Section 93.305 - [Effective 1/1/2025] General conduct of research misconduct proceedings(a)Sequestration of research records and other evidence. An institution must promptly take all reasonable and practical steps to obtain all research records and other evidence, which may include copies of the data or other evidence so long as those copies are substantially equivalent in evidentiary value, needed to conduct the research misconduct proceeding; inventory the research records and other evidence; and sequester them in a secure manner. Where the research records or other evidence are located on or encompass scientific instruments shared by multiple users, institutions may obtain copies of the data or other evidence from such instruments, so long as those copies are substantially equivalent in evidentiary value to the instruments. Whenever possible, the institution must obtain the research records or other evidence: (1) Before or at the time the institution notifies the respondent of the allegation(s); and(2) Whenever additional items become known or relevant to the inquiry or investigation.(b)Access to research records. Where appropriate, an institution must give the respondent copies of, or reasonable supervised access to, the research records that are sequestered in accordance with paragraph (a) of this section.(c)Maintenance of sequestered research records and other evidence. An institution must maintain the sequestered research records and other evidence as required by § 93.318 .(d)Multiple respondents. If an institution identifies additional respondents during an inquiry or investigation, the institution is not required to conduct a separate inquiry for each new respondent. However, each additional respondent must be provided notice of and an opportunity to respond to the allegations, consistent with this subpart.(e)Multiple institutions. When allegations involve research conducted at multiple institutions, one institution must be designated as the lead institution if a joint research misconduct proceeding is conducted. In a joint research misconduct proceeding, the lead institution should obtain research records and other evidence pertinent to the proceeding, including witness testimony, from the other relevant institutions. By mutual agreement, the joint research misconduct proceeding may include committee members from the institutions involved. The determination of whether further inquiry and/or investigation is warranted, whether research misconduct occurred, and the institutional actions to be taken may be made by the institutions jointly or tasked to the lead institution.(f)Using a committee, consortium, or other person for research misconduct proceedings.(1) An institution must address any potential, perceived, or actual personal, professional, or financial conflicts of interest between members of the committee or consortium, or other person, and the complainant, respondent, or witnesses.(2) An institution must ensure that a committee, consortium, or person acting on its behalf conducts research misconduct proceedings in compliance with the requirements of this part.(g)Notifying ORI of special circumstances. At any time during a research misconduct proceeding, as defined in § 93.235, an institution must notify ORI immediately if it has reason to believe that any of the following conditions exist:(1) Health or safety of the public is at risk, including an immediate need to protect human or animal subjects.(2) HHS resources or interests are threatened.(3) Research activities should be suspended.(4) There is reasonable indication of possible violations of civil or criminal law.(5) Federal action is required to protect the interests of those involved in the research misconduct proceeding.(6) HHS may need to take appropriate steps to safeguard evidence and protect the rights of those involved.