Review Procedures

The review process for a research project consists of the following steps.

1. The Principal Investigator submits a completed proposal form and signature page to the chair of the CHSR via email, a signed copy of the signature page, and a consent form and other documents if needed. The various forms mentioned in the previous sentence are available from the website here. Send all required documents to chsr@hastings.edu.

2. The chair will first determine whether the proposal needs to be evaluated by the full committee, whether the project is exempt from review, or whether it qualifies for expedited review. A project that is not exempt and does not qualify for expedited review must undergo a full review. Here are brief descriptions of the requirements a project must satisfy to qualify for each of these categories, as well as the manner in which it is evaluated:

a. Exempt. A project in which the participants remain anonymous (if consent forms are used or required, your study may not be able to meet the exempt category), are not chosen from a vulnerable population, and are exposed to minimal risk qualifies as exempt from review. However, a project involving deception cannot qualify as exempt. A project that is exempt is likely to be approved, unless the CHSR chair(s) find needed modifications or revisions.

b. Expedited. A project that is not exempt from review, but still exposes the participants to minimal risk, qualifies for expedited review. Such a project may draw its participants from a vulnerable population or their identities may be known to the researcher(s) but kept confidential, or it may involve deception. The proposal for a project in this category is forwarded by the chair(s) to a member of the Committee who has expertise in the subject matter of the project for further evaluation. The decision of that member on the status of the proposal, which is reached in consultation with the chair, is final.

c. Full. A project that does not qualify for expedited review is subject to full review. Such a project may draw participants from a special population or expose them to more than minimal risk (e.g., any study that collects medical information or has medical procedures, has physical activity, may have psychological discomfort, and or collects sensitive information or material). The proposal for a project in this category is sent to all members of the Committee, who then discuss and vote on it. A majority of the votes, approval from the chair(s), and a majority within at least 2 divisions is necessary for CHSR approval. It is strongly recommended that the supervising faculty or representative attend the committee’s meeting to discuss the research proposal. If the supervising faculty is a voting member of the committee, the faculty must recuse themselves during voting. Proposals that have not been approved can not be conducted.

3. Once the status of a proposal has been determined, the chair notifies the supervising representative of the result, which is normally one of the following three possibilities:

1. Approved. The project may proceed as proposed.

2. Approved pending specific minor revisions. This means that a small number of straightforward and easily verified modifications are required. The chair will verify that the required revisions have been made, perhaps in consultation with other reviewers. Once verification is complete the supervising representative Principal Investigator is notified by the chair and the project may proceed as revised.

Revise and resubmit. A proposal given this status requires significant revisions that are directly related to ethical considerations. A revised proposal must be submitted and will be reviewed as though it were a new proposal.

Important note: Research activities may not commence until the project proposal has been approved. Additionally, any changes made to the proposal after initial approval needs to be re-approved by CHSR. Investigators should not change any research protocol from what they have originally submitted. Any deviations from the approved protocol must be reported within a timely manner. Any adverse effects must be immediately reported upon its occurrence or when the supervising representative is notified.

The Committee reserves the right to deny any project that it believes is fundamentally unethical. However, such decisions are expected to be extremely rare.