choice means the investigator must not coerce or constrain the potential subject via any form of force, fraud, deceit, or duress. Properly informing the participant consists of the following:
   1. Making certain the subject has the legal and mental capacity to give consent. Should the subject not have this capacity, the subject's representative must give consent.
      
   2. Giving the subject or the representative sufficient opportunity to consider whether to participate.
      
   3. Providing language understandable by the prospective subject or representative the information necessary to consider whether to participate.
      
   4. Ensuring via points 2 and 3, that no possibility of coercion or undue influence exists.
      
   5. Ensuring the prospective subject or representative that none of the subject's legal rights have been waived or appear to have been waived.
      
   6. Ensuring that the investigator, the sponsor, or the institution or its agents have not been released nor appear to have been released from liability for negligence.
      
   In projects where subjects are determined to be at risk:
   
   The actual procedure utilized in obtaining "legally effective informed consent" must be fully documented. This is accomplished by using a written consent form embodying all of the elements of information required for the project.
   
   The consent form must be read by or to the person signing the form and the signed form must be maintained in the investigator's files for an indefinite period of time following completion of the study.
   
   In projects where subjects are determined to be at no more than minimal risk:
   
   Provision may be made for oral or written presentation and consent. Under this procedure, the subject is informed of those basic elements of consent which are applicable to low risk procedures and no signed document is necessary on the part of the subject.
   
   A sample copy of the presentation must be approved by the IRB.
   
   A major exception to this policy occurs when research involves minors as subjects, in which case, written parental consent is usually required.
   
   In some cases, the IRB may approve a consent procedure which does not include, or which alters some or all of the elements of informed consent or may entirely waive the requirement to obtain informed consent.
   
   
2. Socially Sensitive Research
   
   1. Risks. A first planning step for any researcher doing "greater than minimal social risk" research is to outline fully all the potential social and physical risks. In this kind of research, risks often include:
      
      Loss of confidentiality about the identity of the volunteers.
      
      Loss of confidentiality about the information given by the volunteers.
      
      Triggering internal conflicts within volunteer-respondents, e.g., emotional reactions or needs.
      
      Triggering external conflicts of social, stigmatizing, or physical damage against volunteers, e.g., assault by abusing partners or legal action by authorities, if study participation in the study became known.
      
      In some research (e.g., about fetal alcohol syndrome), the people at risk include not only the subjects of the research, but third parties (e.g., the mothers) as well.
      
      The next step is to ensure that the research methods minimize the risks to the volunteers and any others.
      
      
   2. Confidentiality. One of the most important risks in socially sensitive research is the unanticipated effect of a breach of confidentiality. The researcher must make every effort to try to ensure confidentiality; it is suggested relying on anonymity whenever possible. Although research data must be kept confidential in all types of research, this is especially true in socially sensitive research. With some research topics, such as sexuality or criminality research, not only is the information sensitive, but the subjects' presence in the study can itself be a sensitive piece of information. It is important to note that demographic variables can sometimes identify subjects as well as names and other obvious identifiers. When anonymity is not feasible, then the researcher must demonstrate to the IRB how confidentiality is being assured. Depending on the sensitivity of the subject matter, extra care should be taken to ensure that subjects cannot be identified. At times, coding schemes should be used to minimize the risk of a confidentiality breach (see section below on Questionnaires).
      
      
   3. Emotional Risks. To minimize emotional risks triggered by the research itself, the research must take steps before, during, and after the intervention with the subject to assess the emotional impact of the material, to assess the emotional state of each subject, and to deal with any emotional reaction which might take place. Often this includes pilot testing research materials, extended listening, ventilating discussion, and referral to counseling services. (Cooperation of counseling services must be obtained before approving the research.)
      
      
   4. Social Risks. If the research concerns illegal behavior, e.g., a study of HIV and risk factors among prostitutes, the researcher may need to have the cooperation of local legal authorities or a federal Certificate of Confidentiality. If there is a risk of triggering retribution by others, such as violence by abusing partners, the researcher must insure that nothing given can identify a person as a respondent. Risk to the community must be minimized, often by researchers and community agreeing about publication, e.g., whether to identify the community.
      
      
   5. Benefits. Researchers should also attempt to maximize benefits of the research to each volunteer and community. They must ensure availability of services to the volunteers. For a survey of fetal alcohol syndrome, for instance, researchers should link themselves to established, or help establish, real services of prevention and treatment. At the very minimum, subjects should be provided with sources of help and support available in the community.
      
      
   6. Coercion. Research involving emotionally-vulnerable subjects should avoid coercion by caregivers. Many patients who are dependent on caregivers' help may feel that refusing to take part in research will lead to loss of the care they need, in spite of the written "no-coercion disclaimer" in consent forms. One way to avoid the problem is to emphasize repeatedly the freedom to refuse. Another is to have at least the consent, and sometimes the research as well, done by people other than the caregivers.
      
3. Questionnaires
   Questionnaires are probably the most common research technique used in conducting human subjects research at the College. As a result, some researchers may tend to overlook various of the human subjects' concerns, which can hold up approval of a questionnaire study.
   
   1. Consent. Although most questionnaire studies do not require a written consent form, researchers must still ensure that subjects are giving informed consent to participating in the study. All questionnaires must include some form of cover sheet containing instructions to subjects, which provides subjects with the same information which would be normally be included in a consent form. In particular, subjects need to be informed:
      
      About the nature of the questions they are going to be asked (especially any questions pertaining to sensitive topics)
      
      That they can skip any question they chose not to answer
      
      About the procedures in place to protect their confidentiality
      
      
   2. Confidentiality. In even the most innocuous questionnaire research, all research information must be kept strictly confidential. Complete anonymity is the best protection from breaches of confidentiality. However, researchers must be aware that demographic variables can, in some circumstances, be identifiers. Anything which allows an individual subject to be identified is an identifier, and this kind of information must be protected. The degree of protection required depends upon the sensitivity of the information obtained. Another overlooked point pertains to the procedure used for the collection of completed questionnaires. Sometimes, individuals collecting questionnaires can identify who turned in which forms. For sensitive information, it would be best if forms were returned in sealed envelopes.
      
   3. Subject Coding. One method commonly used to protect confidentiality is to use subject codes rather than names or other identifiers. Care must be taken, however, to ensure that the code cannot be used as an identifier. For example, a frequently used code is the last four digits of the subject's Social Security number. Unless an extremely large number of subjects are being used, this number can still be used to identify an individual subject. Arbitrary or random codes are much better at protecting confidentiality. On the other hand, when different sets of data for a single subject must be linked, arbitrary codes are usually unsuitable, because subjects will likely forget them. In such cases, the best method is to provide subjects with a formula they can use to generate a unique personal code which will generally result in the same code number each time the subject uses it. The following is one example of a workable formula:
      
      

      ---

      
      First & Second letters of your letters of your mother's first name
      
      First & Second letters of your letters of your father's first name
      
      Month you were born
      
      Date you were born
      
      For example, if your mother's name was Sally and your father's name was George and you were born on May 1, you would enter:
      
      S A G E 0 5 0 1
      
      

      ---

      
      First & Second letters of your letters of your mother's first name
      
      First & Second letters of your letters of your father's first name
      
      Month you were born
      
      Date you were born
      
      
4. Deception
   Sometimes information must be withheld from subjects to ensure natural reactions. Since this is, inherently, a breach of the concept of informed consent, the IRB has serious concerns which must be met before such research can be approved. These include:
   
   Deception cannot be used in any study where there is risk to subjects.
   
   No information can be withheld from subjects which could significantly affect their decision to participate (i.e., the subjects would likely participate anyway if they knew all of the information).
   
   The terms "Informed Consent" or "Consent Form" should not be used in deception research since there is no informed consent in this type of research.
   
   All subjects should be debriefed as to the true nature of the research after their participation. This debriefing should address the reasons for the deception and reassure subjects that their reactions were normal. If believing erroneous information is not likely to be harmful to subject, the debriefing can be delayed until all subjects have completed their participation. Care should be taken not to inform subjects about information which might damage their self-esteem or hurt their feelings.
   
   
5. International Research
   
   Research in foreign countries also presents special concerns regarding the rights and welfare of human subjects. In general, the IRB accepts the standards of the location in which the research is taking place; unless those standards grossly violate the basic principles of ethical human subjects research. In addition, the following issues apply to international human subjects research:
   
   All human subjects research in foreign countries must be reviewed by the full IRB, regardless of the nature of the research.
   
   All materials, including consent forms, must have English language translations included with the protocol.
   
   Documentation of permission from local authorities is generally required before approval can be granted.
   
   

Last modified: June 17, 2002 by Mark Braun (mbraun@gustavus.edu)