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Table of contents
  1. 1. Protection of Human Subjects

POLICY STATEMENT

Protection of Human Subjects

Purpose:

Juniata is committed to promote, encourage and facilitate academic and clinical research in broad areas of human development. The purpose of this policy then is to protect the rights and well-being of human subjects of that research.

Policy:

Juniata has established an Institutional Review Board (IRB) for Human Subjects, commensurate with the with Title 45 of the Code of Federal Regulations regarding public welfare, Part 46 (45 CFR 46) and promulgated by the federal Office for Human Research Protections (OHRP), National Institutes of Health (NIH). The Juniata IRB is certified by that agency of the United State Government and the Juniata IRB is in all actions, to remain well within the compliance of all applicable federal laws and regulations. A copy of those regulations is found as an attachment to this policy or at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm.

Applicability:

This policy shall apply to all research (see definitions below), conducted under the auspices of Juniata College and involving human subjects. Juniata approval for the use of human subjects in research must be obtained from the Juniata IRB before such research is conducted.

Administration of the IRB:

The Office of the Provost at Juniata College shall be administratively responsible for the Juniata IRB and applications for review can be obtained through that office. In an administratively related but subordinate role, the Juniata College office of Development shall also serve in an administrative and reporting role for the IRB and also maintain applications for IRB review.

Submission Procedures:

The Provost, in consultation with the IRB, shall establish submission procedures for research protocols to the IRB. In general, the IRB will determine where the appropriate forms can be obtained. Completed forms, with all necessary forms as determined by the IRB, will be returned to the ProvostÂ’s office for forwarding to the current chairperson of the IRB.

In general, decisions regarding proposals will be made within two weeks of receipt by the chairperson of the IRB. Any missing materials or other issues (unclear wording, unexpected or undisclosed risks, etc.) will also cause delay in final committee decisions.

Guidelines:

Services provided to the benefit of the subject do not require IRB approval unless the service places the subject in any risk. For example, normal instruction is a service, but does not place the subject at risk.

Signed parental approval is required for any subject that is a minor (under the age of 18). The minor must also provide additional consent.

Research surveys and questionnaires do constitute the use of human subjects in research. Such surveys and questionnaires are therefore subject to this policy, with the following exceptions:

· the survey/questionnaire is not supported by any direct federal or state funding, or

· the survey/questionnaire is purely for administrative purposes, or

· the results will not be included in an scholarly publications, or

· the results will not be disseminated outside of Juniata College.

However, if the data gathered in the survey/questionnaire in any way precludes the respondent’s ability to remain anonymous, an “informed consent” form must accompany the IRB application or the principal investigator must formally indicate that the “informed consent” form will accompany the survey vehicle.

 

Policies established by the Juniata College IRB


IRB Membership:

Membership of the IRB shall be appointed by the Provost. The committee shall be composed of at least 5 members, one of which will be a non-scientist, one will be a natural scientist, and one will be a social scientist. In addition, one member shall be from outside of the Juniata community. Because students can be considered a vulnerable population, and most research at Juniata involves students as participants, the IRB will have one student representative. One person on the IRB will be designated as a prisoner representative OR we will designate an auxiliary prisoner representative IRB member to be called on as needed.
New members, either to replace a member or to add to the membership, shall first be considered by the committee. Then, if a majority of the committee approve of the new member, that person shall be presented to the Provost. They will be considered a full member once appointed by the Provost. All IRB members should read the Belmont Report upon joining the IRB. The chairperson of the committee will be determined by the committee by vote annually.

Definitions:

The following definitions will be used by the IRB:
1. Research - Any collection of data from human participants to advance general scientific knowledge where there is an expectation or possibility that the data may receive an off-campus, non-governmental public exhibition. This would include presentations at off-campus conferences (e.g. NCUR, The Pittsburgh Conference, various Association meetings), publication in professional journals (e.g. Science, Social Problems, Proceedings of the National Academy of Sciences, etc.), in magazines and newspaper articles (e.g. local papers, association magazines such as the American Psychological Association Monitor on Psychology, CUR Quarterly). Excluded from the definition are projects limited to on-campus distribution (e.g. in class projects with no discussion beyond the campus), assessment projects targeted at specific, non-public groups, and mandated assessment projects required for program certification, licensure or accreditation.
2. Risk - The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only "minimal risk." (as per the IRB Guide Book, OHRP)
3. Benefit - A valued or desired outcome; an advantage. (as per the IRB Guide Book, OHRP)
4. Minimal Risk - the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (as defined in federal law, Title 45 CFR 46.102).
5. Exempted Research - Research that is not specifically covered under federal law and that does not require “expedited review” or “full review” by the IRB (Title 45 CFR 46). The conditions of exempt status are set by the IRB in accordance with federal law (Title 46 CFR 46). The designation of “exempt” can only given by the IRB. Therefore, protocols suspected of being exempted still need to be submitted to the IRB.
6. Expedited Review - A special review procedure whereby certain procedures, either those set forth by the Secretary of the Department of Health and Human Services or those deemed to involve only minimal risk by the IRB, may be reviewed by either the chair, or a designated member of the IRB, alone.
7. Principal Investigator - The individual primarily responsible for the conduction of the research.

IRB Meeting Policy:

In order for the IRB to have a quorum, a majority of the IRB members must be present AND a non-scientist IRB member must be present. The IRB Secretary will record attendance, all discussion issues, vote counts, approved protocols, and other relevant meeting information. The Juniata IRB will submit a copy of the IRB meeting minutes to the Provost after every IRB meeting.

IRB Review Policy:

The IRB has considered human research on campus and evaluated which types of research projects need to be reviewed by the IRB. This consideration has been done in light of two guiding principles: the protection of human research participants on campus and the relevant federal regulations regarding human subject research (45 CRF 46). The consensus that resulted from of these discussions is that research conducted at Juniata can be placed into one of three categories.

The first are formal research projects. These are projects that meet the definition of research as determined by the committee following the guidelines set forth in the federal regulations (see above definitions). These projects do require review by the IRB.

The second category is the research conducted primarily for pedagogical purposes; that is, for the purpose of learning research methods. This form of research includes activities done in the classroom setting and is not intended for an “off-campus” audience. This research is generally done as practice and is not necessarily intended to advance general scientific knowledge. This research is not subject to review by the IRB as it does not fulfill the definition of research adopted by OHRP (45 CFR 46.102) and the Juniata IRB (see definition above). However, due to concern for the wellbeing of all research participants, the IRB has recommendations for student researchers in such classes. These research projects should put the participants at no more than minimal risk as defined by 45 CFR 46 (the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests). If the research involves collecting data of a sensitive matter to participants, student researchers should complete the IRB training course so that they have a basic understanding of research ethics, the protection of human subjects, and data integrity.

The third type of human research is institutional programmatic assessment research. This form of research conducted to assess the programs of the college. There are four aspects of this research that the IRB believes allow it to be exempted from IRB review. First, research of this type is not conducted in order to advance general scientific knowledge; it is conducted with the defined scope of assessing and improving programs within the college. Second, this research often times is not conducted with a goal of exhibition beyond the college community. Third, on the infrequent occasions when these data do extend beyond the college community, it is always disseminated in aggregate form. Finally, these projects generally do not involve more than minimal risk as defined by federal regulations. If, for some reason, an assessment research project would not conform to these four typical features, the IRB would strongly suggest review and evaluation of the project prior to continuation of the assessment.

The protocols suggested above are intended as guidelines for the entire campus community. These guidelines are intended to create a learning and research environment that is respectful of the participants while also providing opportunities for members of the Juniata College community to engage in the most rigorous scholarship possible.


IRB Training:

IRB training is required for anyone who will be interacting with human subjects for the purposes of data collection. Once data is collected, IRB training is also required for anyone who has access to data with personally identifying, or potentially personally identifying, information contained in it. IRB training is also required for all members of the Juniata IRB.

Submission and Review Procedures:

The principal investigator shall obtain the form for the review entitled “Initial Approval Request for Studies Involving Human Subjects” (IRBApp.doc) from the Moodle course “Institutional Review Board.”

The completed application shall be submitted to the current chair of the IRB (including any completed “Informed Consent” forms completed by the human subjects and surveys, tests, and/or interview materials).

The chairperson of the IRB shall determine if the proposed activity is exempt from the 45 CFR 46 regulations and shall further determine if an expedited review or full review by the IRB is required.

When a protocol is designated as “exempt”, this means that it is exempt from IRB regulations as per 45 CFR 46.101. Once a protocol is given the designation “exempt” it remains exempt so long as no changes are made to the protocol. Any changes made to the protocol require notification to the IRB as such changes could nullify the exempt status.
All Primary Investigators are responsible for notifying the IRB if changes are made to a previously exempted protocol. As long as no changes are made, data collection can continue without renewal on all exempted protocols.
Exemptions and expedited reviews are usually determined within two weeks. If a full review by the IRB is required, the IRB will be convened as soon as possible, but as Juniata expects limited activity of this body in the foreseeable future, no predetermined and regular meeting dates are established by this policy.
Protocols which place the participants at greater than minimal risk (as defined above) must be reviewed by the IRB at least every six months, rather than the normal yearly review. The exact schedule for such reviews will be determined by the IRB. Any Principle Investigator or protocol that is the subject of a complaint to the IRB will be investigated by talking with the PI and other personnel associated with the project.

Any serious issues of noncompliance (violations of protocol procedures), injury or harm to participants, or suspension/termination of an IRB protocol, will result in several actions by the Juniata IRB. First, the IRB will notify the Provost within 24 hours. Second, the IRB will conduct an investigation and write a summary report within one week. Third, the report will be submitted to the Provost and OHRP (Office of Human Research Protection) within two weeks of the initial incident.

Informed Consent:

All protocols designated as approved are required to follow the guidelines for informed consent set for the by the federal regulations (Title 45 CFR 46.116). In general, written informed consent is required. However, in cases of exempt projects or projects deemed to involve no more than minimal risk, oral consent without a written form and “click through” consent used on the World Wide Web will be allowed. However, in these cases, copies of the informed consent script or web page are required to be submitted with the protocol.


Research conducted by individuals from off-campus:

Individuals from off-campus may be allowed to conduct research with Juniata participants (students, faculty, and staff). They must submit their application and approval letter from their host institutionÂ’s IRB. The Juniata IRB will review this material and make such decisions on a case-by-case basis.

Decisions:

In general, principle investigators should communicate with the chairperson of the IRB about the status of their protocol. Once a decision has been made regarding a protocol, the chair will send a letter to the principle investigator. If the protocol is exempted or approved, the principle investigator will receive a letter stating such. All protocols are approved for one year, at which time the principle investigator can apply for an extension if the protocol has not changed substantially. Exempt protocols remain exempt indefinitely so long as no changes are made to the protocol. Any changes require notification to the IRB as such changes may revoke the exempt status. The renewal application form is located in the course documents section of the IRB course in Moodle. This form must be received and approved prior to continuing the protocol if it is beyond one year from the last approval. Submission is via the same process as the initial approval request.

If the protocol is not approved, the principle investigator may ask for assistance from the chairperson of the IRB to correct any problems with the protocol. If this procedure is not satisfactory, the principle investigator may write a memo formally challenging the decision. Upon receiving the challenge, the chair will provide copies of the protocol to the entire committee and will call a meeting with the principle investigator. The Provost may be invited to this meeting at the request of either the chairperson of the IRB or the principle investigator.

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You need to complete IRB training. However, the information above does not specify what the training is. You might want to look into this now.
Also, are there forms you need to complete? You might want to find them.
Posted 10:13, 18 Jul 2012
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