91×ÔÅÄÂÛ̳

Review Procedure

TIMEFRAME

The HSRB Committee reviews proposals as they are submitted.

• Research cannot commence before formal notification of approval from HSRB.
• The HSRB reviews protocols that are minimal risk or below with an average turn-around time of two weeks.
• Studies that are deemed to include more than minimal risk are reviewed at monthly HSRB meetings, called by the HSRB chair. Turn-around time for these proposals is generally four to six weeks.

Please note that turn-around time is dependent on the submission of a complete and accurate proposal as well as the primary investigator's responsiveness to the review requirements and requests. Poorly written proposals are the largest source of delays and frustration for applicants. Incomplete proposals will be returned to the investigator without review.

GENERAL REVIEW PROCEDURES

The HSRB uses criteria 46.111 of the to evaluate research and criteria 46.416 to evaluate Informed Consent forms.

Approval is typically granted for one year, but the Board may require reports or reviews of the project at three, six or nine months.

The primary investigator of the project will be notified of the Board's decision in writing. The investigator may be asked to file an amended application reflecting any recommended changes with the HSRB by a stated deadline.

The 91×ÔÅÄÂÛ̳ administration may rescind an HSRB research approval, but may not override an HSRB research denial.

REVIEW PROCEDURES FOR NEW RESEARCH

Expedited Review

If the investigator indicates on the HSRB Application for New Research Involving Human Subjects that the proposed project involves not more than minimal risk to participants, and if the chair of the HSRB agrees with that assessment, the chair will distribute copies of the plan of investigation to two board members. If the two board members and board chair give a written notice of approval of the project, no meeting will be held, and the chair shall give formal written HSRB approval of the project for up to one year.

Board members may offer approval with the provision that minor procedural changes be made in the protocol. If the suggestions appear to the chair to be reasonable, and the chair conveys them to the investigator, and the investigator agrees to implement the suggestions, it will not be necessary to convene the board to discuss them. The investigator will be asked to file an amended application reflecting any recommended changes with the HSRB by a stated deadline.

If at least one member of the board does not want to approve the project without a meeting, or if the chair believes that the suggestions offered by one or more board members should be discussed, then the chair shall schedule a meeting for a full review the project.

Full Review

If the investigator indicates on the Application for New Research Involving Human Subjects that the proposed project involves putting the participants at risk or if the HSRB chair disagrees with the investigator's assessment that the project involves no risk to participants, the chair will distribute copies of the plan of investigation to each board member. The chair will schedule a meeting to discuss the project. At the full board review meeting, at least four members of the board must vote. A majority of those voting must agree to one of the three following outcomes:

1. HSRB approval of project
2. HSRB rejection of project
3. HSRB approval of project with modifications

REVIEW PROCEDURE FOR MODIFICATION OF PRIOR-APPROVED RESEARCH

If modifications are made to research procedures at any time during the HSRB approval period (typically one year from approval date), a Modification of Prior-Approved Research Application is required. Expedited review by the HSRB chair or designated member is allowed if modifications do not change the initial risk assessment of a no-risk proposal. If the initial proposal was classified as "at risk," modifications may be brought before full board review, at the discretion of the HSRB chair. Approval of modifications does not change the original HSRB approval expiration date indicated in the original HSRB approval letter.

REVIEW PROCEDURE FOR CONTINUING RESEARCH

Federal guidelines mandate that the HSRB assesses risks, potential benefits, informed consent and safeguards for human subjects both at the initial review and when researchers file a Continuing Research Application. Initial approvals are good for up to one year. When conducting continuing review, the HSRB needs to determine whether any new information has emerged, either from the research itself or from other sources that could alter the HSRB’s previous determinations, particularly with respect to risk to subjects. In addition, any unanticipated problems involving risk to participants or others that occurred since the previous HSRB review will also be relevant to the HSRB’s decision about continued approval.

Expedited Review of Continuing Research

Expedited review of continuing research can occur in two possible ways:

A. Expedited review by HSRB chair or designee

• If the initial study was minimal risk AND no additional risks are identified AND
• The research is permanently closed to the enrollment of new participants, participants have completed all research interventions and the research is active only for long-term follow-up of participants, OR
• Continuing research activities are limited to data analysis.
• The chair reserves the right to conduct an expedited review of full board-approved research projects requesting continuation.

B. Expedited review by three Board members

• If the continuing research has only minimal-risk.

Full HSRB Review of Continuing Research

If the initial procedures were more-than-minimal risk, new risk issues emerged over the year or the continuing research includes additional risk issues, the review will be made by a quorum of the HSRB at a convened HSRB meeting. The researcher may be invited to attend this meeting to address questions.

REQUEST FOR EXEMPTION

Hope faculty who do exempt and nonexempt work with humans still have an ethical responsibility to their participants and still need to take the .

Research that qualifies as exempt must receive formal exemption from the HSRB. The primary investigator should consult the exemption guidelines for more details. A request for exemption will be reviewed by the HSRB chair. If the chair agrees, a formal exemption will be provided. If not, the chair will request that the primary investigator submit a full application for HSRB approval.

REQUEST FOR EXCLUSION

Oral history projects may, if certain criteria are met, be excluded from HSRB review. Please see our oral history projects page for a more complete discussion.