General Procedures of the IRB (updated 12/30/2012)
Processing of Applications Including Reporting Committee Actions to Investigators and Institution
- Instructions and forms for investigators wishing to apply for approval of research involving the use of human subjects are available from the FPCC Institutional Development Office (768-5555) or see links under Instructions and Applications on the right.
The investigator should submit 11 copies of the standard Application Form for full IRB review, 3 copies for expedited review, and 1 copy of requests for exemption (see the website listed above for details on how to decide which category best fits your proposal). Applications must be accompanied by documentation that all investigators involved in the research have received education and instruction in the protection of the rights of human subjects and the ethical conduct of human research (either NIH or CITI) and, when it becomes available, the Fort Peck IRB cultural protocols training. Either NIH or CITI Investigators should complete and submit with their application an individual investigator agreement.
- Applications for full committee review must be received in the Institutional Development Office at least one month prior to the next quarterly meeting of the IRB. The proposal will be considered at that quarterly meeting.
- Applications for consideration at meetings will be sent or hand delivered to members of the IRB at least 5 days prior to the meeting. Members will receive the entire application form, the informed consent document, and additional materials, as needed. Long questionnaires are not always sent to all members; however, a copy will be reviewed by the IRB Chair and will be made available at the meeting or in advance by special request. The IRB Chair is responsible for calling to the attention of the committee members any information from these sources that may be relevant. All members have the responsibility for reading and critiquing each application.
- Decisions of the IRB will be sent to applicants within 10 days after the meeting at which the proposal was discussed. If the IRB has requested revisions or clarifications prior to approval, these must be sent back to the IRB Chair, who will review and insure the revisions address all concerns presented at the IRB meeting. If requested at the IRB meeting for certain applications, revisions would also be sent to IRB members for review. The approved revisions must be incorporated into the application form and consent form, and the final revised application must be approved by the Chair before research can begin. Approvals are effective on the date the IRB Chair approves the revised proposal. The expiration date of the approval is included in the approval memorandum. The memorandum explains the terms of continuing review and the necessity of reporting adverse reactions and protocol changes to the committee.
- Applicants have the right to appeal any decision of the committee. Appeals must be submitted in writing to the IRB Chair. A notice of the intent to appeal must be filed with the IRB Chair within 30 days of a negative decision.
- Applications and copies of letters pertaining to them are kept on file in the Institutional Development Office for at least 5 years and are accessible to IRB members, and the investigator to whom they apply. Applications are filed by the name of the principal investigator. In addition, a chronological log of applications and committee actions is maintained. Records maintained by the Institutional Development Office contain all of the information stipulated by HHS regulations at 45CFR46, 115(a)(1),(3),(4),(7) .
- IRB members and Administrators are obligated to keep up to date with the Office of Human Research Protections (OHRP, within the U.S. Department of Health and Human Services) rules and regulations, FAQs, and guidance documents.
Links to examples of these are as follows:
- Guidance on Reporting Incidents to OHRP
- Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
- Guidance on IRB Continuing Review of Research
- Informed Consent Checklist
Institutional Review Board Membership
- The IRB consists of at least 8 members who are appointed by the FPCC Vice President of Academic Affairs with suggestions from other committee members, the IRB Administrator, and members of the faculty, community and Fort Peck Tribes representatives. In addition, the IRB may, at its discretion, invite individuals with competence and knowledge in special areas, cultural or academic, to assist in the review of issues or specific research projects which require expertise beyond or in addition to that available on the IRB, and provide recommendations to the Board. However, these individuals may not vote with the IRB.
- IRB members may serve indefinitely at the pleasure of the Vice President of Academic Affairs.
- At least two members of the IRB must be non-scientists. These members should be able to review the research from the viewpoint of subjects and may have expertise in law, religion, ethics or matters relevant to committee work.
- The Board membership and any external reviewers will be selected to ensure appropriate research expertise, such as in qualitative and quantitative methods involving humans and Community Based Participatory Research. Elders and academics will be selected for their knowledge of local ethics and ethics in research, to ensure that Indigenous knowledge and philosophy are reflected in a scholarly review, and will take into account any prior IRB, peer and funding agency reviews of the planned project and its involvement of human subjects.
- In selecting Fort Peck IRB members, the appointing authorities will ensure that the Board does not consist entirely of men or entirely of women. Neither shall the Board consist entirely of members of one profession.
- The Vice President of Academic Affairs is an ex-officio member of the IRB.
- The IRB Chair, one of the FPCC faculty members appointed to the Board, is appointed by the Vice President of Academic Affairs.
Institutional Review Board Meetings
- The IRB meets quarterly unless there are no proposals for discussion or other new business. Special meetings may be called by the Chair when necessary.
- In order for the IRB to act at a meeting, a quorum of at least five members, including at least one community member, must be present.
- The IRB strives to operate by consensus. To be approved proposals must be considered by of a quorum of Board members at the meeting. Any member's request for clarification or revision of an application will be included in the IRB's final decision. In the event that the IRB cannot arrive at a unanimous position, a vote will be taken. In this case, a proposal can be approved by a majority (> 50%) of those present at the meeting.
- The IRB Administrator keeps detailed minutes, which are circulated with the materials for the next meeting. These minutes include all the information stipulated by HHS regulations 45CFR46, 115(a)(2), including members present during a vote, the results of any votes, and the substance of the discussion and the decisions for each proposal or action. Minutes are sent to each member prior to the next meeting (or earlier by request) and to the Vice President of Academic Affairs.
- The possible IRB actions are approval, disapproval, or approval pending specified clarifications, corrections, or revisions. Conditional approval is generally not an option. If the IRB wishes, it can offer conditional approval and define the requirements of conditional approval in its decisions.
Procedures and Criteria for Initial Approval of Proposals
Except for research exempted or waived under Sections 101(b) or 101(i) of the Federal Policy, all human subjects research will be reviewed, prospectively approved, and subjected to continuing oversight. The IRB will have authority to approve, require modifications in, or disapprove the covered human subject research. For a proposal to be approved, its benefits must outweigh the risks to the subjects, it must conform to the ethical principles in the Belmont Report, and there must be appropriate methods for obtaining informed consent from the subjects. Investigators and their home institutions will be notified of IRB decisions in writing. Disapproval will be accompanied by a statement of the reasons, and an opportunity for the investigator to respond.
- The need to do experiments in humans as opposed to experimental animals must be evident.
- Risks to subjects must be minimized.
- Risks must be reasonable in relation to anticipated benefits of research.
- Selection of subjects must be fair. The proposals must include a description of the subject population and the committee must ensure that no groups are unnecessarily targeted or excluded, especially minorities and women.
- There must be procedures for obtaining and documenting informed consent.
- There must be provisions to protect the privacy of subjects and maintain confidentiality of records.
- There must be appropriate additional safeguards to protect the rights of children, economically or educationally disadvantaged persons, severely ill persons, mentally ill persons and prisoners.
- To be approved, proposals must receive a majority vote for approval with a quorum of IRB members present when the proposal is considered. Revisions requested by any IRB member in a specific proposal must be incorporated prior to approval.
- Approvals are for a period of one year, unless the IRB votes to impose a shorter period of approval. The approval may be renewed up to four times (5 years total) on the condition that the investigator has complied with the conditions of continuing review specified by the IRB (see below).
- Investigators will be given an opportunity to appeal any disapprovals or unfavorable decisions of the IRB. Appeals must be submitted in writing to the IRB Chair.
- IRB approval must be certified prior to expenditure of research fund by a tribal agency.
Certain kinds of research involving minimal risks may be approved by expedited review or by the IRB Chair according to the policies and procedures in section 110 of the federal policy (and only one of these in the Fort Peck Tribes/Fort Peck Community College Research Code of Ethics):
Clinical studies of drugs and medical devices only when certain conditions are met.
|1.||Such applications will be reviewed by at least two members of the Fort Peck IRB with the following possible outcomes:|
|a.||The reviewers will unanimously approve or disapprove the proposal. Either reviewer may require that modifications to the proposal be made prior to approval.|
|b.||Reviewers can recommend that the application be reviewed by the full IRB, in which case it will be considered at the next meeting.|
|2.||The decision of the reviewers will be presented to the full IRB for approval at the next meeting. Should the IRB wish to add restrictions or clarifications, the investigators will be asked, in writing, to suspend the research until these adjustments have been made. Continuing review of expedited applications will be the same as for applications reviewed by the full committee.|
Minor changes in previously approved research may be reviewed and approved by the Chair.
Research in which there is essentially no risk to subjects is exempt from the requirement that it be reviewed by the full IRB (Code of Federal Regulations, Part 46, section 101):
|1.||Examples of such research are:|
|(b) (1)||Research conducted in established or commonly accepted educational settings, involving normal educational practices such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.|
|(b) (2)||Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) 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.|
|(b) (3)||Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.|
|(b) (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 the subjects cannot be identified, directly or through identifiers linked to the subjects.|
|(b) (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: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.|
|(b) (6)||Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed, or (ii) 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 FDA, or approved by the EPA, or the Food Safety and Inspection Service of the USDA.|
|2.||If the research is believed to be exempt, the investigator should submit the form entitled Request for Designation of Research as Exempt from the Requirement of Institutional Review Board Review (available from the Institutional Development Office or on the IRB website). These applications must still be accompanied by documentation that all investigators involved in the research have received education and instruction in the protection of the rights of human subjects and the ethical conduct of human research.|
|3.||Requests for exemption will be reviewed by the IRB Chair and/or IRB Administrator. If this review determines the research to be exempt, a memorandum of concurrence will be sent to the investigator. The title of the research and the decision will be reported to the IRB at its next meeting. Any member of the IRB may request that the investigator submit a full application for expedited or full IRB review.|
|4.||Investigators should consult with the IRB chair if questions arise about whether planned changes to an exempt study might make the study non-exempt human subjects research.|
Procedures for Continuing Review of approved Human Research (verification of changes etc.)
- Unless a different time interval is specified by the IRB members at the time of full IRB or expedited review, the research will be reviewed prior to approval expiration date.
- Unless a different method of review is specified by the IRB at the time of initial approval, the investigator will be asked to complete a form concerning the research activities quarterly. The fourth quarter review form will be sent to the principal investigator sometime during the months prior to the anniversary date of renewal (end of the protocol year), and this is the report the IRB will use for approving project continuation. The form covers the number of subjects studied, the number of subjects who withdrew, any changes in methodology, any adverse occurrences, any publications resulting from the research, and/or any changes in the informed consent procedure. The Chair or IRB Administrator may approve the renewal if there are no issues of concern, or they may ask for further IRB review if issues of concern are present and not addressed. Outcomes of the quarterly and annual renewal reviews will be reported to the IRB at the next meeting.
- If the renewal document indicates a change in the protocol, the changes must be reviewed and approved. Approved changes to a protocol must be incorporated into a revised protocol and, if applicable, consent form.
- At the time of continuing review, the Chair or IRB Administrator may request additional information from the investigator.
- If the continuing review form is not submitted prior to expiration of approval date, the protocol will be closed and no longer valid. To reactivate a protocol, a new, full proposal must be submitted to the IRB.
- After five years, a protocol must receive a complete review based on a new or resubmitted application form.
Procedures for Handling Adverse Reactions, Non-Compliance, Suspension of Approval
- As indicated on the approval memorandum, all adverse events are to be reported to the IRB Chair or IRB Administrator.
- Following the report of an adverse event, the Chair or IRB Administrator will discuss the problem with the investigator. If there is a chance that other subjects are at increased risk for a similar adverse event than was anticipated at the time of approval of the protocol, the investigator will be asked to suspend the research (this request will be made by phone or email, followed by a letter). The investigator will be required to modify the research and/or informed consent procedures and submit the proposed changes to the IRB for full or expedited review.
- If adverse events involve injury, losses of assets or confidentiality, or other significant matters, they will be reported immediately to the Fort Peck Community College Vice President of Academic Affairs and the Fort Peck Tribes attorney.
- If the IRB finds that investigators are performing human subjects research that has not been approved by the IRB, the Vice President of Academic Affairs will be notified in writing.
- If the IRB finds that investigators are performing research without following the approved protocol, approval will be immediately suspended. The investigator and Vice President of Academic Affairs will be so informed by phone or email, followed by a letter.
- In cases of approval violations, the Vice President of Academic Affairs is empowered to impose appropriate sanctions.
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