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  • Information and Instructions for Preparing Proposals

Institutional Review Board

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  • Information and Instructions for Preparing Proposals


    IRB Review Criteria

    In reviewing proposals the IRB considers the following general criteria.

    1. Are risks and discomforts to subjects minimized?
    2. Are risks and discomforts to subjects reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result? Although the IRB does not specifically evaluate the quality of the proposed research, it may become relevant in determining if potential benefits outweigh risks.
    3. Will voluntary and informed consent to participate in research be obtained from each subject or the subject's legally authorized representative and will it be appropriately documented? The consent process must permit the participant or legally authorized representative to exercise free power of choice without undue inducement or any element of deceit, fraud, force, duress, or other form of coercion or constraint.
    4. Will the privacy of subjects and confidentiality or anonymity of data be protected?

    Time Required

    Allow 10-12 days for an Expedited Reviews and Exempt Status Reviews. Allow up to 30 days for a Full Review.

    Revised proposals may take more time to process because of the growing number of them in recent years. Principal Investigators are advised to review IRB applications carefully to insure that all information is present and correct. This will help to minimize the number of revised proposals processed by the IRB and speed up the turn-over time for proposals.

    IRB Training Requirement for Principal and Co-Investigators

    Office for Human Research Protections (OHRP) approved on-line training is required of principal investigators (PI) and co-investigators (CI) prior to submitting proposals for full review and expedited review. Only the PI is required to complete IRB training prior to submitting proposals for exempt status reviews, except when children are involved in the study. In this case, both the PI and CI are required to complete basic IRB training.

    The on-line training program is available at NIH Office of Extramural Research.

    A copy of the training certificate is to be submitted to the IRB Chair prior to completing an initial proposal. This should be accompanied by the person's Dragon ID number and name of their department. A record of the training will be kept on file, as well as in a database for future reference. Investigators may obtain IRB forms upon completion of their training.

    Debriefing

    A statement should be made that participants will be debriefed orally or in writing. If the debriefing is to be oral, a "script" of what subjects will be told should be attached. If all or part of the debriefing is to be in written format, a copy of the actual debriefing statement to be given participants should be attached. Oral and written debriefings need to contain the following information:

    1. A statement thanking the subject for participating.
    2. A statement of the purpose of the study – the hypothesis/research questions being investigated and results expected.
    3. Information about when and where results will be available.
    4. Information about whom to contact should there be further questions or should the person experience undesirable consequences from participating. This should include the principal investigator and the IRB chair and may include hotlines, counseling centers and other support contacts.

    Keep in mind that the major benefit that most of our research participants get from participating in studies is the experience of being in a study. The more background information you give them about the basis for the study, the more they will learn from the experience.

    Sample Debriefing Form

    Some Common Special Circumstances

    Children or minors as research subjects

    Permission is required from parent or guardian. In addition, assent should also be obtained from the subjects. This will require explaining what their participation means and their rights in age appropriate language.

    Other vulnerable populations as research subjects

    Vulnerable/special populations include those subjects who, as outlined in state and federal regulations, must be provided extra protection. This includes, but is not limited to minors, prisoners, fetuses/pregnant women, elderly and cognitively impaired.

    FDA guidelines broaden the scope of different types of "vulnerable subjects" to include: "individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, of a retaliatory response from senior members of the hierarchy or institution in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects may include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency rooms, ethnic minority groups, homeless persons, refugees, children, and those incapable of giving consent."

    Other groups, such as racial minorities, the economically disadvantaged, the very sick and the institutionalized are described as vulnerable populations by the Belmont Report and are therefore provided similar protection when used as research subjects. Some groups, such as racial minorities, are not considered vulnerable populations if included in a general population.

    Whenever potential subjects are persons of diminished capacity and capable of giving assent, the researcher must obtain their assent in addition to obtaining permission to participate in research from their guardian before involving the individual in a study.

    Surveys and questionnaires

    For surveys and questionnaires that do not involve sensitive topics or minors return of the questionnaire can be taken as implying consent. However, a cover letter must be included which contains the elements of consent and gives enough information about the survey that the subjects can choose to participate or not. In surveys volunteer subjects deserve to know the purpose of the survey and the uses to which their data will be put. The argument that the results would be seriously biased if subjects are informed is not an adequate justification for failing to inform.

    Sensitive questions

    Questions or items on the following topics will require additional protection of subjects' privacy. Parents or guardians and subjects must be informed of the sensitive questions before they give permission or consent to participate. Generally information on these topics will be gathered anonymously.

    1. Information pertaining to illegal, anti-social, self-incriminating, and demeaning behavior;
    2. Information relating to the use of alcohol, drugs, or other addictive products;
    3. Information relating to sexual attitudes, preferences, or practices;
    4. Information that if released could reasonably be damaging to an individual's financial standing, employability, or reputation within the community;
    5. Information that would normally be recorded in a patient's medical record and the disclosure of which could reasonably lead to social stigmatization or discrimination;
    6. Information pertaining to an individual's psychological well-being or mental health;
    7. Information relating to a subjects political affiliations;
    8. Critical appraisals of other individuals with whom the subject has close family relationships;
    9. Income, other than that required by law to determine eligibility for participation in a program or for receiving assistance under a program.

    Audiotaping, videotaping and photographing subjects

    In research projects involving audio or video taping or photographing of subjects, the following guidelines apply:

    1. Subjects must be advised that their participation includes the use of audio/video taping or photographing.;
    2. Before consenting to being taped (audio or video) or photographed, subjects should be informed of the current and planned use of the materials including storage and access by persons other than the researcher. Subjects must be advised when tapes or photographs will be erased or destroyed;
    3. This permission will normally be included in the consent form. If consent forms are not used, the elements of informed consent must be explained to the subjects and an appropriate release must be obtained. This release statement may be included as a preamble to the taped procedure;
    4. The researcher must make proper arrangements for secure storage of all audio and video tapes and assure that their use complies with the guidelines outlined in the informed consent/release form. Plans may include storage, erasing, or destroying after a given time period.

    Research Using Electronic Methods

    Researchers must take added precautions to protect the identities of their research participants when using electronic methods for obtaining and/or storing information and data. A MSUM (mnstate) account designated as a secure site must be used for any research:

    1. Conducted on the Internet (e.g. survey research)
    2. That uses email addresses
    3. Using email as a method of communication

    Other participating institutions or sites

    In cases where subjects are recruited from other institutions (hospitals, community agencies, physicians, schools etc.), the first contact with potential subjects should be made by institutional staff who, after outlining the researcher's interest and obtaining the potential subject's permission, will refer the person to the researcher or vice versa. A letter may also do this from the researcher that is distributed by the institution.

    If other institutions are cooperating with the researcher a letter from the institution indicating the nature of that cooperation should be included with the IRB proposal.

    Access to subjects' medical and educational records

    A researcher may have access to institutional records, i.e., hospital, health service agency, etc., if the institution agrees in writing to the accessing and conforms to state guidelines for such access.